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237 InnovaTV 301/ENGOT-Cx12/GOG-3057: a global, randomized, open-label, phase 3 study of tisotumab vedotin versus investigator’s choice of chemotherapy in 2L Or 3L recurrent or metastatic cervical cancer
  1. Antonio Gonzalez Martín1,
  2. Brian M Slomovitz2,
  3. Keiichi Fujiwara3,
  4. Elsa Kalbacher4,
  5. Andrea Bagameri5,
  6. Sharad Ghamande6,
  7. Jung-Yun Lee7,
  8. Susana Banerjee8,
  9. Fernando Maluf9,
  10. Domenica Lorusso10,
  11. Kan Yonemori11,
  12. Els Van Nieuwenhuysen12,
  13. Luis Manso Sánchez13,
  14. Linn Woelber14,
  15. Anneke Westermann15,
  16. Allan Covens16,
  17. Elizabeth Whalley17,
  18. Melinda Siew Leng Teng17,
  19. Ibrahima Soumaoro18 and
  20. Ignace Vergote12
  1. 1Cancer Center Clinica Universidad de Navarra and GEICO, Madrid, Spain
  2. 2Mount Sinai Medical Center, Miami Beach, USA
  3. 3Saitama Medical University International Medical Center, Saitama, Japan
  4. 4Centre Hospitalier Universitaire de Besançon and GINECO, Besançon, France
  5. 5Országos Onkológiai Intézet, Budapest, Hungary
  6. 6Georgia Cancer Center, Augusta University, Augusta, USA
  7. 7Yonsei University College of Medicine, Seoul, South Korea
  8. 8The Royal Marsden NHS Foundation Trust and Institute of Cancer Research, London, UK
  9. 9Hospital Beneficencia Portuguesa de Sao Paulo, Sao Paulo, Brazil
  10. 10Fondazione Policlinico Gemelli IRCCS, Rome, Italy
  11. 11National Cancer Center Hospital, Tokyo, Japan
  12. 12Universitaire Ziekenhuizen Leuven, Katholieke Universiteit Leuven, and Belgium and Luxembourg Gynaecological Oncology Group, Leuven, Belgium
  13. 13Hospital Universitario 12 de Octubre, Madrid, Spain
  14. 14Arbeitsgemeinschaft Gynäkologische Onkologie Study Group and University Medical Center Hamburg-Eppendorf, Hamburg, Germany
  15. 15Amsterdam University Medical Centres, Amsterdam, The Netherlands
  16. 16Sunnybrook Research Institute, Toronto, Canada
  17. 17Seagen Inc, Bothell, USA
  18. 18Genmab US, Princeton, USA


Introduction/Background Tisotumab vedotin (TV) is an investigational antibody-drug conjugate directed to tissue factor. In the US, TV monotherapy received accelerated approval for the treatment of adult patients with recurrent or metastatic cervical cancer (r/mCC) with disease progression on or after chemotherapy. Here, innovaTV 301 (NCT04697628) study results are presented.

Methodology Eligible patients had r/mCC with disease progression on/after treatment with standard of care chemotherapy doublet ± bevacizumab ± anti-PD-(L)1 therapy, measurable disease per RECIST v1.1, and ECOG PS 0–1. Patients were randomized 1:1 to TV monotherapy or investigator’s choice of topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed. The primary endpoint was OS. Key secondary endpoints included PFS and confirmed ORR by investigator.

Results 502 patients were randomized (TV: 253; chemotherapy: 249); median survival follow-up was 10.8 months (95% CI, 10.3–11.6). Arms were balanced for demographics and disease characteristics, with 63.9% and 27.5% of patients receiving prior bevacizumab and prior anti-PD-(L)1 therapy, respectively. The TV arm had a 30% reduction in risk of death versus chemotherapy (HR 0.70; 95% CI 0.54–0.89; P=0.0038), with significantly longer median OS (11.5 months [95% CI 9.8–14.9] versus 9.5 months [95% CI 7.9–10.7]). PFS was superior in the TV versus chemotherapy arm (HR: 0.67 [95% CI, 0.54–0.82]; P<0.0001). The OS and PFS benefits in the prespecified subgroups were generally consistent with the ITT population. Confirmed ORR was 17.8% and 5.2% in the TV and chemotherapy arms, respectively (odds ratio: 4.0; 95% CI, 2.1–7.6; P<0.0001). Most patients experienced ≥1 treatment-related adverse event (TV: 87.6% [grade ≥3: 29.2%] versus chemotherapy: 85.4% [grade ≥3: 45.2%]). AEs were consistent with the known TV safety profile.

Conclusion In the phase 3 innovaTV 301 study, TV showed a statistically significant and clinically meaningful improvement in OS, PFS, and ORR versus chemotherapy, with a manageable and tolerable safety profile in patients with 2L/3L r/mCC.

Disclosures Previously presented in part at ESMO 2023, ‘LBA9: innovaTV 301/ENGOT-cx12/GOG-3057: A Global, Randomized, Open-Label, Phase 3 Study of Tisotumab Vedotin vs Investigator’s Choice of Chemotherapy in 2L or 3L Recurrent or Metastatic Cervical Cancer ‘, Ignace Vergote et al. - Reused with permission.

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