It’s been a long road for Bristol-Myers Squibb’s Opdivo, but the immuno-oncology star finally has a place in the lucrative market for previously untreated non-small cell lung cancer.
The FDA Friday approved Opdivo alongside fellow BMS checkpoint inhibitor Yervoy for first-line patients whose tumors test positive for biomarker PD-L1, giving patients a chemo-free option and the company a crack at a sales boost.
Of course, racking up revenue in the new indication won’t be easy, considering Bristol’s duo will have to go up against Merck & Co.’s formidable Keytruda-chemo combo, which has shown it can slash patients’ risk of death by 51%—no matter their PD-L1 status.
Bristol’s duo, meanwhile, cut the risk of death among PD-L1 positive patients by just 21% in Part 1 of the phase 3 Checkmate-227 trial.
The company, though, has focused on showing the pairing can make responses last. Three-year data unveiled Wednesday ahead of the American Society of Clinical Oncology (ASCO) virtual annual meeting showed that 38% of those who responded to the combo were still seeing benefits a year after the treatment cutoff mark at Year 2.
"In oncology, the most important thing for physicians and patients is achieving durable survival outcomes. What we've been able to show in this trial" is Opdivo and Yervoy "working together in a complementary way to boost the immune system to destroy tumor cells," Nick Botwood, M.D., BMS' VP of oncology clinical development, said.
"Over one-third of patients are still alive at three years. This is really very remarkable in the context of non-small cell lung cancer," he added.
Bristol has been through somewhat of a rollercoaster in its quest to snag a front-line nod for Opdivo. First, the drug struck out as a monotherapy, while archrival Keytruda went on to grab a green light. Later, with Merck’s treatment already gobbling up market share as part of the chemo combo, BMS was forced to pull its Opdivo-Yervoy application on an FDA quest for more data.
And while it now has the FDA nod it’s long been after, the New Jersey drugmaker still won’t be able to compete on a global scale—at least not yet. In February, it withdrew its European Opdivo-Yervoy filing, citing multiple changes to clinical trial design that a regulatory committee said made it too difficult to evaluate the data. And it won’t be trying again for a nod there, either.
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Meanwhile, though, Bristol is also working on another Opdivo-Yervoy combination regimen to try to spur more early responses to treatment. That cocktail, which combines Opdivo, Yervoy and two cycles of chemo, showed Wednesday that it could cut patients’ risk of death by up to 38%.