The combination treatment is approved for people with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.
The latest development is based on findings from the double-blind, randomised, multicentre, placebo-controlled Phase III KEYNOTE-859 clinical trial of Keytruda along with chemotherapy containing fluoropyrimidine and platinum.
Trial data showed that the combination treatment reduced mortality risk by 22% versus chemotherapy alone.
Median overall survival was 12.9 months in the Keytruda plus chemotherapy arm compared to 11.5 months for the chemotherapy arm alone.
An anti-programmed death receptor-1 treatment, Keytruda acts by enhancing the immune system’s potential to identify and kill tumour cells.
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The latest FDA approval is the 38th indication for Keytruda alone and the seventh indication in gastrointestinal cancer for Keytruda-based regimens in the region.
Merck Research Laboratories global clinical development late-stage oncology senior vice-president and head Dr Marjorie Green stated: “At Merck, we have a comprehensive development programme across a broad range of gastrointestinal cancers with the goal of providing meaningful new options to patients and their healthcare providers.
“This latest approval of a Keytruda-based treatment option is an important milestone for patients with advanced HER2-negative gastric or GEJ adenocarcinoma and re-inforces Merck’s commitment to addressing the needs of these patients in the US.”
The Committee for Medicinal Products for Human Use of the European Medicines Agency had previously provided a positive opinion to approve MSD’s Keytruda combination therapy for biliary tract cancer.