Study of Cemiplimab in Adults With Cervical Cancer
Summary
The primary objective is to compare overall survival (OS) for patients with recurrent or metastatic cervical cancer who have histology of squamous cell carcinoma (SCC) and who have any eligible histology treated with either cemiplimab or investigator's choice (IC) chemotherapy. The secondary objectives performed among SCC patients and among all eligible histologies (SCC and adenocarcinoma/adenosquamous carcinoma (AC) are: * To compare progression-free survival (PFS) of cemiplimab versus IC chemotherapy * To compare objective response rate (ORR) (partial response \[PR\] + complete response \[CR\]) of cemiplimab versus IC chemotherapy per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 * To compare the duration of response (DOR) of cemiplimab versus IC chemotherapy * To compare the safety profiles of cemiplimab versus IC chemotherapy by describing adverse events (AE) * To compare quality of life (QOL) for patients treated with cemiplimab versus IC chemotherapy using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Timeline
- Start
- 2017-09-05
- Primary completion
- 2021-03-15
- Completion
- 2023-04-20
Outcome
Met primary endpoint
registry MEDIAN Cemiplimab: 11.7 (9.6 to 13.4) Months MEDIAN Investigator Choice (IC) Chemotherapy: 8.5 (7.5 to 9.6) Months NCT03257267 ↗
registry p <0.00001; Hazard Ratio (HR) 0.665 (95% CI 0.555 to 0.796) NCT03257267 ↗
registry MEDIAN Cemiplimab: 10.9 (8.9 to 12.9) Months MEDIAN Investigator Choice (IC) Chemotherapy: 8.8 (7.6 to 9.8) Months NCT03257267 ↗
registry p = 0.00024; Hazard Ratio (HR) 0.698 (95% CI 0.570 to 0.855) NCT03257267 ↗
release “Phase 3 trial of Libtayo® (cemiplimab) monotherapy in advanced cervical cancer stopped early for positive result on overall survival” regeneron.com ↗
release “In this Phase 3 trial, Libtayo demonstrated a significant improvement in overall survival in women with advanced cervical cancer after progression on chemotherapy” regeneron.com ↗
release “EMPOWER-Cervical 1 trial. In the trial (n=608), the primary endpoint of overall survival was met” regeneron.com ↗
Publications
- Oaknin A, Monk BJ, Vergote I, Cristina de Melo A, Kim YM, Lisyanskaya AS, Samouelian V, Kim HS, Gotovkin EA, Damian F, Chang CL, Takahashi S, Li J, Mathias M, Fury MG, Ivanescu C, Reaney M, LaFontaine PR, Lowy I, Harnett J, Chen CI, Tewari KS. EMPOWER CERVICAL-1: Effects of cemiplimab versus chemotherapy on patient-reported quality of life, functioning and symptoms among women with recurrent cervical cancer. Eur J Cancer. 2022 Oct;174:299-309. doi: 10.1016/j.ejca.2022.03.016. Epub 2022 Jul 31.
- Tewari KS, Monk BJ, Vergote I, Miller A, de Melo AC, Kim HS, Kim YM, Lisyanskaya A, Samouelian V, Lorusso D, Damian F, Chang CL, Gotovkin EA, Takahashi S, Ramone D, Pikiel J, Mackowiak-Matejczyk B, Guerra Alia EM, Colombo N, Makarova Y, Rischin D, Lheureux S, Hasegawa K, Fujiwara K, Li J, Jamil S, Jankovic V, Chen CI, Seebach F, Weinreich DM, Yancopoulos GD, Lowy I, Mathias M, Fury MG, Oaknin A; Investigators for GOG Protocol 3016 and ENGOT Protocol En-Cx9. Survival with Cemiplimab in Recurrent Cervical Cancer. N Engl J Med. 2022 Feb 10;386(6):544-555. doi: 10.1056/NEJMoa2112187.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cemiplimab | Monoclonal antibody | 350 mg | Intravenous |
| Subject | Gemcitabine | Small molecule | — | — |
| Subject | Irinotecan | Small molecule | — | — |
| Subject | Pemetrexed | Small molecule | — | — |
| Subject | Topotecan | Small molecule | — | — |
| Subject | Vinorelbine | Small molecule | — | — |