Merck’s glorious victory in lung cancer marks a Russian winter for Bristol-Myers

Sunday was checkpoint inhibitor day at ESMO, with the three big players now in the market outlining how they’re lining up in the blockbuster field of lung cancer therapy. Merck was left in the enviable position of driving home some impressive results from its clinical study while Bristol-Myers Squibb had to try to put its miserable outcomes in a somewhat positive context and a determined Roche/Genentech team angled in on its niche.

AstraZeneca CEO Pascal Soriot, meanwhile, had to stand on the sidelines devoutly wishing he was in the game of blockbusters.

Bristol-Myers Squibb $BMY made a Napoleonic miscalculation when it decided to see if Opdivo could beat chemotherapy as a frontline treatment for a broad patient population suffering from non-small cell lung cancer. We already knew from the top-line announcement that the trial failed — triggering something of a Russian winter for Bristol stock. Now we know that it failed really, really badly, and investors weren’t happy, sending its shares down sharply Monday morning.

Lowering the bar to patients with 5% or more of their cancer cells expressing PD-L1, Bristol’s Opdivo delayed tumor progression 4.2 months. Chemo? 5.9 months.

“We thought Opdivo could beat chemotherapy, and we have answered the question — for the broad population it is not enough,” Fouad Namouni, oncology development head at Bristol-Myers, told David Crow at the Financial Times.

That’s actually a very valuable point and in the science world it would and should be applauded. But even in subgroup analyses, Bristol’s investigators could find new evidence of success. To investors expecting Bristol-Myers to continue their domination of the sector, though, it all looks like an epic miscalculation and setback without a single redeeming feature.

Merck R&D chief Roger Perlmutter $MRK made no such mistake in moving on the frontline market front. Playing Wellington in this R&D Waterloo, Perlmutter focused on patients with a 50%-plus PD-L1 expression rate and rounded up a 50% reduction in the risk of disease progression and 40% plunge in risk of death compared to chemo in previously untreated patients.

This is what a new standard of care for a segment of front-line lung cancer cases looks like. This drug is already being sold and you can bet that the pharma giant will move as fast as it can to capitalize on this market. That’s a glorious victory by any biopharma standard.

Over recent months Bristol-Myers stock has retreated significantly while Merck has advanced. That’s how you can score the war. And Monday morning Merck stock bubbled up another 3% while Bristol-Myers shares plunged 8%.

But Merck won’t remain unchallenged. Stealing some of the thunder at ESMO is Genentech’s Tecentriq. Roche’s big checkpoint, the third to be approved and start spreading its wings, achieved a solid success in second-line NSCLC. Their 13.8 month median survival rate compared favorably with the 9.6 months recorded for the chemo arm.

Dan Chen, who’s headed up cancer immunotherapy development for Genentech, told FiercePharma’s Carly Helfand that the data were “essentially unprecedented.” But when you singled out the high PD-L1 expressers, the data weighed even more heavily on Tecentriq’s side: 20.5 months median survival compared to 8.9 months in the chemo arm.

Now Roche $ROG can break out from its unique bladder cancer approval and start to tear up the second-line lung cancer market, looking for an advantage with all the high PD-L1 expressers. A frontline pitch can’t be far off.

While Merck, Bristol-Myers and Roche are divvying up the market, AstraZeneca is still sidelined after its efforts fell well behind its rivals. But who was that standing on the edge of the battlefield?

“Suddenly, this trial news opens quite some opportunities for us, in both monotherapy and combination therapy,” a sunny AstraZeneca Chief Executive Pascal Soriot told Reuters’ Ben Hirschler, sizing up the fast-changing lung cancer market.

AstraZeneca’s checkpoint program $AZN has been a laggard and will arrive to the fray very late. For Soriot, though, it’s all characterized as an advantage; a chance to see how others have done their studies so they can match the best work. But after a series of clinical setbacks, AstraZeneca looks like its receding from Soriot’s promises of great advances on the revenue front, 4 years after he got the top job. He needs a piece of the checkpoint market—and fast.

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
Marketing Associate - Demand Generation
Catalytic Data Science Charleston, SC
Associate Principal, Life Sciences Partnerships
Flatiron Health New York City or San Francisco

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