Podcasts about her2

This week's pod has everything: 1. DDI information and dosing for daraxonrasib, now FDA approved and commercially available for pancreatic cancer 2. A new standard of care (?) in HER(+) gastric cancers, and more nuance on HER2 positivity. And lots of diarrhea. 3. The largest RCT in primary CNS lymphoma Download the Oncology Learning Companion: https://www.kelleycpharmd.com/learning-oncology-companion-oncopharm

In today's episode, we spoke with Adam M. Brufsky, MD, PhD, about the FDA approval of gedatolisib (Revtorpyk) plus fulvestrant (Faslodex), with or without palbociclib (Ibrance), for the treatment of adult patients with hormone receptor–positive, HER2-negative advanced breast cancer without a PIK3CA mutation following progression on or after treatment with 1 or more lines of endocrine therapy in the metastatic setting. Dr Brufsky is a professor of medicine and the associate division chief for the Division of Hematology/Oncology in the Department of Medicine at the University of Pittsburgh School of Medicine; as well as medical director of the Magee-Women's Cancer Program, associate director for clinical investigations, and codirector of the Comprehensive Breast Cancer Center at the University of Pittsburgh Medical Center Hillman Cancer Center, in Pennsylvania.In our exclusive interview, Dr Brufsky highlighted the significance of this approval, key efficacy and safety data from Study 1 of the phase 3 VIKTORIA-1 trial (NCT05501886) that supported this regulatory decision, and what the future may hold for metastatic breast cancer management strategies.

In this episode, Danielle Roman, PharmD, BCOP, and Jordan Hill, PharmD, BCOP, discuss optimal care for patients with HR-positive/HER2-negative breast cancer receiving newer oral targeted therapies. Their conversation addresses treatment selection across early-stage and metastatic disease, biomarker-informed decision-making, adverse event management, and practical strategies to help patients remain on therapy. Key topics include: Selecting and sequencing oral targeted therapies, including CDK4/6 inhibitors, PARP inhibitors, PI3K/AKT pathway inhibitors, and oral SERDs Identifying patients with high-risk early breast cancer and applying evidence from trials such as monarchE, NATALEE, and OlympiA Using biomarkers such as BRCA1/2, PIK3CA, AKT1, PTEN, and ESR1 to guide therapy in metastatic disease Monitoring and managing treatment-related adverse events, including neutropenia, diarrhea, hepatotoxicity, QTc prolongation, hyperglycemia, rash, stomatitis, anemia, nausea, and fatigue Using dose modification, supportive care, patient education, and proactive follow-up to improve adherence and persistence with oral therapy Incorporating oncology pharmacists and the multidisciplinary care team into ongoing treatment monitoring and patient support PresentersDanielle Roman, PharmD, BCOP Manager, Oncology Clinical Pharmacy Services Oncology Clinical Pharmacy Specialist Allegheny Health Network Pittsburgh, Pennsylvania Jordan Hill, PharmD, BCOP Clinical Pharmacy Specialist, Breast Oncology West Virginia University Cancer Institute Morgantown, West Virginia Get access to all of our new podcasts by subscribing to the Decera Clinical Education Oncology Podcast on Apple Podcasts, YouTube Music, or Spotify. Access the full educational program: Link to full program:https://bit.ly/4gvZerW And be sure to try our Interactive Decision Support Tools for Early Breast Cancer and Selecting AKT or PI3K Inhibitors for Patients With Metastatic Breast Cancer. By answering just a few quick questions, you can see what 5 experts would recommend for specific patient scenarios. Early Breast Cancer:https://bit.ly/4gtUiUq AKT or PI3K Inhibitors in MBC:https://bit.ly/4qcyBvk Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

Como melhorar a eficácia da imunoterapia contra o câncer? Esse é o desafio do pesquisador francês Alexandre Detappe, diretor do Laboratório de Nanomedicina do Instituto Gustave Roussy, o maior centro de combate ao câncer da Europa, localizado em Villejuif, nos arredores de Paris. Em seu estudo, ele busca desenvolver nanopartículas capazes de ajudar o sistema imunológico a combater a doença. Taíssa Stivanin, da RFI em Paris Após alguns anos nos Estados Unidos, onde passou por instituições como o Dana-Farber Cancer Institute, em Boston, Alexandre Detappe desenvolveu um projeto com uma equipe do MIT (Massachusetts Institute of Technology) que utiliza nanopartículas para transportar medicamentos. A equipe incorporava anticorpos e proteínas à superfície dos materiais para que reconhecessem as células tumorais. Na França, o alvo das pesquisas do cientista passou a ser as células do sistema imunológico. Esta é a base do seu atual projeto, o Nano-BITE, que acaba de receber financiamento do ERC (Conselho Europeu de Pesquisa), principal agência da União Europeia de fomento à pesquisa científica de excelência. O cientista francês obteve uma bolsa de € 150 mil (cerca de R$ 884 mil) destinada a pesquisadores que buscam aplicações práticas para suas descobertas. O foco inicial dos estudos é a atividade celular de um subtipo de câncer de mama conhecido como HER-2 positivo. Este tipo de doença é caracterizado por uma quantidade excessiva da proteína HER2 e considerado mais agressivo. “A ideia é ativar o sistema imunológico adicionando certos anticorpos à superfície das nanopartículas. Nesse caso, elas funcionam como um meio de transporte, onde podemos colocar imunoterapias ou moléculas que vão estimular o sistema imunológico”, explica. Imunoterapia ainda é limitada A eficácia da imunoterapia ainda permanece limitada em muitos tumores sólidos. As duas principais dificuldades são atrair uma quantidade suficiente de células imunitárias para o local do tumor e fazer com que elas permaneçam ativas por longos períodos, o que exige uma carga maior de medicamentos e aumenta o risco de efeitos colaterais. Nesse contexto, as nanopartículas funcionam como uma espécie de cavalo de Troia mais sofisticado, levando as moléculas terapêuticas de forma mais eficaz e estratégica, eliminando esses dois obstáculos. “Fizemos nossas primeiras provas de conceito e validamos a hipótese de que, dependendo do tipo de nanopartícula utilizado, haverá uma determinada influência na resposta imune. A seleção foi feita após a análise de muitas nanopartículas, entre elas uma à base de PLGA, que é um pequeno polímero. Foi assim que surgiu o projeto Nano-BITE.” As nanopartículas medem entre 60 e 100 nanômetros e são formadas por gordura, colesterol e cadeias de polímeros sintéticos utilizados em diversos produtos, como xampus, por exemplo. Elas são cerca de 10 mil vezes menores que um fio de cabelo. A título de comparação, os anticorpos incorporados à sua superfície têm cerca de 10 nanômetros. “É como uma emulsão com gotículas finas, estabilizada por um polímero chamado PLGA. A ideia é criar esferas minúsculas, com esses anticorpos na superfície, adicionando o princípio ativo, ou seja, a molécula terapêutica que nos interessa”, explica Detappe. O PLGA, sigla para poliácido láctico-co-glicólico, é um polímero biodegradável e biocompatível utilizado em medicina e farmacologia. 'Ponte' entre células A grande questão agora, diz o cientista francês, é confirmar a possibilidade de inserir essa nanopartícula na interface entre a célula tumoral e a imunológica. Sua função seria criar uma ponte de reconhecimento entre as duas células, ativando ao mesmo tempo a resposta imunitária que combaterá o tumor. “O interesse deste projeto de prova de conceito no Gustave Roussy é o acesso a amostras de pacientes e a toda a estrutura clínica que o centro oferece para acelerar nossas pesquisas. A ideia é desenvolver nanopartículas de acordo com as necessidades de cada caso, dependendo do tumor ou da célula que será alvo do medicamento.” De acordo com o cientista, é possível fabricar rapidamente uma nanopartícula personalizada na plataforma criada pelo laboratório do instituto francês, tecnologia que poderá futuramente ser aplicada a outros tipos de câncer. Após a validação da prova de conceito, o objetivo de Alexandre é buscar novos financiamentos europeus para realizar testes clínicos e viabilizar o uso desse meio de transporte biológico inovador como aliada das imunoterapias contra tumores malignos, em um futuro possivelmente próximo, “A transição do meio acadêmico para o setor produtivo pode ser muito rápida. É apenas uma questão de captação de recursos e financiamento, como quase sempre ocorre. A ideia é que, ao longo dos próximos 18 meses, consigamos validar o máximo possível do ponto de vista acadêmico e pré-clínico”, observa. “O processo já existe. Depois, será necessário captar recursos e convencer um médico pesquisador a levar o projeto para os ensaios clínicos. O tempo dos ensaios clínicos em si não pode ser encurtado, porque envolve o recrutamento de pacientes. A fase 1 pode durar de um a dois anos, seguida pelas fases 2 e 3. Devemos prever entre sete e dez anos até uma eventual aprovação para uso no mercado. No entanto, o acesso ao primeiro paciente, se tudo correr bem, poderá ocorrer dentro de dois a três anos”, aposta.

En este episodio del pódcast BreastLink de ScienceLink, conducido por el Dr. Juan Carlos Samamé, se analiza el cambio de paradigma en el tratamiento de primera línea del cáncer de mama triple negativo metastásico (CMTNm). Para abordar este tema, se cuenta con la participación del Dr. Alejandro Lara Bañuelas, oncólogo médico adscrito al Instituto Mexicano del Seguro Social (IMSS) y al Centro Estatal de Cancerología de Chihuahua, México, quien se desempeñó como coinvestigador en los ensayos de la plataforma ASCENT. La conversación profundiza en los resultados del estudio fase III ASCENT-04/KEYNOTE-D19, el cual evalúa la combinación de sacituzumab govitecan —un conjugado anticuerpo fármaco (ADC) dirigido contra Trop-2— junto con pembrolizumab en pacientes con CMTNm no tratadas previamente en el escenario avanzado y con CPS ≥10.El Dr. Lara Bañuelas expone el diseño metodológico del ASCENT-04, destacando la inclusión de pacientes vírgenes a tratamiento metastásico o con recaída tras un intervalo libre de enfermedad de al menos seis meses desde la finalización de la terapia con intención curativa. La discusión aborda el beneficio clínicamente significativo observado en la supervivencia libre de progresión (SLP), objetivo primario del estudio, con una diferencia absoluta de tres meses a favor de la combinación frente a la quimioterapia estándar más pembrolizumab. Asimismo, se destaca la duplicación en la duración de la respuesta objetiva, los análisis de subgrupos que confirman el beneficio independiente de los niveles de expresión de Trop-2, estado mutacional de BRCA o estatus HER2 (incluyendo HER2 low y ultra-low), y la persistencia de la eficacia en la supervivencia libre de progresión de segunda línea (SLP2) a pesar del entrecruzamiento (crossover) permitido en el protocolo.En cuanto a los datos de seguridad, el Dr. Lara Bañuelas comparte la experiencia práctica sobre el perfil de toxicidad del esquema sacituzumab govitecan más pembrolizumab, señalando que la neutropenia es el evento adverso más relevante, pero resulta predecible y manejable mediante el uso profiláctico de factores estimulantes de colonias de granulocitos. Finalmente, se contrapone el nicho terapéutico del ASCENT-04 con el del estudio ASCENT-03 en poblaciones con CPS

New data and broad indications for trastuzumab deruxtecan are changing the paradigm for HER2-positive early breast cancer. Listen to Shanu Modi, MD, and Sara A. Hurvitz, MD, FACP, discuss how they are incorporating these changes into clinical practice in the neoadjuvant, adjuvant, and possibly metastatic settings. Presenters: Sara A. Hurvitz, MD, FACP Professor of Medicine Smith Family Endowed Chair in Women's Health Senior Vice President, Clinical Research Division Fred Hutch Cancer Center Head, Division of Hematology/Oncology, Department of Medicine University of Washington School of Medicine Seattle, Washington Shanu Modi, MD Section Head, HER2 Breast Program Professor and Attending Member Breast Medicine Service, Department of Medicine Memorial Sloan Kettering Cancer Center Weill Cornell Medical College New York, New York Link to full program: https://bit.ly/4z1Xb6a Get access to all of our new podcasts by subscribing to the Decera Clinical Education Oncology Podcast on Apple Podcasts, YouTube Music, or Spotify. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

Featuring an interview with Dr Ramez Eskander, including the following topics: Overview of antibody-drug conjugates (ADCs) and their role in the management of gynecologic cancers; considerations in sequencing (0:00) Choosing between FRɑ- and HER2-directed ADCs for dually eligible patients; role of antigenic target in predicting efficacy benefit of ADCs (7:53) Comparative efficacy and safety of ADCs and conventional chemotherapy (12:58) Current and investigational targets of ADCs in gynecologic cancers (17:14) Current research surrounding raludotatug deruxtecan (R-DXd) and its potential role in clinical practice (21:56) Safety and tolerability profiles of ADCs, including R-DXd, and potential mitigation strategies (27:36) Overview of available TROP2-directed ADCs for gynecologic cancers, including key clinical data (33:34) Evolving use of TROP2-directed ADCs for gynecologic cancers in clinical trials (39:05) Oral mucositis/stomatitis associated with TROP2-directed ADCs and potential mitigation strategies (44:38) CME information and select publications

Featuring perspectives from Dr Joshua K Sabari, including the following topics: Heymach JV et al. Zongertinib in previously treated HER2-mutant non-small cell lung cancer. N Engl J Med 2025;392(23):2321-33. (0:00) Popat S et al. Zongertinib as first-line treatment in patients with advanced HER2-mutant NSCLC: Beamion LUNG-1. ESMO 2025;Abstract LBA74. (5:25) Le X et al. Sevabertinib in advanced HER2-mutant non-small cell lung cancer. N Engl J Med 2025;393(18):1819-32. (12:37) CME information and select publications

