ZURICH (Reuters) - Roche’s hopes of clinching more of the lung cancer treatment market with its Tecentriq immunotherapy had a major setback on Thursday, when a trial failed to deliver survival data the Swiss drugmaker needs to challenge rival Merck.
Tecentriq, mixed with chemotherapy, has not yet achieved a hoped-for overall survival target in first-line non small cell lung cancer treatment, the Swiss drugmaker said on Thursday, though the cocktail did reduce risks of the disease worsening.
Overall survival is the gold standard for judging a medicine’s effectiveness, but Roche now must wait until at least next year to show Tecentriq plays a significant role in keeping patients alive.
In contrast, Merck’s Keynote-189 study demonstrated its Keytruda plus chemotherapy improved survival in newly-diagnosed patients.
That leaves Tecentriq, with sales just a fraction of Keytruda’s and Bristol-Myers Squibb’s Opdivo, an also-ran in the battle for supremacy against lung cancer, the disease’s most-lucrative market.
“While a numerical improvement for the co-primary endpoint of overall survival was observed, statistical significance was not met at this interim analysis,” Roche said. “The study will continue as planned, with final OS results expected next year,”
Sandra Horning, Roche’s chief medical officer, said the company would meet regulators over its findings so far.
Roche shares shed 1.2 percent at 0900 GMT.
Its market capitalization of 202 billion Swiss francs ($202 billion) has slipped by about 10 billion francs this year, four times the decline of fellow Swiss drugmaker Novartis.
Analysts have long awaited the study, IMpower 132, as a bellwether for understanding how Tecentriq stacks up to Keytruda in helping take the brakes off the human immune system so it can attack tumors.
“We expect investors to... see the results as confirming their fears for Tecentriq’s relative efficacy,” Deutsche Bank’s Tim Race said.
Race thinks analysts will downgrade Roche growth forecasts through 2022, which he rates as among the industry’s worst amid patent losses on older blockbusters Rituxan, Avastin and Herceptin that expose the $21 billion trio to cheaper copies.
Baader Helvea’s Bruno Bulic trimmed his peak annual sales estimates for Tecentriq to 1 billion francs, from 5 billion in lung cancer. The medicine, he said, will likely be confined to niche areas of lung cancer that Merck has not yet explored.
“We believe that inevitably...most will now question Roche’s anti-PD-L1 concept,” Bulic said.
Reporting by John Miller, editing by John Revill and Elaine Hardcastle