Merck & Co – known as MSD outside the US and Canada – has announced that its anti-PD-1 therapy Keytruda (pembrolizumab) has been approved by the European Commission (EC) as part of a combination treatment for certain gastric cancer patients.

The therapy is now approved in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Patients eligible for the Keytruda regimen will also have tumours that express PD-L1 with a combined positive score of one or more, the company outlined.

Gastric cancer is the fifth most commonly diagnosed cancer and the fourth leading cause of cancer death worldwide, with nearly 1.1 million new cases diagnosed and more than 768,000 deaths from the disease globally in 2020.

Most gastric cancers are adenocarcinomas, which develop from cells in the innermost lining of the stomach. As the disease tends to develop slowly over many years and rarely causes early symptoms, many cases go undetected until an advanced stage.

The EC’s decision was supported by results from Merck’s phase 3 KEYNOTE-811 trial, in which the Keytruda combination demonstrated a statistically significant improvement in progression-free survival and objective response rate compared to trastuzumab and chemotherapy alone in patients in the intention-to-treat population.

Dr Scot Ebbinghaus, vice president, global clinical development, Merck Research Laboratories, said: “Patients in the EU diagnosed with HER2-positive advanced gastric cancer face an aggressive disease associated with a poor prognosis, underscoring the need for additional first-line treatment options for these patients.

“With [the] approval of Keytruda, we’re proud that patients whose tumours express PD-L1 with a combined positive score of one or more and healthcare providers in the EU will have an option that includes immunotherapy for this difficult-to-treat disease.”

The Keytruda regimen has already been granted accelerated approval in the US for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or GEJ adenocarcinoma.

Merck said it is working with the US Food and Drug Administration to update the current indication for patients whose tumours are PD-L1 positive.

https://www.pmlive.com/pharma_news/merck_receives_ec_approval_for_keytruda_combination_in_gastric_cancer_1496958