[REVISION HISTORY]
Pembrolizumab combo approvals and trial data
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What changed
2026-07-30 08:30 UTC → 2026-07-31 06:21 UTC ·
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Since mid‑2026 the FDA and the EU have authorized pembrolizumab in combination with the HIF‑2α inhibitor belzutifan for adjuvant treatment of high‑risk clear‑cell renal cell carcinoma, and with the antibody‑drug conjugate en‑fortumab vedotin for neoadjuvant and adjuvant therapy of muscle‑invasive bladder cancer, regardless of cisplatin eligibility. Early trial evidence (LITESPARK‑022 and KEYNOTE‑905) showed substantial reductions in recurrence and mortality, prompting the regulatory actions. A new phase III international study (KEYNOTE‑B15/EV‑304) published in July 2026 adds added robust efficacy data for the en‑fortumab vedotin + pembrolizumab regimen. Among 808 patients, two‑year event‑free survival was 79.4 % versus 66.2 % with standard cisplatin‑gemcitabine, a 47 % risk reduction, and overall survival improved to 86.9 % from 81.3 %. These The results reinforce the combination’s benefit were detailed in the peri‑operative setting. New England Journal of Medicine by investigators Maria Kaparelou and Thanos Dimopoulos, confirming the survival benefits across a multinational cohort. Concurrently, a safety trial at CU Anschutz Cancer Center is investigating abatacept with corticosteroids for checkpoint‑inhibitor‑associated myocarditis, highlighting ongoing efforts to manage cardiac toxicities as pembrolizumab‑based regimens expand across cancer types.
Versions
- 2026-07-31 06:21 UTC Pembrolizumab combo approvals and trial data
- 2026-07-30 08:30 UTC Pembrolizumab combo approvals and trial data
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