Oncology Spotlight

New regulatory developments and practice-relevant data feature in this week’s Oncology Updates from ONCOassist.

Dr. Stephanie Haddad, Hematology/Oncology Fellow and Academic Chief Fellow at UT Health San Antonio/Mays Cancer Center, covers:

🔹 Multiple Myeloma: A transplant-ineligible subgroup analysis from the Phase III CEPHEUS trial showed that adding daratumumab to VRd reduced the hazard of progression or death by 49% compared with VRd alone (HR 0.51), while increasing MRD negativity to 60.4% versus 39.3%.

🔹 Colorectal Cancer & NSCLC: The c-Met-directed antibody-drug conjugate telisotuzumab adizutecan received two FDA Breakthrough Therapy Designations, one in combination with bevacizumab in refractory metastatic colorectal cancer and another as monotherapy in previously treated EGFR wild-type, c-Met-expressing non-squamous NSCLC. These are Breakthrough Therapy Designations, not FDA approvals.

🔹 Stage III dMMR Colon Cancer: The FDA approved atezolizumab plus chemotherapy for adjuvant treatment. In the Phase III ATOMIC trial, adding atezolizumab to modified FOLFOX6 reduced the hazard of recurrence or death by 50%, with 36-month disease-free survival of 86% versus 76%.

🔹 ER+/HER2− Breast Cancer: Guardant360 CDx received CE marking in Europe as a companion diagnostic for camizestrant in locally advanced or metastatic disease. The blood test can detect ESR1 mutations before disease progression, supporting ctDNA-guided treatment selection.

Reference Links:

https://ascopubs.org/doi/10.1200/JCO-26-00401 

https://news.abbvie.com/2026-10-07-AbbVies-Telisotuzumab-Adizutecan-Temab-A-Receives-Two-Breakthrough-Therapy-Designations-From-the-U-S-FDA-for-CRC-and-NSCLC 

https://www.globenewswire.com/news-release/2026/10/09/3377811/0/en/fda-approves-roche-s-tecentriq-in-combination-with-a-fluoropyrimidine-and-oxaliplatin-for-the-adjuvant-treatment-of-a-certain-type-of-stage-iii-colon-cancer.html

https://www.businesswire.com/news/home/20261008669405/en/Guardant-Health-Announces-Approval-in-Europe-of-Guardant360-CDx-as-Companion-Diagnostic-for-AstraZenecas-ETCAMAH-camizestrant-in-Advanced-ER-positive-Breast-Cancer 

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New FDA approvals and practice-relevant Phase III data feature in this week’s Oncology Updates from ONCOassist.

Dr. Stephanie Haddad, Hematology/Oncology Fellow and Academic Chief Fellow at UT Health San Antonio/Mays Cancer Center, covers:

🔹 ER+/HER2− Breast Cancer: The FDA approved Imlunestrant plus Abemaciclib for adults with ESR1-mutated advanced or metastatic breast cancer following progression after prior endocrine therapy. In Phase III EMBER-3, median PFS was 11.1 months with the combination versus 5.5 months with imlunestrant alone (HR 0.53).

🔹 EGFR-Mutated NSCLC: Phase III ADVANCE evaluated a chemotherapy-free strategy of aumolertinib plus radiotherapy versus concurrent chemoradiotherapy in unresectable Stage III EGFR-mutated NSCLC. Median PFS was 34 months versus 7.4 months (HR 0.15), although the randomized population included only 43 patients and overall survival remains immature.

🔹 Biliary Tract Cancer: Five-year follow-up from Phase III ASCOT confirmed a sustained survival benefit with adjuvant S-1 following resection. Five-year OS was 64% with S-1 versus 52% with observation (HR 0.72), with median OS of 8.2 versus 5.9 years.

🔹 Advanced Renal Cell Carcinoma: The FDA approved Belzutifan plus Lenvatinib for adults with advanced RCC with a clear cell component following prior PD-1 or PD-L1 inhibitor therapy. The approval was based on LITESPARK-011, which enrolled 747 patients.

Reference Links:

https://investor.lilly.com/news-releases/news-release-details/us-fda-approves-inluriyo-imlunestrant-combination-verzeniohttps://www.nature.com/articles/s41392-026-02891-2  https://ascopubs.org/doi/10.1200/JCO-26-00017   https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belzutifan-combination-lenvatinib-advanced-renal-cell-carcinoma-clear-cell-component 

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🎥 Latest Oncology News

Four developments across breast cancer, lung cancer, multiple myeloma and prostate cancer.

