Merck & Co., Inc. (NYSE:MRK) has announced promising early results from its Phase 1 KANDLELIT-001 trial of MK-1084, an investigational KRAS G12C inhibitor, in patients with advanced colorectal cancer (CRC) and non-small cell lung cancer (NSCLC) harboring KRAS G12C mutations. The study found MK-1084 demonstrated a manageable safety profile and encouraging antitumor activity, both as a standalone treatment and in combination with other therapies, including KEYTRUDA and cetuximab.
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In CRC, confirmed overall response rates (ORR) reached 38% with MK-1084 monotherapy, 46% with MK-1084 plus cetuximab, and 38% when combined with cetuximab and chemotherapy.
For NSCLC, ORRs were 38% for monotherapy, 77% with MK-1084 plus KEYTRUDA, and 53% with the addition of chemotherapy. Treatment-related adverse events were manageable across all study arms, with rates ranging from 58% in monotherapy to 97% in combination regimens.
These results, presented at the 2025 ASCO Annual Meeting, support further Phase 3 trials of MK-1084 in combination therapies for first-line treatment of KRAS G12C-mutant CRC and NSCLC. Merck & Co., Inc.’s senior leadership highlighted the findings as evidence of the company’s commitment to advancing innovative cancer treatments.
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