Merck Keytruda Advances After EU Opinion and China Win

Merck & Co.’s Keytruda advanced on May 22, 2026, after the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of Keytruda plus Padcev for perioperative use in cisplatin-ineligible muscle-invasive bladder cancer. On May 21, Sichuan Kelun-Biotech reported a Phase 3 progression-free survival (PFS) win for a Keytruda combination in China, broadening the drug’s clinical scope.

EU CHMP Recommends Keytruda Plus Padcev for Bladder Cancer

Merck said in a May 22 press release that the CHMP issued a positive opinion recommending KEYTRUDA (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv) as perioperative treatment—both before and after surgery—for adults with resectable muscle-invasive bladder cancer (MIBC) who cannot receive cisplatin chemotherapy.

The recommendation is based on data from the Phase 3 KEYNOTE-905/EV-303 trial, a randomized, multicenter, open-label study comparing three arms: Keytruda plus Padcev as neoadjuvant and adjuvant therapy, Keytruda monotherapy in the same setting, and radical cystectomy alone. The primary endpoints were event-free survival (EFS) and overall survival (OS), with pathologic complete response (pCR)—no residual tumor in resected tissue—as a key secondary endpoint.

The CHMP cited statistically significant improvements in EFS and OS for the combination versus surgery alone. Merck reported a pCR rate of 57.1% with Keytruda plus Padcev, compared with 8.6% for surgery alone. The company described the safety profile as generally consistent with the known profiles of each agent. The CHMP opinion covers the European Union and, if adopted by the European Commission, would expand the EU labels for both drugs. Padcev is co-developed by Astellas and Seagen, with Merck co-developing or co-promoting in certain territories.

Kelun Biotech’s Phase 3 Win in China with Sacituzumab Tirumotecan

On May 21, Sichuan Kelun-Biotech announced that its TROP2-targeting antibody-drug conjugate sacituzumab tirumotecan (sac-TMT), combined with Merck’s Keytruda, met the Phase 3 primary endpoint of progression-free survival in previously untreated patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) whose tumors express PD-L1.

Kelun reported a 65% reduction in the risk of progression or death in a PD-L1–positive subgroup compared with Keytruda alone. Overall survival was numerically longer but not yet mature. Kelun plans to use the PFS result to support a regulatory filing in China. Under existing collaboration agreements, Keytruda was supplied for the program, and Kelun previously licensed sacituzumab tirumotecan to Merck for ex-China territories.

Expanding Keytruda’s Clinical Reach

Together, the CHMP opinion and Kelun’s Phase 3 result highlight efforts to broaden Keytruda’s use into earlier-stage disease and combination regimens. These developments support diversification of the drug’s clinical applications ahead of later patent expiries and may extend its long-term franchise. Merck did not update financial guidance in the CHMP press release, leaving sales implications to future regulatory decisions and market rollouts.

"The positive opinion was based on results from the Phase 3 KEYNOTE-905/EV-303 trial, which demonstrated that KEYTRUDA plus Padcev significantly improved event-free survival, overall survival and pathologic complete response rate compared with radical cystectomy alone in cisplatin-ineligible patients with resectable muscle-invasive bladder cancer," Merck said in its press release.