|The following article features coverage from the European Society for Medical Oncology (ESMO) Congress 2021. Click here to read more of Cancer Therapy Advisor’s conference coverage.|
The checkpoint inhibitor cemiplimab significantly improved survival in patients with recurrent/metastatic cervical carcinoma compared with single-agent chemotherapy. These findings were presented during the European Society of Medical Oncology (ESMO) Congress 2021.
In general, salvage chemotherapy is ineffective for patients with recurrent/metastatic cervical cancer following progression on first-line platinum-based chemotherapy, with or without bevacizumab. EMPOWER-Cervical 1/GOG-3016/ENGOT-cx9 (ClinicalTrial.gov Identifier: NCT03257267) is an open-label, randomized, multicenter, phase 3 trial of the antiprogrammed cell death-1 agent cemiplimab vs investigator’s choice single-agent chemotherapy in recurrent/metastatic cervical cancer that has progressed after first-line platinum-based treatment.
Patients, who were enrolled regardless of PD-L1 expression, received cemiplimab 350 mg intravenously every 3 weeks or investigator’s choice chemotherapy with pemetrexed, vinorelbine, gemcitabine, irinotecan or topotecan for up to 96 weeks. They were stratified by histology, squamous cell carcinoma (SCC)/adenocarcinoma or adenosquamous carcinoma.
“The survival benefit and overall response rate (ORR) were superior in SCC patients who received cemiplimab, and was also seen in the overall population and the adenosquamous population,” said lead author Krishnansu S. Tewari, MD, of the Department of Obstetrics & Gynecology, University of California Irvine, at ESMO 2021.
The primary endpoint of the study was overall survival (OS), which was analyzed hierarchically in patients with SCC followed by the total population (SCC plus adenocarcinoma). Additional endpoints included progression-free survival (PFS), ORR, quality of life (QoL), and safety.
A total of 608 patients, median age 51 years, were randomly assigned, including 477 patients with SCC and 131 patients with adenosquamous carcinoma. They had Eastern Cooperative Oncology Group (ECOG) performance scores of 0 or 1. Median cemiplimab exposure was 15 weeks.
At interim analysis, median OS was significantly longer (12 months) with cemiplimab than with chemotherapy (8.5 months), with a hazard ratio (HR) of 0.69. Median OS was also significantly longer (11.1 months) in the SCC population than the chemotherapy group (8.8 months), with a HR of 0.73, and was also longer (13.3 months) in the adenosquamous carcinoma population as compared to the chemotherapy group (7 months), with a HR of 0.56.
PFS, ORR in the overall and SCC populations, and mean change from baseline QoL in SCC,also favored cemiplimab.
Patients with PD-L1 expression of 1% or more showed an enhanced survival benefit with cemiplimab, he said.
The most common treatment-emergent adverse events of any grade for cemiplimab vs chemotherapy were anemia (25% vs 45%), nausea (18% vs 33%) and vomiting (16% vs 23%). Discontinuation because of adverse events occurred in 8% (cemiplimab) and 5% (chemotherapy) of the study population. No new safety signals were identified.
“In the largest randomized study conducted to date in this population, cemiplimab is the first immunotherapy to demonstrate a statistically significant and clinically meaningful survival benefit in recurrent/metastatic cervical cancer following progression after first-line platinum-containing chemotherapy,” Dr Tewari concluded.
Disclosures: This research was supported by Regeneron Pharmaceuticals, Inc. and Sanofi. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Tewari KS, Monk BS, Vergote I, et al. EMPOWER-Cervical 1/GOG-3016/ENGOT-cx9: Interim analysis of phase III trial of cemiplimab vs. investigator’s choice (IC) chemotherapy (chemo) in recurrent/metastatic (R/M) cervical carcinoma. Presented at: European Society for Medical Oncology (ESMO) Congress 2021; September 16-21, 2021. Abstract VP4-2021.