Phase 2 Trial Suggests TTFields-Chemotherapy Combo May Improve Outcomes in Recurrent Ovarian Cancer

Phase 2 Trial Suggests TTFields-Chemotherapy Combo May Improve Outcomes in Recurrent Ovarian Cancer

Combining Tumor Treating Fields (TTFields), a method that uses electric fields to disrupt cell division, with Taxol (paclitaxel) may be a promising treatment approach for ovarian cancer patients, according to recent data from a Phase 2 trial.

The trial shows that the combo therapy is tolerable and safe for patients with recurrent ovarian cancer, improving patients’ overall survival and more than doubling their progression-free survival rates compared to patients receiving Taxol alone.

“These results are promising,” Dr. Eilon Kirson, Novocure’s chief science officer and head of Research and Development, said in a news release. “Recurrent ovarian cancer is a very difficult-to-treat disease that quickly develops resistance to multiple types of chemotherapies. We are committed to researching TTFields as a potential treatment for ovarian cancer and look forward to beginning a Phase 3 pivotal trial.”

Novocure‘s TTFields are low-intensity alternating electric fields that activate programmed cell death in proliferating cancer cells by preventing them from dividing properly. It is a noninvasive treatment approach that applies transducer arrays directly to the skin’s surface in the region surrounding the tumor. The delivery system is portable and allows patients to perform their normal daily activities.

The INNOVATE Phase 2 trial (NCT02244502) is a single-arm, non-randomized, open-label study, designed to assess the safety and effectiveness of TTFields in combination with Taxol in patients with recurrent ovarian cancer.

The study enrolled 31 patients who were treated continuously with TTFields — using the NovoTTF-100L(O) device — and weekly Taxol (80 mg/m²) for eight weeks, followed by treatment at days 1, 8, and 15 of each subsequent 28-day cycle.

The study’s primary endpoints included the severity and frequency of adverse events and the number of patients who discontinued therapy due to skin toxicity. Secondary endpoints included progression-free survival, overall survival, duration of response, and patient’s compliance. Data from the trial was compared to a recent Phase 3 trial of recurrent ovarian cancer patients treated with Taxol alone.

Results from the trial, which will be submitted for presentation at an upcoming medical conference, have revealed that the combination treatment is tolerable and safe, nearly doubles patient’s progression-free survival, and improves their overall survival.

Novocure is now planning a Phase 3 trial of TTFields in recurrent ovarian cancer patients, which might lead to its approval for this indication.