Abstract 28P
Background
Cemiplimab is an immunoglobulin G4 monoclonal antibody targeting the programmed cell death-1 receptor. A nominal use program is available in Italy for advanced cervical cancer (CC) patients treated with platinum-based chemotherapy based on the results of the EMPOWER-Cervical 1/GOG-3016/ENGOTcx9 trial. This real-world, retrospective cohort, multicenter study aimed at describing the clinical outcomes of patients with advanced CC treated with cemiplimab in Italy.
Methods
The primary objective of the study was to assess the feasibility and replicability of the initial results in a real-world setting of cemiplimab. The primary endpoint of our analysis was progression-free survival (PFS). Secondary endpoints included overall response rate (ORR), overall survival (OS) and safety data.
Results
From March 2022 to December 2023, 135 patients were treated in 12 Multicenter Italian Trials in Ovarian cancer and gynecologic malignancies (MITO) Centers. Forty-two percent of patients had one or more comorbidities, hypertension being the most common (23.4%). Median PFS was 4.0 months (range 3.0-6.0) and median OS was 12.0 months (12.0- NR) with no differences according to PD-L1 status. Complete response (CR) or no evidence of disease (NED) were observed in 8.6%; partial response (PR) in 21.1%, stable disease (SD) in 14.8% and progression was recorded in 44.5% of patients. Most common drug related adverse events (AEs) were anemia (39.1%) and fatigue (27.8%). Immune related AEs occurred in 18.0%.
Conclusions
This study confirms the feasibility and the replicability of the cemiplimab nominal use in advanced CC, in a real-world practice in Italy.
Legal entity responsible for the study
The authors.
Funding
VALG_RIC_COMP_21_01 to GV, funder University of Torino.
Disclosure
V. Tuninetti: Financial Interests, Institutional, Invited Speaker: MSD Oncology, GSK, Eisai. V. Salutari: Financial Interests, Institutional, Invited Speaker: MSD Oncology, GSK, PharmaMar, Novocure; Financial Interests, Institutional, Advisory Board: AstraZeneca, Novocure. C. Pisano: Financial Interests, Institutional, Advisory Board: MSD Oncology, GSK, AstraZeneca. M.C. Petrella, G. Artioli: Financial Interests, Institutional, Invited Speaker: MSD Oncology, GSK, AstraZeneca. S. Pignata: Financial Interests, Institutional, Funding: MSD Oncology, GSK, AstraZeneca, Roche, Pfizer; Financial Interests, Institutional, Invited Speaker: MSD Oncology, AstraZeneca, Roche, GSK, Novartis, Eisai, PharmaMar. G. Valabrega: Financial Interests, Institutional, Advisory Board: AstraZeneca, GSK, Eisai, MSD; Financial Interests, Institutional, Invited Speaker: GSK, MSD Oncology, AstraZeneca. All other authors have declared no conflicts of interest.