Hope for Kidney Cancer Patients, Merck's Keytruda Cuts Risk Of Death By 38% Following Surgery

Saturday, Merck & Co Inc MRK announced results from the Phase 3 KEYNOTE-564 trial evaluating Keytruda for the adjuvant treatment of patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. 

At the third pre-specified interim analysis (median follow-up of 57.2 months, Keytruda as adjuvant therapy (after surgery) significantly improved overall survival (OS), the trial’s key secondary endpoint, by 38% compared to placebo. 

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At 48 months, the estimated OS rate was 91.2% for patients who received Keytruda compared to 86.0% for patients who received a placebo. 

The OS 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 K. Choueiri, director, Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute and Jerome and Nancy Kohlberg professor of medicine, Harvard Medical School.

“Results from KEYNOTE-564 show that pembrolizumab as adjuvant therapy significantly improved overall survival by 38% compared to placebo, becoming the first ever Phase 3 adjuvant trial to show improved survival for renal cancer patients at risk of recurrence after surgery.”

As previously reported, at an earlier pre-specified interim analysis with a median follow-up of 24.1 months, KEYNOTE-564 met its primary endpoint of disease-free survival (DFS), reducing the risk of disease recurrence or death by 32% compared to placebo. 

In this third interim analysis, the DFS benefit was consistent with these previously reported data, with Keytruda as adjuvant therapy reducing the risk of disease recurrence or death by 28% compared to placebo.

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.

Price Action: MRK shares closed at $120.81 on Friday.

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