New Roche PD-L1 Tecentriq shines in study of untreated bladder cancer patients


CHICAGO--Highly anticipated Roche immunotherapy Tecentriq hit the scene just last month with an FDA approval to treat advanced bladder cancer in patients who’ve failed on platinum-based chemotherapy. But the company already has data in hand that could help snag a first-line go-ahead, too.

In a Phase II study of patients ineligible for standard cisplatin chemo, 24% saw their tumors shrink--and that number went as high as 28% in patients with higher levels of PD-L1 expression, Dan Chen, head of cancer immunotherapy development for Roche’s Genentech unit, told FiercePharma.

Three-fourths of those who responded did not see their cancers worsen after an average follow-up of 14.4 months. And 7% of study participants achieved a complete response, showing no sign of disease. The data were presented Sunday at the American Society of Clinical Oncology’s annual meeting here.

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As Chen pointed out, the response rate seen in the study was even higher than the one Tecentriq posted in the second-line setting, which came in at 16%. “The concept of immunotherapy working better as you get into earlier lines of therapy is one that we very much want to test. We think it’s possible, and we think this data supports the idea,” he said, noting that Roche hopes to eventually extend even into adjuvant therapy with Tecentriq.

Entering the first-line setting, which boasts a wider pool of patients that generally stay on therapy longer, would also expand sales of the young Roche drug, which is the third checkpoint inhibitor on the market behind Merck’s Keytruda and Bristol-Myers Squibb’s Opdivo. Its rivals have been racing to rack up approvals in melanoma and lung cancer, and Opdivo recently nailed down a go-ahead in kidney cancer, too.

Roche certainly wouldn’t mind the sales boost. It’s counting on Tecentriq to make hefty top-line contributions--both on its own as a monotherapy and as part of combinations--that’ll help fill the gap as its older cancer superstars come under increased competition. Earlier at ASCO, investigators presented research showing that a Mylan copy of breast cancer star Herceptin had matched the Roche original in terms of efficacy and safety in a Phase III study.

- read the release 

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