Merck Presents Phase 1 KANDLELIT-001 Data at ASCO 2025 for Investigational KRAS G12C Inhibitor MK-1084 in NSCLC and CRC

Rowe, New Jersey, USA2025Year5Month30Day——MSD (the corporate name of Merck & Co., Inc., located in Rahway, New Jersey, U.S.) announced the safety and efficacy results from the open-label Phase I KANDLELIT-001 study. This clinical trial aims to evaluate the effects of the investigational next-generation KRAS G12C inhibitor MK-1084 as a monotherapy and in combination with other therapies for patients with specific KRAS G12C-mutated solid tumors, including advanced colorectal cancer (CRC) and non-small cell lung cancer (NSCLC). Data on CRC and NSCLC from the KANDLELIT-001 study were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting (abstract numbers #3508 and #8605, respectively).

      "We look forward to further exploring the potential of MK-1084 as a monotherapy or combination therapy, including in certain cases in combination with pembrolizumab for patients with KRAS mutations. KRAS mutations are one of the most common types of mutations in cancer," said Dr. Marjorie Green, Senior Vice President of Merck & Co., Inc., and Head of Oncology and Global Clinical Development. "We are committed to evaluating the potential of innovative therapies to help more cancer patients. These data further demonstrate the potential of our robust and differentiated R&D pipeline."

      KANDLELIT – 001 is a Phase I, open-label, multi-center clinical trial (ClinicalTrials.gov Identifier: NCT05067283) designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of MK – 1084 as monotherapy and in combination with other therapies in patients with advanced solid tumors harboring KRAS G12C mutations. The primary endpoints of the trial are safety and tolerability, assessed by the number of patients experiencing dose-limiting toxicities, adverse events, and treatment discontinuations. Secondary endpoints include objective response rate (ORR) and duration of response.

      In the field of colorectal cancer (CRC), this study evaluated MK-1084 monotherapy as well as its combination with cetuximab (with or without chemotherapy; the chemotherapy regimen consisted of oxaliplatin, leucovorin, and 5-fluorouracil [mFOLFOX6]).

      In non-small cell lung cancer (NSCLC), the evaluation covered MK-1084 monotherapy as well as its combination with pembrolizumab (with or without chemotherapy, where the chemotherapy regimen consisted of carboplatin and pemetrexed).

      Apart from the KANDLELIT – 001 study, MK – 1084 is also being evaluated in the Phase III KANDLELIT – 012 study. The KANDLELIT – 012 study aims to investigate the use of MK – 1084 in combination with cetuximab and mFOLFOX6 as a first-line treatment for patients with locally advanced unresectable or metastatic CRC carrying KRAS G12C mutations. Additionally, MK – 1084 is being evaluated in the Phase III KANDLELIT – 004 study. The KANDLELIT – 004 study aims to explore the use of MK – 1084 in combination with pembrolizumab as a first-line treatment for patients with metastatic NSCLC carrying KRAS G12C mutations and a programmed death-ligand 1 (PD-L1) tumor proportion score (TPS) ≥50%.

      MK-1084 is being developed under a collaboration and license agreement with Taiho Pharmaceutical Co., Ltd., and Astex Pharmaceuticals (UK), a wholly-owned subsidiary of Otsuka Pharmaceutical Co., Ltd.

*As of now, MK-1084 has not been approved in China.

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