- A regimen involving AstraZeneca’s immunotherapy Imfinzi met the first of two main study goals in a Phase 3 trial in early non-small cell lung cancer, the British drugmaker said Thursday.
- Upon an interim analysis, study investigators found patients who’d received Imfinzi and chemotherapy starting before, and continuing after surgical removal of a tumor had a statistically significant and “meaningful” improvement versus chemo alone in so-called pathological complete responses, or absence of tumor cells on a scan. AstraZeneca didn’t disclose specifics.
- The study, known as AEGEAN, will continue to see how well the drug combination stops cancer from recurring, its other main objective and a measure other companies have used to support approvals in early lung cancer. In the meantime, though, AstraZeneca will share the results it has with global health authorities.
Over the last decade, immunotherapies known as checkpoint inhibitors have steadily worked their way forward in non-small cell lung cancer, the most common form of the disease. First, drugs like Merck & Co.’s Keytruda, Bristol Myers Squibb’s Opdivo and Roche’s Tecentriq became go-to treatments for patients with metastatic disease. This year, they’ve started to become available earlier, either before or after surgery to remove a tumor.
Since January, the FDA has approved drug combinations involving Opdivo and Tecentriq for patients with early-stage lung cancer. Merck, which detailed Phase 3 study results in March, has said it aims to follow with an application for Keytruda.
With its announcement on Thursday, AstraZeneca’s Imfinzi could soon join them, though it’s not yet clear how the drug compares to its competitors. Pathological complete responses are a surrogate marker for more definitive outcomes, like slowing cancer’s return or extending survival, and the study hasn’t gone on long enough to tell how the drug performed on those measures.
Those numbers, when they are revealed, could help answer whether treating a tumor with immunotherapy has more impact before surgery to remove a tumor.
Bristol Myers tested a short, nine-week course of Opdivo and chemotherapy before surgery, and reported a 37% reduction in risk of relapse or death in all study participants. Roche and Merck tested longer regimens of their drugs after surgery. Roche ended up with a 21% risk reduction in all patients, and better results — a 34% reduction — among patients whose tumors express at least some of a protein, PD-L1, that’s associated with a better treatment response. Merck reported a 24% risk reduction overall, but a lower 18% average reduction in people with high PD-L1 levels. None have definitively proven how long they can extend lives. Studies are ongoing.
AstraZeneca, by comparison, tested a 12-week course of Imfinzi and chemotherapy before surgery that continued for up to 12 treatment cycles afterwards. Study details will be disclosed at a future medical meeting.
Roche, meanwhile, also has an ongoing Phase 3 trial testing a regimen of Tecentriq that begins before surgery and continues afterwards.