Featuring perspectives from Dr Joshua K Sabari, including the following topics: Jänne PA et al. Final analysis results and patient-reported outcomes from DESTINY-Lung02 — A dose-blinded, randomized, phase 2 study of trastuzumab deruxtecan in patients with HER2-mutant metastatic NSCLC. J Thorac Oncol 2025;20(12):1814-28. (0:00) Heymach JV et al. Circulating tumor DNA (ctDNA) analysis following zongertinib treatment (tx) in patients (pts) with human epidermal growth factor receptor 2 (HER2)-mutant non-small cell lung cancer (NSCLC): Phase Ia/Ib Beamion LUNG-1 study. ESMO 2025;Abstract 2020P. (8:30) Schram AM et al. Beamion PANTUMOR-1: Rationale and design of a phase II trial of zongertinib in HER2-overexpressed/amplified or HER2-mutant solid tumors. Future Oncol 2026;22(7):795-803. (12:53) Johnson ML et al. Beamion LUNG-2: A phase III randomized controlled trial of zongertinib (BI 1810631) versus standard of care in patients with locally advanced/metastatic non-squamous NSCLC harboring HER2 tyrosine kinase domain (TKD) mutations. ASCO 2024;Abstract TPS8654. (19:40) Le X et al. SOHO-02: Phase III trial of BAY 2927088 in patients with locally advanced or metastatic NSCLC with HER2-activating mutations. ASCO 2025;Abstract TPS8648. (21:41) Li BT et al. Open-label, randomized, multicenter, phase 3 study evaluating trastuzumab deruxtecan (T-DXd) as first-line treatment in patients with unresectable, locally advanced, or metastatic non-small cell lung cancer (NSCLC) harboring HER2 exon 19 or 20 mutations (DESTINY-Lung04). ASCO 2022;Abstract TPS9137. (22:59) Jänne PA et al. Trastuzumab deruxtecan for ERBB2-mutant metastatic NSCLC with or without brain metastases: A secondary analysis of randomized clinical trials. JAMA Netw Open 2025;8(11):e2543107. (24:37) CME information and select publications

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Biogen has made a significant acquisition by purchasing Apellis Pharmaceuticals, a move expected to boost its 2026 revenue guidance with promising growth prospects. This strategic acquisition, along with strong sales from new drugs, enhances Biogen's position in the competitive market for neurological disorders. By integrating Apellis' offerings, Biogen is poised to strengthen its portfolio, particularly in areas of unmet medical need. On the regulatory front, AbbVie has achieved a milestone with its drug Rinvoq (upadacitinib), which has received dual approvals from the European Union for treating non-segmental vitiligo and severe alopecia areata. These approvals were based on successful Phase 3 data, underscoring Rinvoq's efficacy as a JAK inhibitor in tackling autoimmune conditions. This development not only highlights AbbVie's commitment to expanding its therapeutic portfolio but also positions upadacitinib as a potential mainstay treatment for dermatological autoimmune diseases. AstraZeneca Pharma India has secured approval from the Central Drugs Standard Control Organization for Enhertu (trastuzumab deruxtecan) in the neoadjuvant setting for HER2-positive early breast cancer. This approval marks a significant advancement in personalized cancer therapy, offering new hope for patients with this aggressive form of breast cancer. In terms of industry collaborations, the landscape is witnessing numerous partnerships and strategic alliances that are driving innovation forward. Skyverna Therapeutics and ElevateBio have entered a five-year clinical and commercial supply agreement for autoimmune CAR-T therapy, reflecting the growing interest in cell therapies for rare diseases. Meanwhile, Vertex Pharmaceuticals and AbCellera have joined forces to accelerate drug discovery in autoimmune T-cell engagement, supported by a $28 million upfront investment. These collaborations emphasize the importance of combining expertise and resources to advance complex therapeutic solutions. The integration of artificial intelligence in drug development continues to gain momentum. Evinova and Merck KGaA's strategic collaboration aims to leverage AI and machine learning to enhance clinical trials' efficiency, potentially ushering in a new era of precision medicine. Such partnerships highlight the transformative potential of AI in streamlining research and development processes. In funding news, Core Biomedicine has secured $21 million in Series A financing to advance its precision oncology therapeutics. Enlivex's substantial $400 million private placement aims at advancing prediction markets treasury and Allocetra immunotherapy, further accentuating the focus on personalized medicine targeting specific cancer pathways. Clinical trials have also delivered promising results. ProMIS Neurosciences reported positive interim safety and biomarker data from its Phase 1b study of PMN310 for Alzheimer's disease. This monoclonal antibody targets amyloid-beta oligomers implicated in Alzheimer's pathology, offering hope for patients with this debilitating disorder. Mergers and acquisitions remain active, exemplified by Caldera Therapeutics' reverse merger with Synlogic alongside $278 million in financing to advance its bispecific antibody for inflammatory bowel disease. This move reflects a broader trend toward consolidating resources to tackle complex autoimmune conditions. Eli Lilly's ascent to the top of Norstella's pipeline-to-patient productivity index is noteworthy, driven by successful launch strategies and rapid development cycles. This achievement underscores Eli Lilly's effective alignment of R&D efforts with market needs, particularly in areas such as GLP-1 receptor agonists that have transformed diabetes care. Teva Pharmaceuticals is demonstrating resilience through its innovative medicines portfolio amidst declining generic sales. The unexpected surge in Ajovy sales highlights Teva's pivot toward high-value branded drugs amidst competitive pressures. Novo Nordisk faces legal challenges as it navigates allegations regarding Cagrisema's Phase 3 study protocol changes. Legal scrutiny around transparency in clinical trial disclosures continues to highlight the importance of ethical practices and investor trust. Collectively, these developments illustrate a vibrant yet challenging environment where scientific advancements in immunotherapy and targeted treatments intersect with strategic business alignments focused on sustainable growth. As these trends unfold, they promise more effective treatments for complex diseases while companies adapt to an evolving market environment demanding agility and foresight. As always, stay tuned to Pharma Daily for more insights into how these transformations continue to shape the future trajectory of drug development and healthcare delivery globally.Support the show

In today's episode, we spoke with Paolo Tarantino, MD, PhD. Dr Tarantino is a breast medical oncologist and advanced fellow at Dana-Farber Cancer Institute and Harvard Medical School in Boston, Massachusetts.In our exclusive interview, Dr Tarantino discussed practice-informing data regarding antibody-drug conjugates in breast cancer that were presented at the 2026 ASCO Annual Meeting, including the use of fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) plus pertuzumab (Perjeta) for first-line treatment of HER2-positive breast cancer based on findings from the phase 3 DESTINY-Breast09 trial (NCT04784715); updated safety data from the phase 3 DESTINY-Breast05 trial (NCT04622319) that indicated that T-DXd–associated interstitial lung disease is reversible with steroids, although radiation pneumonitis is non-reversible; and the phase 3 OPTIMA trial (ISRCTN42400492) results, which suggested that the PAM50 signature can identify patients who may not need chemotherapy, potentially sparing them from unnecessary treatment.

Dr. Sonam Puri joins the podcast to share the update to the living guideline on stage IV NSCLC with driver alterations. Dr. Puri discusses the practice-changing evidence reviewed for both NTRK rearrangements, including the TRIDENT-1 trial, and HER2 activating mutations, including the Beamion LUNG-1 study. She shares how these results impacted the clinical practice guideline with the addition of repotrectinib and zongertinib, what these new TKIs mean for patients, and where the panel is waiting for additional randomized data to clarify the role of therapeutic options. Dr. Puri encourages listeners to stay tuned for future updates to the living guideline as new evidence is published. Read the full living guideline "Therapy for Stage IV Non-Small Cell Lung Cancer With Driver Alterations: ASCO Living Guideline, Version 2026.3.2" at www.ascopubs.org/guidelines/therapy-stage-iv-non-small-cell-lung-cancer-driver-alterations" LINK TO FULL TRANSCRIPT

Highlights from the PER® CME activity "Hot Seat: Which Agent, and When? Integrating Next-Generation Endocrine Strategies Into HR+/HER2– Breast Cancer Management" — this podcast is not certified for credit. To participate in the full accredited activity and earn CME credit, use the link below.In this podcast, experts Ruta D. Rao, MD; Kamel Abou Hussein, MD; Jame Abraham, MD, FACP; and Paolo Tarantino, MD, PhD, discuss the data supporting the approvals of next-generation endocrine therapies for ESR1-mutated hormone receptor (HR)–positive, HER2-negative metastatic breast cancer, and how they think through these data when individualizing treatment recommendations for these patients.Earn CME credit by completing the full accredited activity (available through June 30, 2027): https://www.gotoper.com/courses/hot-seat-which-agent-and-when-integrating-next-generation-endocrine-strategies-into-hrher2-breast-cancer-management-rjgdThis podcast, including the narration, was developed by PER® (Physicians' Education Resource®, LLC) editorial staff from the full online CME activity developed with these faculty. The narration was voiced by a PER staff member or by an AI tool. The podcast contains no product advertising. The full activity is supported by educational grants from Stemline Therapeutics, Inc; and Rigel Pharmaceuticals, Inc..This content is for educational purposes only and is not a substitute for the independent clinical judgment of a health care professional. Faculty may discuss investigational or off-label uses; consult prescribing information for any products discussed.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into some of the most exciting scientific breakthroughs and regulatory developments that are shaping the future of healthcare. Eli Lilly's retatrutide, a promising small molecule GLP-1 receptor agonist, has achieved significant results in Phase 3 trials, leading to an impressive 22.6% weight loss in patients with obesity and cardiovascular disease. This breakthrough underscores the potential of GLP-1 receptor agonists in transforming treatment paradigms for metabolic disorders. The drug's ability to target metabolic pathways associated with obesity and type 2 diabetes could herald a new era in managing these conditions, offering hope for millions struggling with obesity—a major risk factor for cardiovascular diseases. In oncology, Johnson & Johnson has unveiled remarkable results with its combination therapy of Tecvayli (teclistamab) and Talvey (talquetamab), achieving an 89% reduction in disease progression risk for multiple myeloma patients during a Phase 3 trial. This bispecific antibody approach targets BCMA and GPRC5D, representing a significant advancement in treating this challenging hematological malignancy. Such efficacy could set a new standard for multiple myeloma treatment strategies, enhancing patient outcomes considerably. Meanwhile, GSK has made strides with FDA approval of Jideytro (zidesamtinib) for ROS1-positive metastatic non-small cell lung cancer. This small molecule kinase inhibitor targets the ROS1 mutation, providing a targeted therapeutic option that aligns with the progress in precision medicine—offering treatments based on patients' genetic profiles. On the regulatory front, the passage of FDA Modernization Act 3.0 by the House reflects a shift towards more ethical preclinical testing methods by updating outdated animal testing regulations. This legislative change could expedite drug development timelines and improve the translation of preclinical findings into clinical success—an encouraging step forward for the industry. In China, Takeda's Orzeyful (oveporexton) received approval as the first ox2r agonist for narcolepsy type 1 treatment. This approval marks advancements in addressing neurological conditions through novel mechanisms targeting orexin receptor pathways. Similarly, Haisco Pharmaceutical's Ciprocopan has been approved as an oral complement factor B inhibitor for paroxysmal nocturnal hemoglobinuria (PNH), offering a more convenient treatment option compared to existing therapies. AstraZeneca's Etcamah (camizestrant) gained EU approval following its success in Phase 3 trials for estrogen receptor-positive, HER2-negative advanced breast cancer. As an oral selective estrogen receptor degrader (SERD), it presents an innovative approach to targeting ESR1 mutations and could be combined with CDK4/6 inhibitors to enhance therapeutic efficacy further. On the strategic collaboration front, partnerships like those formed by Arcus Biosciences with Aveo Oncology and Summit Therapeutics exemplify efforts to advance drug discovery capabilities, particularly in kidney cancer treatments. These collaborative approaches reflect a broader trend in oncology therapeutics development. Financial investments are also fueling growth within the sector. Mentari Therapeutics secured $200 million to propel its migraine prevention biologics pipeline forward, highlighting confidence in biologic treatments for neurological disorders. Beone Medicines has committed $300 million to expand manufacturing capabilities, demonstrating ongoing investment in infrastructure to support future drug production demands. In summary, these developments illustrate significant scientific advancements and regulatory progress within the pharmaceutical and biotech industries. The implications are profound: improved patient care through innovative therapies, enhanced precision medicine approaches tailored to genetic mutations, and accelerated drug discovery processes facilitated by evolving regulatory frameworks. As these trends continue to evolve, they promise to reshape patient outcomes and redefine standards across various therapeutic areas. Thank you for tuning into Pharma Daily today. Stay informed as we continue to bring you updates on cutting-edge advances that are transforming healthcare worldwide.Support the show

Are you testing for HER2-mutated disease and aware of the new therapeutic options available for your patients? Credit available for this activity expires: 7/21/27 Earn Credit / Learning Objectives & Disclosures: https://www.medscape.org/viewarticle/reality-care-her2-mutated-advanced-nsclc-closing-community-2026a1000mfr?ecd=bdc_podcast_libsyn_mscpedu

