Cemiplimab plus peltopepimut-S vaccine in recurrent cervical cancer: A phase 2 clinical trial

IF 4.5 2区 医学 Q1 OBSTETRICS & GYNECOLOGY
Domenica Lorusso , Ana Oaknin , Giuliano S. Borges , Fernanda Damian , Nelleke Ottevanger , Toon Van Gorp , Carlos E. Paiva , Judith R. Kroep , Yong-Man Kim , Hee-Seung Kim , Jae-Kwan Lee , Hannelore Denys , Roy Lalisang , Andreia Cristina De Melo , Andres Redondo , Anna K.L. Reyners , Paulo Mora , Celine Closset , Cornelis J.M. Melief , Leon Hooftman , Nicoletta Colombo
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引用次数: 0

Abstract

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.
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来源期刊
Gynecologic oncology
Gynecologic oncology 医学-妇产科学
CiteScore
8.60
自引率
6.40%
发文量
1062
审稿时长
37 days
期刊介绍: Gynecologic Oncology, an international journal, is devoted to the publication of clinical and investigative articles that concern tumors of the female reproductive tract. Investigations relating to the etiology, diagnosis, and treatment of female cancers, as well as research from any of the disciplines related to this field of interest, are published. Research Areas Include: • Cell and molecular biology • Chemotherapy • Cytology • Endocrinology • Epidemiology • Genetics • Gynecologic surgery • Immunology • Pathology • Radiotherapy
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