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Merck Nabs European Approvals for Keytruda in Cervical Cancer, Biomarker-Defined Solid Tumors

NEW YORK – The European Commission on Friday approved Merck's Keytruda (pembrolizumab) for several new indications: for advanced, PD-L1-expressing cervical cancer and for five solid tumor types characterized by high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR).

For cervical cancer patients, European regulators approved Keytruda in combination with chemotherapy with or without Genentech's Avastin (bevacizumab). Treatment-eligible patients must have persistent, recurrent, or metastatic tumors that express PD-L1 with a combined positive score of at least one.

The EC's decision is based on data from the Phase III KEYNOTE-826 trial, in which the checkpoint inhibitor-chemotherapy regimen with or without Avastin improved patients' overall survival and progression-free survival versus chemotherapy alone with or without Avastin.

In the US, Keytruda is approved in both the first-line and later-line treatment setting for PD-L1-expressing cervical cancer.

As for the approval in the five MSI-H/dMMR solid tumors, the EC specified that it is authorizing Keytruda as a treatment for five types of previously treated, advanced cancer, including colorectal, endometrial, gastric, small intestine, and biliary cancer. Regulators approved Keytruda for unresectable or metastatic colorectal cancer patients after fluoropyrimidine-based combination therapy; for advanced or recurrent endometrial cancer patients who can't have curative surgery or radiation, after they've received platinum-containing therapy; and for unresectable or metastatic gastric, small intestine, or biliary cancer patients who have progressed on at least one prior therapy.

This is the second time the EC has approved Keytruda based on MSI-H/dMMR biomarkers. In January 2021, the regulator approved Keytruda as a first-line treatment for MSI-H/dMMR metastatic colorectal cancer based on data from the Keynote-177 trial.

For the latest approval, regulators relied on data from the Phase II KEYNOTE-164 trial and the Phase II KEYNOTE-158 trial, which both included patients with advanced MSI-H or dMMR solid tumors.  

While the EC decided to approve Keytruda in five distinct MSI-H/dMMR solid tumor indications, the US Food and Drug Administration in 2017 granted tissue-agnostic approval to Keytruda using these biomarkers. In the US, the checkpoint inhibitor is approved for any previously treated, unresectable or metastatic MSI-H or dMMR solid tumor for which the patient has no satisfactory alternative treatment options.

The latest EC approvals allow Merck to market Keytruda in these settings in all 27 EU member states as well as in Iceland, Lichtenstein, Norway, and Northern Ireland.

These EC approvals come a day after the drugmaker reported a 50 percent revenue increase in the first quarter of 2022, largely driven by sales of Keytruda, its top-selling therapeutic product.