Cemiplimab Biologics License Application for Advanced Cervical Cancer Withdrawn Following Discourse With FDA

In a regulatory update on cemiplimab for advanced cervical cancer, Regeneron Pharmaceuticals announced that the agent’s biologics license application has been withdrawn.

A biologics license application for cemiplimab (Libtayo) for the second-line treatment of advanced cervical cancer was voluntarily withdrawn following discourse with the FDA, according to a press release from Regeneron Pharmaceuticals.1

The regulatory decision was made after Regeneron, Sanofi, and the FDA did not align on specific post-marketing studies. Discussions with external regulatory organizations beyond the United States are in progress.

Cemiplimab was granted priority review by the FDA for patients with recurrent or metastatic cervical cancer in September 2021.2 The decision came as a result of the phase 3 EMPOWER-Cervical 1 trial (NCT03257267), which assessed the agent in a population of patients with recurrent or metastatic disease following treatment with chemotherapy.3

The results of the study, which were presented at the European Society for Medical Oncology Virtual Plenary, expanded onpreviously reported findings of cemiplimab published in March 2021. Investigators reported the trial was stopped early due to a reduction in risk of disease progression or death in patients treated with cemiplimab (HR, 0.69; 95% CI, 0.56-0.84; P = .00011). Additional findings from the EMPOWER study indicated that patients treated with cemiplimab achieved an improvement in both progression-free survival and objective response rate.

Patients included in the trial either received treatment with cemiplimab at a dose of 350 mg every 3 weeks or investigator's choice of chemotherapy, which included pemetrexed, vinorelbine, topotecan, irinotecan, or gemcitabine.

Patients in the overall population had a 25% reduction in risk compared with chemotherapy (HR, 0.75; 95% CI, 0.63-0.89; P = .00048). Moreover, patients with squamous cell carcinoma had a 27% reduction in risk of death (HR, 0.73; 95% CI, 0.58-0.91; one-sided P = .00306) and those with adenocarcinoma had a 44% reduction in risk of death (HR, 0.56; 95% CI, 0.36-0.85; nominal one-sided P <.005) and a 9% reduction in risk of progression (HR, 0.91; 95% CI, 0.62-1.34).

The research did not turn up any new safety signals for cemiplimab, with 88% of patients experiencing any grade adverse effects (AEs) vs 91% in the chemotherapy arm. The most common grade 3 or higher AEs in both the cemiplimab and chemotherapy arms included asthenia (2% vs 1%) and pyrexia (<1% vs 0%). Additionally, immune-related AEs were reported in 16% and 1% of patients, respectively, with 6% and 1% of respective events being grade 3 or higher.


  1. Regeneron and Sanofi provide regulatory update on Libtayo® (Cemiplimab-rwlc) in advanced cervical cancer. News release. Regeneron Pharmaceuticals. January 28, 2022. Accessed January 28, 2022. https://bit.ly/3u8Wfhi
  2. FDA accepts Libtayo (cemiplimab-rwlc) for priority review for advanced cervical cancer. News Release. Regeneron Pharmaceuticals, Inc. September 28, 2021. Accessed January 28, 2022. https://prn.to/3osRTPv
  3. Positive phase 3 Libtayo® (cemiplimab) results in advanced cervical cancer presented at ESMO Virtual Plenary. News release. Regeneron Pharmaceuticals, Inc. and Sanofi. May 12, 2021. Accessed January 28, 2022. https://prn.to/3huFSWl