Looking to rebound from rejection in TNBC, Merck's Keytruda passes a new kidney cancer test
Keytruda has long been a dominant force in biopharma, racking up billions in sales for Merck and continuing to expand into more and more types of cancer. And coming on the heels of a rare CRL in triple-negative breast cancer, the drug took another step toward a potential next indication.
Merck’s blockbuster met its primary endpoint in a Phase III study looking at Keytruda as an adjuvant therapy for patients with renal cell carcinoma following surgical removal of a kidney, the Big Pharma announced. Compared with placebo, Keytruda demonstrated a statistically significant improvement in disease-free survival.
“These new data are the result of our research to evaluate the role of Keytruda in helping patients with earlier stages of disease,” Merck Research Laboratories CMO Roy Baynes said in a statement, “and are the first positive results for an anti-PD-1 therapy in the adjuvant treatment of patients with renal cell carcinoma.”
Merck did not release specific data points or p-values in their announcement, but noted that the study enrolled 950 who were randomized into receiving either Keytruda IV infusions once every three weeks up to 17 times, or placebo.
The study is continuing to be evaluated for secondary endpoints, which include overall survival and safety, Merck said. Researchers did reveal that safety in this trial was consistent with previous studies of the drug.
Renal cell carcinoma already sits among Keytruda’s swath of approvals, with the drug notching an OK two years ago in combination with axitinib for the first-line treatment in patients with advanced stages of the cancer.
Thursday’s news comes a little over a week after the FDA slapped down Merck’s pitch to expand the drug into triple-negative breast cancer as both a pre-operative (with chemo) and post-op (without chemo) treatment with a CRL. Merck had examined Keytruda as a post-surgical monotherapy following a combo of Keytruda and platinum-based chemotherapy, but their data were panned at an ODAC hearing in February.
The committee unanimously recommended waiting for further data for Merck’s I/O superstar, saying the pharma should wait for more definitive safety data from its Phase III study. At issue was that researchers hadn’t watched patients long enough after treatment to determine EFS and OS, having seen just 53% of targeted EFS events and 32% of OS events.
But Merck went ahead anyway, despite FDA concerns over the maturity of the dataset after multiple meetings. The CRL didn’t, however, affect Keytruda’s approval as a combination therapy with chemo in locally advanced, PD-1 expressing TNBC tumors that are metastatic or cannot be surgically removed.
The new RCC data also come at a time when regulators are getting tougher on drugmakers that miss their mark in confirmatory studies following accelerated approvals. Also last month, Merck pulled a Keytruda indication for metastatic small cell lung cancer, part of what it described as an “industry-wide evaluation” by the FDA of such misses.