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Novocure Announces Last Patient Enrolled in Phase 3 Pivotal INNOVATE-3 Trial of Tumor Treating Fields in Ovarian Cancer
Final data from INNOVATE-3 trial anticipated in 2023 ST. HELIER, Jersey--(BUSINESS WIRE)-- Novocure (NASDAQ: NVCR) today announced that the final patient has
About this update from Novocure Limited
[{"type":"text","content":"\nFinal data from INNOVATE-3 trial anticipated in 2023 \n\n ST. HELIER, Jersey--(BUSINESS WIRE)--\nNovocure (NASDAQ: NVCR) today announced that the final patient has been enrolled in phase 3 pivotal INNOVATE-3 trial evaluating the efficacy of Tumor Treating Fields (TTFields) together with paclitaxel for treatment of patients with platinum-resistant ovarian cancer.\n\n“This is a major step forward for our clinical trial program and an important achievement for patients, trial investigators and our company,” said William Doyle, Novocure’s Executive Chairman. “Ovarian cancer is the fifth leading cause of cancer death in women, impacting nearly 100,000 patients annually in the U.S., Europe and Japan, alone. INNOVATE-3 is the largest abdominal trial to complete enrollment in Novocure history, and we are excited to be enhancing the clinical field in support of people with this deadly disease.”\n\nFollowing the completion of enrollment, an independent Data Monitoring Committee (DMC) will conduct the pre-specified interim analysis pursuant to the trial protocol. Final data from the INNOVATE-3 trial is anticipated in 2023.\n\nINNOVATE-3 is a randomized, open-label study which was designed to enroll 540 adult patients with recurrent, platinum-resist ovarian cancer. Patients have been randomized to receive either weekly paclitaxel alone or weekly paclitaxel concomitant with TTFields tuned to 200 kHz until progression. The primary endpoint is overall survival. Secondary endpoints include progression free survival, objective response rate, severity and frequency of adverse events, time to undisputable deterioration in health-related quality of life or death, and quality of life. The European Network for Gynecological Oncological Trials (ENGOT) and The GOG Foundation, Inc. collaborated with Novocure on the design and facilitation of this trial.\n\nAbout Ovarian Cancer\n\nIn the U.S., ovarian cancer ranks fifth in cancer deaths among women, with approximately 24,000 women diagnosed each year. Ovarian cancer incidence increases with age, and the median age at time of diagnosis is 63 years old. Physicians use different combinations of surgery and pharmacological therapies to treat ovarian cancer, depending on the stage of the disease. Surgery is usually used in early stages of the disease and is usually combined with chemotherapy, including pacl...