Merck pulls Keytruda for SCLC. Pharmaceutical company, Merck announced plans to pull Ketruda for SCLC due to disappointing results from Phase III trial.

Merck pulls Keytruda for SCLC: On March 1, 2021, pharmaceutical company, Merck announced plans to pull Ketruda for SCLC.

Merck’s Keytruda (pembrolizumab) is the dominant checkpoint inhibitor in the immuno-oncology space, approved for a laundry list of cancer indications. In the third quarter of 2020 alone, Keytruda had sales of $3.7 billion, an increase of 21% from the same period the previous year. So it can come as a surprise when the drug fails to hit a clinical trial endpoint.

On March 1, Merck announced it had voluntarily withdrawn the U.S. indication for Keytruda for metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least one other previous line of therapy.

This was done in consultation with the U.S. Food and Drug Administration (FDA). The complete process will take a few weeks. The company notes that this decision has no effect on other indications for Keytruda.

Clinical Trial results key to Merck decision to pull Keytruda for SCLC

The checkpoint inhibitor received accelerated approval for this indication in June 2019 based on tumor response rate and durability of response data from KEYNOTE-158 (cohort G) and KEYNOTE-028 (cohort C1). The deal with the FDA was that the approval was contingent on completing a post-marketing evaluation proving Keytruda was superior to other products in extending overall survival (OS).

On January 2020, KEYNOTE-604, the confirmatory Phase III trial, hit one of the dual primary endpoints, progression-free survival (PFS), but didn’t reach statistical significance for the other primary endpoint of OS.

“The accelerated pathways created by the FDA have been integral to the remarkable progress in oncology care over the past five years and have helped many cancer patients with advanced disease, including small cell lung cancer, access new treatments,” said Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “Keytruda remains a foundational treatment for certain patients with metastatic non-small cell lung cancer. We will continue to rigorously evaluate the benefits of Keytruda in small cell lung cancer and other types of cancer, in pursuit of Merck’s mission to save and improve lives.”