Novocure: INNOVATE-3 trial of TTFields for OC did not meet primary endpoint

Novocure announced that the phase 3 ENGOT-ov50 / GOG-3029 / INNOVATE-3 clinical trial of Tumor Treating Fields, TTFields, together with paclitaxel in patients with platinum-resistant ovarian cancer did not meet its primary endpoint of overall survival, OS at the final analysis. Patients randomized to receive TTFields therapy plus paclitaxel (n=280) demonstrated a median OS of 12.2 months versus a median OS of 11.9 months in patients treated with paclitaxel alone . Consistent with previously reported studies, TTFields therapy was well-tolerated with no added systemic toxicities. “Recurrent ovarian cancer is a particularly aggressive cancer and options for patients diagnosed with platinum-resistance remain extremely limited,” said Ignace Vergote, MD, PhD, Principal Investigator and Chairman of the Belgium and Luxembourg Gynaecological Oncology Group and Professor at the Catholic University of Leuven, Belgium. “We are committed to continuing research with TTFields and exploring innovative approaches to treat this area of immense unmet need, and we are extremely grateful to all the investigators and patients for their participation in these studies.” The ENGOT-ov50 / GOG-3029 / INNOVATE-3 trial enrolled patients with a maximum of five total prior lines of systemic therapy. An analysis of exploratory subgroups suggests a potential survival benefit in patients who received only one prior line of therapy. This signal could merit further exploration given the unmet need for the ~20% of ovarian cancer patients who have a limited response to frontline platinum-based treatment. Full evaluation of the data from the ENGOT-ov50 / GOG-3029 / INNOVATE-3 trial, including subgroup analyses, is ongoing. “While the final results of the ENGOT-ov50 / GOG-3029 / INNOVATE-3 trial differ from our initial expectation, these data add important context to the treatment paradigm,” said David O’Malley, MD, Professor of Obstetrics and Gynecology at The Ohio State University Wexner College of Medicine and Director of the Division of Gynecologic Oncology at The James Comprehensive Cancer Center. “We see treatment exposure and number of prior therapies are relevant and can drive outcomes, and we will leverage these data as we explore and identify new opportunities to treat this deadly disease.” Novocure will work with investigators to share the full results with the scientific community.