In this episode of Oncology Updates from ONCOassist, Dr. Stephanie Haddad reviews:

🔹 HER2+ metastatic breast cancer: The European Commission has approved Enhertu (Trastuzumab deruxtecan) plus Pertuzumab as first-line treatment for adults with unresectable or metastatic HER2-positive breast cancer. In Phase III DESTINY-Breast09, the combination reduced the risk of disease progression or death by 44% versus THP, with median PFS of 40.7 vs 26.9 months.

🔹 Relapsed/refractory multiple myeloma: Phase III CERVINO topline results showed an ORR of 74.0% with investigational Etentamig versus 45.7% with standard available therapies, alongside a 60% reduction in the risk of progression or death.

🔹 Prostate cancer: The randomized STAMINA trial evaluated a 12-month supervised programme combining exercise, dietary advice and behavioural support for men receiving androgen deprivation therapy. Dr. Haddad reviews its reported effects on prostate cancer-specific quality of life, fatigue and overall cancer-related quality of life.

🔹 HER2-mutated NSCLC: The FDA granted accelerated approval to Sevabertinib for adults with locally advanced or metastatic non-squamous NSCLC harbouring HER2/ERBB2 activating mutations, based on response rate and duration-of-response data from SOHO-01.

Reference Links:

https://www.astrazeneca.com/media-centre/press-releases/2026/enhertu-approved-in-eu-for-1l-her2-positive-mbc.html  

https://news.abbvie.com/2026-09-03-AbbVie-Announces-Positive-Topline-Results-from-the-Phase-3-CERVINO-Trial-Showing-Etentamig-Significantly-Improved-Response-Rate-and-Progression-Free-Survival-in-Patients-with-Relapsed-Refractory-Multiple-Myeloma  

https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(26)00304-9/fulltext  

https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sevabertinib-locally-advanced-or-metastatic-non-squamous-non-small 

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🎥 Latest Oncology News

From a landmark mRNA-based individualized neoantigen therapy result in melanoma to an important advance in metastatic pancreatic cancer, this edition brings several major developments across oncology.

Dr. Stephanie Haddad, Hematology/Oncology Fellow and Academic Chief Fellow at UT Health San Antonio/Mays Cancer Center, breaks down four updates oncology professionals should know.

The FDA approved Daraxonrasib, a RAS inhibitor, for metastatic pancreatic adenocarcinoma following at least one prior systemic therapy or for patients not eligible for multi-agent chemotherapy.

In RASolute 302:

• Median OS: 13.2 vs 6.7 months

• Median PFS: 7.2 vs 3.6 months

• Response rate: 30% vs 11%

• OS hazard ratio: 0.40

The European Commission approved Sacituzumab Govitecan + Pembrolizumab for first-line PD-L1-positive metastatic triple-negative breast cancer with CPS ≥10.

Together with its recent monotherapy approval for patients who are not candidates for immunotherapy, Sacituzumab govitecan-based options now extend across PD-L1 status in first-line metastatic TNBC.

In ASCENT-04, the combination reduced the risk of progression or death by 35%.

The Phase III INTerpath-001 trial of Intismeran autogene + Pembrolizumab met its primary endpoint of recurrence-free survival and key secondary endpoint of distant metastasis-free survival in completely resected Stage IIB–IV melanoma.

The study represents the first Phase III readout for an individualized neoantigen therapy or mRNA cancer therapy and the first to outperform Pembrolizumab alone in the adjuvant setting. Detailed results are expected at an upcoming congress, while overall survival remains immature.

New quality-of-life and safety data from the Phase III ALINA trial build on the previously reported disease-free survival benefit with adjuvant Alectinib in resected ALK-positive NSCLC.

Treatment discontinuation was lower with Alectinib than chemotherapy (5% vs 13%), while quality of life improved early and was maintained for more than two years.

Reference Links:https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daraxonrasib-metastatic-pancreatic-adenocarcinoma  

https://www.gilead.com/news/news-details/2026/european-commission-expands-role-of-gileads-trodelvy-in-first-line-metastatic-triple-negative-breast-cancer-across-pd-l1-status 

 https://www.merck.com/news/merck-and-moderna-announce-phase-3-interpath-001-trial-of-intismeran-autogene-plus-keytruda-met-endpoints-of-recurrence-free-survival-rfs-and-distant-metastasis-free-survival-dmfs-in-patient/ 

 https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(26)00283-4/fulltext 

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🧬 Daraxonrasib in metastatic pancreatic cancer🎗️ Sacituzumab Govitecan + Pembrolizumab in TNBC🧬 Landmark Phase III mRNA melanoma result🫁 ALINA: Alectinib in ALK+ NSCLC

👉 Visit https://oncoassist.com/ to streamline patient care with cutting-edge tools, treatment protocols, and calculators! 

🔬In this episode of Oncology Spotlight - Expert Insights, Dr Yüksel Ürün, medical oncologist at Ankara University, reviews key studies presented at the ASCO Genitourinary Cancers Symposium, 2026.

