Back in 2016, Roche’s Tecentriq became the first in its class of immuno-oncology drugs to break into the bladder cancer arena. And it’s now in position to become the first into the previously untreated market, too.
Monday, the Swiss drugmaker unveiled that a combination of Tecentriq and chemo had beaten out chemo alone at cutting the risk of disease progression or death among untreated metastatic urothelial carcinoma patients.
At the interim look, the pairing also demonstrated “encouraging” results when it came to extending patients’ lives, Roche said, but the trial will continue until that data mature.
Roche isn’t saying more about the results for now, at least publicly. But it’ll be distributing the details to the FDA and other health authorities around the world, it said.
The win marks the first positive, phase 3 front-line study for the PD-1/PD-L1 class in bladder cancer. Tecentriq became the third drug in that group to hit the market just over three years ago when it picked up a conditional green light in bladder cancer based on tumor response rate and durability of response data.
Just one year later, though, its failure to prolong patients’ lives in that same study shocked industry watchers and put the approval at risk. The FDA ultimately let Tecentriq keep the indication, and first-line study success should help cement that decision.
The new trial score could also set Roche up for a new lead in immuno-oncology’s most crowded market. Five of six approved drugs in the class boast a bladder cancer OK, and so far, sales in the indication have paled in comparison to those racked up in other cancers.
Luckily for Roche, a different Tecentriq-chemo combo—this one adding older Roche giant Avastin to the mix—bears a go-ahead in one of those more lucrative markets. Last December, the FDA ushered that cocktail onto the previously untreated non-small cell lung cancer market. Of course, the move set up a showdown with Merck & Co.’s ultra-formidable Keytruda-chemo combo, which didn’t exactly make for an easy path to sales.
But while Merck presents some stiff competition, scoring an approval at all is farther than Roche rivals Bristol-Myers Squibb and AstraZeneca have gotten in the same indication. In phase 3 trials, those companies eschewed chemo in favor of CTLA4 checkpoint drugs and suffered damaging performances in the process.
Roche, meanwhile, is looking to capitalize on its bladder cancer edge with four other phase 3 tests for Tecentriq, both alone and in combination with other medicines. The trials span from early to advanced bladder cancer, Roche said.
By: Carly Helfand
Source: Fierce Pharma
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