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  • 2022-RA-324-ESGO Phase 2 results from the LIO-1 STUDY (NCT04042116; ENGOT-GYN3/AGO/LIO): efficacy and safety of lucitanib + nivolumab in patients with advanced gynaecological malignancies

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2022-RA-324-ESGO Phase 2 results from the LIO-1 STUDY (NCT04042116; ENGOT-GYN3/AGO/LIO): efficacy and safety of lucitanib + nivolumab in patients with advanced gynaecological malignancies
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  1. Nicole Concin1,
  2. Manish R Patel2,
  3. Vicky Makker3,
  4. Ana Oaknin4,
  5. Sandro Pignata5,
  6. Floor J Backes6,
  7. Antonio González-Martín7,
  8. Ramez N Eskander8,
  9. Bhavana Pothuri9,
  10. Debra L Richardson10,
  11. Angeles Alvarez Secord11,
  12. Els van Nieuwenhuysen12,
  13. Joyce F Liu13,
  14. Fernanda Musa14,
  15. Richard T Penson15,
  16. Kenton Wride16,
  17. Rachel Dusek17,
  18. Terri Cameron18 and
  19. Erika Hamilton19
  1. 1Department of Gynecology and Obstetrics, Medical University of Innsbruck, Innsbruck, Austria and Department of Gynecology and Gynecologic Oncology, Evang. Kliniken Essen-Mitte, Essen, Germany
  2. 2Drug Development Unit, Florida Cancer Specialists/Sarah Cannon Research Institute, Sarasota, FL
  3. 3Department of Medicine, Memorial Sloan Kettering Cancer Center, Weill Cornell Medical Center, New York, NY
  4. 4Gynaecologic Cancer Programme, Vall d’Hebron Institute of Oncology (VHIO), Hospital Universitari Vall d’Hebron, Vall d’Hebron Barcelona Hospital Campus, Barcelona, Spain
  5. 5Department Uro-Ginecologico, Istituto Nazionale Tumori – Fondazione ‘G. Pascale’, Naples, Italy
  6. 6Division of Gynecologic Oncology, Ohio State University Wexner Medical Center and James Cancer Hospital, Columbus, OH
  7. 7GEICO and Medical Oncology, Clínica Universidad de Navarra, Madrid, Spain
  8. 8Department of Obstetrics, Gynecology, and Reproductive Sciences, UC San Diego Moores Cancer Center, La Jolla, CA
  9. 9Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York, NY
  10. 10Division of Gynecologic Oncology, Stephenson Cancer Center/Sarah Cannon Research Institute, The University of Oklahoma, Oklahoma City, OK
  11. 11Department of Obstetrics and Gynecology, Gynecologic Oncology Division, Duke Cancer Institute, Duke University School of Medicine, Durham, NC
  12. 12Department of Gynecological Oncology, Campus Gasthuisberg, University Hospitals Leuven, Leuven, Belgium
  13. 13Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA
  14. 14Department of Gynecologic Oncology, Swedish Cancer Institute, Seattle, WA
  15. 15Medical Oncology, Massachusetts General Hospital, Boston, MA
  16. 16Biostatistics, Clovis Oncology, Inc., Boulder, CO
  17. 17Translational Medicine, Clovis Oncology, Inc., Boulder, CO
  18. 18Clinical Science, Clovis Oncology UK Ltd., Cambridge, UK
  19. 19Medical Oncology, Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN

Abstract

Introduction/Background LIO-1 (NCT04042116) assesses the combination of lucitanib, an oral anti-angiogenic, multikinase inhibitor administered using safety-based dose titration, and nivolumab, an inhibitor of programmed cell death receptor 1 (PD-1). Here, we present phase 2 study results of this combination in 4 advanced gynaecological malignancies.

Methodology LIO-1 enrolled patients with advanced, recurrent or metastatic endometrial cancer (EC), cervical cancer (CC), high-grade ovarian cancer (OC) or EC/OC with clear-cell histology (EOCC). Patients with EC, CC or EOCC received ≥1 prior platinum-based chemotherapies (CC, ± bevacizumab; EOCC, + taxane); patients with OC received ≥2 prior chemotherapies (including ≥1 platinum doublet). Patients received lucitanib at a starting dose of 6 mg QD plus intravenous nivolumab 480 mg every 28 days. Lucitanib dose could be escalated to 8 mg then 10 mg QD. The data cutoff was 14 April 2022.

Results Total treated was 124 patients; 31 (25.0%) patients are ongoing. At data cutoff, 32 (25.8%) patients escalated to lucitanib 8 mg and 20 (16.1%) to 10 mg. The confirmed best overall response rates at data cutoff were: EC cohort, 5/22 (22.7%); CC cohort, 12/46 (26.1%); OC cohort, 4/33 (12.1%); EOCC cohort, 6/23 (26.1%). Among EC-cohort patients, confirmed responses were reported for 2/5 patients who received prior PD-1 inhibitor (both were non-responders to prior PD-1 inhibitor). Among EC-cohort patients with known microsatellite status, confirmed responses were observed in 3/14 with microsatellite stability and 2/3 with high instability. Grade ≥3 treatment-emergent adverse events (TEAEs) considered study-treatment related were reported in 55 (44.4%) patients, with the most frequent being hypertension (n=30 [24.2%]). TEAEs leading to lucitanib dose reduction or discontinuation occurred in 21 (16.9%) and 20 (16.1%) patients, respectively.

Conclusion Lucitanib + nivolumab displays anti-tumour activity in patients with advanced gynaecological malignancies, including clear-cell cancer. Effective dose titration resulted in manageable safety, similar to previous reports.

https://doi.org/10.1136/ijgc-2022-ESGO.397

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