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#1350 Tumor treating fields (TTFields) therapy in platinum-resistant ovarian cancer: results from the ENGOT-ov50/GOG-3029/INNOVATE-3 phase 3 study
  1. Ignace Vergote1,
  2. Larry Copeland2,
  3. Toon Van Gorp1,
  4. Annouschka Laenen1,
  5. Giovanni Scambia3,
  6. Premal H Thaker4,
  7. David Cibula5,
  8. Nicoletta Colombo6,
  9. Jayanthi Lea7,
  10. Antonio Gonzalez-Martin8,
  11. Jacob Korach9,
  12. Jalid Sehouli10,
  13. Bradley J Monk11,
  14. Viola Heinzelmann-Schwarz12,
  15. Regina Berger13,
  16. Joseph Buscema14,
  17. Susie Lau15,
  18. Radoslaw Madry16,
  19. Hannelore Denys17 and
  20. David M O’malley2
  1. 1Division of Gynecological Oncology, University Hospitals Leuven, KU Leuven, Leuven, Belgium
  2. 2The Ohio State University and James Cancer Center, Division of Gynecologic Oncology, Columbus, USA
  3. 3Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Gynecologic Oncology Unit, Roma, Italy
  4. 4Washington University School of Medicine, St. Louis, USA
  5. 5Department of Gynaecology, Obstetrics and Neonatology, General University Hospital in Prague, First Faculty of Medicine, Charles University, Prague, Czech Republic
  6. 6Università Milano-Bicocca, Istituto Europeo Oncologia, Milan, Italy
  7. 7Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, USA
  8. 8Medical Oncology Department Cancer Center, Clínica Univerdad de Navarra, Madrid, and Program in Solid Tumours CIMA, Pamplona, Spain
  9. 9Sheba Medical Center, Tel Aviv University, Tel Hashomer, Israel
  10. 10Department of Gynecology with Center of Gynecological Oncology, Charité, University Medicine of Berlin, Berlin, Germany
  11. 11Arizona Oncology (US Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine, Phoenix, USA
  12. 12Gynecological Tumor Center, University Hospital Basel, Basel, Switzerland
  13. 13Department of Obstetrics and Gynaecology, Medical University of Innsbruck, Innsbruck, Australia
  14. 14Arizona Oncology Associates, PC – HOPE – USOR, Tucson, USA
  15. 15McGill University, Jewish General Hospital, Montreal, Quebec, Canada
  16. 16Department of Gynecological Oncology, Poznan University of Medical Sciences, Poznan, Poland
  17. 17Department of Medical Oncology, Universitair Ziekenhuis Gent, Ghent, Belgium


Introduction/Background Tumor Treating Fields (TTFields) have shown efficacy in glioblastoma, non-small-cell lung cancer and pleural mesothelioma, with favorable safety. TTFields’ anti-mitotic effects are dose-dependent and may be affected by tissue conductivity changes. Preclinical data (unpublished) showed doxorubicin induces tumor fibrosis and changes tissue conductivity. This randomized phase 3 study investigated TTFields therapy with paclitaxel (TTFields+PTX) vs paclitaxel (PTX) in patients with platinum-resistant ovarian cancer (PROC).

Methodology ENGOT-ov50/GOG-3029/INNOVATE-3 (NCT03940196) enrolled adults with PROC, ≤5 prior lines of therapy (LOT), ≤2 prior LOT following platinum-resistance, and ECOG 0-1. Patients received TTFields (200 kHz; ≥18 hours/day) + PTX (80 mg/m2) weekly or PTX. Primary endpoint was overall survival (OS).

Results 558 patients were randomized to receive TTFields+PTX (n=280) or PTX (n=278) March 2019 to November 2021. Baseline characteristics were well-balanced (median age, 62 [22-91] years; serous histology, 88.7%; ECOG 0, 60.2%; BRCA+, 15.6%). 24.4% of patients received 4+ prior LOT; 65.9% received prior bevacizumab. In the intention-to-treat population, TTFields therapy median duration was 15.9 (0.1–159.7) weeks. Median OS was 12.2 months with TTFields+PTX versus 11.9 months with PTX (HR, 1.01; 95% CI, 0.83-1.24; p=0.89). Grade ≥3 adverse events (AEs) occurred in 60% of patients with no TTFields-related increase in severe systemic toxicities; 83.6% of patients receiving TTFields had a device-related skin AE (all Grade 1/2). Post-hoc analysis in pegylated liposomal doxorubicin (PLD)-naïve patients showed extended survival with TTFields+PTX (n=113) vs PTX (n=88) (16 vs 11.7 months; HR, 0.67; 95% CI, 0.49–0.94; p=0.03). Multivariate Cox regression analyses to eliminate alternative covariates potentially leading to survival superiority in PLD-naïve patients showed that TTFields and prior PLD status were statistically significant covariates following stepwise narrowing (HR, 0.56; p=0.0006).

Conclusion In the overall cohort TTFields+PTX did not improve OS compared with PTX. Post-hoc analysis of PLD-naïve patients showed clinically and statistically significant survival improvement in patients receiving TTFields therapy

Disclosures Medical writing support was provided by Makaila Wallin, PharmD, of The Curry Rockefeller Group, LLC (Tarrytown, NY), and was funded by Novocure, Inc.

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