MUNICH—Roche’s Tecentriq is gunning to become first in its class of immuno-oncology agents to score an indication in tough-to-treat triple-negative breast cancer (TNBC), and it’s out with the data that could help it get the job done.
Saturday at the European Society for Medical Oncology annual meeting, the Swiss drugmaker said adding Tecentriq to Celgene's chemo med Abraxane in newly diagnosed patients pared down the risk of disease worsening or death by 20%. The combo staved off cancer progression by a median 7.2 months, compared with 5.5 months for solo chemo.
But in the group of patients whose tumors tested positive for biomarker PD-L1, those numbers were even better. The duo pared down risk by 38%, keeping cancer at bay for 7.5 months compared with 5 months for the control group.
“We believe right now that the benefit is primarily in the PD-L1 positive population, and I think it’s important that we focus on that,” Amreen Husain, M.D., global development team leader for Roche immuno-oncology, said.
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While the study hadn’t yet met the statistical significance mark for overall survival at the interim check-in, the numbers did show a “clinically meaningful” improvement in PD-L1-positive patients. In that group, patients lived 9.5 months longer than their chemo-only counterparts, Roche said.
TNBC is an aggressive tumor type that has foiled drugmakers in the past, in part because it lacks targets such as hormone receptors or HER2. “Triple negative disease is an absence of markers, but now—wow. Maybe we have a new marker with PD-L1,” Husain said. “We hope that Tecentriq will be the treatment for PD-L1-positive metastatic triple negative breast cancer patients, really bringing them an important clinical benefit.”
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Roche, which is playing from behind rivals Merck & Co. and Bristol-Myers Squibb in the lung cancer market, wasted no time sharing these results with regulators around the world after unveiling top-line data in early July. The study is the first successful phase 3 for a member of the ultra-competitive PD-1/PD-L1 class in TNBC, a type of disease that affects about 15% of the 269,000 U.S. patients diagnosed with breast cancer each year. And that makes Roche first in line for an approval, too.
“The response from the physician community has been phenomenal,” Husain said, adding, "They have expressed to us that they feel that this is really an unprecedented, transformative benefit for patients and they can’t wait to be able to bring this to their patients.”
With the Swiss drugmaker looking to Tecentriq to chip in big-time as older cancer moneymakers—such as Herceptin and Avastin—come up against cheaper biosimilar contenders, the company is working to stretch its lead as far as it can. It’s currently testing Tecentriq in seven phase 3 TNBC studies, it said, including in early and advanced stages of the disease.