Roche's Tecentriq extends its hot streak with liver cancer combo breakthrough

tecentriq
If Roche can grab a first-line liver cancer approval for Tecentriq, it'll be the first I-O drugmaker to do so. (Roche)

Roche’s Tecentriq is on a much-needed hot streak.

On Tuesday, the immuno-oncology drug—in combination with Roche’s Avastin—picked up a breakthrough therapy designation from the FDA in previously untreated liver cancer patients, putting it on the path to a speedy approval.

The agency based the decision on phase 1b data, presented at last month’s American Society of Clinical Oncology annual meeting, that showed the Tecentriq-Avastin pairing could provoke a response in 65% of study patients at a median 10.3 months of follow-up.

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First-line liver cancer would be a new market for Tecentriq, which currently boasts approvals only in the hotly contested bladder cancer and non-small cell lung cancer (NSCLC) markets. Right now, Bristol-Myers Squibb’s Opdivo is the only I-O drug to bear a liver cancer nod, though its indication is for patients who have previously been treated with Bayer’s Nexavar.

RELATED: Bristol-Myers' I-O star Opdivo steps up to challenge Bayer's Stivarga in liver cancer

And Tecentriq has been making headlines recently in some other new-to-immunotherapy markets, too. Earlier this month, it posted positive data in a tough-to-treat form of breast cancer, and in late June it nabbed a victory in a form of small-cell lung cancer.

Still, Tecentriq’s biggest recent win—at least in terms of sales potential—may have come in late May. The company unveiled a top-line win in previously untreated NSCLC for a combination of Tecentriq and chemo that could keep it in the conversation with market leader Keytruda from Merck.  

RELATED: Roche's Tecentriq grabs badly needed lung cancer win to keep Keytruda in its sights

Meanwhile, a liver cancer approval could also mean a new sales avenue for Avastin, an older drug that biosimilars makers are circling. Last September, Amgen and Allergan picked up an FDA approval for a cheaper version of the product, but it’s still unclear when the copy, dubbed Mvasi, will launch.