Ramucirumab improves PFS in advanced urothelial carcinoma

The addition of ramucirumab to docetaxel significantly extended PFS for previously treated patients with urothelial carcinoma, according to randomized phase 3 trial results.

The double blind, placebo-controlled RANGE study included 532 patients with locally advanced, unresectable or metastatic urothelial carcinoma whose disease progressed on or after platinum-based chemotherapy.

Researchers assigned patients to docetaxel with or without the antiangiogenic agent ramucirumab (Cyramza, Eli Lilly).

PFS served as the primary endpoint. Secondary endpoints included OS, objective response rate, disease control rate and duration of response.

Patients who received ramucirumab achieved longer PFS than those who received chemotherapy alone, according to an Eli Lilly–issued press release. Final OS results are expected by mid-2018.

The RANGE study is the first phase 3 study of any therapy to demonstrate superior PFS compared with chemotherapy in a post-platinum setting in urothelial cancer.

“People with advanced urothelial cancer — an aggressive disease — who have progressed on prior therapy need more treatment options that can help to control their disease,” Levi A. Garraway, MD, PhD, senior vice president of global development and medical affairs at Lilly Oncology, said in the press release. “While there have been several recent advancements to treat this type of cancer, most patients progress despite treatment with existing therapies, including immune checkpoint inhibitors.”

The combination exhibited a safety profile comparable to that observed in other ramucirumab studies. Grade 3 or higher adverse events that occurred among at least 5% of ramucirumab-treated patients included neutropenia, febrile neutropenia and hypertension.

Detailed efficacy and safety results will be submitted for publication at an upcoming medical meeting.

“These results are encouraging, and we look forward to seeing the OS results when they are mature,” Garraway said.