AstraZeneca's oncology efforts have yielded some major wins over the last year, but Monday the drugmaker revealed a lung cancer setback for its blockbuster Imfinzi.
In the phase 3 PEARL study, Imfinzi failed to meet its primary endpoint of extending overall survival in certain metastatic lung cancer patients. Specifically, investigators tested the immuno-oncology drug against chemotherapy in patients with stage IV non-small cell lung cancer with high levels (25% or more) of PD-L1, or those with a low risk of early mortality.
Imfinzi binds to the PD-L1 protein on tumors and inhibits its interaction with other proteins, allowing the body to mount a stronger immune response.
While the trial failed to meet its primary endpoint, Imfinzi did improve overall survival in patients with PD-L1 tumor expression above 50%. That was a secondary endpoint and a "clinically meaningful" result, the company said in a statement.
AZ started the study "at a time when patient selection for immune checkpoint inhibitors was still evolving," Susan Galbraith, the company's executive vice president of oncology R&D, said in a statement. AZ is "encouraged" that metastatic lung cancer patients with higher levels of PD-L1 "demonstrate the most benefit with Imfinzi monotherapy treatment," she added.
Investigators conducted the study mostly in Asia.
While the result marks a setback for AZ's cancer division, the drugmaker has racked up some major wins recently in oncology. For one, Daiichi Sankyo-partnered Enhertu is breaking ground in the HER2-low breast cancer space. And Imfinzi itself snared a first-in-class FDA approval back in September to treat locally advanced or metastatic biliary tract cancer when paired with chemotherapy.
Aside from the Imfinzi fail, AstraZeneca on Monday said its SGLT2 inhibitor Forxiga nabbed a recommendation for European approval to treat heart failure patients across the full spectrum of left ventricular ejection fraction.