Featuring an interview with Prof Dr Sibylle Loibl, including the following topics: Perspectives on overall survival gains achieved over the years for patients with metastatic breast cancer (mBC) (0:00) Previous treatment and patient outcomes in the DESTINY-Breast09 trial of trastuzumab deruxtecan (T-DXd) with or without pertuzumab (5:35) Role of endocrine therapy in the treatment of hormone receptor-positive, HER2-positive mBC (8:01) Targeting the PI3K signaling pathway in HER2-positive mBC (11:08) Contraindications for T-DXd; T-DXd-associated gastrointestinal toxicities and interstitial lung disease (13:53) Optimal duration of and therapeutic partner for T-DXd as first-line maintenance therapy for patients with HER2-positive mBC (20:44) Case: A woman in her early 40s with metastatic relapse of HER2-positive breast cancer 2 years after completing neoadjuvant and adjuvant therapy (26:54) Role of exercise and weight control in the management of breast cancer; effect of pregnancy on the breast tumor immune environment (40:03) CME information and select publications

Featuring a slide presentation and related discussion from Prof Dr Sibylle Loibl, including the following topics: ·      Overview of the changing landscape of treatment for patients with HER2-positive metastatic breast cancer (mBC) (0:00) ·      Results from the CLEOPATRA, PATINA and HER2CLIMB-05 trials of first-line treatment and maintenance approaches for HER2-positive mBC (5:26) ·      Efficacy and safety findings from the Phase III DESTINY-Breast09 trial comparing trastuzumab deruxtecan with or without pertuzumab to taxane/trastuzumab/pertuzumab as first-line therapy for HER2-positive mBC (14:56) ·      Predictors of long-term benefit from first-line treatment with HER2-targeted agents; contribution of pertuzumab to the efficacy of first-line HER2-targeted combination regimens (22:57) ·      Control of brain metastases and CNS disease with first-line HER2-targeted regimens (26:31) CME information and select publications

Highlights from the PER® CME activity "Oncology Town Hall: Updates From Chicago: Oral SERDs in HR+/HER2− Metastatic Breast Cancer–What the Latest Data Really Tell Us" — this podcast is not certified for credit. To participate in the full accredited activity and earn CME credit, use the link below.In this podcast, experts Virginia Kaklamani, MD, DSc; Kamel Abou Hussein, MD; Javier Cortés, MD, PhD; and Seth A. Wander, MD, PhD, discuss American Society of Clinical Oncology (ASCO) 2026 updates about data for oral selective estrogen receptor degraders (SERDs) to treat metastatic, HR-positive breast cancer.Earn CME credit by completing the full accredited activity (available through June 29, 2027): https://www.gotoper.com/courses/oncology-town-hall-updates-from-chicago-oral-serds-in-hrher2-metastatic-breast-cancerwhat-the-latest-data-really-tell-us This podcast, including the narration, was developed by PER® (Physicians' Education Resource®, LLC) editorial staff from the full online CME activity developed with these faculty. The narration was voiced by a PER staff member or by an AI tool. The podcast contains no product advertising. The full activity is supported by an educational grant from Stemline Therapeutics, Inc.This content is for educational purposes only and is not a substitute for the independent clinical judgment of a health care professional. Faculty may discuss investigational or off-label uses; consult prescribing information for any products discussed.

Featuring an interview with Dr Mark Jeng and Dr Joshua K Sabari, including the following topics: ·      Case: A woman in her late 90s with recurrent HER2-mutant metastatic non-small cell lung cancer (NSCLC) receives third-line zongertinib (0:00) ·      Case: A woman in her early 60s with multiregimen-recurrent HER2-mutant metastatic NSCLC experiences a response to zongertinib (8:07) ·      Case: A man in his mid 80s experiences metastatic recurrence after resection of PD-L1-positive, HER2-mutant metastatic NSCLC (17:50) CME information and select publications

Highlights from the PER® CME activity "Cases and Conversations: Optimizing Oral SERD-Based Therapy After CDK4/6 Inhibition in HR+/HER2– MBC" — this podcast is not certified for credit. To participate in the full accredited activity and earn CME credit, use the link below.In this podcast, experts Virginia Kaklamani, MD, DSc; Antonio Giordano, MD, PhD; Nadia Harbeck, MD, PhD; and Sarah Sammons, MD, discuss the use of oral SERD-based therapy in the treatment of HR+/HER2– metastatic breast cancer through a series of clinical cases. Earn CME credit by completing the full accredited activity (available through June 30, 2027): https://www.gotoper.com/courses/cases-and-conversations-optimizing-oral-serd-based-therapy-after-cdk46-inhibition-in-hrher2-mbc-xv6m This podcast, including the narration, was developed by PER® (Physicians' Education Resource®, LLC) editorial staff from the full online CME activity developed with these faculty. The narration was voiced by a PER staff member or by an AI tool. The podcast contains no product advertising. The full activity is supported by an educational grant from Stemline Therapeutics, Inc.This content is for educational purposes only and is not a substitute for the independent clinical judgment of a health care professional. Faculty may discuss investigational or off-label uses; consult prescribing information for any products discussed.

Send us Fan MailThe July 2026 PBS update brings a number of important changes for oncology clinicians, with several new and expanded cancer medicine listings set to improve access to cancer treatments across breast, lung, blood and biliary tract cancers.In this episode, Rachael Babin and Professor Craig Underhill discuss the clinical significance of the latest Pharmaceutical Benefits Scheme changes, including who is now eligible for treatment, what these listings mean for multidisciplinary care and why comprehensive biomarker testing continues to grow in importance.In this episode:PBS listing for pertuzumab (Perjeta®) in high-risk HER2-positive early breast cancer Listing of alectinib (Alecensa®) for ALK-positive non-small cell lung cancer Osimertinib (Tagrisso®) listing for EGFR-mutated unresectable Stage III NSCLC following chemoradiation First PBS listing of romidepsin (Romidepsin-Reach®) for relapsed peripheral T-cell lymphoma First PBS listing of futibatinib (Lytgobi®) for FGFR2-altered advanced cholangiocarcinoma What the new broad (multi-cancer) PBS listing principles for PD-(L)1 inhibitors could mean for future cancer drug fundingFollow The PBS Update for regular discussions on PBS listings and oncology policy changes affecting Australian healthcare professionals.Visit the Show Notes for links to the PBS updates discussed in this episode and to send us audio feedback or questions for future episodes.Proudly produced by The Oncology Network

We know that clinical trials are a critical lifeline, offering new ways to prevent, detect, diagnose and treat breast cancer. Today, patient advocates are transforming clinical trials by bringing the real-world experiences of patients directly to researchers. By acting as a bridge between science and the community, patient advocates boost enrollment in clinical trials, and help build a lasting trust Today we are speaking with Dr. Lior Braunstein, a radiation oncologist and researcher at Memorial Sloan Kettering Cancer Center, and Dr. Ellen Landsberger, a retired OB-GYN and patient advocate, also at Memorial Sloan Kettering Cancer Center. Together they are working on the ARCHER clinical trial, a study that is investigating a new treatment strategy for HER2-positive metastatic breast cancer. We'll talk about what they are hoping to accomplish through the ARCHER trial, what their collaborative process looks like and how patient advocates in clinical trials can help improve patient outcomes. Key Takeaways: Patient advocates help design better clinical trials The ARCHER trial aims to improve treatment outcomes Patient voices shape research from the very beginning Clinical trials study both treatment and quality of life Better access helps more patients join clinical trials Chapters 00:00:00 – Why patient advocates belong at the clinical trial design table 00:04:44 – From breast cancer survivor to patient advocate 00:07:46 – How advocates shape research and address patient concerns 00:12:08 – Inside the ARCHER trial and its goal to improve metastatic breast cancer treatment 00:19:03 – Measuring quality of life and improving access to clinical trials 00:26:28 – How patients can become advocates and influence future research

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into a series of transformative updates and strategic shifts within the industry, reflecting both remarkable progress and inherent challenges. Sanofi's recent achievement marks a significant milestone in oncology with the FDA approval of Sarclisa Escena (isatuximab) as the first on-body injector for multiple myeloma treatment. This monoclonal antibody, targeting CD38, offers a novel subcutaneous delivery method, simplifying administration and potentially enhancing patient compliance by reducing the need for frequent clinic visits. This aligns with the industry's ongoing shift towards patient-friendly drug delivery systems, emphasizing convenience without compromising efficacy. In another promising development, GSK and Hansoh Pharmaceutical have reported positive results from their Phase 3 trial evaluating risvutatug rezetecan for small cell lung cancer. This antibody-drug conjugate, targeting B7-H3, has shown potential when combined with chemotherapy to extend patient survival. Given the aggressive nature of small cell lung cancer and limited treatment options, these findings underscore the potential of targeted therapies to improve clinical outcomes significantly. Forte Biosciences' FB102 also takes a spotlight in clinical advancements. In its Phase 1b trial for vitiligo, FB102 demonstrated a 45.8% placebo-adjusted benefit. This monoclonal antibody works by modulating immune responses through the IL-15 pathway via CD122, offering new hope for patients with this challenging autoimmune condition. On the regulatory front, ARPA-H's commitment of up to $160 million towards developing personalized genetic medicines for rare diseases is noteworthy. This investment is set to accelerate innovations in gene therapy and personalized medicine platforms. Such advancements promise to revolutionize pediatric care and extend beyond by tailoring treatments to individual genetic profiles, enhancing efficacy while minimizing adverse effects. Strategic collaborations continue to reshape the industry landscape. Rani Therapeutics' partnership with PegBio aims at advancing oral delivery systems for obesity and metabolic diseases. Similarly, Simcere Pharmaceutical's collaboration with Schrödinger leverages AI-driven drug discovery efforts. These alliances highlight an increased reliance on computational platforms to streamline therapeutic development processes. From a financial perspective, Mesoblast Limited reports substantial revenue from its cell therapy product Ryoncil, signaling strong commercial viability for cell-based treatments targeting rare diseases. Additionally, Cue Biopharma's successful $50 million fundraising underscores investor confidence in advancing therapies for immunological disorders. However, not all news is positive. Roche has decided to halt two programs targeting Huntington's disease due to inadequate efficacy and safety concerns. This decision reflects the complexities involved in developing effective treatments for neurological disorders—a field fraught with scientific challenges yet rich with potential rewards. In market dynamics, McKinsey's report advocates for a structural redesign of biopharmaceutical R&D to fully leverage AI's capabilities. This recommendation resonates with current industry trends focusing on strategic innovation to maximize efficiency and discovery potential. The FDA's third rejection of Hengrui Pharma and Elevar Therapeutics' combination therapy for liver cancer underscores the rigorous scrutiny such treatments face despite their promise in addressing complex cancers. In contrast, BioNTech's preparation to launch its HER2 antibody-drug conjugate (ADC) signifies its strategic pivot back towards oncology after mRNA vaccine successes. Bayer's decision to sell a minority stake in its contraceptives business demonstrates how companies are strategically realigning portfolios to focus on core areas while securing funding for innovation. This move reflects broader trends within pharma as companies navigate financial landscapes to support long-term research goals. Amid these developments, regulatory environments continue evolving. NICE's stance against future Lumakras reimbursement in the UK highlights ongoing challenges in balancing cost-effectiveness with access to innovative therapies. Meanwhile, ARPA-H's significant funding allocation signals robust governmental support for advancing precision medicine within genetic therapies. In conclusion, today's updates reveal an industry characterized by a relentless pursuit of innovation amidst complex regulatory landscapes. As companies navigate these dynamics through strategic collaborations and scientific breakthroughs, their efforts hold promise for enhancing patient care across diverse therapeutic areas globally. Stay tuned as we continue to track these exciting developments shaping the future of pharmaceuticals and biotechnology. Thank you for tuning into Pharma Daily—your go-to source for up-to-date insights from the world of pharmaceuticals and biotechnology.Support the show

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/NCPD/AAPA information, and to apply for credit, please visit us at PeerView.com/EXH865. CME/NCPD/AAPA credit will be available until June 15, 2027.Mastering the Breakthroughs in HER2-Mutant NSCLC: Decoding Alterations, Refining Treatment, and Empowering Patients In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, and LUNGevity Foundation. PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by an independent medical educational grant from Boehringer Ingelheim Pharmaceuticals, Inc.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/NCPD/AAPA information, and to apply for credit, please visit us at PeerView.com/EXH865. CME/NCPD/AAPA credit will be available until June 15, 2027.Mastering the Breakthroughs in HER2-Mutant NSCLC: Decoding Alterations, Refining Treatment, and Empowering Patients In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, and LUNGevity Foundation. PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by an independent medical educational grant from Boehringer Ingelheim Pharmaceuticals, Inc.Disclosure information is available at the beginning of the video presentation.

