TY - JOUR
T1 - Cemiplimab plus peltopepimut-S vaccine in recurrent cervical cancer
T2 - A phase 2 clinical trial
AU - Lorusso, Domenica
AU - Oaknin, Ana
AU - Borges, Giuliano S.
AU - Damian, Fernanda
AU - Ottevanger, Nelleke
AU - Van Gorp, Toon
AU - Paiva, Carlos E.
AU - Kroep, Judith R.
AU - Kim, Yong-Man
AU - Kim, Hee-Seung
AU - Lee, Jae-Kwan
AU - Denys, Hannelore
AU - Lalisang, Roy
AU - Melo, Andreia Cristina De
AU - Redondo, Andres
AU - Reyners, Anna K. L.
AU - Mora, Paulo
AU - Closset, Celine
AU - Melief, Cornelis J. M.
AU - Hooftman, Leon
AU - Jamil, Shaheda
AU - Boersm, Lisa
AU - Yoo, Suk-Young
AU - Seebach, Frank
AU - Lowy, Israel
AU - Fury, Matthew G.
AU - Mathias, Melissa
AU - Colombo, Nicoletta
PY - 2025/5/1
Y1 - 2025/5/1
N2 - 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 RECISTversion 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. (c) 2025 Published by Elsevier Inc.
AB - 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 RECISTversion 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. (c) 2025 Published by Elsevier Inc.
KW - Cemiplimab
KW - Recurrent/metastatic
KW - Cervical cancer
KW - Peltopepimut-S vaccine
KW - HPV16
KW - SURVIVAL
U2 - 10.1016/j.ygyno.2025.03.019
DO - 10.1016/j.ygyno.2025.03.019
M3 - Article
SN - 0090-8258
VL - 196
SP - 28
EP - 35
JO - Gynecologic Oncology
JF - Gynecologic Oncology
ER -