Health Canada has approved Merck & Co Inc (MSD)’s Keytruda (pembrolizumab), an anti-programmed cell death protein 1 (PD-1) therapy for use in combination with fluoropyrimidine- and platinum-containing-chemotherapy as a first-line treatment for adult gastric cancer patients.
The combination treatment is approved for adult patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2-negative gastric or gastroesophageal junction adenocarcinoma.
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Keytruda is a humanised monoclonal antibody that operates by enhancing the immune system’s capability to detect and combat tumour cells.
It inhibits the interaction between PD-1 and its ligands, PD-L1, and PD-L2, in turn activating T lymphocytes that may impact both tumour cells and healthy cells.
The latest approval is based on the outcomes of the Phase III KEYNOTE-859 trial, which indicated significant improvements in overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) when compared to placebo in combination with chemotherapy in the intention-to-treat study population.
The Keynote-859 trial was a randomised, double-blind, placebo-controlled study that enrolled 1,579 patients who had not previously received systemic therapy for their metastatic condition.
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By GlobalDataThe trial’s primary endpoint was OS, with PFS and ORR as secondary endpoints.
Patients were randomised 1:1 to be administered pembrolizumab (200mg every three weeks) in combination with fluoropyrimidine- and platinum-containing chemotherapy (n=790) or a placebo alongside chemotherapy, with the pembrolizumab group showing a 22% reduction in the risk of death compared to chemotherapy alone.
The median overall survival for patients on pembrolizumab plus chemotherapy was 12.9 months when compared to 11.5 months for those on chemotherapy alone.
First approved in Canada in 2015, Keytruda holds indications across various disease areas including advanced renal cell carcinoma, bladder cancer, and non-small cell lung carcinoma, among others.
Merck Canada Oncology Business Unit executive director and vice-president André Galarneau said: “We are proud of the recent expansion of Keytruda’s indications in gastric cancers, which often go undetected until an advanced stage, at which point patients face a poor prognosis.
“This milestone underscores our commitment to helping improve the lives of patients by offering treatment options that can lead to better health outcomes.”
Last year, the US Food and Drug Administration approved Keytruda plus chemotherapy as a first-line treatment for gastric cancer in adult patients