In this episode of Onc Now, Mary Disis, Director of the University of Washington's Medicine Cancer Vaccine Institute, Seattle, USA, explores the science and future of cancer vaccines. She discusses how vaccines fit into today's immunotherapy landscape, the evolution of human epidermal growth factor receptor 2 (HER2)-targeted therapies, progress in breast cancer vaccines, the promise of cancer prevention, and the key priorities for survivorship and future oncology care.  Timestamps:   00:00 – Introduction   01:28 – Cancer Vaccines Explained   03:57 – Journey Into Cancer Immunology   06:38 – Cancer Vaccines in Immunotherapy   10:02 – Leading the Cancer Vaccine Institute   13:26 – Progress in Breast Cancer Vaccines   18:39 – HER2 Research and Treatment Evolution   21:30 – Future of Preventive Cancer Vaccines   26:39 – Priorities for Cancer Survivorship   30:30 – Three Wishes for Oncology's Future 

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/NCPD/AAPA information, and to apply for credit, please visit us at PeerView.com/EXH865. CME/NCPD/AAPA credit will be available until June 15, 2027.Mastering the Breakthroughs in HER2-Mutant NSCLC: Decoding Alterations, Refining Treatment, and Empowering Patients In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, and LUNGevity Foundation. PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by an independent medical educational grant from Boehringer Ingelheim Pharmaceuticals, Inc.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/NCPD/AAPA information, and to apply for credit, please visit us at PeerView.com/EXH865. CME/NCPD/AAPA credit will be available until June 15, 2027.Mastering the Breakthroughs in HER2-Mutant NSCLC: Decoding Alterations, Refining Treatment, and Empowering Patients In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, and LUNGevity Foundation. PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by an independent medical educational grant from Boehringer Ingelheim Pharmaceuticals, Inc.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/NCPD/AAPA information, and to apply for credit, please visit us at PeerView.com/EXH865. CME/NCPD/AAPA credit will be available until June 15, 2027.Mastering the Breakthroughs in HER2-Mutant NSCLC: Decoding Alterations, Refining Treatment, and Empowering Patients In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, and LUNGevity Foundation. PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by an independent medical educational grant from Boehringer Ingelheim Pharmaceuticals, Inc.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/NCPD/AAPA information, and to apply for credit, please visit us at PeerView.com/EXH865. CME/NCPD/AAPA credit will be available until June 15, 2027.Mastering the Breakthroughs in HER2-Mutant NSCLC: Decoding Alterations, Refining Treatment, and Empowering Patients In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, and LUNGevity Foundation. PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by an independent medical educational grant from Boehringer Ingelheim Pharmaceuticals, Inc.Disclosure information is available at the beginning of the video presentation.

Highlights from the PER® CME activity "Medical Crossfire®: Precision Oncology in NSCLC – Translating HER2 and TROP2 Innovation into Practice-Changing Care" — this podcast is not certified for credit. To participate in the full accredited activity and earn CME credit, use the link below.In this podcast, focusing on precision oncology in non-small cell lung cancer (NSCLC), experts Helena Yu, MD; Jacob Sands, MD; and Sarah Goldberg MD, MPH; will discuss the rapidly evolving landscape of Human Epidermal growth factor Receptor 2 (HER2)- and Trophoblast cell-surface antigen 2 (TROP2)-directed therapies in NSCLC. The podcast covers the spectrum of targeted agents from antibody-drug conjugates (ADCs) to novel HER2-selective tyrosine kinase inhibitors (TKIs), along with key clinical trial data and practical strategies for managing the unique adverse event profiles associated with these treatments.Earn CME credit by completing the full accredited activity (available through June 30, 2027): https://www.gotoper.com/courses/medical-crossfire-precision-oncology-in-nsclc-translating-her2-and-trop2-innovation-into-practice-changing-care-mr5qThis podcast, including the narration, was developed by PER® (Physicians' Education Resource®, LLC) editorial staff from the full online CME activity developed with these faculty. The narration was voiced by a PER staff member or by an AI tool. The podcast contains no product advertising. The full activity is supported by educational grants from AstraZeneca Pharmaceuticals; Daiichi Sankyo, Inc.; and Gilead Sciences, Inc.This content is for educational purposes only and is not a substitute for the independent clinical judgment of a health care professional. Faculty may discuss investigational or off-label uses; consult prescribing information for any products discussed.

Die Biomarkerdiagnostik in der Onkologie wird zunehmend komplexer, aber auch immer wichtiger für individualisierte Therapieentscheidungen. Im Dezember 2025 wurde vom Leitlinienprogramm Onkologie die aktualisierte deutsche S3-Leitlinie Früherkennung, Diagnostik, Therapie und Nachsorge des Mammakarzinoms vorgelegt. Unter anderem wurden die Empfehlungen für Diagnostik und Screening überarbeitet. Welche Auswirkungen dies auf den Praxisalltag sowohl von Pathologie als auch Klinik hat, hören Sie im Podcast.

In today's episode, we welcomed Charles E. Geyer, MD, to discuss recent FDA approvals of fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) for the management of HER2-positive breast cancer. Dr Geyer is a professor of medicine and chief of Malignant Hematology and Medical Oncology in the Department of Medicine at the University of Pittsburgh and the University of Pittsburgh Medical Center Hillman Cancer Center in Pennsylvania.On May 15, 2026, the FDA approved T-DXd for the neoadjuvant treatment of adult patients with HER2-positive stage II or III breast cancer, as determined by an FDA-authorized test, followed by a taxane, trastuzumab (Herceptin), and pertuzumab (Perjeta); the regulatory agency simultaneously approved post-neoadjuvant T-DXd for the treatment of adult patients with HER2-positive breast cancer who have residual invasive disease after neoadjuvant HER2-targeted treatment.In our exclusive interview, Dr Geyer discussed the significance of these approvals, key data from the pivotal trials, and how these new indications for T-DXd are shaking up the HER2-positive breast cancer treatment paradigm.

In today's episode, we spoke with David O'Malley, MD. Dr O'Malley is a professor in the Department of Obstetrics and Gynecology at The Ohio State University College of Medicine and the director of the Division of Gynecologic Oncology at The Ohio State University Comprehensive Cancer Center–James in Columbus, Ohio. In our exclusive interview, Dr O'Malley discussed his approach to treatment selection and sequencing in platinum-resistant ovarian cancer, a disease setting he described as representing the highest unmet need in the field. He emphasized the central role of clinical trial enrollment and biomarker-driven decision-making, alongside practical patient-centered considerations, such as infusion schedule and quality of life.He highlighted the growing importance of antibody-drug conjugates (ADCs) in this setting, noting that folate receptor alpha and HER2 are the two biomarkers most relevant to current practice. Dr O'Malley outlined how National Comprehensive Cancer Network guidelines support treatment across a broader range of expression levels than initial approvals reflected, citing emerging data suggesting activity even at lower expression thresholds. He also addressed payload sequencing, explaining that outside of a clinical trial, he currently uses topoisomerase I–based ADCs and antimicrotubule-based ADCs each one time only, and remains open to targeting the same antigen again if the payload differs.The discussion also touched on combination strategies, resistance biology, and the evolving role of immunotherapy following the survival benefit observed with pembrolizumab (Keytruda) in the phase 3 KEYNOTE-B96 trial (NCT05116189). Dr O'Malley expressed enthusiasm for next-generation payloads, dual-target approaches, and the potential for bispecific antibodies and novel DNA damage response–targeting agents to define the post-ADC treatment landscape.Finally, Dr O'Malley underscored the need for more tumor biopsies to better characterize resistance mechanisms and called for expanded pharmaceutical investment in retreatment and cross-resistance studies to guide future sequencing decisions.

Please visit answersincme.com/GXT860 to participate, download slides and supporting materials, complete the post test, and get a certificate. Presented by Sarah Donahue, MPH, ANP, AOCNP. In this activity an expert in breast cancer discusses the efficacy and safety of oral SERDs in HR+, HER2- advanced breast cancer. Upon completion of this activity, participants should be better able to: Review the evidence-based use of oral SERDs in the treatment plan for patients with HR+, HER2- advanced breast cancer; Specify the key roles of nurses and NPs in optimizing the overall care for patients with HR+, HER2- advanced breast cancer who are candidates for oral SERDs; and Outline a multidisciplinary treatment plan to maximize the long-term care of patients with HR+, HER2- advanced breast cancer.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into the dynamic landscape of the pharmaceutical and biotech sectors, where significant scientific advancements, regulatory shifts, and strategic business maneuvers are reshaping patient care and therapeutic approaches. A pivotal moment recently unfolded with Ipsen's acquisition of Kartos Therapeutics for up to $1.75 billion. This strategic move adds navtemadlin, a promising myelofibrosis candidate, to Ipsen's oncology pipeline. Navtemadlin is a small molecule inhibitor targeting MDM2, a crucial regulator of the tumor suppressor p53. This acquisition reflects a strategic emphasis on expanding therapeutic options in hematologic oncology, aiming to improve outcomes for patients with myelofibrosis—a rare and debilitating bone marrow disorder. In regulatory advancements, Viridian Therapeutics achieved a significant milestone with FDA approval of Lumvoa (veligrotug-vvze) for treating thyroid eye disease across both active and chronic stages. This monoclonal antibody targets IGF-1R, addressing an unmet need in autoimmune conditions by potentially altering disease progression and improving patient quality of life. Concurrently, AstraZeneca and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) secured EU approval for HER2-positive metastatic solid tumors after successful Phase 2 trials. Enhertu's role as an antibody-drug conjugate highlights a breakthrough in targeting cancer cells more precisely while sparing healthy tissues, underscoring the growing importance of personalized medicine in oncology. The clinical trial landscape saw pivotal results with AstraZeneca's efzimfotase alfa demonstrating efficacy in Phase 3 trials for hypophosphatasia—a rare bone disease characterized by defective bone mineralization due to enzyme deficiencies. This protein therapy aims to replace deficient alkaline phosphatase enzymes, offering hope for improved skeletal outcomes in affected children. Furthermore, BridgeBio Pharma's infigratinib showed promise in Phase 3 trials for treating achondroplasia by demonstrating significant growth improvements. As a fibroblast growth factor receptor (FGFR) inhibitor, it underscores the potential of targeted therapies in addressing genetic disorders. On the business development front, Zymeworks' acquisition of Theravance for $929 million adds the COPD drug Yupelri to its portfolio alongside lucrative royalty arrangements. Yupelri is a long-acting muscarinic antagonist (LAMA) that offers once-daily bronchodilation for COPD patients. This strategic move bolsters Zymeworks' respiratory franchise and highlights the ongoing consolidation trend in the industry as companies seek growth through diversification and enhanced therapeutic offerings. In parallel, Talawar Therapeutics is planning a $285 million SPAC merger to advance its bispecific antibody for eczema treatment. Similarly, Lycia Therapeutics raised $75 million in Series D funding to progress its extracellular protein degrader pipeline aimed at autoimmune diseases. These investments signal robust interest in novel modalities such as bispecific antibodies and targeted protein degradation technologies that promise new therapeutic avenues. However, not all news was positive. The FDA rejected Sobi's NASP (pegadricase) application due to manufacturing issues, highlighting ongoing challenges firms face in meeting regulatory standards for complex biologics. Additionally, Evommune's Evo756 failed its primary endpoint in Phase 2b trials for chronic spontaneous urticaria, illustrating the high-risk nature of drug development. Looking at the broader industry trends, Roche's launch of Axelios 1 represents a strategic push into the gene sequencing arena, directly challenging Illumina's market dominance. As precision medicine continues to gain traction, advancements in gene sequencing technologies are likely to play an instrumental role in personalized medicine strategies, offering more tailored treatment options based on genetic profiles. Finally, we see significant shifts driven by recent regulatory changes and scientific breakthroughs across the sector. The FDA's revised stance on rare disease drug approval criteria could expedite processes for companies like Skyhawk Therapeutics and Biohaven, providing new opportunities to bring treatments to market more swiftly. These regulatory adjustments reflect an evolving landscape where innovation is poised to meet unmet medical needs more efficiently. In conclusion, these developments underscore a dynamic pharmaceutical and biotech landscape characterized by strategic acquisitions, regulatory successes, and scientific advancements aimed at addressing complex diseases with innovative therapies. As these sectors continue to evolve, stakeholders must navigate a complex interplay of technological advancements, regulatory scrutiny, and competitive pressures to drive meaningful advancements in healthcare outcomes. Stay tuned with Pharma Daily as we continue to explore these significant shifts shaping the future of healthcare and drug development. Thank you for joining us today as we unpack these pivotal stories impacting our industry.Support the show

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we explore the dynamic shifts and breakthroughs shaping the industry, from major acquisitions to groundbreaking scientific advancements. Merck KGaA has made headlines with its bold $11.3 billion acquisition of Bio-Techne Corporation. This marks Merck's most significant deal since purchasing Sigma-Aldrich in 2015, reinforcing its strategic focus on expanding its life sciences tools portfolio. The acquisition aims to accelerate innovation in drug development and diagnostics, highlighting Merck's commitment to enhancing its capabilities in biotechnology under the leadership of CEO Kai Beckmann. Such strategic moves underscore a broader trend towards bolstering biotech portfolios through mergers and acquisitions as companies aim to remain competitive in an ever-evolving market landscape. In regulatory news, the FDA has approved a pioneering combination therapy involving Gilead's Trodelvy and Merck & Co.'s Keytruda for the first-line treatment of triple-negative breast cancer (TNBC). This aggressive cancer subtype has historically had limited treatment options, making this approval particularly significant. The combination therapy leverages an antibody-drug conjugate targeting Trop-2 alongside a PD-1 inhibitor, offering a promising new strategy that could substantially improve patient survival outcomes. This development also highlights the growing role of antibody-drug conjugates in oncology, illustrating how innovative therapeutic combinations can enhance treatment efficacy. Meanwhile, Pfizer's Ibrance has received FDA approval for label expansion to treat HR-positive, HER2-positive metastatic breast cancer. As a CDK4/6 inhibitor crucial in cell cycle regulation, Ibrance's expanded use reflects ongoing advancements in targeted therapies that personalize cancer treatment based on specific molecular characteristics. Such expansions demonstrate the importance of continuous clinical evaluation and regulatory engagement in extending the lifecycle and applications of existing drugs. Ionis Pharmaceuticals has gained FDA approval for Tryngolza for severe hypertriglyceridemia, marking a significant milestone for antisense oligonucleotide therapies. By targeting apolipoprotein C-III, Tryngolza offers a novel approach to managing metabolic conditions linked to pancreatitis risks. This approval underscores the growing importance of antisense technology in addressing complex lipid disorders and highlights Ionis' strategic efforts to expand market reach through global partnerships. On the business development front, Boehringer Ingelheim's partnership with Immunai aims to leverage artificial intelligence in T-cell target discovery for cancer and autoimmune diseases. The integration of AI/ML technologies into drug discovery processes is increasingly seen as essential for enhancing precision and efficiency. This collaboration reflects an industry-wide shift towards embracing technology to improve research and development outcomes. In clinical trials, Otsuka's centanafadine shows promise for adults with ADHD and comorbid anxiety following successful Phase 3b trials. As a small molecule reuptake inhibitor, centanafadine could provide dual therapeutic benefits for patients with these overlapping conditions. Such developments highlight ongoing innovation in neuropsychiatric treatments aimed at addressing mental health conditions with greater precision. Financially, Oblenio Bio's $62 million Series B funding round will support advancing its tri-specific autoimmune T-cell engager into trials, potentially offering new solutions for autoimmune diseases through innovative immunotherapy approaches. These financial movements illustrate how companies are strategically positioning themselves to capitalize on emerging therapeutic opportunities. Amid these developments, regulatory dynamics continue to evolve, as seen with the FDA's pilot program aimed at streamlining drug approval processes. Initiatives like these are pivotal in restoring confidence in regulatory frameworks while adapting to new scientific insights and technological advancements. Overall, these developments underscore the pharmaceutical and biotech sectors' dynamic nature, characterized by strategic collaborations, regulatory milestones, and innovative treatment options poised to enhance patient care and strengthen drug development pipelines. The ongoing integration of cutting-edge technologies such as AI signifies an evolution towards more personalized and efficient healthcare solutions. Thank you for tuning into Pharma Daily, where we bring you the latest insights from the forefront of pharmaceutical and biotech innovation. Join us next time as we continue to explore the trends shaping the future of healthcare globally.Support the show

