Just days away from an FDA decision that could finally bring Bristol Myers Squibb’s Opdivo to previously untreated non-small cell lung cancer patients, the company’s Opdivo-Yervoy combo has put up positive three-year data.
At that juncture, the duo showed it was still outperforming chemo when it came to helping patients live longer. The combo cut the risk of death by 21% among patients whose tumors tested positive for biomarker PD-L1, BMS said ahead of the American Society of Clinical Oncology (ASCO) virtual annual meeting, and 38% of those patients who responded to the combo were still seeing benefits at the three-year mark.
That last piece is key, especially considering that patients only received the combo treatment for two years. “Importantly, especially for those patients who get into a response,” they see “a continuation of that response beyond that two-year treatment,” said Samit Hirawat, BMS’ chief medical officer.
The data come from Part 1 of the Checkmate-227 trial, which made headlines at last fall’s European Society for Medical Oncology annual meeting when BMS unveiled the survival benefit.
But it also generated some disagreements among experts. Some heralded the results as “practice-changing,” noting that the regimen provided a chemo-free option for patients.
Others, though, pointed out that chemo is no longer the treatment option to beat in newly diagnosed patients—that would be a combination of chemo and Opdivo’s archrival, Keytruda from Merck, or Keytruda on its own for those who can’t tolerate chemo.
Some of the skeptics said it would take more time—and more data—to really determine the appropriate place for Opdivo-Yervoy in the first-line setting, and that’s part of what BMS is getting at with its latest update.
“If you think about it, there’s continuous and growing evidence of dual (immuno-oncology agents) providing an overall benefit in terms of overall survival for these patients, and I think that’s the way to look at it from an overall perspective,” Hirawat said.
Of course, the New Jersey drugmaker can’t start making that pitch to doctors until it has an FDA approval, which could come at any time. The agency is due to make a decision by Friday after bestowing the pairing with a priority review back in January.
Across the pond, though, things haven’t gone so well on the regulatory side for the Opdivo-Yervoy combo. BMS pulled its application in February after reviewers at the European Medicines Agency's Committee for Medicinal Products for Human Use determined that multiple changes to the trial’s design had made it too difficult to evaluate the data.
If BMS can secure a green light, it’ll be counting on doctors’ familiarity with the combo—as well as new data from ASCO—to drive prescriptions.
“Fifty percent of oncology prescribers are already using this combo in other diseases. For them to continue to see the evolution of these data … I think will provide the confidence that ‘Yes, we can go ahead and start to use this once approved by the FDA,'” Hirawat said.