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RAHWAY, N.J. - Merck & Co., Inc. (NYSE:MRK), also known as MSD outside the United States and Canada, has revealed positive safety and efficacy results from the Phase 1 KANDLELIT-001 study, which evaluated MK-1084, a novel investigational KRAS G12C inhibitor. The results were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.
The study focused on MK-1084 as a monotherapy and in combination with other treatments, targeting specific patient groups with KRAS G12C-mutant solid tumors, including advanced colorectal cancer (CRC) and non-small cell lung cancer (NSCLC). The drug demonstrated a manageable safety profile and antitumor activity in these patients. This research adds to Merck’s robust pipeline, supported by the company’s strong gross profit margin of 77% and substantial R&D investments. Get deeper insights into Merck’s financial metrics and 8 additional exclusive ProTips with InvestingPro.
For CRC, the study assessed MK-1084 alone and in combination with cetuximab, with or without chemotherapy. The overall response rate (ORR) varied across different patient groups, with previously treated CRC patients showing a confirmed ORR of 38% for monotherapy and 46% when combined with cetuximab. When MK-1084 was combined with cetuximab and mFOLFOX6 chemotherapy, the ORR was 38% in metastatic CRC patients with 0-1 lines of prior therapy.
In NSCLC, MK-1084 as monotherapy yielded an ORR of 38% in previously treated patients. The combination of MK-1084 with KEYTRUDA, Merck’s anti-PD-1 therapy, resulted in an ORR of 77% in untreated metastatic NSCLC patients whose tumors express PD-L1. When MK-1084 was used with KEYTRUDA and chemotherapy, the ORR was 53%.
Treatment-related adverse events (TRAEs) were reported across all arms of the study, varying in frequency depending on the treatment combination. The monotherapy arm had TRAEs in 58% of patients, while combinations with other therapies showed higher incidences.
MK-1084 will continue to be investigated in the Phase 3 KANDLELIT-012 and KANDLELIT-004 studies for first-line treatment of certain patients with locally advanced unresectable or metastatic CRC and NSCLC, respectively.
The development of MK-1084 is part of a collaboration and license agreement with Taiho Pharmaceutical Co. Ltd and Astex Pharmaceuticals (UK), a subsidiary of Otsuka Pharmaceutical Co., Ltd.
This report is based on a press release statement from Merck & Co., Inc. and does not include any opinions or recommendations from the author.
In other recent news, Merck & Co., Inc. reported positive outcomes from a clinical trial for its investigational drug zilovertamab vedotin, intended to treat diffuse large B-cell lymphoma (DLBCL). The trial showed a 56.3% objective response rate when the drug was combined with standard care, with eight out of 16 patients achieving complete responses. Additionally, Merck and Daichii Sankyo decided to withdraw their U.S. approval request for the lung cancer drug patritumab deruxtecan after the Herthena-Lung02 trial did not achieve statistical significance in overall survival results. At the company’s annual meeting, Merck shareholders approved the board nominees and executive pay, though proposals on human rights and tax transparency were rejected. Merck announced a quarterly dividend of $0.81 per share for the third quarter of 2025, reflecting its financial stability and commitment to shareholder value. UBS maintained its Buy rating on Merck, with a $105 price target, anticipating results from Merck’s Phase 3 CORALreef program. The program’s success could potentially shift market sentiment and influence Merck’s market position positively.
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