This week we discuss a new approval for pabociclib in HER2-positive disease based on the PATINA trial as well as the use of sacituzumab govitecan + pembrolizumab in TNBC, recently approved based on the ASCENT04/KEYNOTED19 trial. And the concept of T-cell "stemless" is intriguing with possibilities: DOI: 10.1056/NEJMcibr2601002 Learning Oncology Companion: https://www.kelleycpharmd.com/learning-oncology-companion-oncopharm

Gillian Burles was 39 years old when her breast cancer metastasized to her spine — so severely that her T10 vertebra had to be replaced with a titanium alloy cage. She was living in the Northwest Territories, 1,500 kilometers from the nearest major cancer center, with two young children at home. Her oncologist gave her 18 to 24 months.That was 20 years ago.In this conversation, Gillian talks about what it actually looked like to rebuild her life after that diagnosis — returning to work, raising her kids, completing the Camino de Santiago with her husband, and managing HER2+ metastatic breast cancer from a small city in Northern Canada. She also shares the mantra that has stayed with her since the beginning: averages are the abstraction, variation is the reality. If you're newly diagnosed and struggling to see past the statistics, this one is worth your time.Heather was diagnosed with metastatic breast cancer at 26 and has now been living with the disease for more than 25 years. Through this podcast she shares perspective, lived experience, and conversations that help people navigate life with metastatic cancer.Sensational Survivor SeriesIf you have been living with metastatic breast cancer for 10 years or more and would like to share your story on the podcast, you can apply here:https://forms.gle/6H9K7NXMAeN1QEv87Digital Guideshttps://shop.heatherjose.com/all-guides/Listener QuestionsHave a question you'd like answered in a future episode? Submit it through the contact form:https://heatherjose.comConnect with HeatherInstagram: https://instagram.com/heatherbjoseWebsite: https://heatherjose.comMusicIntro and outro music for the podcast was created by Heather's son, Ty. You can find his music here:Instagram: https://instagram.com/tyjosee

How This Is Building Me, hosted by world-renowned oncologist D. Ross Camidge, MD, PhD, is a podcast focused on the highs and lows, ups and downs of all those involved with cancer, cancer medicine, and cancer science across the full spectrum of life's experiences.In this episode, Dr Camidge sat down with Mary (Nora) L. Disis, MD, a professor in the Clinical Research Division at Fred Hutchinson Cancer Center; as well as a professor in the Division of Hematology and Oncology, an adjunct professor of pathology in obstetrics and gynecology, holder of the Helen B. Slonaker Endowed Professorship for Cancer Research, director of the Cancer Vaccine Institute, and associate dean for Translational Health Science at the School of Medicine at the University of Washington in Seattle.Drs Camidge and Disis discussed Dr Disis's evolution from a science-focused student to a global leader in cancer immunology. Raised in a family that prioritized education, Disis found her passion for chemistry as a young adult before pursuing an MD and a master's degree. Although deeply drawn to practicing medicine in rural communities, she ultimately chose to focus on the field of tumor immunology.In the discussion, Disis offered a candid look at the strategic discipline required to succeed as a clinician-scientist. She emphasized the importance of protecting research time and refusing to let clinical duties overshadow her lab work. Her pioneering research involved identifying HER2 as a tumor antigen and developing vaccines that demonstrated significant long-term survival through intermolecular epitope spreading.Beyond the lab, Disis highlighted how her editorial roles allow her to observe scientific trends and maintain a broad understanding of the clinical landscape. Ultimately, Disis emphasized that the path to cancer prevention and vaccine licensing requires finance, focus, fortitude, and fearlessness. Having witnessed immunotherapy become a standard of care, she remains dedicated to climbing the mountain of vaccine development. By sifting through scientific “buzz” and maintaining deep focus, Disis believes the next frontier of cancer research lies in immunizing individuals to prevent cancer from ever developing.

Drs. Waks and Sammons discuss how new long-term data and key updates in the NCCN Guidelines® are reshaping treatment strategies for HER2+ breast cancer in both early-stage and metastatic settings. They highlight the growing role of T-DXd, including its benefits, risks, and optimal patient selection, alongside how to sequence it with other HER2-directed therapies like pertuzumab and T-DM1.

Featuring perspectives from Dr Erika Hamilton and Dr Shanu Modi, including the following topics: Introduction (0:00) Considerations in the Care of Patients with Localized HER2-Positive Breast Cancer — Dr Modi (0:58) Contemporary Management of HER2-Positive Metastatic Breast Cancer — Dr Hamilton (25:51) CME information and select publications

