Source: Merck
Merck’s renowned cancer drug, Keytruda, may soon see an updated label for its effectiveness in treating HER2-positive stomach cancer. Promising results from a combination study demonstrate its ability to prevent tumor progression. Keytruda initially received accelerated approval from the FDA in 2021 based on data showing tumor shrinkage. However, its continued approval relies on positive confirmatory data. Merck is currently collaborating with the FDA to include disease progression data in patients with PD-L1 expressing tumors in the current indication.
It remains unclear whether Merck aims to convert the approval into a full one. Bristol Myers Squibb’s Opdivo secured the first approval in stomach cancer for the PD-1 inhibitor class, demonstrating its ability to save lives.
“These new data from KEYNOTE-811, demonstrating a significant improvement in progression-free survival, are meaningful and build on the earlier insights from this study that supported the accelerated approval of this KEYTRUDA combination in the U.S. for certain patients with HER2-positive gastric or GEJ adenocarcinoma. We look forward to sharing these results with the medical community and regulatory authorities to ensure this KEYTRUDA-based regimen is available to appropriate patients, and we are working with the FDA to update the current indication for KEYTRUDA to those patients whose tumors are PD-L1 positive.”
– Dr. Scot Ebbinghaus, vice president, global clinical development, Merck Research Laboratories
The updated results of Keytruda stem from a comprehensive trial involving 732 patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma. In combination with Roche’s Herceptin and chemotherapy, Keytruda showed improved progression-free survival compared to the Herceptin-chemo combination, specifically in patients with PD-L1 positive tumors, which constituted over 80% of the trial participants. While the study indicated a “trend toward improvement” in overall survival, it did not reach statistical significance. Further analysis will explore this endpoint.
This recent trial is just one among the 1,600 ongoing Keytruda trials, encompassing various cancer types and treatment settings. Keytruda has been a significant commercial success, generating $20.9 billion in sales last year.
