Merck & Co. speeds KRAS inhibitorKRAS inhibitor into pivotal study
04 Apr 2024
Phase 1Phase 3
Merck & Co. is rushing an experimental KRAS G12C inhibitorKRAS G12C inhibitor into late-stage development as part of a combination regimen with its anti-PD-1 therapy Keytruda (pembrolizumab). The start of the trial comes less than 6 months after the company reported preliminary Phase I data for the oral drug, dubbed MK-1084, at the European Society for Medical Oncology (ESMO) congress.
“Based on early evidence showing MK-1084 in combination with Keytruda had a manageable safety profile and promising antitumour activity, we are now proceeding to a larger Phase III trial,” remarked Marjorie Green, head of oncology, global clinical development at Merck Research Laboratories.
The study will investigate MK-1084 plus Keytruda for the first-line treatment of certain patients with metastatic non-small-cell lung cancer (NSCLC) whose tumours harbour KRAS G12C mutations and express PD-L1. The trial will recruit around 600 participants, with primary endpoints being progression-free and overall survival.
MK-1084 stems from a collaboration with Taiho Pharmaceutical and Otsuka Pharmaceutical’s Astex Pharmaceuticals unit dating back to 2020. Last year, Merck deepened its ties with Astex to include small-molecule candidates with activity towards the p53 tumour suppressor protein.
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