Merck & Co. (NYSE:MRK) began a late-stage clinical trial for a new combination therapy aimed at untreated lung cancer, seeking to eliminate the need for traditional chemotherapy and intravenous infusions for patients with a specific genetic mutation.
The Rahway, New Jersey-based drugmaker initiated the KANDLELIT-007 study to evaluate calderasib, an oral drug designed to inhibit the KRAS G12C mutation, in tandem with Keytruda Qlex, a subcutaneous formulation of its blockbuster immunotherapy.
The trial will focus on patients with advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC), the company said in a statement Wednesday.
The move underscores Merck’s strategy to defend its oncology dominance by pairing Keytruda with newer, targeted medicines.
The KRAS G12C mutation is a frequent driver of tumor growth, appearing in approximately 4% to 14% of lung cancer cases worldwide.
The global study will enroll roughly 675 patients.
Researchers will compare the oral-and-subcutaneous duo against a standard-of-care regimen consisting of Keytruda, pemetrexed, and platinum-based chemotherapy.
The primary goal is to measure progression-free survival in patients whose tumors express the PD-L1 protein.
Merck is developing calderasib through a 2020 partnership with Taiho Pharmaceutical Co. and Astex Pharmaceuticals, a unit of Otsuka Pharmaceutical Co.
The drug is also being tested in separate Phase 3 trials for colorectal cancer and other lung cancer settings.