NICE recommends Merck's Keytruda combo for advanced gastric cancer

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 certain advanced gastric cancer patients. Keytruda, an anti-PD-1 therapy, has been approved for use in combination with platinum- and fluoropyrimidine-based chemotherapy. This regimen is designated for the treatment of untreated locally advanced unresectable or metastatic human epidermal growth factor 2-negative gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumors express PD-L1 with a combined positive score (CPS) of one or more.

Gastric cancer diagnoses in the UK exceed 6,500 annually, with adenocarcinomas, which originate from cells in the stomach lining, being the predominant form. The disease typically progresses slowly over many years, often without early symptoms, leading to late-stage detection in the majority of cases.

NICE's decision marks the first immunotherapy-chemotherapy combination treatment for patients whose tumors express PD-L1 with a CPS of one to four. The recommendation was based on successful results from the late-stage KEYNOTE-859 trial. The trial demonstrated that the combination of Keytruda and chemotherapy significantly improved overall survival, progression-free survival, and objective response rate compared with a placebo plus chemotherapy.

NICE, in its final draft guidance, stated, "When considering the condition's severity and its effect on quality and length of life, the most likely cost-effectiveness estimates for [Keytruda]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."

Earlier this year, the Scottish Medicines Consortium also approved the Keytruda combination for use in the same patient population. Dr. Urmi Shukla, head of oncology medical affairs at MSD UK, commented on the recent authorization, stating, "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 tumors which express a PD-L1 biomarker combined positive score of one or more will now have access to an alternative treatment option."

In addition to gastric cancer, Keytruda is approved for a variety of oncology indications, including specific instances of cervical cancer, endometrial cancer, and renal cell carcinoma.