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.
塞米单抗联合peltopepimut-S疫苗治疗复发性宫颈癌:一项2期临床试验
目的评价头孢米单抗+ peltopepimuts疫苗在一线化疗进展后的临床获益。方法:这项全球2期开放标签研究(NCT04646005)招募了在一线化疗后曾经历疾病进展的复发性HPV16+宫颈癌患者。患者在第1、29和50天共接受3次剂量的peltopepimuts疫苗,每3周接受一次350 mg的cemiplimab疫苗,直到疾病进展或其他原因导致早期停药。主要终点是RECIST 1.1版的客观缓解率(ORR);次要终点是反应持续时间(DOR)、总生存期(OS)、无进展生存期(PFS)和安全性。结果在2021年6月28日至2023年5月22日期间入组的113例患者中,80.5%为白人,中位年龄为49.0岁,58.4%的ECOG PS为0。中位随访时间为4.9个月。每个研究者评估的ORR (95% CI)为16.8%(9.9-23.7)。PD-L1阳性的鳞状细胞癌患者肿瘤细胞中PD-L1表达的ORR为15.8%;PD-L1≥1%的患者分别为1%和24.1%。中位DOR (95% CI)为5.6(3.5 -不可估计)个月。中位(95% CI) OS和PFS分别为13.3(10.8-16.3)个月和3.0(1.7-4.0)个月。92.9%的患者出现治疗不良事件(teae),最常见的是注射部位反应(38.9%)和贫血(25.7%)。6例(5.3%)患者死于TEAE。结论:塞米单抗+peltopepimut-S疫苗与单药治疗效果相似;肿瘤细胞中PD-L1表达较高的患者可能更有可能从治疗中获益。
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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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