Hosted by John Bossaer · EN

This week's pod covers some brief updates comparing the timelines of the FDA approvals for daraxonrasib vs. enfortuamb vedodin + pembrolizumab, before devoting the rest of the time to the new approval of gedatolisib, a PIK3CA inhibitor, with fulvestrant and maybe palbociclib if you feel like it for metastatic breast cancer in the 2nd line. Oh, in patients WITHOUT PIK3CA mutations. Download the Oncology Learning Companion: https://www.kelleycpharmd.com/learning-oncology-companion-oncopharm

Did lenalidomide maintenance in multiple myeloma just get limited to 2 years? Endurance Trial, Part 2: https://www.nejm.org/doi/full/10.1056/NEJMoa2600157 Learning Oncology Companion: https://www.kelleycpharmd.com/learning-oncology-companion-oncopharm

We are a decade into the CAR-T era, and what to long term outcomes look like with tisagenlecleucel in B-cell lymphomas? Orca-T is approved, an allogenic cocktail of stem & progenitor cells, Tregs, and then conventional T-cells. Neato. Polar-Go! or PolARGo? 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

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

Lots of bite-size updates in this episode. Capitello-281: capivasertib + abiraterone (+ prednisone + ADT) Adjuvant Belzutifan + Pemroblizumab is FDA approved Durvalumab approved with BCG for non-muscle invasive bladder cancer Insightful commentary: https://doi.org/10.1200/JCO-25-02670 Talquetamab + Durvaluamb - a new safety signal? Learning Oncology Companion: https://www.kelleycpharmd.com/learning-oncology-companion-oncopharm

ASCO 2026 is a wrap, and we needed an extra week to digest it all! Here the review list: 1. RASolute 302 - daraxonrasib and its standing ovation 2. MajesTEC-9 - 2L teclistamab in multiple myeloma in patient population 100% exposed to CD-38 targeting drugs 3. Initsmeran autogene + pembrolizumab in resected melanoma. Only a Phase 2 study, but super promising and exciting use of personalized medicine using mRNA technology 4. Libretto-043 - adjuvant selpercatinib in RET-fusion positive NSCLC following resection and platinum-based chemotherapy (in most of these patients) 5. PROTEUS - meh 6. SARC041 - Phase study of abemaciclib vs. placebo in dedifferntiated liposarcoma. The placebo did very poorly 7. CROWN at 7-years continues to offer an enticing PFS plateau with lorlatinib use in advanced ALK rearrangement+ NSCLC The Learning Oncology Companion from KelleyCPharmD: https://www.kelleycpharmd.com/learning-oncology-companion-oncopharm

Pivekimab sunirine, a novel CD-123 antibody drug conjugate is approved for Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN). Also, what the heck is BPDCN? Check out the Oncology Insights Newsletter: www.kelleycpharmd.com/newsletter-oncopharm

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