Merck recently announced it initiated a Phase 3 clinical trial evaluating MK-1084 in combination with Keytruda for treating patients with metastatic non-small cell lung cancer (NSCLC).
The Rahway, N.J.-based company is evaluating MK-1084, an investigational oral selective KRAS G12C inhibitor, in combination with Keytruda to treat patients with NSCLC whose tumors have KRAS G12C mutations and express PD-L1.
“KRAS is among the most prevalent mutations in cancer and KRAS G12C is the most common KRAS mutation in patients with non-small cell lung cancer,” Dr. Marjorie Green, senior VP and head of oncology and global clinical development at Merck, said in a news release. “Based on early evidence showing MK-1084 in combination with KEYTRUDA had a manageable safety profile and promising anti-tumor activity, we are now proceeding to a larger Phase 3 trial to evaluate this combination in certain patients with metastatic non-small cell lung cancer.”
Merck’s Phase 3 trial is a randomized, double-blind, multicenter clinical trial evaluating once-daily MK-1084 in combination with Keytruda administered once every three weeks compared with Keytruda plus placebo in previously untreated patients with KRAS G12C-mutated metastatic NSCLC with a PD-L1 tumor proportion score ≥50%. The company will enroll approximately 600 patients globally.
Keytruda is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the body’s immune system’s ability to detect and fight tumor cells. It is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, activating T lymphocytes that may affect tumor cells and healthy cells. More than 1,600 trials are currently studying Keytruda across various cancers and treatment settings.
The study’s primary endpoints are progression-free survival and overall survival. The key secondary endpoints include objective response rate and duration of response.
MK-1084 is being evaluated in a Phase 1, open-label multicenter clinical trial to assess its safety, tolerability, pharmacokinetics and efficacy as a monotherapy and as part of various combination therapies in patients with advanced KRAS G12C mutant solid tumors. The company presented preliminary safety and efficacy data from this trial at the European Society for Medical Oncology Congress last year.
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