Keytruda plus Lenvima Combo FDA Approved for Advanced Endometrial Carcinoma with No MSI-H or dMMR Tumors

Web Exclusives - FDA Updates

On September 17, 2019, the FDA accelerated the approval of a new combination of pembrolizumab (Keytruda; Merck) plus lenvatinib (Lenvima; Eisai) for patients with advanced endometrial carcinoma that is not associated with microsatellite instability high (MSI-H) or mismatch repair–deficient (dMMR) tumors in patients whose disease progressed after systemic therapy and who are candidates for curative surgery or radiation. The FDA granted this application priority review and a breakthrough therapy designation.

The approval of this combination was based on Study 111/KEYNOTE­146, a single-arm, multicenter, open-­label, multicohort clinical trial of 108 patients with metastatic endometrial carcinoma that had progressed after ≥1 systemic therapies. Patients received oral lenvatinib 20 mg daily plus intravenous pembrolizumab 200 mg every 3 weeks, until disease progression or unacceptable toxicity.

Of the 108 patients, 94 had non–MSI-H or non-dMMR tumors, 11 patients had MSI-H or dMMR tumors, and 3 patients had unknown MSI-H or dMMR status. Efficacy was measured by objective response rate (ORR) and duration of response.

In the 94 patients without MSI-H or dMMR tumors, the ORR was 38.3% (95% confidence interval, 29%-49%), including 10 (10.6%) complete responses and 26 (27.7%) partial responses. The median duration of response was not reached at the time of data cutoff, and 25 (69%) responders had responses lasting ≥6 months.

Side effects with this combination were similar to those previously seen with each treatment.

Related Items
FDA NEWS: February 28, 2022 to March 31, 2022
TOP - May 2022 Vol 15, No 3 published on May 6, 2022 in FDA Updates
FDA NEWS: January 10, 2022, and January 25, 2022
TOP - March 2022 Vol 15, No 2 published on March 16, 2022 in FDA Updates
FDA NEWS: November 29, 2021, and December 15, 2021
TOP - January 2022 Vol 15, No 1 – Online Only published on January 20, 2022 in FDA Updates
FDA NEWS: August 13, 2021 to September 22, 2021
TOP - November 2021 Vol 14, No 7 published on November 10, 2021 in FDA Updates
FDA Issues Revised Final Guidance on Biosimilar Development and the BPCI Act
TOP - October 2021 Vol 14, No 6 | Biosimilars published on November 5, 2021 in FDA Updates, Biosimilars
FDA NEWS: June 30, 2021, and July 26, 2021
TOP - September 2021 Vol 14, No 5 published on September 7, 2021 in FDA Updates
FDA NEWS: May 5, 2021 to May 28, 2021
TOP - July 2021 Vol 14, No 4 published on July 20, 2021 in FDA Updates
FDA NEWS: April 13, 2021 to April 23, 2021
TOP - May 2021 Vol 14, No 3 published on May 14, 2021 in FDA Updates
FDA NEWS: February 5, 2021 to February 22, 2021
TOP - March 2021 Vol 14, No 2 published on March 11, 2021 in FDA Updates
FDA News: November 25th To December 18th
TOP - January 2021 Vol 14, No 1 published on February 9, 2021 in FDA Updates
Last modified: July 22, 2021