Roche is out with phase 3 Tecentriq results in liver cancer, and it’s out in full force.
The immuno-oncology med, in combination with fellow Roche drug Avastin, not only showed it could beat Bayer's standard-of-care Nexavar at stalling cancer progression in previously untreated patients. It helped them live longer, too.
Details from the study, called Imbrave150, are still under wraps, with Roche planning to unveil them at an upcoming medical meeting. But in the meantime, the company will be submitting the data to regulators around the world, including those in the U.S., Europe and China, it said.
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Those data back up phase 1b results that already scored the pairing a breakthrough designation from the FDA. That data, presented at last year’s ASCO meeting, showed the Tecentriq and Avastin duo provoked a response in 65% of study patients.
The double win is a big one for Tecentriq, which has run up against competition from other PD-1/PD-L1 drugs—including Merck & Co.'s Keytruda—in some of its other big indications.
This time, Tecentriq is the first drug in its class to deliver phase 3 data showing it can both keep cancer at bay and lengthen lives—and that second piece could prove to be a key advantage. Doctors and payers consider overall survival the gold standard for cancer drugs and while regulators will sometimes grant conditional green lights without it, they’ll look for life-lengthening results to back up those decisions.
RELATED: Bristol-Myers Squibb's Opdivo misses its shot at earlier use in liver cancer
Meanwhile, Tecentriq’s in-class nemeses have stumbled in the liver cancer arena recently. Bristol-Myers Squibb’s Opdivo, already approved in later lines of therapy, failed in June to show it could best Nexavar at extending lives, frustrating its attempts to move earlier into treatment.
Plus, earlier in the year, Keytruda failed to top placebo on either the progression-free survival or overall survival fronts, jeopardizing an accelerated approval in previously untreated patients that it earned based on phase 2 data.
That’s not to say the Tecentriq-Avastin pairing won’t face big competition if it can get to the front-line setting, though. Bayer’s Nexavar has been the go-to drug for years, and since picking up a second-line approval for Stivarga, the German drugmaker has billed the pair as a two-phase regimen. And Merck and Eisai’s Lenvima nabbed its own approval last summer after showing it could outdo Bayer’s old standby, if only slightly.