Tumor Treating Fields therapy in platinum-resistant ovarian cancer: Results of the ENGOT-ov50/GOG-3029/INNOVATE-3 pivotal phase 3 randomized study
Mené sur 558 patientes atteintes d'un cancer de l'ovaire résistant aux sels de platine (âge médian : 62 ans), cet essai randomisé de phase III évalue l'intérêt, du point de vue de la survie globale, d'ajouter au paclitaxel un traitement par application de champs électriques
Purpose: Tumor Treating Fields (TTFields) are electric fields that disrupt processes critical for cancer cell viability and tumor progression. The pivotal, phase 3 ENGOT-ov50/GOG-3029/INNOVATE-3 study evaluated efficacy and safety of TTFields therapy with paclitaxel (PTX) vs PTX in patients with platinum-resistant ovarian cancer (PROC).
Patients and Methods: Adult patients with PROC with ≤5 total prior lines of therapy (LOT), including ≤2 prior LOT for platinum-resistant disease, and ECOG PS of 0–1 were randomized 1:1 to receive TTFields (200 kHz; ≥18 hours/day) + PTX (80 mg/m2 weekly) or PTX. Primary endpoint was overall survival (OS). Exploratory post-hoc analyses assessed OS in pegylated liposomal doxorubicin (PLD)-naive patients.
Results: Between March 2019 and November 2021, 558 patients (ECOG PS 0, 60.2%; median [range] age, 62 [22–91] years) were assigned TTFields+PTX (n=280) or PTX (n=278). 24.4% had 4+ prior LOT. Median OS was 12.2 months with TTFields+PTX vs 11.9 months with PTX (HR, 1.01; 95% CI, 0.83–1.24; p=0.89). Grade ≥3 adverse events (AEs) were similar between treatment groups. Grade 1/2 device-related skin AEs occurred in 83.6% of patients receiving TTFields therapy. In exploratory post-hoc analysis in PLD-naive patients, median OS was 16 months with TTFields+PTX (n=113) vs 11.7 months with PTX (n=88; nominal HR, 0.67; 95% CI, 0.49–0.94; p=0.03).
Conclusions: No new safety signals were identified. TTFields+PTX did not significantly improve OS compared with PTX in the intent-to-treat population. An exploratory post-hoc analysis suggests a potentially favorable benefit-risk profile for TTFields therapy in PLD-naive patients.