Bristol-Myers' Opdivo-Yervoy combo hits a regulatory snag in lung cancer

MUNICH—Bristol-Myers Squibb presented a raft of results for its Opdivo-Yervoy immuno-oncology combo across multiple tumor types at the European Society for Medical Oncology. But it was results it didn’t present that stole the weekend spotlight.

On Friday, the New Jersey drugmaker disclosed that EU regulators had requested more survival data from its Checkmate-227 trial, which is evaluating the duo in previously untreated lung cancer. And while the company has already submitted a new analysis, it’s now facing a regulatory slowdown. The FDA pushed back its decision date by three months, and now expects to hand down a verdict by May 20 of next year.

RELATED: FDA accepts Bristol-Myers' Opdivo-Yervoy app in lung cancer, but without a speedy review

While the delay isn’t great news for Bristol, which is already standing on the outside looking in as archrival Merck & Co.'s Keytruda gobbles up first-line share, the new data themselves may represent an even bigger problem, Credit Suisse analyst Vamil Divan wrote to clients in a note titled, “A series of unfortunate events.”

BMS is currently chasing an approval of its Opdivo-Yervoy regimen in patients with high levels of tumor mutational burden (TMB), a new biomarker Bristol-Myers is trying to herald. But as the company's new analysis showed, the survival benefit in patients with high TMB and low TMB appeared “quite similar (based on hazard ratios compared to chemotherapy),” Divan noted.

“This leads us to wonder why regulators would approve the regimen strictly for patients with high TMB as per the current filing,” he wrote, adding that a “potential approval in first-line NSCLC may still be 12-plus months away.”

At one time, industry watchers expected Keytruda and Opdivo to go neck-and-neck in the ultra-lucrative first-line setting—but that was before Opdivo flopped a monotherapy trial. Keytruda went on to rack up approvals both solo and in tandem with chemo, and then to back up its chemo-combo indication with big-time survival data.

RELATED: BMS' Opdivo-Yervoy combo posts big win in first-line lung cancer—but big enough to challenge Merck?

Bristol, on the other hand, has staked its hopes on the Opdivo-Yervoy marriage—and on TMB. Even if the company can snag a TMB-oriented approval, however, its success would depend on doctors routinely testing for the biomarker, which isn’t yet the norm.

Meanwhile, BMS presented positive results for the combo in a number of other tumor types over the weekend, including bladder cancer, melanoma and a rare form of colorectal cancer.