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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