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 h/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.

Arizona Oncology Associates PC HOPE USOR Tucson AZ USA

Belgium and Luxembourg Gynaecological Oncology Group Namur Belgium

Department of Gynaecology Obstetrics and Neonatology General University Hospital Prague 1st Faculty of Medicine Charles University Prague Czech Republic

Department of Gynecological Oncology Poznan University of Medical Sciences Poznan Poland

Department of Gynecology and Obstetrics 3rd Faculty of Medicine and University Hospital Kralovske Vinohrady Prague Czechia

Department of Gynecology with Center of Gynecological Oncology Charité University Medicine of Berlin Berlin Germany

Department of Medical Oncology University Hospital Ghent Belgium

Department of Obstetrics and Gynaecology Medical University of Innsbruck Innsbruck Austria; AGO Austria Arbeitsgemeinschaft Gynäkologische Onkologie Österreich Vienna Austria

Department of Obstetrics and Gynecology University of Texas Southwestern Medical Center Dallas TX USA

Division of Gynecologic Oncology University of Florida Gainesville FL USA

Division of Gynecological Oncology University Hospitals Leuven KU Leuven Leuven Belgium and Luxembourg Gynaecological Oncology Group Belgium

Florida Cancer Specialists and Research Institute West Palm Beach FL USA

Fondazione Policlinico Universitario Agostino Gemelli IRCCS Gynecologic Oncology Unit Roma Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy

Gynecologic Oncology Department National Institute of Oncology Budapest Hungary

Gynecologic Oncology Program European Institute of Oncology IRCCS Milan Italy; Department of Medicine and Surgery University of Milan Bicocca Italy

Gynecological Tumor Center University Hospital Basel Basel Switzerland

McGill University Jewish General Hospital Montreal Quebec Canada

Medical Oncology Department Hospital Universitario 12 de Octubre Madrid Spain

Medical Oncology Department Translational Oncology Group Cima Universidad de Navarra Cancer Center Clínica Universidad de Navarra Madrid Spain

Minnesota Oncology PA USOR Maplewood MN USA

Ospedale Alessandro Manzoni ASST Lecco Lecco Italy

RAMBAM Health Care Campus Technion Israel Institute of Technology Haifa Israel

Sheba Medical Center Tel Aviv University Tel Hashomer Israel

The Ohio State University and James Cancer Center Division of Gynecologic Oncology Columbus OH USA

Uro Gynecological Department National Cancer Institute of Naples Naples Italy

Washington University School of Medicine and Siteman Cancer Center St Louis MO USA

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