FDA Grants Keytruda-Lenvima Combo Priority Review for Treatment of Advanced Kidney Cancer and Endometrial Cancer

The Food and Drug Administration (FDA) has granted priority review to a set of applications for Keytruda (pembrolizumab) in combination with Lenvima (lenvatinib) for the first-line treatment of advanced renal cell carcinoma (RCC), according to the agents’ manufacturers, Merck and Eisai.

Moreover, the FDA also granted priority review to the combination regimen for the treatment of patients with advanced endometrial carcinoma whose disease has progressed after previous systemic therapy and are not candidates for surgery or radiation.

“Advanced renal cell carcinoma and advanced endometrial carcinoma are aggressive cancers, and patients urgently need new treatment options that may help improve outcomes,” said Dr. Gregory Lubiniecki, vice president of oncology clinical research at Merck Research Laboratories, in a news release. “We appreciate that the FDA has recognized this significant unmet need and the potential for the combination of Keytruda plus Lenvima in these patients by granting priority review for these applications.”

The filings for the indication of the first-line treatment of patients with advanced RCC were based on results of the CLEAR study, which demonstrated that treatment with the Keytruda and Lenvima combo significantly improved overall survival (OS), progression-free survival (PFS) and objective response rates compared to Sutent (sunitinib) alone.

The application for the combination’s indication in advanced endometrial carcinoma was based on data from the KEYNOTE-775 study, which demonstrated that treatment with Keytruda and Lenvima was associated with significant PFS, OS and objective response rate improvements compared to investigator’s choice of chemotherapy. The results of this trial are part of a follow-up to data from the KEYNOTE-146 trial, which led to an accelerated approval of the combination in certain patients with endometrial carcinoma.

The agency is expected to make its decisions on whether to approve the combination in advanced RCC by August 2021, and in advanced endometrial carcinoma by September 2021.

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