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FDA approves Keytruda for certain gastric cancers
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The FDA today approved pembrolizumab for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma, according to a press release from the manufacturer.
The approval applies to use of pembrolizumab (Keytruda, Merck) — a humanized monoclonal antibody that blocks the interaction of PD-1 and its ligands — among patients whose tumors express PD-L1 and who experienced disease progression on or after two or more prior lines of fluoropyrimidine- and platinum-based chemotherapy or HER-2/neu-targeted therapy.
The accelerated approval is based on results from the KEYNOTE-059 clinical trial.
“The results observed in the diverse population of heavily pretreated advanced gastric or [gastroesophageal junction] patients from the KEYNOTE-059 clinical trial demonstrated that pembrolizumab in the third-line setting has the potential to shift how we care for certain patients facing this difficult-to-treat disease,” Charles S. Fuchs, MD, MPH, lead investigator on the KEYNOTE-059 trial and director of Yale Cancer Center, said in a press release. “Historically, advanced gastric cancer has been particularly challenging to treat, and new treatment options are needed for these patients.”
In the KEYNOTE-059 trial, 259 patients with gastric or gastroesophageal junction adenocarcinoma received 200 mg pembrolizumab every 3 weeks until toxicity or disease progression. Patients without disease progression received treatment for up to 2 years.
Fifty-five percent of patients (n = 143; median age, 64 years) had tumors that expressed PD-L1 based on a combined positive score greater than 1. Of these patients, 77% were men, 8% white and 11% Asian; they had an ECOG performance status of 0 (43%) and 1 (57%).
The overall response rate in the PD-L1-positive cohort was 13.3% (95% CI, 8.2-20), which included a complete response rate of 1.4% and a partial response rate of 11.9%.
The duration of response among the 19 responding patients ranged from 2.8+ to 19.4+ months. Eleven patients responded for 6 months or longer and five patients responded for 12 months or longer.
The most common adverse reactions reported in more than 20% of patients included fatigue, musculoskeletal pain, decreased appetite, pruritis, diarrhea, nausea, rash, pyrexia, cough, dyspnea and constipation.
The FDA granted priority review to pembrolizumab for the treatment of recurrent or advanced gastric or gastroesophageal junction adenocarcinoma in May.
Pembrolizumab also is approved for several other indications, including treatment of certain patients with unresectable or metastatic melanoma, metastatic non-small cell lung cancer, recurrent or metastatic head and neck squamous cell carcinoma, classical Hodgkin lymphoma and urothelial carcinoma.