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Phase III trial of Libtayo shows benefits in efficacy in cervical cancer.- Regeneron Pharma
Regeneron Pharmaceuticals announced the presentation of positive results from the Phase III trial investigating the PD-1 inhibitor Libtayo (cemiplimab) in patients with recurrent or metastatic cervical cancer who had previously progressed on chemotherapy.
Regeneron Pharmaceuticals announced the presentation of positive results from the Phase III trial investigating the PD-1 inhibitor Libtayo (cemiplimab) in patients with recurrent or metastatic cervical cancer who had previously progressed on chemotherapy. In the overall population, those treated with Libtayo (n=304) experienced significant improvements in OS, progression-free survival (PFS) and objective response rate (ORR), compared to chemotherapy (n=304), including: a 31% reduction in the risk of death (hazard ratio [HR]: 0.69; 95% confidence interval [CI]: 0.56-0.84; one-sided p=0.00011), a 25% reduction in the risk of disease progression (HR: 0.75; 95% CI: 0.63-0.89; one-sided p=0.00048), and a 16% ORR (50 patients; 95% CI: 13-21%; one-sided p=0.00004), compared to 6% with chemotherapy (19 patients). Median duration of response was 16 months with Libtayo (95% CI: 12 months to not yet evaluable) and 7 months with chemotherapy (95% CI: 5-8 months), per Kaplan-Meier estimates. In the trial, 78% of patients had advanced cervical cancer that was classified as squamous cell carcinoma (SCC). In this patient subgroup, significant improvements were also seen with Libtayo (n=239), compared to chemotherapy (n=238), including: a 27% reduction in the risk of death (HR: 0.73; 95% CI: 0.58-0.91; one-sided p=0.00306), a 29% reduction in the risk of disease progression (HR: 0.71; 95% CI: 0.58-0.86; one-sided p=0.00026) and an 18% ORR (42 patients; 95% CI: 13-23%), compared to 7% with chemotherapy (16 patients; 95% CI: 4-11%). While assessment of the adenocarcinoma was not a pre-specified endpoint, a post-hoc analysis demonstrated the following outcomes for Libtayo-treated patients (n=65) compared to chemotherapy (n=66), including a: 44% reduction in the risk of death (HR: 0.56; 95% CI: 0.36-0.85; nominal one-sided p<0.005). a 9% reduction in the risk of disease progression (hr: 0.91; 95% ci: 0.62-1.34). a 12% orr (8 patients; 95% ci: 6-23%), compared to 5% with chemotherapy (3 patients; 95% ci: 1-13%). additionally, the phase iii trial found libtayo-treated patients were able to generally improve or maintain their baseline global health status quality of life (ghs qol) over time, while those treated with chemotherapy experienced a deterioration that became clinically meaningful starting at cycle 8, per the eortc qlq-c30 (overall estimated mean change [95% ci]: improvement of 1.01 [-2.033, 4.047] for libtayo, worsening of -6.81 [-10.977, -2.637] for chemotherapy; difference: 7.81; one-sided nominal p="0.00040)." no new libtayo safety signals were observed. the data were shared as part of a european society for medical oncology (esmo) virtual plenary and add to previously reported data showing an improvement in overall survival (os) with libtayo compared to chemotherapy. the data will form the basis of regulatory submissions in 2021.>0.005).>
Condition: Cervical Cancer
Type: drug