BMS nets another Opdivo lung cancer win—but it still has to beat Merck's high bar

It’s been a rocky road for Bristol-Myers Squibb’s immuno-oncology duo in previously untreated non-small cell lung cancer (NSCLC), but a new addition to the regimen might hold the ticket.

Tuesday, the New Jersey drugmaker said its Opdivo-Yervoy duo—plus two cycles of chemo—had lengthened patients’ lives compared with placebo in a phase 3 study. The company was tight-lipped on the other details, but it did say it would be sharing the data with regulators.

Results from the trial, called CM-9LA, provide a “much-needed positive surprise,” as Wolfe Research analyst Tim Anderson put it in a note to clients. After striking out with solo Opdivo in the front-line setting, Bristol last year pulled its combo Opdivo-Yervoy filing—in a move that horrified investors—to wait for further results.

RESULTS: ESMO: Can Bristol-Myers' Opdivo-Yervoy pairing be 'practice-changing' in first-line NSCLC? Experts disagree

It got those recently, showing the pair could cut the risk of death by 21% against placebo, but experts questioned just how significant those results were in light of market-dominating competition from Merck’s Keytruda.

The latest win gives investors hope that Bristol may just be able to measure up to the Merck heavyweight with the early addition of chemo, though.

“Chemotherapy, when given to lung cancer patients, often shows a fast initial response, but one that lacks durability. But by combining chemotherapy+Opdivo+Yervoy, BMY may have (finally) found a cocktail of drugs that delivers both near- and longer-term benefit, leading to an early response and improved long-term survival,” Anderson wrote.

Of course, it’s not that simple. Adding an extra drug into the mix will not only raise “the cost of therapy somewhat,” but also up toxicity levels.

“The commercial value of CM-9LA will therefore depend on the balance between the clinical benefit and the toxicity.  It will only be once full results are presented that this risk:benefit assessment will be possible,” Anderson noted, adding that safety and tolerability of the three-drug cocktail “will very likely look worse” than what Merck produced in its Keynote-189 trial.

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Meanwhile, Bristol’s victory may also bode well for AstraZeneca, another company that’s repeatedly struck out in the all-important field. It’s awaiting data from a similar trial that combines chemo with its Opdivo rival, Imfinzi, and Yervoy counterpart tremelimumab.

There are a few key differences AZ investors should note before getting too excited, though. Among them: Tremelimumab has yet to show a benefit in any tumor type, where Yervoy already bears multiple approvals. The British drugmaker’s trial, Poseidon, also gives chemotherapy continuously in lieu of the short course Bristol used.

“This may or may not be a good thing – it can be predicted that more chemotherapy likely yields more toxicity, but will it yield more benefit?” Anderson wrote.