# Pembrolizumab combo approvals and trial data

> Live situation record from CLSTR: https://clstr.news/situations/pembrolizumab-combo-approvals-in-oncology
> Updated: 2026-07-30T07:06:00.000Z. Sources: 10. Developments: 4.

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 phase III international study (KEYNOTE‑B15/EV‑304) published in July 2026 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 %. The results were detailed in the 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.

## Claims

- The KEYNOTE‑B15/EV‑304 trial enrolled 808 patients with muscle‑invasive bladder cancer. (corroborated by 3 sources)
- Patients were randomized to receive enfortumab vedotin plus pembrolizumab before cystectomy or standard neoadjuvant chemotherapy with cisplatin and gemcitabine. (corroborated by 3 sources)
- The trial results were published in the New England Journal of Medicine. (corroborated by 3 sources)
- The study was conducted by Dr Maria Kaparelou and Prof Thanos Dimopoulos at the Alexandra Hospital, Medical School of the University of Athens (EKPA). (corroborated by 3 sources)
- Two‑year event‑free survival was 79.4 % with enfortumab vedotin‑pembrolizumab versus 66.2 % with chemotherapy. (corroborated by 2 sources)
- Two‑year overall survival was 86.9 % with the combination therapy versus 81.3 % with chemotherapy. (corroborated by 2 sources)
- The improvement represented a 47 % reduction in the risk of recurrence, progression or death. (single source)

## Timeline

### 2026-07-30: Enfortumab Vedotin‑Pembrolizumab Combo Boosts Survival in Muscle‑Invasive Bladder Cancer

Phase III KEYNOTE‑B15/EV‑304 showed that enfortumab vedotin + pembrolizumab yields 79.4% 2‑yr event‑free survival versus 66.2% with standard chemo, and 86.9% overall survival versus 81.3%, a 47% risk reduction.

3 sources. https://clstr.news/cluster/enfortumabpembrolizumab-combo-improves-survival-in-muscleinvasive-bladder-cancer

### 2026-07-09: FDA approves Merck bladder cancer combo; trial tests abatacept for checkpoint inhibitor myocarditis

FDA green‑lights Merck’s pembrolizumab‑enfortumab combo for bladder cancer; CU Anschutz begins a trial of abatacept for checkpoint inhibitor‑related myocarditis.

2 sources. https://clstr.news/cluster/fda-approves-merck-bladder-cancer-combo-trial-tests-abatacept-for-checkpoint-inhibitor-myocarditis

### 2026-07-06: EU approves pembrolizumab‑enfortumab combo for bladder cancer

The EU has approved the pembrolizumab‑enfortumab vedotin combo as peri‑operative therapy for muscle‑invasive bladder cancer, citing KEYNOTE‑905 data showing 60% lower recurrence risk and 50% lower death risk.

3 sources. https://clstr.news/cluster/pfizers-enfortumabe-vedotina-and-pembrolizumab-cut-bladder-cancer-recurrence-by-60

### 2026-06-12: FDA approves belzutifan‑pembrolizumab combo for high‑risk kidney cancer

The US FDA approved the belzutifan‑pembrolizumab combination as adjuvant therapy for high‑risk clear‑cell renal cell carcinoma, citing a 28% drop in recurrence or death in the LITESPARK‑022 trial.

3 sources. https://clstr.news/cluster/fda-approves-belzutifanpembrolizumab-combo-for-highrisk-kidney-cancer

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Cite as: Pembrolizumab combo approvals and trial data. CLSTR, https://clstr.news/situations/pembrolizumab-combo-approvals-in-oncology