Dr. Deb Muth 00:02What if I told you that before a single drop of chemotherapy goes into a cancer patient’s body, we can take a blood sample, grow their actual living cancer cells in a lab, and test 70 different drugs against those cells, all outside the patient’s body, to find out which ones actually work. And what if I told you that the conventional oncology doesn’t routinely use this test? Well, today we’re going to talk about why that matters and we’re going to go through and I’m going to share a story that is very personal to me. It’s about a 38 year old man with a rare complex cancer diagnosis and the precision testing that is helping to keep that cancer from progressing. Stay with me. This is one that is going to change how you think about cancer treatment. Dr. Deb Muth 01:05You guys can put a little ad right in here before we start the next segment here. Hey everybody, welcome back to Let’s Talk Wellness Now. I’m Dr. Deb and today we’re going deep. I mean really deep. It’s some of the most cutting edge cancer testing I have ever seen in clinical practice. Now, normally I don’t talk about cancer. And I would not be sharing this story if it was anyone other than my own family. I do have permission to share and talk about this publicly. So I want to do this. I want to make sure that I share this message. And he is giving his blessing to share this story because we both believe that it can save lives. So his name is Cameron. He’s 38 years old. And he is my son-in-law. And two years ago, he came to me with a small lymph node underneath his arm and a bullseye rash. So of course, being the lime literate person that I am, my first inclination was to say, yeah, this makes sense. You have an enlarged lymph node because you have this bullseye rash. You got bit by the tick. Let’s keep an eye on it. If it doesn’t go away, let me know. So Fast forward a year and a half later, he comes to me and says, mom, what do you think about this? This thing is getting a little bit larger. And I said, yeah, it’s a little larger. Not sure. Let’s keep an eye on it. He wasn’t feeling anything. All his labs looked okay. And then one day he was out chopping wood and he started getting numbness in that arm and he felt it again. And it had exploded in size. And so after some evaluation with my daughter and him, we decided to do a ultrasound. And we thought what was going to come back was a fatty tumor. It felt like one looks like one responded to one. He’s 38 years old. He’s healthy. There’s nothing in our mind that’s ever thinking the result that we’re going to get back. Dr. Deb Muth 03:28Is a possible lymphoma. Needless to say, we were shocked by that ultrasound result. And we go fast forward, we have the biopsy. I requested a total excisional biopsy. I was told by the oncologist that that was old school. They don’t do that that way anymore. And I need to stay out of this. I need to let the experts take care of this because that’s what they do best. And this came from a breast surgeon here in Wisconsin. And so I stepped back for a moment. I let him do his biopsy and what came back was adenocarcinoma of an unknown origin. Had we excised the entire lymph node, we would have had more tissue to work with. I think we could have gotten a better diagnosis. So over the course of the next two and a half, three months, we have some more imaging done. We have some more testing done. They send a pathology out to Mayo Clinic. And what continues to come back is this incongruent test results. If anybody’s ever had this, it’s extremely frustrating. One test shows lymphoma. Now it shows breast cancer. Then the next week it shows estrogen receptor HER2 positive breast cancer. Two weeks later, another test comes back and it says, no, it’s not HER2, it’s triple negative breast cancer. And now it looks like it’s out of the lymph nodes. Now it looks like it’s in the lymph nodes. And we do a PET scan and they can’t find cancer anywhere except in this axilla area. But now we find a lymph node on the right side. So it must have spread.Let’s go ahead and do a biopsy on that. And so they biopsy the right side and the right side comes back with nothing other than tattoo ink. Now, all of this is kind of crazy. I am not a cancer specialist. I want to start by saying that I am not a cancer specialist. What I am sharing today is from a mother-in-law’s perspective, from a medical detective’s perspective, I do know how to do research. I do know how to find answers. And so what I’m going to share with you Dr. Deb Muth 05:54Is totally my opinion and totally my experience. And I’m not telling anybody to do anything different than what their doctors are telling them to do. But I am telling you to ask questions. So I go deep down the rabbit hole and find out that Tattoo Ink can appear like metastatic cancer on a PET scan. And we all know everybody gets tattoos today. They’re all over everyone. And yet we’re not thinking about how this tattoo ink can cause problems for us down the road, not to mention that there are heavy metals in them and it’s a toxin and it’s creating an inflammatory process in your body that your body’s constantly trying to get rid of. So the surgeon says to us, well, yes, that’s normal that that lymph nodes inflamed. It’s normal that there’s tattoo ink in it. The body’s doing what it’s supposed to do. It’s trying to get rid of a toxin. Okay. I will agree with that, but My son-in-law is covered with tattoos everywhere. And why didn’t we mention the tattoo ink that was found in the left axilla? We are only mentioning it in the right axilla. So there’s a lot of controversy, a lot of confusion. Many of you would never know any of this because A, you either don’t look at your lab results. And if you do, you don’t understand what you’re looking at. And that creates a problem for us, right? You don’t know what questions to ask. So we go into the doctor and the doctor tells us you have cancer and we’re going to swoop you in. And in the next two weeks, you’re going to be doing chemotherapy and radiation. And six months from now, we’re going to be doing surgery and there’s no time for questions and you’re scared shitless and you’re just doing what you can to survive. And I get that. And I totally understand that. And I appreciate that. But I’m telling you that If that is your choice, that is your choice. But as you’re doing that, take the time to ask the right questions. When this happened to us, there was a lot of challenging things with the oncology team. Nobody bothered to allow them to be a partner in their care. They dictated their care, but didn’t allow them to be a partner. So, Dr. Deb Muth 08:17Here’s what most oncologists do when patients get a cancer diagnosis. They look at the tumor type, they look at the stage, they look up the NCC guidelines, the National Comprehensive Cancer Network, and they follow the algorithm. Now, I have an enormous respect for conventional oncology. I really do. Working with cancer is probably one of the hardest things in medicine that anyone can do. The advances in this field over the last 10 years have been remarkable. But here’s my issue. Standard treatment assumes your cancer is the same as the cancer in the clinical trial that created the guidelines. It’s assuming that you and your cancer are the exact same as everyone else. You are the unique fingerprint, not the cancer. And this is the problem because your cancer is unique, just as unique as if you had your fingerprint taken, the mutations driving your tumor, the drugs your cancer cells are sensitive to, the metabolic vulnerabilities of your cancer. These are all different from the person sitting next to you in the chemo suite that has the same triple negative breast cancer or HER2 positive breast cancer or prostate cancer or colon cancer that you have. So what do do about that? Well, in my world, in the integrative medicine world, we test precisely, intelligently with the tools that most oncologists have never heard of. Or if they have, they haven’t incorporated it into their treatment modality for a variety of reasons. Either it’s not acceptable by the organization that they work for, they don’t understand it, They’re not going to be able to change their protocol anyway because they have to follow the NCCN protocol. So they don’t do it or they use a portion of it and they don’t do anything outside the protocol. So today I want to cover three things with you, three tools that we used that I think every cancer patient should be asking for when they start treatment or wherever you are in treatment at this point. Dr. Deb Muth 10:44you need to have these tests done. I don’t have any affiliation with any of these companies. I don’t get paid to tell you any of this. So let me just start by saying that I understand the chemistry behind these and how important it is to give you precision cancer treatment. And that’s why I’m talking about them today. The first one we’re going to talk about is the North Star response. This is your cancer surveillance score in the blood. How much cancer is circulating in the blood. The North Star Select, your cancer’s genomic blueprint from a blood draw. And the Datar Cancer Genetic Chemoscale, the live cell drug sensitivity test that tells us which drugs actually kill your cancer. So let’s go. Let’s dive into this. Let me just take a drink here. I’m going to cough a little bit. I apologize. I have this horrible tickle. It just never seems to go away, but that is not for today to discuss. So what is all of this? OK, the North Star response is a test that was developed by a company called Billion to One. And yes, that name is intentional because of the precision involved. It’s a next generation sequencing test, meaning it reads DNA at an incredibly detailed level. And it looks at something called methylated circulating tumor DNA or methylated CT DNA. Now let me break this down in plain English for you, because this can get a little overwhelming. When the cancer cells die or shed, they release tiny fragments of DNA into your bloodstream. We call this cell-free DNA or CFDNA, and it’s hidden within that cell-free DNA. And there are fragments that come from tumor cells. We call those CT DNA or circulating tumor DNA. Here’s what makes North Star’s response different. Rather than just looking for mutations in that tumor DNA, which is what most liquid biopsies do, and a liquid biopsy is just a blood test, Dr. Deb Muth 13:03This test looks at something called methylation patterns. Think of methylation like a dimmer switch on a gene. In healthy cells, certain genes are switched on and off in a very predictable way. In cancer cells, those dimmer switches go haywire. And cancer DNA has a characteristic hypermethylation, meaning switches are turning on and should be off or off and they should be on. And these patterns are essentially a cancer fingerprint in the blood. Now the North Star response scans more than 2000 locations in the genome for these cancer specific methylation patterns. And then it adds them all up into a single number called the tumor methylation score or TMS. So for Cameron, Cameron’s blood which was drawn on April 20th, 2026, his baseline tumor methylation score came back at 13. Now here’s the critical thing, to understand this was his baseline test, his starting point. And the real power of this test is in serial monitoring, meaning we run it again and again and again over time. And if that number goes up, the cancer activity is likely increasing. If it goes down, we’re likely suppressing the tumor activity. And if it stays flat or falls, that’s telling us that the disease is responding. So this is now in the blood. We have an actual fingerprint and every test from here forward will be compared to this number. Now let’s talk a little bit about this because I was not familiar with this test at all. I wasn’t sure what to expect. I wasn’t sure what to do with it. I did not order this test. He’s working with Inveda Medical and they are fabulous over there. I will tell you that from the beginning. This is coming from a practitioner and from a mother-in-law. They were absolutely wonderful to us. So when I saw this North Star, I didn’t know, should it be zero? Should it be a hundred? And when I talked to the doctor, he said, Dr. Deb Muth 15:29This number is actually really good. An average person walking around who’s never been diagnosed with cancer, who doesn’t have cancer, their number will be between 75 and 100. Cameron’s was 13. I think that’s fantastic. But what was the first question that went through my head? It’s probably the same question that you guys are doing. How can he have cancer with a number of 13 when it’s less than the normal average? And if we’re supposed to use this to track what’s happening with his cancer, how are we going to do that once we remove the cancer? Is this number going to go to zero? And it could possibly do that. And we may not be able to use this to track whether or not the disease is actually gone. But what we can do is use this to track over the course of his lifetime to see if the cancer cells are coming back long before we detect them on imaging. And that’s the huge part of this.So this is not a test that just anybody should go out and get because you’re worried about cancer. It is a test that should be done in somebody that is already diagnosed with cancer. So let’s start by making sure we explain that, okay? So imagine if every time your cancer cells are active and they’re shedding and they’re multiplying and they’re fighting back, they’re leaving a signature in your blood not just any signature, but a specific chemical tag that says, cancer’s here. That’s what the North Star Response Test reads. Those tags across thousands of locations and gives us a single score. So we track that score over time like a thermometer for your tumor. If it goes up, we get concerned. If it stays stable or goes down, we celebrate. And we can catch a change in the blood often months before it will show up on a scan. Pretty important when we’re talking about surveilling somebody for cancer returning, when we’re worried about it, and everybody knows the cancer patient is always worried after they get that clean bill health that something’s gonna come back, and most of the time they’re told that there is no way for them to determine that or know that from a blood test. And here is the blood test that can tell us, yes, it can. Dr. Deb Muth 17:51So I would really encourage you guys to talk to your oncologist about this. If you can’t find an oncologist that will do this, talk to an integrative cancer doctor. They will most likely be familiar with it. If not, ask them to find it for you and order it for you. So next, let’s talk about that genetic blueprint because North Star Select is a different test also by billion to one run on the same blood draw, but this one is doing something completely different. This is a comprehensive genomic liquid biopsy. Liquid biopsy just means blood tusks, meaning it’s looking for specific mutations in 84 cancer related genes, all from a blood sample, no biopsy needle, no surgery, just a blood draw. It looks for CNVS, single nucleotide variants, tiny one-letter typos in the DNA code. It looks for indels, small insertions or deletions in the DNA. It looks for copy number changes, the sections of the genomes that are duplicated or deleted. It looks at fusions. So when two genes incorrectly link together to create a dangerous hybrid, MSI status, micro satellite instability, which tells us whether immunotherapy is likely to work. And it has extraordinary sensitivity. It can detect a mutation that represents as little as 0.15 % of cell free DNA in the bloodstream. That is an almost impossibly small signal in the ocean of genetic noise. So what did this show for Cameron? This is where Cameron’s case gets clinically fascinating and where it tells the story of how his cancer is being held in check. Two major mutations were identified as actionable. One was called CRAS G12C. Dr. Deb Muth 20:11And it’s a variant-ELI fraction at 0.1%. Now, CRAS, if you’ve spent any time in integrative oncology, you’ve heard this name. CRAS is one of the most well-known oncogenes in cancer biology. Think of it like an accelerator pedal in the car. In a healthy cell, CRAS pushes the cell to grow when it receives the signal to do so. And then it stops. In cancer, crass gets stuck in the go position, like on the accelerator, foot on the accelerator, to the floor, going as fast as you can around that track, right? But it’s stuck there permanently. It doesn’t turn off and it’s supposed to be turning off. The G12C variant specifically is a mutation at a very precise location. Position 12 of the CRAS protein, where a glycine is replaced by cysteine. And this matters because CRAS G12C is now a drugable target. There are FDA approved drugs specifically designed to lock this mutation into its inactive state, essentially putting a foot on the brake. Now those are drugs like, and I’m gonna slaughter these names, Sordisib, a brand name is Lumacras, and Atacras, the brand name is Crastol. Neither is yet FDA approved for breast cancer, but they are approved for lung and colorectal cancer with CrasG2C. And Cameron’s tests identified 10 active clinical trials within a region that he could potentially qualify for with this mutation. The fact that his CRAS G12C is circulating at only 0.1%. That is a very low fraction. We call that a VAF, V-A-F, very low fraction. And it tells us something important. It means that this mutation is present in a small subclone of the tumor. It’s not the overall tumor burden. So either way, when we identify, we know it’s there. Dr. Deb Muth 22:37We can catch it and we can watch it. Now, here’s another interesting thing that we saw. His TP53 was at 0.23%. This is a tumor suppressor gene, the guardian of genome. And this gene is responsible for telling damaged cells to either repair themselves or self-destruct. And when it mutates as it is here in the position R196Q, that guardian goes off duty. The cell no longer has a reliable mechanism to prevent uncontrolled growth. So TP53 mutations are present in roughly 50 % of all human cancers. And there’s currently no FDA approved drug directly targeting the TP53 but there are clinical implications. TP53 mutant tumors may respond differently to chemotherapy and several investigational approaches, including TP53 vaccines and aurora kinase inhibitors are under active investigation. So we are seeing things happen in this part of cancer right now. Now there’s something called the VUS list and we are watching This is what we’re watching. beyond those two actionable mutations, NORSTAR Select identified what we call variants of an unknown significance, VUS, adenocarcinoma of an unknown significance, ACUP. These are mutations where we don’t yet have enough clinical evidence to determine whether they’re driving cancer or not, but we watch them. So on our mutation list was CDH1, a gene linked to hereditary gastric and lobular breast cancer, CDKN2A, a tumor suppressor cell cycle regulator, CDK12, involved in DNA repair, EGFR, ERBB, this is HER2 receptor, tyrosine kinases. Dr. Deb Muth 24:55I thought this one was pretty interesting since he had an IHC that showed a three plus HER2, but then when we confirmed it with FISH, FISH showed that was negative, but now we’re actually seeing genes expressing this HER2. So is there a HER2? Is there not a HER2? This is really important because if we don’t get these diagnoses right in cancer the first time, people will spend months and years treating the wrong type of cancer with the wrong type of medication. And this may be in part why some people do better than others. If we get it right out of the gate, they do good. If we don’t get it right out of the gate, they don’t do so good. Very important to have the actual genetic makeup of the tumor that’s growing in somebody. Now last, we have something called Notch C1, NRAS and RAF1. These are key pathway components. Now all of these were at very low baffs under 0.5%. These are just whispers, not shouts, but whispers that this cancer is excreting, but your body is listening. We have to be listening. We have to be able to watch these things and monitor these. Now here’s another note of clinical interest. It was an androgen receptor positive cancer. So also detected as a VUS.We know from tissue pathology that Cameron’s tumor was androgen receptor positive. So seeing this in circulation confirms that this AR expression of the cells are present in the bloodstream and that an anti-androgen approach remains worth considering. What that means is suppressing the testosterone. What all of you know I’m about ready to say is that I hate ever suppressing hormones, especially in a 38 year old male. That is not necessarily a good thing. So before we go suppressing hormones willy-nilly, we have to know that it’s the right thing to do. And we have to be able to combat all of the complications that are going to result of that. A 38-year-old male with no testosterone could lead to heart disease down the road, could lead to bone loss, could lead to dementia, Alzheimer’s. Not to mention the sexual side effects that are going to be present. And in a man that is very, very Dr. Deb Muth 27:20Difficult for someone to manage. So you have to be very specific and you want to be very, very diligent about what you’re doing in these cases like this. Now the MSI status was not detected. This tells us that cancer is not a microsatellite instability high, meaning that standard monotherapy may have a lower baseline response of probability and the strategic integration that we’re working with with in Vita could create an immunogenesis genicity becomes even more critical. So immunotherapy is going to be very critical in a cancer case like this and working with somebody that understands that and can carefully navigate that, especially if you have an autoimmune disease like Hashimoto’s or lupus, this is all very, very pristine and has to be looked at very carefully and done very diligently in order for somebody to do this without overstimulating that immune system and causing more problems. So when we looked at the blood and found this DNA fingerprint of the cancer cells circulating in the body, from that, what we see exactly is the genetic switches that are stuck on. They’re stuck on in the wrong position. This tells us which drugs were designed to fix exactly that problem. And it opens the door to clinical trials built for these specific mutations. It also gives us a list of things to watch for over time. And if one of those tiny little signals starts to grow, we know that cancer is gaining a ground in that area. And if it shrinks or disappears, we know we’re winning. This is like, I cannot tell you how exciting this is in the cancer world and the medical world because this is really pristine cancer therapy that we’re dealing with here. And to be able to have this is just so important to life saving events in treating cancer. So. Dr. Deb Muth 29:41Let’s talk about something called the Dittar Chemoscale. This is the battle before the battle. Okay, so I’ve saved the most remarkable test for last, and this is one from a company called Dittar Cancer Genetics. They’re based out of the UK. They are CAP and CLIA certified, which means it meets the rigorous standards required for clinical laboratory testing in the US. And this test is called the ChemoScale. And it is a live cell chemosensitivity assay. So let me explain exactly what that means because it sounds complex, but the concept is actually quite elegant. When we drew the blood from Cameron, the Dittar’s laboratory isolated what are called circulating tumor associated cells or CTACs. And these are actually living cancer cells and they’re associated cells that are traveling through his bloodstream. Excuse me. So let’s think about that for a moment. Real live cancer cells isolated from a blood draw. Those living cancer cells were placed into a lab environment and exposed to over 70 different drugs, both conventional chemotherapy agents and what we call repurposed drugs. I’ll talk more about those in a minute. The lab then measured how many of those cancer cells were killed by each drug expressed as a percentage of cell death. So the scale runs from zero to a hundred and below 25%, that drug doesn’t work well against any type of cancer in that person. Might work great in somebody else, but in that particular person’s cancer that they have, it’s not gonna work so great. Anything that’s 25 to 50 % is intermediate and above 50 % is a high response. And that’s really where Dr. Deb Muth 31:43we want to be. We want to see anything higher than 50 % because that’s a great medication that can be used to kill the cancer. This is not a theoretical test. This is not based on tumor’s genetic sequence and the computer algorithm that predicts the drug response. This is a HIS actual tumor cell being killed or not being killed in real time. That is the difference. So in traditional chemotherapy, we have our protocols. If you have triple negative breast cancer, if you have HER2 positive breast cancer, if you have prostate cancer, if you have colon cancer, here’s the protocol that you’re going to use because that’s the type of cancer you have. That’s what’s been studied. Now, the problem is most of these cancers have mutated over time, especially depending on how long they’ve been in your body, because that’s what they do to try to survive. They have to change so they can survive because your immune system’s constantly trying to kill them. And so this is a really important thing. And if we don’t take an individual into response or into our thought process when we’re creating these protocols, we may give a drug that doesn’t work at all towards that cancer and you just wasted seven cycles of chemotherapy with a drug that never would have worked in the first place or had such low resistance to it that it’s now just created side effects for you but did nothing to the cancer. And then we pull out another drug and we try that. And then we pull out another drug and we try that. Instead of us knowing precisely what we can use and what we can do. And this goes for both the conventional world and the alternative world. In the alternative world of cancer, we use things like IV vitamin C and tumeric and lately ivermectin and fenbendazole and mendendazole and all kinds of other things. And if we are not truly aware that this is going to do anything, we could be wasting somebody’s time and money. So I love that this test is available. I want to walk you through a little bit about what Dr. Deb Muth 34:01we are what we saw in our case, because I think this can make a big impact on people to ask the right questions. So this particular blood test looked at several different drugs. Cameron had sensitivity from 44 % up to 61 % on different medications. Now he was really lucky. The three main drugs that they would use to treat his cancer he had greater than a 50 % response to. So that was great. However, the drugs that were recommended for him to use out of the gate had less than 50 % activity. So he would have had one drug that was really good, one drug that was not so good. And we don’t know what the outcome would have been, right? So I think this is such an incredible, incredible test to have done. This is critical friends. I’m telling you if his oncologist had chosen the two drugs based on the general guidelines for his tumor, his cells would have largely not survived. But because we ran this test, we know. So we know to avoid the drugs that won’t work and we focus on the firepower where it really counts. So I want to also talk about this repurposed drug result because this is where it gets integrated for us. Now, this section is what I want everyone in our community, our Let’s Talk Wellness community, our members to understand. This is where conventional medicine and integrative medicine intersect in a peer-reviewed clinical validated way. So the Dittar test looks at live cancer cells against what they call repurposed drugs, meaning pharmaceuticals and natural compounds that were developed for the purposes, for other purposes, like it could be an antibiotic, it could be an herbal medicine, it could be all kinds of things, vitamins, whatever. But they have demonstrated anti-cancer activity in research. And when we’re talking about integrative medicine, this is a lot of where we get Dr. Deb Muth 36:26The integrative protocols from because these particular drug compounds are known for having anti-cancer benefits. And so that’s how integrative protocols get developed. But again, it could be just like medication, like cancer drugs. If your body doesn’t have a susceptibility to it, then you’re using a product that’s not necessarily going to work. And we all know we cannot take everything that somebody recommends just simply because it has an anti-benefit to whatever it is we’re treating. There’s only so many supplements you can take. There’s only so many things you can do before you get burnt out on taking it. We call it supplement fatigue. And so we want to be very precise with what we’re doing and target this very specific area. So one of the things that showed up really, really well for our case was artemisium, sweet wormwood. It’s an anti-malarial drug that has very potent anti-cancer effects. Now I found this extremely interesting in Cameron’s case because he does have a positive tick-borne illness called Babesia. And this is one of the things that we use to treat Babesia. The other thing I think is very interesting in this case is we are studying how parasites affect cancer these days. And that’s how Ivermectin, Fenbendazole, and Menbendazole have all gotten thrown into the treatment of cancer. And so for this drug or this herb to be sensitive to this type of cancer is really intriguing to me in the world of parasites and how parasites are truly decreasing the body’s immune system and causing cancer to grow. Another thing that worked, showed up really well for him was Valprolac acid. It’s an anti-seizure drug with HDAC inhibitor properties, and this disrupts cancer cell gene expression. There was a soy formula that showed up really well. Naltrexone, you guys have heard me talk about low dose naltrexone, LDN. This actually stimulates an endogenous opioid immune response feeling, and this drug actually showed up really well. Dr. Deb Muth 38:49Something as simple as quercetin. It’s an anti-inflammatory. This is a crass inhibitor in some studies. So this is really important. I’m sure most of you have heard about the benefits of green tea and green tea also actually has anti-angiogenic or anti-cancer benefits to it. Hydroxychloroquine, very popular drug. It’s another anti-malarial drug. So again, now we have two anti-malarial drugs that are susceptible to this type of cancer. And on top of it, he has a positive babesia test. So just saying, you got to connect the dots sometimes. You got to think outside the box sometimes. Metformin is very well known as a anti-proliferative in cancer. We use it to suppress the sugar because sugar feeds cancer. Nobody should be eating sugar if they have cancer. So this one showed up as well. And then CBD, we all know of the benefits of THC, the Rick Simpson oil, and CBD can be tested to see if that is beneficial to a particular cancer cell. This is different than THC. THC works very differently in cancer. CBD is your healthy component of it. It’s the part of the marijuana plant that does not make you high. So very important here. So now let me be very clear, because I always try to be very clear. This is not FDA approved. I’m going to repeat that. This is not FDA approved. This test is a laboratory developed test, not FDA cleared. These results represent in vitro testing, meaning in a lab, not inside the human body. And the results can differ in what we call in vivo, inside the body. And this is why I always say work with a qualified clinician who can interpret these results in full clinical context. But here’s why this matters. We now have evidence, live evidence of a cancer cell that shows sensitivities to compounds that are accessible, relatively safe, and some of which he may already be using, which some of them we were. Dr. Deb Muth 41:13We were already using some of them, which made us sit back and say, this cancer has been in there for two years. If it’s a triple negative breast cancer, it’s supposed to be an aggressive breast cancer that should have spread to a different organ already after two years. It is not, it has stayed in one spot. Also interesting in this case is that there is no breast tumor that they could find anywhere. This was all confined to the axilla into the lymph node. So to have this growing for this period of time with such a small tumor marker number, that 13 that we talked about in the North Star test originally, and to see some mutations, there’s a lot of questions to this particular case. And there are lots of questions to everybody’s cancer case. They are not all straightforward cancer cases. So this is what’s important to understand this fingerprint of these cancer cells so that you can identify exactly, exactly what’s going on and treat it exactly the correct way. Super important. So this kind of information gives us the direction in an integrative protocol. It’s not guessing. This is not eat more tumor, I can hope for the best. This is personalized tumor specific precision guided integrative oncology. It is very precise. There are several countries, several clinics like this around the country that offer this type of therapy. If it’s something that you’re interested in doing, I would encourage you to look at in Vita Medical. Hope for Cancer is another great facility. There are several great facilities around the country. Like I said, that could put together an integrative approach for you if this is something that you are thinking about doing. If you’re looking for answers, if you’re in stage four or stage three and you are not getting the results that you want to get, you want to look at a different approach. You want to do a combo approach of integrative medicine and traditional medicine and alternative medicine. Dr. Deb Muth 43:37I think this is so important to look at and have experts on your team. You know, in our case, Cameron’s cancer is very complex. It’s genomically aggressive in its presentation, yet it’s not progressing to distant areas, which is so wonderful. And I want to be careful here. I can’t tell you with certainty that this is any one thing. Biology is complex. Cancer is adaptive. It’s trying to survive. That’s what it is supposed to do. It is changing its shape. It’s changing its genetic structure. It’s changing everything to try to survive and try to hide against your immune system. Now we are not even close to the finish line in our journey, but what I can tell you is that what the integrative precision approach has done that standard care alone might not do. I can tell you that today and I will share our journey along the way for any of you that are going through this that want to look at a different approach as well because I think it’s important to have this information. So first of all, we know the tumor’s fingerprint. North Star response gives us that TMS score. so we can track it over time. And if the cancer tries to gain ground, we’ll see it in the blood before a scan, we’ll show it. We know the cancer’s genetic vulnerability. We know how to handle the DNA now. We know the watch list of things to look for. And when those signals start to grow, we have a roadmap of how to address it next, how to change it. We know which drugs will automatically work against the tumor cells. We’re not guessing based on a tumor type. We tested the cells. We know how many drugs in the commercial world and in the repurposed world will and will not work. And this is going to guide the treatment protocol that we walk forward with. So we’re not giving him drugs that won’t work or have a low response. Dr. Deb Muth 45:55We’re avoiding them completely and that matters because every ineffective drug is a dose of toxicity with no benefit. There is no lie to this. Chemotherapeutic drugs are toxic. That’s how they kill the cells, but they kill the good cells and the bad cells. And if we can avoid using a drug that’s not going to work, that is so important. And then we’re layering in those repurposed and natural compounds with proven activity against specific cells. This is not complementary fluff. This is biologically active tumor tested precision medicine. Very, very important. So here is what I need you all to know and what I want you to walk away with today. If you or someone you love is facing a cancer diagnosis before treatment starts, before the first infusion goes in, I want you to ask these questions so quick. Go grab something to write with. Pause this if you need to, because this is really, really important for you to do that. And we’re going to take a break for just a second while you guys go and do that. We’re going to give you a word from our sponsor, and then we’re going to come back. And I’m going to give you the four questions that I want you to ask specifically of your medical team so that you have the answers and the ammunition that you need to work with. So we’ll be right back. Dr. Deb Muth 47:29All right, everybody, welcome back. I hope you got your pencil, your paper, your pen, your phone, whatever you’re going to take notes with because this is important. So I’m to give you four questions that I want you to ask your medical team before you get started. Question one, can we do a chemo sensitivity test before we choose a chemotherapy regime? Ask specifically about DATAR, D-A-T-A-R. cancer genetics, Oncostat Plus, or a similar functional chemosensitivity platform. Very, very important to ask those specific things. All right, question two. Can we do a comprehensive liquid biopsy to identify actionable mutations and monitor tumor burden? Ask about North Star Select, Billion to One, Guardian 360, or Foundation One Liquid CDX? I’m gonna say those for you one more time, because I said them kind of fast. North Star Select by Billion to One, Guardian 360 or Foundation One Liquid CDX? Okay, question three. Can we establish a baseline tumor methylation score, TMS, so we have a surveillance marker to track over time? and ask specifically about the North Star Response Test. All right, question four. Is there an integrative oncology center that can layer precision guided natural compounds alongside conventional treatment? Research institutes like Inveda Medical Center, CTA CA Integrative Medicine, or Hope for Cancer, these people are doing integrative medical miracles. Let me tell you, I have researched every one of them. I have spoken to each of them individually before we made our decision of who we were going to work with. They are all fantastic. You want to work with an integrative nurse practitioner who understands oncology. And if you’re working with an integrative practitioner, you want to ask them these same questions about this test so that you can get the best outcome. Dr. Deb Muth 49:56For what you’re dealing with. You are allowed to ask these questions. You are allowed to want more information from that protocol that was designed for the average patient. You’re not average and your cancer is not average either. And your care doesn’t have to be. You do not have to settle for the same thing that the person sitting next to you in the IV suite is dealing with when you both have different cancers excreting different genetic material. This is so incredibly important. want to make sure you understand precision medicine is what changes the lives for people every single day, every single day. So I started this episode by telling you about a 38 year old man with a cancer that baffled conventional medicine and integrative medicine, an occult primary that was not found complex genetic genomic profile, a presentation that in many hands might have resulted in a one size fits all treatment protocol and a prayer. And instead we ran the tests, we mapped the fingerprint, we watched the cells, we guided the protocol, and we are still fighting with precision, with data, with intelligence. This is what Let’s Talk Wellness is all about not giving up. This is what not accepting we don’t know as a final answer and demanding the level of scrutiny and personalization that every cancer patient deserves. So if this episode resonates with you, please share it because somewhere out there, there is a person who is about to get the wrong chemotherapy because no one ran the right test. And maybe, just maybe, that This episode will be the reason someone asks the right question at the right moment. If you’re going through something like this, you need a group, you need somebody to connect with, please join our free Facebook group called Seen At Last. It is where we support one another, we share this information, we share knowledge, and we help people for free support and ask the right questions. Dr. Deb Muth 52:23And if you’re inclined in your heart to pray, pray for Cameron, we could use every ounce of prayer. If you are in a position where you can help support this journey financially, we do have a fund going in free funder. I can post the link below. Every little bit helps. If you have $5, $500, it doesn’t matter. We’re raising money for this treatment. And along the way, I am documenting every step of what we’re going through so I can provide more episodes like this for you guys to share the outcome and share what our journey is like so that it can help the next person along. I really always believe that whatever happens to us happens to us because we’re meant to share it. That’s why I’ve shared my personal journey. I’m sharing his personal journey and we want to help other people. So until next time, I’m Dr. Deb. Keep asking questions, keep advocating, and never ever accept being unseen.The post Episode 274 – Stop Guessing on Chemotherapy: The Live Cell Test Most Doctors Miss first appeared on Let's Talk Wellness Now.

