MSD's K药-Based Combination Therapy MK-1308A Receives CDE Approval for Clinical Trial in China

Merck Sharp & DohmeKeytrudaDomestic Clinical Trial Application for Combination Therapy Accepted

On December 27, Yiou Health learned that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration recently published a notice on its website indicating that MSD had submitted an investigational new drug application in China for MK-1308A injection, a Class 1 novel drug, and that the application had been accepted.

MK-1308A is a combination therapy of MK-1308 and pembrolizumab, where MK-1308 is an anti-CTLA-4 antibody licensed by MSD from Akeso Biopharma, and pembrolizumab is MSD's flagship anticancer drug.PD-1Inhibitor Keytruda (K drug).

Keytruda is a PD-1 inhibitor developed by Merck Sharp & Dohme (MSD). It activates T lymphocytes by blocking the binding of PD-1 to PD-L1 and PD-L2, thereby enhancing their ability to recognize and attack cancer cells. This drug has acquired the largest number of indications among comparable PD-1 inhibitors, including melanoma, non-small cell lung cancer, classical Hodgkin lymphoma, head and neck squamous cell carcinoma, and triple-negative breast cancer.

According to information on the ClinicalTrials.gov website, MSD is currently conducting a Phase I/II open-label, multi-arm, multicenter study to evaluate the efficacy of the MK-1308/Keytruda combination therapy (also known as MK-1308A) in patients with advanced solid tumors. The acceptance of the clinical trial application for this combination therapy in China indicates that clinical studies are expected to commence in the country soon.

At the International Association for the Study of Lung Cancer (IASLC) North America Conference on Lung Cancer held in October 2020, researchers reported the results of a Phase I/II clinical trial of the MK-1308/Keytruda combination therapy. The study aimed to evaluate the safety and tolerability of the combination therapy as first-line treatment for advanced non-small cell lung cancer (NSCLC) and to determine the recommended Phase 2 dose (RP2D) for further clinical investigation.

The study results indicate that the MK-1308/Keytruda combination therapy, used as first-line treatment for advanced NSCLC, demonstrated antitumor activity across all dose levels with a favorable overall safety profile. Furthermore, 25 mg administered once every 6 weeks (Q6W) was identified as the recommended Phase 2 clinical trial dose for the MK-1308/Keytruda combination regimen.

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