Merck & Co – known as MSD outside the US and Canada – has received a recommendation from the National Institute for Health and Care Excellence (NICE) for the use of Keytruda (pembrolizumab) in a subset of advanced gastric cancer patients.
The anti-PD-1 therapy has been specifically recommended for use alongside platinum- and fluoropyrimidine-based chemotherapy to treat untreated locally advanced unresectable or metastatic human epidermal growth factor 2-negative gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a combined positive score (CPS) of one or more.
More than 6,500 new diagnoses of gastric cancer are made in the UK every year and adenocarcinomas, which develop from cells in the innermost lining of the stomach, account for the majority of cases.
The disease usually develops slowly over many years without early symptoms, meaning the majority of cases go undetected until an advanced stage.
The agency’s decision, which provides the first immunotherapy-chemotherapy combination treatment option for patients whose tumours express PD-L1 with a CPS of one to four, was supported by positive results from the late-stage KEYNOTE-859 trial.
Results showed that the Keytruda/chemotherapy combination led to statistically significant improvements in overall survival, progression-free survival and objective response rate compared to placebo plus chemotherapy.
“When considering the condition’s severity and its effect on quality and length of life, the most likely cost-effectiveness estimates for [Keytruda] plus doublet chemotherapy compared with doublet chemotherapy alone are within the range that NICE considers an acceptable use of NHS resources,” NICE said in its final draft guidance.
The Scottish Medicines Consortium approved the Keytruda combination for use in the same patient population earlier this year.
Commenting on the latest authorisation for the therapy, Dr Urmi Shukla, head of oncology medical affairs at MSD UK said: “Advanced or metastatic gastric or gastro-oesophageal junction adenocarcinomas are aggressive cancers which are hard-to-treat.
“I am therefore incredibly proud that eligible patients with HER2-negative tumours which express a PD-L1 biomarker combined positive score of one or more will now have access to an alternative treatment option.”
Beyond gastric cancer, Keytruda is approved for a wide range of oncology indications, including specific cases of cervical cancer, endometrial cancer and renal cell carcinoma.