What do you do when you're 31, just bought your first house, and hear the words "you have breast cancer"? In this powerful episode, Jen sits down with Jessica Slocumb — a nearly nine-year breast cancer survivor, prevention advocate, and the heart behind the Instagram community @breast.friends_united. Jessica shares the moment everything changed, from feeling a lump while getting ready for work to the radiating pain she believes was God telling her to get checked. We talk about her stage 2, estrogen- and HER2-positive diagnosis, five rounds of chemo, a double mastectomy, and the year of HER2 infusions that followed — plus the honest, messy, in-between parts no one prepares you for. Jessica opens up about the testimony she received on her front stoop, the question her oncologist couldn't answer ("what caused this?"), and how that one unanswered question sent her on a journey to research the lifestyle, environmental, and wellness factors so often left out of the conversation. This conversation is for any woman who's newly diagnosed, in the thick of treatment, or trying to reduce her risk — and for anyone who loves someone walking this road. In this episode we cover: Finding a lump at 31 and why she almost skipped the mammogram Her full treatment path: chemo, double mastectomy, tissue expanders, and recalled implants The "we don't know what causes cancer" answer that changed everything Small, doable swaps to reduce everyday toxic burden — laundry detergent, skincare, food, candles, and water Why diet and going organic were her first changes (glyphosate, grass-fed, pasture-raised) The 28-day study on switching to non-toxic products and breast cancer gene expression Childhood trauma, nervous system regulation, and why stress is part of healing How cancer reshaped her relationships — and the wisdom her husband gave her Releasing the fear of recurrence and living fully anyway Her message for the woman hearing "you have breast cancer" tonight "God takes our ashes and turns them to beauty. This is only a season — your world is not over." Connect with Jessica: Instagram: @breast.friends_united A note: This episode is for education and encouragement, not medical advice. Always work with your own care team on decisions about screening, treatment, and prevention. If this episode moved you, share it with a woman who needs it today — someone is sitting alone in her diagnosis right now, and your share might be the thing that reaches her. And as always… Not Today Cancer.