The discussion focuses on clinically relevant trial results across bladder cancer, kidney cancer, and metastatic prostate cancer, highlighting data that may influence treatment decisions in daily oncology practice.

Key Studies Discussed:• KEYNOTE-B15 trial – Enfortumab vedotin + pembrolizumab in muscle-invasive bladder cancer- https://www.asco.org/abstracts-presentations/256834

• LITESPARK-011 – Belzutifan + lenvatinib after IO therapy in kidney cancer - https://www.asco.org/abstracts-presentations/256659 

• LITESPARK-022 – Adjuvant belzutifan + pembrolizumab in high-risk kidney cancer - https://www.asco.org/abstracts-presentations/256660 

• BRCAAway trial – Abiraterone + olaparib combination in metastatic castration-resistant prostate cancer - https://www.asco.org/abstracts-presentations/256832 

Key Clinical Takeaways

✔ EV + pembrolizumab improves event-free survival in muscle-invasive bladder cancer ✔ Belzutifan combinations show promising activity in renal cell carcinoma ✔ Combination PARP inhibitor + ARPI therapy may significantly extend survival in selected mCRPC patients

A must-watch for oncologists and trainees looking for clear, clinically relevant takeaways from the latest GU oncology trials presented at ASCO GU26.

📌 CHAPTERS & TIMESTAMPS

🎙 00:08 – Introduction

👨‍⚕️ 00:14 – Meet Dr. Yüksel Ürün

🧬 00:20 – KEYNOTE-B15: EV + Pembrolizumab in Muscle-Invasive Bladder Cancer

📊 02:30 – Event-Free Survival & Pathologic Response Results

⚕️ 05:18 – LITESPARK-011: Belzutifan + Lenvatinib in RCC

📈 06:20 – Progression-Free Survival Improvement

💊 08:47 – LITESPARK-022: Adjuvant Belzutifan + Pembrolizumab

📉 10:01 – Disease-Free Survival Outcomes

🧪 11:34 – BRCAAway Trial: PARP + ARPI Combination

📊 13:00 – Survival Benefit in HRD-Mutated Prostate Cancer

🔬 15:16 – Clinical Implications for Practice

👋 15:24 – Closing Thoughts

📢 JOIN THE CONVERSATION! ❓Drop your thoughts in the comments below!📲 Oncology at your fingertips.

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🔬In this episode of Oncology Spotlight, Dr. Shaqil Kassam shares a powerful perspective from the front lines of community oncology in Canada.

From drug access delays in publicly funded systems to the real-world challenges of administering bispecific therapies outside academic centers, this conversation dives into the complexity of modern oncology.

We also explore:

• Community vs academic oncology – what truly differs?

• The global equity gap in cancer care

• How AI is already transforming clinic workflows and pathology

• The real challenges behind sequencing new therapies

• Why equitable access remains the biggest global barrier
  

 This is a must-watch for oncologists, trainees, and healthcare leaders navigating rapid innovation in constrained systems.

Check out the MedOncNow podcast: https://medoncnow.podbean.com/

📌 CHAPTERS & TIMESTAMPS

🏥 00:00 – The Biggest Issue: Drug Access in Public Healthcare

🎙️ 00:36 – Introduction & Guest Overview

👨‍⚕️ 01:07 – Dr. Kassam’s Journey to Medical Oncology

🌍 03:29 – Community vs Academic Oncology Explained

📊 06:33 – Are 80% of Patients Treated in Community Settings?

🤝 08:00 – Collaboration Between Community & Academic Oncologists

🎧 08:44 – The MedOncNow Podcast: Why It Started

💊 10:49 – Practical Implementation of New Cancer Drugs

🌎 13:07 – The Future of Oncology in Canada

⚖️ 16:05 – Equity: Canada’s Strength & Global Weakness

🌍 17:05 – Barriers to Global Cancer Care

🧠 21:40 – AI in Oncology: From Dictation to Digital Pathology

🎓 25:14 – Advice for Future Oncologists

📢 JOIN THE CONVERSATION! ❓Drop your thoughts in the comments below!📲 Oncology at your fingertips.

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 👉 Visit https://oncoassist.com/ to streamline patient care with cutting-edge tools, treatment protocols, and calculators! 

🔬In this episode of Oncology Spotlight, Dr. Shaqil Kassam shares a powerful perspective from the front lines of community oncology in Canada.

From drug access delays in publicly funded systems to the real-world challenges of administering bispecific therapies outside academic centers, this conversation dives into the complexity of modern oncology.

We also explore:

• Community vs academic oncology – what truly differs?

