Merck Keytruda meets primary endpoint of DFS in patients with muscle-invasive urothelial carcinoma

known as MSD outside of the United States and Canada, today announced that the Phase 3 AMBASSADOR (A031501), (also known as KEYNOTE-123) is a randomized and open-label study evaluating Keytruda, Merck's anti-PD-1 therapy, met one of its dual primary endpoints of disease-free survival (DFS) for the adjuvant treatment of patients with localized muscle-invasive urothelial carcinoma  and locally advanced urothelial carcinoma versus observation.

At a pre-specified interim analysis review conducted by an independent data monitoring expert committee, Keytruda showed a statistically significant and clinically meaningful improvement in disease-free survival versus observation in these patients after surgery. The trial will continue to evaluate its other dual primary endpoint of overall survival.

The safety profile of Keytruda in this trial was consistent with that observed in previously reported studies; no new safety signals were identified. Results will be presented at an upcoming medical meeting and discussed with regulatory authorities.

Details of the study were limited but Merck said that at a pre-specified interim analysis review Keytruda treatment led to a statistically significant and clinically meaningful improvement in disease-free survival compared with simple observation. AMBASSADOR is ongoing and will continue to assess the effects of Keytruda on overall survival, the study’s second primary endpoint.

The promising initial data from AMBASSADOR point to the “potential of Keytruda to prevent recurrence” in patients who had undergone surgery, Marjorie Green, senior vice president and head of late-stage oncology, global clinical development at Merck Research Laboratories, said in a statement.

AMBASSADOR study enrolled approximately 740 patients with localized muscle-invasive or locally advanced urothelial carcinoma. Pembrolizumab was administered intravenously for up to 18 cycles, while comparators in the observation arm were given no intervention beyond routine clinical procedures including a CT scan, blood analysis and an MRI.

Aside from efficacy, the study also evaluated Keytruda’s safety profile in this indication and found no new signals of concern. Keytruda’s adverse event profile in AMBASSADOR was consistent with what had been established in prior trials.

Merck will present the study’s results at an upcoming medical meeting and discuss the data with regulators.

Keytruda, a PD-1-blocking antibody, was first approved in bladder cancer in May 2017, allowing its use in specific cases of locally advanced or metastatic urothelial carcinoma. The blockbuster cancer therapy has since picked up more approvals in this disease area, including one for non-muscle invasive bladder cancer. Keytruda has not yet been authorized to treat muscle-invasive urothelial carcinoma.

This phase III victory continues Keytruda’s winning streak in bladder cancer. In September 2023, Merck reported that the PD-1 blocker aced a collaborative late-stage study with Astellas and Seagen in locally advanced and metastatic urothelial cancer. Patients treated with the combination of Keytruda and Padcev (enfortumab vedotin-ejfv) saw significant improvements in overall survival and progression-free survival, the study’s dual primary endpoints, compared with chemotherapy.

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