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Phase III trial of Libtayo halted early in cervical cancer after positive report from IDMC.- Regeneron Pharma/Sanofi

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Published:16th Mar 2021
Regeneron Pharmaceuticals and Sanofi announced positive results demonstrating an overall survival (OS) benefit from the Phase III trial investigating the PD-1 inhibitor Libtayo (cemiplimab) monotherapy compared to chemotherapy, in patients previously treated with chemotherapy whose cervical cancer is recurrent or metastatic. The trial will be stopped early based on a unanimous recommendation by the Independent Data Monitoring Committee (IDMC), and the data will form the basis of regulatory submissions in 2021. Compared to chemotherapy, patients receiving Libtayo experienced: Total population: 31% reduced risk of death. Median 12.0 months survival for Libtayo (n=304) compared to 8.5 months for chemotherapy (n=304); hazard ratio (HR): 0.69; 95% confidence interval (CI): 0.56-0.84 (p<0.001). squamous cell carcinoma: 27% reduced risk of death. median 11.1 months survival for libtayo (n="239)" compared to 8.8 months for chemotherapy (n="238);" hr: 0.73; 95% ci: 0.58-0.91 (p="0.003)." adenocarcinoma: 44% reduced risk of death. median 13.3 months survival for libtayo (n="65)" compared to 7.0 months for chemotherapy (n="66);" hr: 0.56; 95% ci: 0.36-0.85 (p><0.005; not adjusted for multiplicity). the primary endpoint for the trial was os, analyzed first among patients with squamous cell carcinoma, then in the total population. per a protocol-specified interim analysis, the idmc reviewed os data when approximately 85% of events had occurred among patients with squamous cell carcinoma. based on the highly significant effect on os among these patients, the idmc recommended stopping the trial. detailed results will be presented at an upcoming medical meeting. the use of libtayo in cervical cancer is investigational and has not been fully reviewed by any regulatory authority. no new libtayo safety signals were observed.>
Condition: Cutaneous Squamous Cell Carcinoma
Type: drug

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