Merck reports early success for Keytruda in combination with Pfizer’s Inlyta for the treatment of frontline kidney cancer.

Well in advance of the expected date for reporting results of its KEYNOTE-426 clinical trial, Merck presented positive initial results. The clinical trial is designed to evaluate the efficacy and safety of Merck’s PD-1 checkpoint inhibitor Keytruda (pembrolizumab) in combination with Pfizer’s tyrosine kinase inhibitor antineoplastic agent Inlyta (axitinib) versus tyrosine kinase inhibitor antineoplastic agent Sutent (sunitinib malate) monotherapy, as a first-line treatment for participants with advanced/metastatic renal cell carcinoma (mRCC). The Keytruda/Inlyta combination treatment exhibited superior results compared to Sutent with respect to both progression-free and overall survival.

Merck is hoping to gain another supplementary approval from the FDA for Keytruda, which has already approved (early 2018) Bristol-Myers Squibb’s Yervoy (ipimulab)/Opdivo (nivolumab) combination for previously untreated patients with advanced RCC. The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), however, did not recommend this combination for approval as a first-line kidney cancer treatment, indicating that the company had not “demonstrated the contribution of components sufficiently well.” Bristol-Myers is currently appealing that decision.