- Roche's new cancer immunotherapy Tecentriq helped patients with advanced non-small cell lung cancer (NSCLC) live longer than those treated with standard chemotherapy, top-line data from a Phase 3 study showed. The positive results should boost Tecentriq's chances of winning U.S. approval in NSCLC later this year.
- Treatment with Tecentriq led to a statistically significant improvement in overall survival among patients whose cancer had progressed, compared to treatment with docetaxel, Roche said Thursday.
- Roche hopes to catch market leaders Bristol-Myers Squibb and Merck, both of which already have immuno-oncology drugs approved for use in NSCLC. Tecentriq was the first PD-L1 inhibitor okayed for use in the U.S., winning approval for treatment of bladder cancer in May.
Having first gained a spot in the checkpoint inhibitor race with Tecentriq's approval in bladder cancer, Roche plans to take on Bristol-Myers' Opdivo and Merck's Keytruda in NSCLC. Opdivo and Keytruda, both of which target the closely related PD-1 protein, have quickly racked up sales and follow-on approvals in the U.S. since launching in 2014.
Opdivo, in particular, has staked out a commanding lead, pulling in over $1.5 billion in sales over the first six months of 2016.
Yet the positive results for Tecentriq come as Bristol-Myers Squibb's commanding lead over Merck, and in the broader immmuno-oncology market, looks shakier. Earlier this month, Opdivo failed to meet its goal in a key Phase 3 study testing the drug for first-line use in NSCLC.
Bristol-Myers had hoped to prove Opdivo's efficacy in a broad patient population who hadn't yet been treated with other drugs.
The setback opens the door for Merck to catch up. Keytruda recently demonstrated superior progression-free survival and overall survival compared to placebo in a first-line setting, but only among those patients whose tumors expressed PD-L1 levels of 50% or more.
Of course, both Opdivo and Keytruda are already approved for second-line use in NSCLC, the indication which Roche is gunning for with Tecentriq's newly released Phase 3 data. But given Tecentriq's third-to-market position, any shake-up at the top of market could help new entrants.
Roche said the Phase 3 study met both of its primary endpoints, extending overall survival in all patients randomized to treatment and in a sub-group of patients selected by PD-L1 expression. Demonstration of a survival benefit regardless of PD-L1 expression is important, as the relationship between PD-L1 levels and drug efficacy is still not entirely clear
"These results add to the growing body of evidence that supports the role of Tecentriq as a potential new treatment for specific types of advanced NSCLC," said Sandra Horning, chief medical officer at Roche.
Notably, Roche's study is testing Tecentriq across a much larger group of patients — over 1,200 in total — than studies completed by Bristol-Myers and Keytruda to win approval in second-line NSCLC.
The Food and Drug Administration is expected to make a decision on final approval by October 19.
Roche has eight other lung cancer studies testing Tecentriq currently underway, part of its strategy to quickly build a body of evidence of the drug's efficacy. With competitive threats looming for Roche's 'big three' cancer drugs, the Swiss pharma is counting on newer drugs like Tecentriq, Gazyva and Perjeta to help drive future growth.