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O002/#43 Randomized phase 3 study of lenvatinib plus pembrolizumab for advanced endometrial cancer (aec): subgroup analysis of patients with DNA mismatch repair deficient (DMMR) tumors
  1. V Makker1,
  2. N Colombo2,
  3. A Casado Herráez3,
  4. A Santin4,
  5. E Colomba5,
  6. D Miller6,
  7. K Fujiwara7,
  8. S Pignata8,
  9. S Banerjee9,
  10. B Monk10,
  11. K Ushijima11,
  12. R Penson12,
  13. R Kristeleit13,
  14. M Fabbro14,
  15. M Orlando15,
  16. H Mackay16,
  17. M Ren17,
  18. R Orlowski18,
  19. L Dutta19 and
  20. D Lorusso20
  1. 1Memorial Sloan Kettering Cancer Center; Weill Cornell Medical Center, Department of Medicine, New York, USA
  2. 2University of Milan-Bicocca, European Institute of Oncology IRCCS, Gynecologic Oncology Program, Milan, Italy
  3. 3San Carlos University Teaching Hospital, Department of Medical Oncology, Madrid, Spain
  4. 4Yale University School of Medicine, Department of Obstetrics, Gynecology and Reproductive Sciences, New Haven, USA
  5. 5Gustave Roussy Cancerology Institute, Department of Cancer Medicine, Villejuif, GINECO group, France
  6. 6University of Texas Southwestern Medical Center, Gynecologic Oncology, Dallas, USA
  7. 7Saitama Medical University International Medical Center, Department of Gynecologic Oncology, Hidaka, Japan
  8. 8Instituto Nazionale Tumori IRCCS-Fondazione G. Pascale, Department of Urology and Gynecology, Naples, Italy
  9. 9The Royal Marsden NHS Foundation Trust, Gynaecology Unit, London, UK
  10. 10Arizona Oncology, Gynecologic Oncology, Obstetrics and Gynecology, Phoenix, USA
  11. 11Kurume University School of Medicine, Department of Obstetrics and Gynecology, Kurume, Japan
  12. 12Harvard Medical School, Massachusetts General Hospital, Division of Hematology and Oncology, Boston, USA
  13. 13Guy’s and St Thomas’ NHS Foundation Trust, Department of Oncology, London, UK
  14. 14Institut Régional du Cancer de Montpellier, Service De Radiothérapie, Montpellier, France
  15. 15Instituto Alexander Fleming, Oncologo Medico, Buenos Aires, Argentina
  16. 16Odette Cancer Centre, Sunnybrook Health Sciences Centre, Medical Oncology, Toronto, Canada
  17. 17Eisai Inc., Biostatistics, Oncology Business Group, Woodcliff Lake, USA
  18. 18Merck and Co., Inc., Late Stage Clinical Development, Kenilworth, USA
  19. 19Eisai Inc., Clinical Research, Woodcliff Lake, USA
  20. 20Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Division of Gynecologic Oncology, Rome, Italy


Objectives In Study 309/KEYNOTE-775, lenvatinib + pembrolizumab (LEN+pembro) significantly improved PFS, OS, and ORR versus treatment of physician’s choice (TPC) in aEC patients with DNA mismatch repair proficient tumors and all-comers following platinum-based therapy. We report results for dMMR aEC patients.

Methods Patients in Study 309/KEYNOTE-775 were randomized 1:1 to lenvatinib 20 mg orally daily + pembrolizumab 200 mg IV Q3W or TPC (doxorubicin 60 mg/m2 IV Q3W or paclitaxel 80 mg/m2 IV QW [3 weeks on/1 week off]). Patients had aEC with 1 prior platinum-based chemotherapy regimen (2 if one was given in the neoadjuvant/adjuvant setting). Prespecified efficacy (PFS, OS, and ORR) and safety analyses among dMMR patients are reported. P-values are nominal. Tumors were assessed by blinded independent central review per RECIST v1.1.

Results 130 Patients with dMMR aEC were randomized to LEN+pembro (n=65) or TPC (n=65). Median follow-up was 13.5 months for the LEN+pembro group and 8.8 months for the TPC group (data cutoff: October 26, 2020). PFS (median 10.7 vs 3.7 months) and OS (median not reached vs 8.6 months) were longer with LEN+pembro vs TPC. ORR was greater with LEN+pembro (40.0%) vs TPC (12.3%). Additional results are in the Table. Grade ≥3 treatment-emergent adverse events occurred in 95% and 73% of patients in the LEN+pembro and TPC groups, respectively.

Abstract O002/#43 Table 1

Conclusions LEN+pembro improved PFS, OS, and ORR vs TPC in patients with dMMR aEC, with a manageable safety profile generally consistent with all-comers and previous studies.

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