European Commission Approves Cemiplimab for Recurrent/Metastatic Cervical Cancer

The European Commission has approved cemiplimab (Libtayo) for the treatment of recurrent or metastatic cervical cancer that has progressed on or after platinum-based chemotherapy regardless of PD-L1 expression status or tumor histology, according to a press release from Regeneron Pharmaceuticals.¹

The European Commission based its approval on data from the phase 3 EMPOWER-Cervical 1 trial (NCT03257267), which compared cemiplimab monotherapy with an investigator’s choice of chemotherapy. Results from the trial indicated that the use of cemiplimab yielded a 31% reduction in the risk of death compared with chemotherapy.

Additionally, the median overall survival (OS) for the patients in the cemiplimab and chemotherapy cohorts, respectively, was 12.0 months vs 8.5 months (HR, 0.69; 95% CI, 0.56-0.84; P = 0.00011). Among patients with squamous cell carcinoma histology, cemiplimab produced a 27% reduction in the risk of death, and the median OS for patients in each respective cohort was 11.1 months vs 8.8 months (HR, 0.73; 95% CI, 0.58-0.91; P = 0.00306). Moreover, cemiplimab yielded a 25% reduction in the risk of progressive disease in the overall population (HR, 0.75; 95% CI, 0.62-0.89; P = 0.00048), and the objective response rate (ORR) in each respective cohort was 16% (95% CI, 12.5%-21.1%) vs 6% (95% CI, 3.8%-9.6%).

“[Cemiplimab] was the first PD-1 inhibitor to demonstrate significant improvements in survival compared to chemotherapy in a phase 3 trial,” Israel Lowy, MD, PhD, senior vice president, Translational and Clinical Services, Oncology at Regeneron, said in the press release. “With this…approval from the European Commission, [cemiplimab] can now be extended to appropriate patients in the European Union with advanced cervical cancer, irrespective of their PD-L1 status or histology.”

The most common grade 3 or higher adverse effects occurring in more than 1% of patients in the EMPOWER-Cervical 1 trial included anemia (5.2%), hypertension (2.6%), fatigue (2.6%), urinary tract infection (2.3%), hepatitis (1.8%), musculoskeletal pain (1.8%), rash (1.6%), dyspnea (1.2%), and pneumonitis (1.1%). Investigators of the trial reported no new safety signals for cemiplimab.

Cemiplimab is not indicated for use in the same patient population in the United States as the manufacturers — Regeneron and Sanofi — pulled its biologics license application after the Food and Drug Administration (FDA) did not align on post-marketing studies.²

However, cemiplimab was approved by the FDA for use along with platinum-based chemotherapy for patients with advanced non-small cell lung cancer in November 2022.³ The FDA based its approval on results from the phase 3 EMPOWER-Lung 3 trial (NCT03409614).

References

1. Libtayo® (cemiplimab) approved by the European Commission as the first immunotherapy in second line recurrent or metastatic cervical cancer irrespective of PD-L1 expression level or tumor histology. News release. Regeneron Pharmaceuticals, Inc. November 22, 2022. Accessed November 23, 2022. bit.ly/3EU91Wa
2. Regeneron and Sanofi provide regulatory update on Libtayo® (cemiplimab-rwlc) in advanced cervical cancer. News release. Sanofi. January 28, 2022. Accessed November 23, 2022. https://bit.ly/3u8Wfhi
3. FDA approves cemiplimab-rwlc in combination with platinum-based chemotherapy for non-small cell lung cancer. News release. FDA. November 8, 2022. Accessed November 23, 2022. https://bit.ly/3WO0BX1