COPENHAGEN, Denmark--Get ready to move over, Merck and Bristol-Myers Squibb. Roche has some new Tecentriq data that could soon help it break into the lung cancer space--and give its immuno-oncology rivals a run for their money.
In a Phase III study presented at the ESMO 2016 Congress, the Swiss pharma giant’s PD-L1 checkpoint inhibitor improved overall survival among previously treated non-small cell lung cancer patients by a median 4.2 months over chemo. On Tecentriq, patients lived a median 13.8 months, topping the 9.6-month figure for the chemo arm.
The study enrolled patients who'd failed on one or two previous treatment regimens, and regardless of whether they expressed the PD-L1 biomarker.
That 13.8 month median survival figure is “essentially unprecedented,” Dan Chen, head of cancer immunotherapy development for Roche’s Genentech unit, told FiercePharma in an interview at ESMO. “It suggests that Tecentriq really does have a powerful survival effect.”
That survival benefit was “pretty similar” among those patients who expressed PD-L1 and those who didn’t, Chen said, suggesting that “not only do you get a benefit in patients who have preexisting immunity," but patients who don’t “have evidence of preexisting immunity can get a survival benefit” as well.
On the other end of the spectrum, however, patients with the highest PD-L1 levels seemed to derive a greater benefit, posting median survival of 20.5 months in the Tecentriq arm compared with just 8.9 months in the chemo arm.
The data are part of a package that’s already been submitted to the FDA--and could become a green light in lung cancer any day now. The regulator has set a decision date of Oct. 19 for the med, which also snagged a breakthrough therapy designation that helped speed the regulatory process.
For Roche, a lung cancer nod would represent the first head-to-head showdown among Tecentriq and rival immuno-oncology drugs Keytruda from Merck & Co. and Opdivo from Bristol-Myers Squibb, both of which are already approved for second-line treatment. So far, Tecentriq’s only green light is in bladder cancer, an area neither Merck nor Bristol has yet to break into.
A Tecentriq entry may not be the only major shake-up the second-line race sees in the near future, though, thanks to new data from both of Roche’s competitors. Bristol, which held an advantage in previously treated patients--thanks to Keytruda’s PD-L1 testing requirement--recently saw Opdivo misfire in a first-line trial, while Keytruda put up impressive numbers among patients with high PD-L1 levels. With that in mind, physicians may be more likely to run PD-L1 tests, removing Keytruda’s key uptake hurdle.
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