Novocure (NSDQ:NVCR) said today that it kicked off a Phase 3 pivotal trial testing its Tumor Treating Fields therapy combined with paclitaxel in people with recurrent, platinum-resistant ovarian cancer.
The 540-patient trial has a primary endpoint of overall survival, with secondary endpoints that include progression-free survival, objective response rate, severity and frequency of adverse events and quality of life.
The Innovate-3 trial is Novocure’s fourth Phase 3 pivotal trial designed to study solid tumors beyond glioblastoma, according to the St. Helier-based company.
Novocure’s device, Optune, uses electric fields – which it calls Tumor Treating Fields – to disrupt cell division, stop tumor growth and initiate cell death in tumors.
“Innovate-3 is Novocure’s fourth phase 3 pivotal trial beyond glioblastoma, demonstrating our commitment to developing Tumor Treating Fields for a variety of solid tumors,” CEO Asaf Danziger said in prepared remarks.
“At Novocure, we strive to extend survival in some of the most aggressive forms of cancer. Ovarian cancer has been an important area of focus for our research because of the great unmet need faced by these patients. We are now working closely with trial sites and institutional review boards to open sites and enroll patients as quickly as possible,” Danziger added.
Shares in Novocure fell slightly last month after the company missed expectations on Wall Street with its fourth quarter and full-year financial results.
Want to stay on top of DDBN content? Sign up for our e-mail newsletter for a weekly dose of drug-device news.