Oncopharmpod

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

This week's pod has lots of updates! IMHOTEP: Pre-operative doses of pembrolizumab lead to significant pCR rates in dMMR colon cancer. https://doi.org/10.1200/JCO-25-02169 Real world rates of PJP suggest room for improvement in prophylaxis, especially those on corticosteroids + additional immunosuppressants. https://doi.org/10.1177/10600280261443794 Daraxonrasib given expanded access by FDA before approval: https://www.fda.gov/news-events/press-announcements/fda-permits-expanded-access-investigational-pancreatic-cancer-drug And yes, the ivermectin boom was real: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2848862 Check out the Oncology Insights Newsletter: www.kelleycpharmd.com/newsletter-oncopharm

The latest FDA drug approval is vepdegestrant, a heterobifunctional protein degrader, for ESR1 mutated breast cancer. We discuss what that actually means and some possible implications for clinical practice. Check out the Oncology Insights Newsletter: www.kelleycpharmd.com/newsletter-oncopharm

This is our 1st in a series of podcasts/videos to role out once or twice a year on therapeutic targets in cancer. First up - Trop2 Check out the Oncology Insights Newsletter: www.kelleycpharmd.com/newsletter-oncopharm Video with slides: https://youtu.be/mrDQyYkaF7A

This week we highlight some promising clinical research in the pancreatic cancer space. Daraxonrasib has shown OS benefit vs. chemo in the 2nd-line setting of metastatic pancreatic cancer compared to investigator's choice chemotherapy. Hopefully, we will get the abstract soon and publication shortly thereafter. A personalized mRNA vaccine for early-stage pancreatic cancer has some encouraging results (for those patients who mounted a sizable immune response to the vaccine). Check out the Oncology Insights Newsletter: www.kelleycpharmd.com/newsletter-oncopharm

Bibliography: 1.. 2019 Systematic Review of Published Cases: https://doi.org/10.1111/dme.14050 2. Mass General Data & Publication: https://jamanetwork.com/journals/jamaoncology/fullarticle/2822927 3. Japanese Claims Data & Pub: https://doi.org/10.1111/jdi.14362 Check out the Oncology Insights Newsletter: www.kelleycpharmd.com/newsletter-oncopharm

Discussing the new nab-paclitaxel adjunctive medication, relacorilant, for ovarian cancer. As a glucoCORticoid receptor antagonist, it is hard to pronounce. Also, a 10-year follow-up study of ibrutinib provides big picture insight on the impact of the BTKi era in CLL. Link: https://doi.org/10.1182/blood.2025029971 Check out the Oncology Insights Newsletter: www.kelleycpharmd.com/newsletter-oncopharm

Recapping what I learned at HOPA 2026: -Beyond steroids for irAs -IT chemo beyond methotrexate and cytarabine -Pre-emptive CMV management in patients receiving certain bispecifics -semaglutide-alectinib drug interaction -Safety (n = ~40) of MMR vaccine in patients post-Auto transplant on maintenance daratumumab Check out the Oncology Insights Newsletter: www.kelleycpharmd.com/newsletter-oncopharm

Nivolumab-AVD is finally approved for Hodgkin Lymphoma, and primary G-CSF prophylaxis is recommended (?) in the PI. Also, brief NOLA preview for HOPA attendees. The Big Easy Debate: sazerac or hurricane? Check out the Oncology Insights Newsletter: www.kelleycpharmd.com/newsletter-oncopharm

Tazemetostat is withdrawn from the market due to a risk of secondary malignancies. RECITE asks if romiplostim improves platelet counts for patients on oxaliplatin-based regimens with thrombocytopenia. Spoiler - yes it does, but does that make a difference? Check out the Oncology Insights Newsletter: www.kelleycpharmd.com/newsletter-oncopharm

Lots of FDA approval updates to discuss from the past few weeks: -Zongertinib gets approved in 1st line setting for ERBB2 TKD mutated metastatic NSLCLC -Encorafenib approval with cetuximab + FOLFOX -Teclistamab + Daratumumab approved in 2nd line setting for r/r multiple myeloma -Acalabrutinib + venetoclax (but NOT acalabrutinib + venetoclax + obinutuzumab) is approved for CLL Check out the Oncology Insights Newsletter: https://www.kelleycpharmd.com/newsletter-oncopharm

This week discuss BR.31 trial of adjuvant durvalumab in NSCLC and put it into the context of the positive studies with atezolizumab and pembrolizumab. We also highlight 2 notable presentations at ASCO GU 2026 on perioperative enfortumab vedotin + pembrolizumab in cisplatin-eligible patients with resectable bladder cancer (KEYNOTE-B15) and advjuant pembrolizumab + belzutifan in RCC (LITESPARK-022) Check out the Oncology Insights Newsletter: https://www.kelleycpharmd.com/newsletter-oncopharm

An exciting new drug, rezatapopt, may be effective in restoring p53 activity in cancers - a possible major therapeutic breakthrough. Can colchicine treat pyrexia from tremetinib & dabrafenib use? This case series says - maybe: https://doi.org/10.1007/s00520-019-4654-2 Check out the Oncology Insights Newsletter: https://www.kelleycpharmd.com/newsletter-oncopharm

The EV-303 trial that led to the FDA approval of perioperative enfortumab vedotin + pembrolizumab in cisplatin-ineligible bladder cancer patients in now published in NEJM. We discuss the results and ponder potential future changes to treating bladder cancer in the future. Urinary diversion surgeries: https://jamanetwork.com/journals/jamaoncology/fullarticle/2842595

We have FDA changes to the labels of Axi-Cel (to allow for its use in primary CNS lymphoma) and 5-flourouracil (pre-treatment DPYD testing). Also, pembrolizumab nets another approval, this time in conjunction with paclitaxel for platinum-resistant ovarian cancer (limited to PD-L1 CPS of 1% of greater)

A brief discussion of the Core Communication Skills* and how to incorporate them into a chemotherapy education session. *Rapport Building *Agenda Setting *Information Management *Active Listening *Addressing Feelings *Common Ground

Reviewing the hot-off-the press publication of PATINA, palbociclib in HER-2 amplified breast cancer along with endocrine therapy and HER-2 targeted antibodies.

We review the recent ASCENT-04/Keynote-D19 publication of sacituzuab govitecan + pembrolizumab for PD-L1 CPS of 10% and above TNBC compared to chemo + pembrolizumab alone. Also, a quick recap of ASCO GI earlier this month with mentions of zanidatamab and zolbetuximab. Finally, a check-in on The Pitt.

This episode is the 2nd chapter in a broader presentation about putting together the puzzle pieces of oncology drug use. This chapter discusses examples of how oncology drug use changes over time. Video & slides available at: https://youtu.be/Kxs0Xg9Ug_c?si=yOwEU1X-7mCPoQl5

A Holiday tradition like few other. Are we keeping, regifting, or returning new oncology drugs approved in 2025?