FDA Approves Merck’s KEYTRUDA® (pembrolizumab) as Monotherapy for MSI-H/dMMR Advanced Endometrial Carcinoma

Today, MSD announced that the U.S. FDA has approved the重磅 PD-1 inhibitor Keytruda (pembrolizumab) as a monotherapy for the treatment of patients with advanced endometrial cancer. These patients have tumors with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) features as identified by an FDA-approved test. Their disease has progressed following prior systemic therapy and they are not candidates for curative surgery or radiation.

Endometrial cancer is the most common type of cancer in the uterus, with approximately 30% of patients being MSI-H or dMMR. Keytruda is an anti-PD-1 therapy that enhances the body's immune system’s ability to detect and combat tumor cells by blocking PD-1 mediated immunosuppressive signals. Previously, the combination therapy of Keytruda and the oral tyrosine kinase inhibitor Lenvima has received FDA approval for treating specific advanced endometrial cancer patients.

The efficacy of Keytruda is based on the results of the open-label, non-randomized clinical trial KEYNOTE-158 in a cohort of 90 patients with unresectable or metastatic endometrial cancer. The primary efficacy outcome measures were objective response rate (ORR) and duration of response (DoR). The trial results showed an ORR of 46% (95% CI: 35, 56), with the median DoR not yet reached (2.9, 55.7+). Sixty-six percent of responding patients had a duration of response lasting more than 12 months, and 44% had a duration of response exceeding 24 months.

References:

[1] FDA approves pembrolizumab for advanced endometrial carcinoma. Retrieved March 21, 2022, from https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-advanced-endometrial-carcinoma

[2] FDA Approves Merck’s KEYTRUDA® (pembrolizumab) for Patients With MSI‑H/dMMR Advanced Endometrial Carcinoma, Who Have Disease Progression Following Prior Systemic Therapy in Any Setting and Are Not Candidates for Curative Surgery or Radiation. Retrieved March 21, 2022, from https://www.businesswire.com/news/home/20220321005859/en

Note: The original text has been abridged.

Original Title: Express | Keytruda Secures New Indication for Monotherapy in Endometrial Cancer

▽Follow 【WuXi AppTec】Germany】WeChat Official Account