KEY TAKEAWAYS
- Phase 3 of EMPOWER-Cervical 1 aimed to demonstrate the efficacy of using Cemiplimab monotherapy as a treatment for cervical cancer and compared the results to chemotherapy.
- The primary outcome measure of this study was OS which stood at (5.2 months vs 6.5 months) while PFS and ORR were among the secondary outcome measures.
- Admittedly, Cemiplimab monotherapy remained less effective. However, it demonstrated a superiority over earlier standard-of-care regimens.
Phase 3 of the EMPOWER-Cervical 1 study followed the new evidence that suggests that liver mets have immune privileges and can cause a widespread loss of tumor-specific CD8+ T cells, which lowers the body’s ability to fight tumors. The effectiveness of immunotherapy (as opposed to chemotherapy [chemo] or targeted treatment) has been shown to be negatively correlated with liver mets in a number of cancer types. However, few observational data are available on immunotherapy’s impact on liver metastasis patients (pts).
In this posthoc analysis, patients with baseline liver metastases from the EMPOWER-Lung 1, EMPOWER-Lung 3 Part 2, and EMPOWER-Cervical 1 phase 3 trials of cemiplimab (cemi; anti-PD-1) for non-small cell lung cancer (NSCLC) and cervical cancer were included. Analysis was done on objective response rate (ORR), progression-free survival (PFS), and overall survival (OS).
17% of participants in EMPOWER-Lung 1, 15% in EMPOWER-Lung 3 Part 2, and 24% in EMPOWER-Cervical 1 had initial liver metastases. Patients with liver mets usually had worse OS, PFS, and ORR, no matter the treatment arm. However, among patients with liver mets in EMPOWER-Cervical 1, cemiplimab monotherapy showed decreased OS (5.2 months vs 6.5 months; HR 0.92); PFS (1.4 vs 1.9 months; HR 0.89); and higher ORR (9% vs 3%) compared to chemo.
Although Cemiplimab was less effective in patients with primary lung/cervical cancer who had liver mets than in those who did not, the relative advantage over earlier standard-of-care regimens was maintained and, for some patients, even increased.
Source:https://cslide.ctimeetingtech.com/immuno22hybrid/attendee/confcal/show/session/44
Clinical Trial: https://clinicaltrials.gov/ct2/show/NCT03257267
Gessner C., Sezer A., Gumus M., Tewari K.S., Monk B.J., de Melo A.C., Oakin A., Li S., Gao B., Gullo G., Salvati M.E., Seebach F., Lowy I., Fury M., Rietschel P., 168P – Liver metastases (mets) and treatment effect of cemiplimab-based therapy: an analysis from three Phase 3 trials (EMPOWER-Lung 1, EMPOWER-Lung 3 Part 2, and EMPOWER-Cervical 1). (2022, October 21). Retrieved February 28, 2023, from https://cslide.ctimeetingtech.com/immuno22hybrid/attendee/confcal/show/session/44
