▎WuXiEdited by Kant Content Team

MSD announced today that the U.S. FDA has accepted the supplemental Biologics License Application (sBLA) for its重磅 PD-1 inhibitor Keytruda and granted Priority Review for the treatment ofPatients with primary advanced or recurrent endometrial cancer, with a PDUFA target date of June 21, 2024.Keytruda was first used in combination with standard-of-care chemotherapy, followed by its use as a monotherapy to treat this patient population.According to the press release, if approved, Keytruda will become the first immunotherapy for the first-line treatment of advanced endometrial cancer, regardless of the mismatch repair status of the patient's tumor.

The submission of this sBLA is primarily based on data from the Phase 3 clinical trial NRG-GY018. The study results were published in The New England Journal of Medicine in June 2023. The results showed that, compared to patients receiving chemotherapy alone,In cancer patients with mismatch repair-proficient (pMMR) tumors, Keytruda in combination with chemotherapy (carboplatin and paclitaxel) reduced the risk of disease progression or death by 46%.（HR=0.54，95% CI：0.41-0.71，p<0.00001）；In patients with mismatch repair-deficient (dMMR) tumors, the combination therapy of Keytruda can reduce the risk of disease progression or death by 70%.（HR=0.30，95% CI：0.19-0.48，p<0.00001）。

The adverse events of Keytruda in combination with chemotherapy were consistent with expectations.

Keytruda (pembrolizumab) is a humanized anti-PD-1 monoclonal antibody that blocks the binding of PD-1 to its ligands PD-L1 and PD-L2, thereby activating T lymphocytes.

Keytruda has two FDA-approved indications for endometrial cancer.Based on the KEYNOTE-775 trial, Keytruda in combination with the VEGF tyrosine kinase inhibitor Lenvima (lenvatinib) has been approved for the treatment of patients with advanced endometrial cancer whose tumors are determined to be pMMR by an FDA-approved test, or whose tumors are microsatellite instability-high (MSI-H) and have progressed following prior systemic therapy and who are not candidates for surgery or radiation. The second indication, based on the KEYNOTE-158 trial, is for Keytruda as a monotherapy to treat patients with advanced endometrial cancer that is MSI-H or dMMR as determined by an FDA-approved test, and who have progressed following prior systemic therapy and are not candidates for surgery or radiation.

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ReferenceReferences:

[1] FDA Grants Priority Review to Merck's Application for KEYTRUDA® (pembrolizumab) Plus Chemotherapy as Treatment for Primary Advanced or Recurrent Endometrial Carcinoma. Retrieved February 20, 2024 from https://www.businesswire.com/news/home/20240220626403/en

[2] Eskander, Ramez N et al. “Pembrolizumab plus Chemotherapy in Advanced Endometrial Cancer.” The New England journal of medicine vol. 388,23 (2023): 2159-2170. doi:10.1056/NEJMoa2302312

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