Merck rains on Roche's parade with double Keytruda win in squamous lung cancer

Merck & Co. already controls a big part of the first-line non-small cell lung cancer market, and it likely just secured most of the rest of it.

On Wednesday, the pharma giant said Keytruda had nailed its primary endpoints in a study testing the drug among previously untreated patients with the squamous form of the disease, who represent about 25% to 30% of the overall market.

Paired with chemo, the blockbuster held off cancer growth for longer and helped patients live longer, too, compared with chemo alone—something it’s already done in other front-line populations. And now, "the areas in which Keytruda has shown positive data" in lung cancer represent a potential market opportunity of $6.6 billion in the U.S. alone, Credit Suisse analyst Vamil Divan, M.D., wrote to clients.

The news will be a downer for Roche and its PD-L1 checkpoint inhibitor Tecentriq, which in March finally managed to come up with positive results in an area of lung cancer its rivals hadn’t already reached. Not only does Merck now have a progression-free survival win to match Roche’s, but it has an overall survival victory—often regarded as a more important endpoint—to its name, too.

Of course, which drug prevails in the real world depends on expanded data—including specifics on just how big a benefit Keytruda delivers—which Merck will roll out at the American Society of Clinical Oncology meeting early next month. "Barring any surprises," though, Divan sees Merck "in a dominant position going forward."

Keytruda has been leading the lung cancer race ever since its No. 1 nemesis, Bristol-Myers Squibb’s Opdivo, flopped a first-line monotherapy trial in non-squamous NSCLC back in 2016. Merck went on to score a solo FDA nod for Keytruda in that group, followed by a quick chemo-combo approval. And meanwhile, Bristol-Myers and AstraZeneca are still working to drum up positive data for their own combos, which combine PD-1/PD-L1 drugs with CTLA4s—Yervoy in BMS' case and the candidate tremelimumab in AZ's.

From the driver’s seat, Keytruda has continued to deliver a steady flow of positive lung cancer news over the course of this year. Early in April, Keytruda showed it could deliver big survival gains across the spectrum of patients whose tumors bear the PD-L1 biomarker. And later that month, Merck’s Keytruda-chemo regimen showed it could halve the risk of death among front-line patients.

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