UPDATED: Still no Opdivo benefit in subgroup breakdown of Bristol's first-line NSCLC flop

Opdivo

COPENHAGEN, Denmark--Bristol-Myers Squibb is out with the details on its first-line non-small cell lung cancer failure for immuno-oncology med Opdivo--and it’s ready to move on.

Sunday, the New Jersey pharma giant unveiled details of the flop, which spurred revised sales estimates and plenty of market movement when the company announced the failure in early August. Among patients with PD-L1 expression levels of 5% or greater, Opdivo failed to top chemo in progression-free survival--posting a median 4.2 months versus platinum-based doublet chemotherapy’s 5.9.

The med didn't statistically significantly beat out the chemo regimen on the secondary endpoint of overall survival, either, recording a 14.4-month mark versus chemo’s 13.2.

Breaking it down by subgroup also did not yield any Opdivo benefits. “We have not seen major differences in the biomarker cutoffs,” Fouad Namouni, Bristol’s head of oncology development, told FiercePharma in an interview at ESMO.

Namouni did note some imbalances between the study’s two arms, including more patients with high-level PD-L1 expression in the chemo arm. “It makes the interpretation of the data at the high level of cutoffs very difficult because it was not stratified,” he said.

But what’s done is done, as Bristol and analysts both well know. The misfire put the company “on its back foot from a commercial perspective,” Bernstein analyst Tim Anderson wrote in an August note to clients, and made Merck’s Keytruda--Opdivo’s nemesis--the drug to beat in the lung cancer space.

Leerink Partners analyst Seamus Fernandez, for one, doesn't even think Opdivo will get a chance to play in the front-line setting. "We believe Merck will dominate first line lung for years to come in patients with 50%+ PDL1 expression," he said, noting that he assumes no first-line use of Opdivo or combinations in the setting.

BMS doesn’t intend to dwell, though. It’s focusing its efforts on combination therapies, on which it believes “the future of lung cancer for the majority of patients will probably be based,” Namouni said.

That includes testing Opdivo alongside fellow Bristol immunotherapy Yervoy in patients who express PD-L1, and testing it alongside Yervoy and alongside chemo in those who don’t, he said.

“We really know the answer for monotherapy,” Namouni said. “I think the bar needs to be raised above what we are seeing with Opdivo monotherapy through our combination strategy in the first line.”

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