• The global equity gap in cancer care

• How AI is already transforming clinic workflows and pathology

• The real challenges behind sequencing new therapies

• Why equitable access remains the biggest global barrier
  This is a must-watch for oncologists, trainees, and healthcare leaders navigating rapid innovation in constrained systems.

Listen to MedOncNow Podcast: https://medoncnow.podbean.com/

Watch on YouTube: https://youtu.be/i99YKaCArwI

📌 CHAPTERS & TIMESTAMPS

🏥 00:00 – The Biggest Issue: Drug Access in Public Healthcare

🎙️ 00:36 – Introduction & Guest Overview

👨‍⚕️ 01:07 – Dr. Kassam’s Journey to Medical Oncology

🌍 03:29 – Community vs Academic Oncology Explained

📊 06:33 – Are 80% of Patients Treated in Community Settings?

🤝 08:00 – Collaboration Between Community & Academic Oncologists

🎧 08:44 – The MedOncNow Podcast: Why It Started

💊 10:49 – Practical Implementation of New Cancer Drugs

🌎 13:07 – The Future of Oncology in Canada

⚖️ 16:05 – Equity: Canada’s Strength & Global Weakness

🌍 17:05 – Barriers to Global Cancer Care

🧠 21:40 – AI in Oncology: From Dictation to Digital Pathology

🎓 25:14 – Advice for Future Oncologists

📢 JOIN THE CONVERSATION! ❓Drop your thoughts in the comments below!📲 Oncology at your fingertips.

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🔬In this episode, Dr. Shreyas Kalantri shares his journey from medical training in India to academic oncology in the United States, and reflects on what truly defines progress in cancer care.

The conversation dives deep into quality of life as a critical endpoint, disparities in immunotherapy access, the role of academic research, global oncology collaboration, and how AI can reshape oncology workflows. Dr. Kalantri also discusses his work with the HemOnc Fellows Network and ASCO’s Training & Early Career Advisory Group, highlighting the importance of mentorship and democratizing oncology education worldwide.

This episode is essential listening for oncologists, trainees, and healthcare professionals navigating the rapidly evolving oncology landscape.

🔹 Key Topics Covered

• Why quality of life should contextualize survival outcomes

• Gaps in quality-of-life reporting in clinical trials

• The HemOnc Fellows Network

• Academic oncology vs community practice

• Global oncology and trainee mentorship initiatives

• AI, digital tools, and the future of oncology workflows

• Advice for trainees considering a career in oncology

🎬A must-watch episode for oncologists, trainees, and healthcare leaders shaping the future of cancer care.

Connect with Shreyas Kalantri here: https://www.linkedin.com/in/shreyaskalantrimd/ 

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🔬In this episode of Oncology Spotlight, we sit down with Katy Winckworth-Prejsnar, Director of the Global Program at NCCN (National Comprehensive Cancer Network). Katy offers a behind-the-scenes look at how NCCN’s guidelines are being adapted and implemented globally especially in low- and middle-income countries.

She speaks on equity in access to cancer care, the challenges and opportunities in global implementation of NCCN Guidelines, and her unique path into oncology from a background in cancer genetics, community outreach, and health equity.

🧭 What you’ll learn in this episode:

• The mission of NCCN’s Global Program and its real-world impact

• How local adaptation of guidelines empowers low-resource settings

• Challenges in global cancer guideline dissemination

• Why policy, education, and advocacy are just as important as treatment

• Katy's powerful career journey into global oncology
  

🎧 Listen now and get inspired by how strategic collaboration and culturally informed adaptations are shaping the future of oncology around the world.

Connect with Katy Winckworth-Prejsnar here: https://www.linkedin.com/in/katywinckworthprejsnar/

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🔬We sit down with Dr. Douglas Flora, Executive Medical Director at St. Elizabeth Healthcare and Editor-in-Chief of the AI in Precision Oncology Journal. In this episode, Dr. Flora shares how artificial intelligence is revolutionizing oncology, from early detection and precision treatment to the importance of human-centered care in an increasingly tech-driven world.

Dr. Flora shares his candid insights on:

• How AI is being used in cancer detection and diagnostics

• The ethical challenges of integrating AI into clinical practice

• Why human connection remains at the heart of great cancer care

• Building emotionally intelligent care teams

• Leadership lessons from years on the front lines of oncology

• The mission behind the AI in Precision Oncology Journal

🧠 “AI won’t replace oncologists — it’ll empower them.”

📌 Don’t miss this powerful discussion on the intersection of compassion, tech, and cutting-edge cancer care.

Connect with Dr. Douglas Flora here: https://www.linkedin.com/in/douglasflora/

Ai in Precision Oncology Journal: https://home.liebertpub.com/publications/ai-in-precision-oncology/679

📢 JOIN THE CONVERSATION! ❓Drop your thoughts in the comments below!📲 Oncology at your fingertips.

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