Article
Author: Seebach, Frank ; De Melo, Andreia Cristina ; Ottevanger, Nelleke ; Kim, Yong-Man ; Mathias, Melissa ; Reyners, Anna K L ; Kim, Hee-Seung ; Lee, Jae-Kwan ; Jamil, Shaheda ; Borges, Giuliano S ; Hooftman, Leon ; Paiva, Carlos E ; Van Gorp, Toon ; Fury, Matthew G ; Damian, Fernanda ; Closset, Celine ; Denys, Hannelore ; Boersma, Lisa ; Lowy, Israel ; Redondo, Andres ; Colombo, Nicoletta ; Melief, Cornelis J M ; Yoo, Suk-Young ; Lalisang, Roy ; Mora, Paulo ; Kroep, Judith R ; Lorusso, Domenica ; Oaknin, Ana
OBJECTIVE:To estimate the clinical benefit of cemiplimab+peltopepimut-S vaccine after disease progression on first-line chemotherapy.
METHODS:This global phase 2 open-label study (NCT04646005) recruited patients with recurrent HPV16+ cervical cancer who had previously experienced disease progression after first-line chemotherapy. Patients received a total of 3 doses of peltopepimut-S vaccine on days 1, 29, and 50 and cemiplimab 350 mg every 3 weeks until disease progression or other reason for early discontinuation. Primary endpoint was objective response rate (ORR) per RECIST version 1.1; secondary endpoints were duration of response (DOR), overall survival (OS), progression-free survival (PFS), and safety.
RESULTS:Of 113 patients enrolled between June 28, 2021 and May 22, 2023, 80.5 % were white, with a median age of 49.0 years, and 58.4 % had an ECOG PS of 0. Median duration of follow-up was 4.9 months. ORR (95 % CI) per investigator assessment was 16.8 % (9.9-23.7). ORR of patients with squamous cell carcinoma by PD-L1 expression in tumor cells was 15.8 % for patients with PD-L1 < 1 % and 24.1 % for patients with PD-L1 ≥ 1 %. Median (95 % CI) DOR was 5.6 (3.5-not estimable) months. Median (95 % CI) OS and PFS were 13.3 (10.8-16.3) months and 3.0 (1.7-4.0) months, respectively. Treatment-emergent adverse events (TEAEs) occurred in 92.9 % of patients, the most common being injection-site reaction (38.9 %) and anemia (25.7 %). Six (5.3 %) patients died from a TEAE.
CONCLUSION:Cemiplimab+peltopepimut-S vaccine provides similar benefits to cemiplimab monotherapy; patients with higher PD-L1 expression in tumor cells may be more likely to benefit from treatment.