Approvals

The approval follows data from the phase 3 KEYNOTE-859 trial, in which Keytruda in combination with chemotherapy reduced the risk of death by 22% compared to chemotherapy alone. Median overall survival (OS) was 12.9 months for Keytruda compared to 11.5 months with chemotherapy alone.

Immune-mediated adverse reactions could include pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, dermatologic reactions, solid organ transplant rejections and complications of allogeneic haematopoietic stem cell transplantation.

Dr Marjorie Green, senior vice president and head of late-stage oncology, global clinical development, Merck Research Laboratories, commented: “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 reinforces Merck’s commitment to addressing the needs of these patients in the US.”

Dr Zev A Wainberg, professor of medicine at the University of California, Los Angeles School of Medicine and co-director of the UCLA GI Oncology Program, all US, added: “The majority of patients with gastric cancer are diagnosed at an advanced stage, at which point they face a poor prognosis with a five-year survival rate of 6%. This approval of pembrolizumab plus chemotherapy offers patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction cancer a new immunotherapy regimen that has demonstrated the potential to help these patients live longer.”