In the immuno-oncology world, all eyes have been on the market battle playing out in the lucrative lung cancer arena. But with its latest data, breast cancer leader Roche is bringing that battle to its home turf.
Its I-O entrant Tecentriq, combined with Celgene’s chemothrapy Abraxane, significantly pared down the risk of disease worsening or death in previously untreated patients with metastatic triple negative breast cancer (TNBC), a particularly hard-to-treat form of the disease, the Swiss drugmaker said Monday. It's the first PD-1/PD-L1 med to tally a win in TNBC, and that win could make it the first of the class to nab an indication strictly for breast cancer.
What's more, researchers also saw “encouraging” signs among patients with the biomarker PD-L1 that Tecentriq could help patients live longer, which is considered a more valuable goal by investors and regulators alike.
Numbers on the victory aren’t yet available—they’ll roll out at an upcoming medical meeting—but in the meantime, Roche is readying the data for submission to the FDA, the European Medicines Agency and other regulators around the world, it said. A TNBC approval could help Roche shore up a breast cancer legacy that includes Herceptin, a once-revolutionary treatment that's now coming under biosimilar attack.
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The study, dubbed IMpassion130, is “the first positive phase 3 immunotherapy study in triple negative breast cancer, an aggressive disease with limited treatment options,” Sandra Horning, M.D., Roche’s chief medical officer, said in a statement, adding that the company is “highly encouraged by these results.”
Roche has been looking for a niche for Tecentriq, which currently bears approvals in bladder cancer and lung cancer. Unfortunately for the pharma giant, bladder cancer just so happens to be the one disease area where all five currently approved members of the PD-1/PD-L1 crew—Tecentriq, along with Pfizer and Merck KGaA’s Bavencio, Merck’s Keytruda, Bristol-Myers Squibb’s Opdivo and AstraZeneca’s Imfinzi—boast green lights. And in lung cancer, Tecentriq’s data so far hasn’t measured up to that from leader Keytruda in the eyes of industry watchers.
But while Roche may be the only I-O drugmaker trumpeting positive TNBC results for now, there are others outside the class putting up strong showings, too. AstraZeneca and Merck’s PARP inhibitor Lynparza, for one, won clearance in the population after posting big results at last year’s American Society of Clinical Oncology (ASCO) annual meeting, and its competitors—Tesaro’s Zejula and Clovis’ Rubraca—are trying for indications of their own.