Merck’s KEYTRUDA Now FDA Approved for Previously Treated Patients w/ Recurrent Locally Advanced Cancer Whose Tumors Express PD-L1
Dr. Roger M. Perlmutter, president, Merck Research Laboratories stated “KEYTRUDA is now the first PD-1 checkpoint inhibitor approved in the United States for previously treated advanced gastric or GEJ cancer, helping to address a recognized treatment gap. This approval marks another milestone – the tenth new indication for KEYTRUDA in just three years – which further demonstrates both our commitment to patients and the progress we have made in the fight against many cancers.”
Formally on September 22nd, Merck ( NYSE: MRK) announced that The U.S. Food and Drug Administration (FDA) has approved KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 (programmed death receptor-1) therapy, for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under the FDA’s accelerated approval regulations based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
“Historically, advanced gastric cancer has been particularly challenging to treat, and new treatment options are needed for these patients,” said Charles S. Fuchs, M.D., MPH, lead investigator, and director of Yale Cancer Center. “The results observed in the diverse population of heavily pretreated advanced gastric or GEJ patients from the KEYNOTE-059 clinical trial demonstrate that pembrolizumab in the third-line setting has the potential to shift how we care for certain patients facing this difficult-to-treat disease.”
The accelerated approval for KEYTRUDA was reported to be based on data from a global, multicenter, non-randomized, open-label multi-cohort trial, KEYNOTE-059, that enrolled 259 patients with gastric or GEJ adenocarcinoma who progressed on at least two prior systemic treatments for advanced disease. Previous treatment must have included a fluoropyrimidine and platinum doublet; HER2/neu-positive patients must have previously received treatment with approved HER2/neu-targeted therapy. Patients with active autoimmune disease or a medical condition that required immunosuppression or with clinical evidence of ascites by physical exam were ineligible. Patients received KEYTRUDA at a dose of 200 mg every three weeks until unacceptable toxicity or disease progression that was symptomatic, rapidly progressive, required urgent intervention, occurred with a decline in performance status or was confirmed at least four weeks later with repeat imaging. Patients without disease progression were treated for up to 24 months. Assessment of tumor status was performed every six to nine weeks. The major efficacy outcome measures were objective response rate (ORR) according to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1, as assessed by an independent central review, and duration of response.
KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.
Merck has the industry’s largest immuno-oncology clinical research program, which currently involves more than 550 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient’s likelihood of benefiting from treatment with KEYTRUDA, including exploring several different biomarkers.