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# Novocure Phase 3 Study Misses Primary Endpoint
- URL: https://www.fdaweb.com/novocure-phase-3-study-misses-primary-endpoint/
- Published: 2023-08-28T12:00:00.000Z
- Updated: 2026-09-14T18:52:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155192

Novocure says its 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 (n=278),” the company says.

The trial enrolled patients with a maximum of five total prior lines of systemic therapy, the company says, adding that 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.”

Tumor Treating Fields are described as electric fields that exert physical forces to kill cancer cells while not significantly affecting healthy cells because they have different properties than cancer cells. “Due to its multimechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and demonstrates enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or PARP \[*poly-ADP ribose polymerase\]* inhibition in preclinical models,” the company says.