Merck’s cancer star Keytruda could be on its way to an updated label in HER2-positive stomach cancer after showing it can stave off tumor progression in a combination study.
Keytruda scored its original gastric cancer approval in 2021 under the FDA’s accelerated approval program based on tumor shrinkage data. Its continued approval hinges on positive confirmatory data. Now, the company is working with the FDA to update the current indication to include disease progression data in patients whose tumors express PD-L1, the company said in its Friday release.
It’s not immediately clear whether Merck intends to convince the FDA to convert the approval into a full one. Bristol Myers Squibb’s Opdivo scored the PD-1 inhibitor class’s first nod in stomach cancer based on data showing it could save lives.
Keytruda’s new results come from a 732-patient trial in locally advanced unresectable or metastatic HER2-positive gastric or GEJ (gastroesophageal junction) adenocarcinoma. Keytruda, used along with Roche’s Herceptin and chemotherapy, showed an improvement in progression-free survival compared with the Herceptin-chemo combo, but only in patients with PD-L1 positive tumors. The group made up more than 80% of the trial.
