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  • 2022-RA-1392-ESGO Tisotumab vedotin combinations with pembrolizumab or carboplatin in patients with recurrent/metastatic cervical cancer: interim results of ENGOT Cx8/GOG-3024/innovaTV205

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Cervical cancer
2022-RA-1392-ESGO Tisotumab vedotin combinations with pembrolizumab or carboplatin in patients with recurrent/metastatic cervical cancer: interim results of ENGOT Cx8/GOG-3024/innovaTV205
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  1. Domenica Lorusso1,
  2. Ignace Vergote2,
  3. Roisin E O’Cearbhaill3,
  4. Anne M Westermann4,
  5. Susana Banerjee5,
  6. Els van Nieuwenhuysen2,
  7. David A Iglesias6,
  8. Dearbhaile Collins7,
  9. David Cibula8,
  10. Kristine Madsen9,
  11. Krishnansu S Tewari10,
  12. Sandro Pignata11,
  13. Jean-Francois Baurain12,
  14. Ingrid A Boere13,
  15. Hannelore Denys14,
  16. Camilla Mondrup Andreassen15,
  17. Ibrahima Soumaoro16,
  18. Shweta Jain17,
  19. Christine Gennigens18 and
  20. Bradley J Monk19
  1. 1Fondazione Policlinico Gemelli IRCCS, Rome, Italy
  2. 2Belgium and Luxembourg Gynaecological Oncology Group (BGOG) and Leuven Cancer Institute University Hospital Leuven, Leuven, Belgium
  3. 3Memorial Sloan Kettering Cancer Center, New York, NY
  4. 4Dutch Gynaecological Oncology Group (DGOG) and Amsterdam University Medical Centers, Amsterdam, Netherlands
  5. 5The Royal Marsden NHS Foundation Trust and Institute of Cancer Research, National Cancer Research Institute (NCRI), London, UK
  6. 6Virginia Tech Carilion School of Medicine and Carilion Clinic, Roanoke, VA
  7. 7Cork University Hospital, Wilton, Cork, Ireland
  8. 8General University Hospital in Prague and First Faculty of Medicine, Charles University, Prague, Czech Republic
  9. 9Rigshospitalet and University Hospital of Copenhagen, Copenhagen, Denmark
  10. 10UC Irvine, Irvine, CA
  11. 11Istituto Nazionale Tumori di Napoli IRCCS ‘Fondazione G. Pascale’, Naples, Italy
  12. 12Belgium and Luxembourg Gynaecological Oncology Group, Cliniques Universitaires Saint-Luc, and Université Catholique de Louvain, Brussels, Belgium
  13. 13Erasmus MC Cancer Institute, Rotterdam, Netherlands
  14. 14Belgium and Luxembourg Gynaecological Oncology Group and University Hospital, Ghent, Belgium
  15. 15Genmab A/S, Cophenhagen, Denmark
  16. 16Genmab US, Inc., Princeton, NJ
  17. 17Seagen Inc., Bothell, WA
  18. 18Belgium and Luxembourg Gynaecological Oncology Group and CHU of Liege, Liege, Belgium
  19. 19GOG Foundation, Creighton University, and University of Arizona, Phoenix, AZ

Abstract

Introduction/Background Pembrolizumab + chemotherapy as first-line (1L) and tisotumab vedotin (TV) monotherapy as second-line plus (2L+) have improved outcomes in patients with recurrent/metastatic cervical cancer (r/mCC). Previous reports show potentially enhanced efficacy and tolerable safety with TV + pembrolizumab, carboplatin, or bevacizumab. We report interim safety and efficacy results from the dose-expansion cohorts evaluating 1L TV + pembrolizumab (1L-TP), 2/3L TV + pembrolizumab (2/3L-TP), and 1L TV + carboplatin (1L-TC) in patients with r/mCC.

Methodology In the 1L-TP cohort, patients with r/mCC who had no prior systemic therapy (excluding chemoradiation) received TV 2.0 mg/kg + pembrolizumab 200 mg IV Q3W. In the 2/3L-TP cohort, patients with r/mCC who experienced disease progression on/after 1–2 prior systemic therapies received TV 2.0 mg/kg + pembrolizumab 200 mg IV Q3W. In the 1L-TC cohort, patients with r/mCC who had no prior systemic therapy (excluding chemoradiation) received TV 2.0 mg/kg + carboplatin AUC 5 IV Q3W. The primary end point was confirmed objective response rate (cORR) per RECIST v1.1.

Results In the 1L-TP, 2/3L-TP, and 1L-TC cohorts, respectively, 33, 35, and 33 patients received treatment, and, at data cut-off, median follow-up was 18.8, 15.0, and 14.6 months. cORR was 41%, 38%, and 55%, with a median DOR of not reached, 14.0, and 8.6 months in the 1L-TP, 2/3L-TP, and 1L-TC cohorts, respectively. Adverse events (AEs) of special interest in patients in the 1L-TP, 2/3L-TP, and 1L-TC cohorts (grade 1–2/grade ≥3) included ocular events (58/9; 51/3; 58/9), bleeding (61/6; 61/9; 52/6), and peripheral neuropathy (49/3; 37/3; 48/12), respectively; one patient in 2/3L-TP and one patient in 1L-TP experienced grade 4 and 5 treatment-related bleeding, respectively. Additional data will be presented at the meeting.

Conclusion TV + pembrolizumab or carboplatin in patients with r/mCC demonstrated encouraging and durable anti-tumour activity, with tolerable safety profiles.

© 2022 American Society of Clinical Oncology, Inc. Reused with permission. This abstract was accepted and previously presented at the 2022 ASCO Annual Meeting. All rights reserved.

https://doi.org/10.1136/ijgc-2022-ESGO.125

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