The results of a Phase 3 trial confirmed that immunotherapy cimiprimab (Libtayo) yielded a survival benefit when used in second-line treatment for recurrent or metastatic cervical cancer.
Cimiprizumab has been approved in the United States for the treatment of non-small cell lung cancer and basal cell carcinoma. The drug's manufacturer, Regeneron, is currently awaiting approval for cervical cancer indications, and in September 2021, cimiprizumab was granted priority review by the FDA (meaning the FDA will make a decision within 6 months).
These data were from the Phase 3 randomized, open-label EMPOWER-Cervical Cancer 1/GOG-3016/ENGOT-cx9 study in which 608 women who developed disease progression after first-line platinum chemotherapy received either cimiprizumab or chemotherapy at 350 mg every 3 weeks.
At the median follow-up of 18.2 months, the overall survival (OS) of the cimiprilizumab group was significantly longer than that of the chemotherapy group (12.0 months vs 8.5 months). Progression-free survival (PFS) was also improved.
The authors conclude: "In our randomized trials, cimiprizumab showed a clear benefit in terms of overall survival and was of clinical significance. The results suggest that some women with recurrent cervical cancer may benefit from treatment with cimiprizumab. ”
The objective response rates (ORRs) of cimiprizumab and chemotherapy were 16.4% vs 6.3%, respectively. PD L-1 expression ≥ 1% of patients with PD-L1 expression
Adverse events of grade 3 or greater occurred in 45% and 53.4% of people in the cimiprizumab group and 53.4% of the chemotherapy group, respectively.
Introducing the findings of the interim study, lead author Dr. Krishnansu S. Tewari, director of the Department of Gynecologic Oncology and Obstetrics and Gynecology at the University of California, Irvine, said, "Cimiprizumab can provide a new standard treatment regimen for this population with a poor prognosis." ”