Merck's Keytruda Reduces Risk Of Death By 38% In Adjuvant RCC Therapy In Phase 3 Trial

(RTTNews) - Merck & Co. Inc.'s (MRK) Keytruda (pembrolizumab) reduced the risk of death by 38% compared to placebo as adjuvant therapy for patients with renal cell carcinoma at an increased risk of recurrence following nephrectomy, as per the phase 3 KEYNOTE-564 trial results.

The company noted that the KEYNOTE-564 is the first Phase 3 trial to demonstrate superior overall survival (OS) with adjuvant therapy compared to placebo in patients with renal cell carcinoma.

At the third pre-specified interim analysis (median follow-up of 57.2 months), Keytruda as adjuvant therapy significantly improved overall survival, the trial's key secondary endpoint, by 38% compared to placebo. At 48 months, the estimated overall survival rate was 91.2% for patients who received Keytruda compared to 86.0% for patients who received placebo. The overall survival benefit for patients who received Keytruda was observed across key subgroups.

For patients with renal cell carcinoma, up to 40% may experience recurrence following surgery, at which point there is a significantly lower chance of survival," said Toni Choueiri, director, Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute and Jerome and Nancy Kohlberg professor of medicine, Harvard Medical School.

Keytruda is approved for the adjuvant treatment of patients with RCC in the U.S., European Union, Japan and other countries worldwide based on DFS data from KEYNOTE-564, which were first presented at the 2021 ASCO Annual Meeting.

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