Bristol-Myers Squibb has been waiting years to get a crack at the previously untreated non-small cell lung cancer market, but the end to its waiting may finally be in sight.
The FDA accepted the New Jersey drugmaker’s combo application for immuno-oncology meds Opdivo and Yervoy in NSCLC patients without EGFR or ALK mutations, the company said Wednesday—and it’s bestowed its priority review tag on the filing, shortening the review timeline. The agency's now set to make a decision by May 15.
Regulators based the decision on data from Bristol’s phase 3 Checkmate-227 trial, which pitted the duo against chemo and found it could cut the risk of disease or death by 21%.
Bristol has long been under pressure to break into the first-line NSCLC market, considered the most lucrative for immuno-oncology drugs. But the company’s previous attempts with its PD-1 inhibitor Opdivo have been unsuccessful, both on the monotherapy and combo fronts.
Not so for archrival Keytruda from Merck & Co., which has gone on to dominate the crucial arena between its solo and chemo-combo approvals. In particular, data showing Keytruda-plus-chemo could slash patients’ death risk by half has helped the drug gobble up market share, and that’s the competition Bristol will be dealing with if it can pick up an FDA okay.
The thing is, in the years Bristol’s been trying for a regulatory success, Keytruda has changed the treatment landscape so much that the Opdivo-Yervoy comparator from Checkmate-227—solo chemo—is no longer all that relevant. Most patients now receive immunotherapy in the front-line setting, as BMS’ critics have pointed out.
But there may still be room in the market for patients who either can’t undergo chemotherapy or prefer to avoid it, study investigators pointed out at last year’s European Society for Medical Oncology (ESMO) annual meeting, where Bristol presented the data.
“In my opinion these data are practice-changing,” lead author Solange Peters said in a statement at the time. “We already have several front-line treatment options for these patients, including chemotherapy combined with an anti-PD1 agent or an anti-PDL1 agent alone. And now we have a chemotherapy-sparing option of nivolumab plus ipilimumab.”