Welcome back to the Oncology Brothers podcast! In this episode, we were joined by Dr. Nina Sanford, a GI radiation oncologist from UT Southwestern, to discuss a critical topic in cancer treatment: when to hold and not to hold systemic therapy during radiation and for how long.   Join us as we explore: The framework for balancing systemic therapy with different types of radiation, including SBRT, palliative, and conventional radiation. Insights on managing cytotoxic chemotherapy, immunotherapy, TKIs, and targeted therapies in conjunction with radiation. The importance of individualized treatment plans and the evolving data around various drug classes, including BRAF inhibitors, PARP inhibitors, and anti-HER2 therapies. Practical recommendations for community oncologists navigating these complex decisions.   Listen us on: Spotify: https://open.spotify.com/show/31BXhY9FM4gPWG10WgE11o   Follow us on social media: X/Twitter: https://twitter.com/oncbrothers Instagram: https://www.instagram.com/oncbrothers Website: https://oncbrothers.com/ Don't forget to check out Dr. Sanford's teaching video for more in-depth information! #RadiationOncology, #SystemicTherapy, #SBRT, #MultidisciplinaryCare, #OncologyBrothers

Featuring perspectives from Dr Joyce F Liu, Dr David M O'Malley and Dr Brian M Slomovitz, moderated by Dr O'Malley, including the following topics: Introduction (0:00) Strategies to Identify Patients with HER2-Positive Gynecologic Cancers — Dr Liu (2:52) Available Data with and Practical Application of HER2-Targeted Therapy in Advanced Gynecologic Cancers — Dr Slomovitz (25:16) Identification and Management of Adverse Events with Trastuzumab Deruxtecan — Dr O'Malley (1:00:31) CME information and select publications

In this podcast, experts Hope S. Rugo, MD, FASCO; Fabrice André, MD, PhD; Nadia Harbeck, MD; and Heather McArthur, MD, MPH; discuss updates from the SERENA-6, evERA, PREcoopERA, and TRAK-ER trials of oral selective estrogen receptor degraders (SERDS) in patients with hormone receptor–positive/HER2-negative (HR+/HER2–) early, advanced, and metastatic breast cancer (MBC). These results were presented at European Society for Molecular Oncology (ESMO) Breast 2026.

Marilyn is an attorney, CPA, and president of the Bill and Helen Crowder Foundation, the private foundation whose generosity helped build The Rose's podcast studio. She has been a Rose patient since the late 1970s, when she came in for her very first mammogram after moving to Houston. Decades later, she found herself in a very different role, as a Stage III HER2 positive breast cancer patient. Her advice is simple and direct: check yourself between mammograms, get second opinions, take care of yourself first, and know that The Rose and organizations like it exist so that every woman, insured or not, has a path to care. Support The Rose HERE. Subscribe to Let’s Talk About Your Breasts on Apple Podcasts, Spotify, iHeart, and wherever you get your podcasts. Key Questions Answered 1. How can a woman with a clean mammogram and ultrasound develop stage three breast cancer within eight months? 2. What does HER2 positive breast cancer mean and how does it affect treatment options? 3. What does a full 18-month breast cancer treatment plan look like, from the Red Devil through post-op chemo? 4. What are the visible side effects of aggressive chemo, including hair, nail, and eyebrow loss, and how do women manage them while working? 5. How did Marilyn continue working through 18 months of treatment and what did that decision do for her mentally? 6. What is the cold cap and why do some patients choose not to use it? 7. What are the stakes of declining post-op treatment, and how should a woman weigh a 45 percent recurrence risk? 8. How does a very private, high-achieving career woman learn to accept help, say no, and make herself the priority? 9. What role does the Bill and Helen Crowder Foundation play in supporting The Rose's mission, including the podcast studio? 10. How does self-exam between annual mammograms save lives, and why does Marilyn emphasize it so strongly? 11. What practical advice does Marilyn offer to women facing a breast cancer diagnosis for the first time? Timestamped Overview 00:00 Dorothy introduces Marilyn Sims: attorney, CPA, president of the Bill and Helen Crowder Foundation, and the donor behind the podcast studio. She previews Marilyn's stage three HER2 positive diagnosis, 18 months of treatment, and her evolution from private person to open advocate. 00:52 Dorothy describes Marilyn's treatment arc and the shift in her willingness to talk publicly. Episode CTA delivered. 01:49 Dorothy welcomes Marilyn on air and thanks the Crowder Foundation for the studio gift. 02:22 Marilyn gives the history of the Bill and Helen Crowder Foundation: established in 1998 under Bill's will, started with $3.5 million, has given away $6 million over 28 years, and still has millions remaining. 03:36 Marilyn explains Bill's passion for children's charities throughout his life, how the foundation was structured to give in perpetuity, and why Helen carried on that mission after his passing. 04:46 Marilyn explains why The Rose, while not a children's charity, fit the foundation's values. Children are affected by breast cancer, and the studio would carry Bill and Helen's legacy forward. 05:36 Dorothy reflects on the studio's impact, including young mothers sharing stories that reach other young women who don't know they could be at risk. 06:25 Marilyn shares that she first came to The Rose for her very first mammogram after moving to Houston in the late 1970s. 06:55 Dorothy asks about Marilyn's background. Marilyn traces her path from a small town to Pasadena, through night school, a business associate's degree at San Jacinto College, an accounting degree at UH Clear Lake, and ultimately to the University of Houston Law Center. 08:30 Marilyn explains how she chose estate planning over bankruptcy and litigation, combining her CPA credentials with her law degree at Ernst and Young before joining her current firm in 1993. 10:43 Dorothy moves to Marilyn's breast cancer story. Marilyn says she was shocked. She ate right, exercised, had no family history, and never anticipated a diagnosis. 11:24 Marilyn describes her screening history: annual mammograms, ultrasounds in recent years, and a clean scan in October 2023. 11:47 In August 2024, she felt a lump just before Labor Day. She made an appointment immediately. On September 13, 2024, she received her confirmed diagnosis. 12:47 Dorothy notes the cancer was particularly aggressive. Marilyn explains: HER2 positive, stage three, with lymph node involvement under the arm and in the neck, within eight months of her last clean scan. 13:30 Marilyn describes her treatment sequence: eight aggressive Red Devil chemo infusions every two weeks starting October 2nd, then mastectomy with same-day reconstruction on the right side, then 30 rounds of daily radiation. 14:58 Marilyn describes the post-op decision point. Scans came back clear, but declining the 14 lower-grade post-op chemo treatments carried a 45 percent recurrence risk. She chose to continue. She finished February 15th of this year. 15:50 Dorothy congratulates her. Marilyn reflects on the predictable rhythm of the later treatments: okay on day one, fine on day two, flu-like on day three, and cumulative fatigue over time. 16:56 Marilyn describes how she emailed her fellow shareholders the day she was diagnosed, asked to keep her routine, and worked through the full 18 months. Her colleagues' support gave her stamina and purpose. 18:00 Dorothy asks how many organizations Marilyn stays active in. Marilyn says staying busy and giving back, particularly to young women and girls, kept her mind off how serious things were. 18:55 Marilyn shares that she has no biological children but has long mentored young women. Her motivation for philanthropy is giving others the opportunity and role models she had access to. 19:35 Dorothy asks about Marilyn's support system. Marilyn credits her husband, who attended every single treatment, sometimes napping in the chair beside her, and her fully supportive office colleagues. 20:37 Marilyn describes the physical side effects of the Red Devil: hair loss, eyebrow and eyelash loss, fingernail and toenail loss, and varying neuropathy. She notes no two patients react the same way. 21:43 Marilyn explains the cold cap option, its time commitment of five to seven hours per treatment session, and the lack of guarantees. She chose wigs instead. 22:29 Dorothy notes that Marilyn's wig was convincing throughout treatment. Marilyn explains she had a custom wig made to match her hair before it fell out, then transitioned out of the wig after 18 months. Her hair grew back curly for the first time in her life. 23:41 Marilyn acknowledges the ongoing anxiety about recurrence and scans. She manages it with a deliberately positive mindset and a carry bag someone gave her early in treatment that reads "You Got This." 24:23 Marilyn describes how talking with other patients, even those with different symptoms and reactions, helped relieve anxiety and provided perspective. 24:59 Dorothy notes that Marilyn was once extremely private. Marilyn reflects on how treatment gradually opened her up, partly because of the sheer volume of medical appointments and people involved in her care. 26:41 Dorothy recalls watching the shift happen in real time. Marilyn explains the difference between being at the beginning of the tunnel versus the end, and how the inability to plan ahead was one of the hardest parts of treatment. 28:08 Dorothy observes that treatment forced Marilyn to stop being Superwoman. Marilyn agrees and names the lesson directly: career women push themselves to be everything to everyone, but you have to make yourself the priority first. 29:34 Dorothy asks if Marilyn sees herself as stronger now. Marilyn says not stronger exactly, but with a clearer sense of priorities, especially the importance of time and quality over constant activity. 30:09 Marilyn delivers her most direct advice: check yourself between mammograms. A year is a long time, and her cancer went from undetectable to stage three in eight months. 30:55 Marilyn advises listeners to explore all treatment options, get second opinions, and be clear with their care team about whether the goal is cure or minimal intervention. 32:20 Marilyn reflects on her insurance advantage and acknowledges how many women raising families and working jobs do not have the same options. She names The Rose's mobile units and reach across Texas as a critical resource. 33:04 Dorothy thanks Marilyn for the foundation's support and for coming on the show. Marilyn expresses genuine relief at being finished with treatment.See omnystudio.com/listener for privacy information.

What do you do when you're 40, building a "perfect on paper" life, and a routine first mammogram turns into a stage 4 cancer diagnosis? In this episode, Jen sits down with Chelsea Hassink, who was diagnosed with HER2-positive breast cancer that had metastasized to her liver — and later her brain — at just 40 years old, with two young kids at home. Chelsea takes us through her entire journey: the intuition that told her it was worse than the doctors first said, six rounds of chemo, her decision to stop treatment and spend a year going fully integrative, and her transformative three weeks at Hope for Cancer in Mexico. She opens up about the brain tumor that led to a craniotomy, temporary paralysis, and a recovery she credits as much to mindset as to medicine. This is a raw, hopeful conversation about refusing to be put in a box, advocating fiercely for yourself, and merging the medical and integrative worlds on your own terms. Chelsea shares the exact framework she lives by, the role faith and prayer have played in her healing, and why she believes the stress she was carrying — not genetics — created the terrain her cancer thrived in. In this episode, we cover: Chelsea's original diagnosis and the "boring" checkup that missed every red flag Why she trusted her intuition over her initial stage 2 diagnosis Stopping chemo after 6 rounds and going integrative for a full year What Hope for Cancer is really like — and the mind, body, spirit work that changed her The bold, specific prayer and the "messenger in the parking lot" that led her to her craniotomy Losing and regaining mobility after brain surgery Where her scans stand today — and how she handles a curveball Finding an oncologist who meets you where you are (without guilt or scare tactics) Her 4-bucket healing framework: Nutrition & Movement, Emotional & Spiritual, Non-Toxic Therapies, and Detoxification Specific therapies: mistletoe, high-dose vitamin C (and how to do it safely), SPDT / sono-photodynamic therapy, hyperthermia, coffee enemas, sauna, red light, vibration plate, acupuncture Her go-to supplements and why supplementation is deeply individual The #1 thing she wishes someone had told her at diagnosis: you have time to pause Resources & mentions: Hope for Cancer (integrative clinic, Mexico) SPDT — sono-photodynamic therapy (light + sound device) Supplements mentioned: black seed oil, beta-glucan, PectaSol (modified citrus pectin), Vitamin D3, curcumin with K2, greens powder Follow Chelsea on Instagram: https://www.instagram.com/hassink_health_bites/ Chelsea's book — currently in the works Community: Not Today Cancer — The Inner Circle GET BrocElite: Mara Labs supplements - Use code NotTodayCancer for 20% off Instagram: https://www.instagram.com/jendelvaux/ Email me: coachjennyd@gmail.com A note: This episode shares personal experiences and is not medical advice. Always work with your own care team before changing your treatment, diet, or supplement routine — especially while on chemo. Don't forget to share this episode so it reaches more people who need it. And as always — not today, cancer.

The FDA has been a bunch of busy bees with new approvals: 1. Sonrotoclax, an exciting new BCL2 inhibitor approved for 3rd-line Mantle Cell Lymphoma 2. An all PO regimen of decitabine/cedazuridine + venetoclax is approved for AML. 3. Zenoctuzumab gets an FDA approval for cholangiocarcinoma with an efficacy patient population = 19 4. T-DXd is a good drug and continues to pile on FDA approvals 5. Adjuvant atezolizumab in bladder cancer is approved in conjunction with ctDNA serial monitoring to determine who gets treatment Check out the Oncology Insights Newsletter: www.kelleycpharmd.com/newsletter-oncopharm