Merck Launches Phase 3 Trial of KRAS G12C Inhibitor MK-1084 Combined with Keytruda in First-Line NSCLC

Apr 05, 2024 07:29 CST Updated 07:30

MSD

Pharmaceutical R&D and Manufacturer

▎WuXiEdited by Kant Content Team

MSD announced today that it hasA phase 3 clinical trial has been initiated, using the investigational oral selective KRAS G12C inhibitor MK-1084 in combination with the重磅 PD-1 inhibitor Keytruda, as a first-line treatment for patients carryingKRASPatients with metastatic non-small cell lung cancer (NSCLC) harboring G12C mutations and high PD-L1 expression (tumor proportion score [TPS] ≥50%).The trial will recruit approximately 600 patients worldwide.The primary endpoints of the study are progression-free survival and overall survival, with key secondary endpoints including objective response rate and duration of response.

MK-1084 is currently being evaluated in an open-label Phase 1 clinical trial, with preliminary safety and efficacy data from this trial previously presented at the 2023 European Society for Medical Oncology (ESMO) Congress. In the dose-finding clinical trial, MK-1084 as a monotherapy achieved an objective response rate (ORR) of 22% in patients with solid tumors (across all doses).MK-1084 in combination with Keytruda achieved an objective response rate of 71% in the treatment of NSCLC, with an objective response rate of 75% in patients with high PD-L1 expression (TPS≥50%).

MK-1084 is a specific KRAS G12C covalent inhibitor.KRASThe mutation is one of the most common mutations found in cancer, occurring at high frequencies in non-small cell lung cancer, pancreatic cancer, genitourinary cancer, and colorectal cancer.KRASG12C mutation is the most common in patients.KRASMutation, accounting for approximately 14% of non-small cell lung cancer (adenocarcinoma). MK-1084 is co-developed by MSD, Taiho Pharmaceutical, and Astex Pharmaceuticals.

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References:

[1] Merck Initiates Phase 3 Clinical Trial of MK-1084, an Investigational Oral KRAS G12C Inhibitor, in Combination with KEYTRUDA® (pembrolizumab) for First-Line Treatment of Certain Patients With Metastatic Non-Small Cell Lung Cancer. Retrieved April 4, 2024, from https://www.businesswire.com/news/home/20240404295988/en

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