Adjuvant Belzutifan Plus Pembrolizumab in ccRCC After Nephrectomy: Toni K. Choueiri, MD
Toni K. Choueiri, MD, of Dana-Farber Cancer Institute and Harvard Medical School, discusses data from the phase 3 LITESPARK-022 trial (NCT05239728) examining belzutifan (Welireg) paired with pembrolizumab (Keytruda) as adjuvant therapy for patients with clear cell renal cell carcinoma. He reported at the 2026 Genitourinary Cancers Symposium that the study met its primary end point, demonstrating a disease-free survival (DFS) benefit with a hazard ratio of 0.72 vs pembrolizumab plus placebo. At a median follow-up of 28.4 months, the median DFS was not reached in either arm. Choueiri noted that although toxicity was higher with the combination, the toxicity profile was manageable, and treatment discontinuation rates were low.
Implications of the Full FDA Approval of Rucaparib in BRCA+ mCRPC: Alan H. Bryce, MD
Alan H. Bryce, MD, of City of Hope Cancer Center Phoenix, discusses the FDA’s regular approval of rucaparib (Rubraca) for patients with BRCA mutation–associated metastatic castration-resistant prostate cancer. He explained that the December 2025 decision builds on the previous accelerated approval supported by findings from the phase 2 TRITON2 trial (NCT02952534) and is now confirmed by randomized data from the phase 3 TRITON3 study (NCT02975934). In TRITON3, rucaparib significantly improved radiographic progression-free survival vs physician’s choice therapy in patients with BRCA mutations. Bryce emphasized that the updated label allows use before taxane-based chemotherapy, expanding treatment flexibility in this molecularly defined population.
FDA Breakthrough Therapy Designation for Amivantamab in HNSCC: Ranee Mehra, MD
Ranee Mehra, MD, of the University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center, discusses data supporting the FDA breakthrough therapy designation for amivantamab and hyaluronidase-lpuj (Rybrevant Faspro) in patients with recurrent or metastatic human papillomavirus–unrelated head and neck squamous cell carcinoma. She reviewed data from cohort 1 of the phase 1/2 OrigAMI-4 trial (NCT06385080), which examined subcutaneous amivantamab in patients previously treated with platinum-based chemotherapy and PD-1/PD-L1 inhibitors. The study revealed a 45% overall response rate with durable responses and a low rate of administration-related reactions. Mehra highlighted the drug’s EGFR-MET bispecific mechanism and immune-directed activity as promising features in a setting with limited options.
Potential Effect of CELMoDs on Multiple Myeloma Management: Gurbakhash Kaur, MD
Gurbakhash Kaur, MD, of Mount Sinai, discusses the emerging role of CELMoDs in multiple myeloma, particularly for patients progressing after CAR T-cell therapy or bispecific antibodies. She noted that as T-cell–directed therapies like teclistamab-cqyv (Tecvayli) plus daratumumab and hyaluronidase-fihj (Darzalex Faspro) from MajesTEC-3 (NCT05083169) move earlier in treatment, new rescue strategies are urgently needed. Kaur explained that CELMoDs may help restore immune fitness and reinvigorate exhausted T cells, making them attractive after or between immune-based therapies. Early findings suggest encouraging activity even in heavily pretreated and extramedullary disease populations, supporting ongoing development across several treatment settings.