NovoCure (NASDAQ: NVCR) will present today for the first time the design of its phase 3 pivotal trial of Tumor Treating Fields combined with paclitaxel in patients with recurrent, platinum-resistant ovarian cancer at the American Society of Clinical Oncology (ASCO) Annual Meeting 2018 in Chicago. Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division, inhibiting tumor growth and causing affected cancer cells to die.
INNOVATE-3, a prospective, open-label study, will include 540 patients with recurrent, platinum-resistant ovarian cancer. Patients will be randomized to receive either weekly paclitaxel alone or weekly paclitaxel in combination with Tumor Treating Fields 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. Patients must be 18 years or older, and have an epithelial histology of ovarian/primary peritoneal or fallopian tube carcinoma at diagnosis, an Eastern Cooperative Oncology Group (ECOG) score of 0-1, and evaluable disease in the abdominal/pelvic region. Patients may have had a maximum of two prior lines of systemic therapy following diagnosis of platinum-resistance. Patients who have participated in prior clinical trials may be included.
The trial design for INNOVATE-3 was based on the promising results of Novocure’s phase 2 pilot trial in recurrent ovarian cancer, which examined Tumor Treating Fields in combination with standard of care chemotherapy. This trial was a single-arm, open-label, historically-controlled, multi-center study, designed to test the feasibility, safety and preliminary efficacy of Tumor Treating Fields in combination with weekly paclitaxel. The paclitaxel control arm from the bevacizumab phase 3 FDA registration trial was used as a historical control in this trial.
A total of 30 patients were enrolled with a minimum follow-up of six months. Safety results suggested that Tumor Treating Fields in combination with weekly paclitaxel may be tolerable and safe as first-line treatment for patients with recurrent ovarian cancer. Median progression free survival in the Tumor Treating Fields-treated group was 8.9 months (compared to 3.9 months in the paclitaxel-alone historical control) and median overall survival was not yet reached. Median one-year survival was 61 percent. Efficacy results based on the 30 evaluable patients suggested more than doubling of the progression free survival and an improvement in overall survival among patients who received Tumor Treating Fields therapy with paclitaxel compared to paclitaxel alone.
“After having a recurrence, women with ovarian cancer experience a median overall survival of only 13 to 14 months,” said Dr. Eilon Kirson, Novocure’s Chief Science Officer and Head of Research and Development. “Our preclinical research has demonstrated synergistic effects between Tumor Treating Fields and taxane-based chemotherapies. We are excited to present the trial design for INNOVATE-3 at the ASCO Annual Meeting and are eager to make this trial available to patients who are in need of better outcomes.”
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