Issue: May 25, 2018
April 23, 2018
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Cyramza improves response in urothelial cancer

Issue: May 25, 2018
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A randomized phase 3 study that evaluated ramucirumab in combination with docetaxel for certain patients with urothelial carcinoma showed the regimen improved objective response rate.

The double-blind RANGE trial included 530 patients with locally advanced or unresectable or metastatic urothelial carcinoma whose disease progressed on or after platinum-based chemotherapy.

Researchers randomly assigned 530 patients to docetaxel plus either ramucirumab (Cyramza, Eli Lilly) or placebo.

As HemOnc Today previously reported, the ramucirumab regimen significantly improved PFS.

Eli Lilly released additional topline results today. Researchers observed a positive trend in OS, but the difference did not reach statistical significance, according to a company-issued press release.

Results did show improvement in ORR.

The regimen’s safety profile appeared consistent with previous studies of ramucirumab. Researchers observed no new safety signals.

Efficacy and safety results will be submitted for a presentation at a medical meeting.

“People with advanced urothelial carcinoma who experience disease progression urgently need treatment options that can control the disease — to help stop or slow the cancer from growing and spreading,” Levi Garraway, MD, PhD, senior vice president of global development and medical affairs at Lilly Oncology, said in the release. “Although this study didn’t reach statistical significance for OS, we are encouraged by the totality of the RANGE results and look forward to reviewing the data with internal and external experts to determine next steps.”