Merck to Share KEYNOTE-B15 and LITESPARK Data at ASCO GU 2026

Merck has shared late-breaking and press-program data readouts slated for the 2026 ASCO Genitourinary (ASCO GU) Cancers Symposium across bladder and kidney cancer, highlighting three Phase 3 studies: KEYNOTE‑B15, LITESPARK‑022, and LITESPARK‑011.

KEYNOTE‑B15/EV‑304 is a randomized, open-label Phase 3 trial evaluating pembrolizumab plus enfortumab vedotin as neoadjuvant and adjuvant treatment (before and after surgery) for patients with muscle-invasive bladder cancer who are eligible for cisplatin. The company reported that the combination significantly improved event-free survival, overall survival, and pathologic complete response rates in patients with “certain types of bladder cancer."

In kidney cancer, Merck described the first interim analysis of the Phase 3 LITESPARK‑022 trial evaluating adjuvant pembrolizumab in combination with belzutifan following nephrectomy for patients with clear cell renal cell carcinoma. The company characterized belzutifan as its first-in-class oral hypoxia-inducible factor‑2 alpha (HIF‑2α) inhibitor and reported a disease-free survival benefit.

Merck also announced a first presentation from the Phase 3 LITESPARK‑011 trial evaluating belzutifan plus lenvatinib versus cabozantinib for patients with advanced renal cell carcinoma whose disease progressed on or after anti‑PD‑1/L1 therapy. This readout was described as demonstrating a progression-free survival benefit for the belzutifan–lenvatinib combination compared with cabozantinib, in a later-line, post–checkpoint inhibitor setting that differs from the adjuvant context of LITESPARK‑022.