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O013/#573 Tisotumab vedotin (TV) + bevacizumab or pembrolizumab or carboplatin in recurrent/metastatic cervical cancer (R/MCC): phase 1B/2 engot-CX8/GOG-3024/innovaTV 205 study dose-escalation results
  1. B Monk1,
  2. T Van Gorp2,
  3. D Lorusso3,
  4. R Eilish O’Cearbhaill4,
  5. A Westermann5,
  6. S Banerjee6,
  7. D Collins7,
  8. J Klat8,
  9. K Madsen9,
  10. J-F Baurain10,
  11. A Jackson11,
  12. I Boere12,
  13. S Pignata13,
  14. E Gort14,
  15. J Moroney15,
  16. I Soumaoro16,
  17. CM Andreassen17,
  18. L Nicacio18,
  19. C Gennigens19 and
  20. I Vergote20
  1. 1Arizona Oncology (US Oncology Network) University of Arizona, Creighton University, Division of Gynecologic Oncology, Phoenix, USA
  2. 2KU Leuven University Hospitals Leuven, Gynecological Oncology, Leuven, Belgium
  3. 3Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Division of Gynecologic Oncology, Rome, Italy
  4. 4Memorial Sloan Kettering Cancer Center, Medicine, New York, USA
  5. 5Academisch Medisch Centrum, Department of Medical Oncology, Amsterdam, Netherlands
  6. 6The Royal Marsden NHS Foundation Trust, Medical Oncology, London, UK
  7. 7Cork University Hospital, Oncology Trials Unit, Cork, Ireland
  8. 8University Hospital Ostrava, Gynecologic Oncology, Ostrava, Czech Republic
  9. 9Righospitalet, University Hospital of Copenhagen, Medical Oncology, Copenhagen, Denmark
  10. 10Université Catholique de Louvain (UCLouvain), Medical Oncology, Brussels, Belgium
  11. 11University of Cincinnati Cancer Center, Gynecologic Oncology, Cincinnati, USA
  12. 12Erasmus MC Cancer Institute, Medical Oncology, Rotterdam, Netherlands
  13. 13Instituto Nazionale Tumori IRCCS Fondazione G Pascale, Medical Oncology, Naples, Italy
  14. 14University Medical Center Utrecht, Medical Oncology, Utrecht, Netherlands
  15. 15University of Chicago, Obstetrics and Gynecology, Chicago, USA
  16. 16Genmab US, Inc., Medical Oncology, Princeton, USA
  17. 17Genmab, Biostatistics, Copenhagen, Denmark
  18. 18Seagen Inc., Medical Oncology, Bothell, USA
  19. 19Centre Hospitalier Universitaire de Liege, Medical Oncology, Liege, Belgium
  20. 20University of Leuven, Leuven Cancer Institute, Belgium and Luxembourg Gynaecological Oncology Group, Leuven, Belgium


Objectives Tisotumab vedotin (TV) monotherapy has shown a manageable and tolerable safety profile with clinically meaningful and durable antitumor activity in previously treated r/mCC (Lancet Oncol. 2021;22:609–619). The potential of investigational TV combination regimens in r/mCC was assessed in a multi-cohort phase 1b/2 trial (NCT03786081).

Methods Patients with r/mCC with progression on/after or ineligible for/intolerant to standard-of-care were treated with escalating doses of TV + bevacizumab (Arm A) or pembrolizumab (Arm B) or carboplatin (Arm C) all given Q3W (figure 1). Primary objectives were to determine recommended phase 2 dosing (RP2D) and evaluate safety/tolerability.

Results A maximum tolerated dose was not reached with any combination. In Arm A, 15 patients received 9 cycles (median) for both TV and bevacizumab. Grade≥3 adverse events (AEs) occurred in 5 patients (33%). The RP2D was TV 2.0 mg/kg + bevacizumab 15 mg/kg Q3W. Five patients had confirmed objective response (cOR). In Arm B, 13 patients received a median of 5 cycles of TV and 4 cycles of pembrolizumab. Grade≥3 AEs occurred in 12 patients (92%). The RP2D was TV 2.0 mg/kg + pembrolizumab 200 mg Q3W. Two patients had cOR. In Arm C, 13 patients received 5 cycles (median) of TV + 4 cycles of carboplatin. Grade≥3 AEs occurred in 8 patients (62%). The RP2D was TV 2.0 mg/kg + carboplatin AUC 5 Q3W. Four patients had cOR.

Abstract O013/#573 Figure 1

AUC, area under the curve; DL, dose level; DLT, dose-limiting toxicity; TV, tisotummab vedotin.Drugs administered IV on day 1 of 21-day cycle.Patients were treated for at least 2 cycles to evaluate DLTs.Escalation to the next DL was permited when fewer than 1 in 3 patients at the current DL experienced a DLT.The recommended phase 2 does (RP2D) was highest planned DL reached with DLTs in no more than 1 in 6 patients.

Conclusions TV plus bevacizumab, pembrolizumab, or carboplatin was tolerated and had an acceptable safety profile with encouraging activity in patients with r/mCC.

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