Merck Announces Phase 3 KEYNOTE-A39/EV-302 Trial Met Dual Primary Endpoints of Overall Survival (OS) and Progression-Free Survival (PFS) in Certain Patients With Previously Untreated Locally Advanced or Metastatic Urothelial Cancer

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive topline results from the Phase 3 KEYNOTE-A39 trial (also known as EV-302), which was conducted in collaboration with Seagen and Astellas, evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv) versus chemotherapy (gemcitabine plus cisplatin or carboplatin) in patients with previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC). The trial enrolled patients who may or may not be eligible for treatment with cisplatin-based chemotherapy, regardless of PD-L1 status.

In the trial, KEYTRUDA in combination with enfortumab vedotin met its dual primary endpoints of overall survival (OS) and progression-free survival (PFS), demonstrating a statistically significant and clinically meaningful improvement versus chemotherapy in patients with previously untreated la/mUC. The combination also showed a statistically significant improvement in overall response rate (ORR), a key secondary endpoint, versus chemotherapy. The safety profile of KEYTRUDA and enfortumab vedotin in this study was consistent with previously reported studies of this combination.

“The results of this pivotal Phase 3 study are highly encouraging and showed a statistically significant survival benefit for the combination of KEYTRUDA with the antibody-drug conjugate enfortumab vedotin in cisplatin-eligible or cisplatin-ineligible patients with previously untreated locally advanced or metastatic urothelial carcinoma,” said Dr. Eliav Barr, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “This is an important milestone, as many patients with advanced urothelial carcinoma still experience disease progression following chemotherapy. We look forward to sharing these data with the medical community and regulatory authorities.”

The Phase 3 KEYNOTE-A39 trial is intended to serve as the confirmatory trial for the current U.S. accelerated approval of KEYTRUDA in combination with enfortumab vedotin as first-line treatment for patients with la/mUC who are not eligible to receive cisplatin-containing chemotherapy based on data from the KEYNOTE-869 trial (also known as EV-103) dose escalation cohort, Cohort A and Cohort K.

Merck, in collaboration with Seagen and Astellas, are evaluating this combination as part of an extensive clinical development program in multiple stages of urothelial cancer, including two Phase 3 clinical trials in muscle-invasive bladder cancer in KEYNOTE-B15 (NCT04700124, also known as EV-304) and KEYNOTE-905 (NCT03924895, also known as EV-303).

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