Efficacy and safety of sintilimab plus anlotinib for PD-L1–positive recurrent or metastatic cervical cancer: a multicenter, single-arm, prospective phase ii trial
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Authors
Xu, Qin
Wang, Junjie
Sun, Yang
Lin, Yibin
Liu, Jing
Zhuo, Yanhong
Huang, Zhangzhou
Huang, Songhua
Chen, Ying
Chen, Li
Issue Date
2022-02-22
Type
Article
Language
en_US
Keywords
Efficacy and Safety , Sintilimab Plus Anlotinib , PD-L1–Positive Recurrent , Metastatic Cervical Cancer
Alternative Title
Abstract
PURPOSE:
No combined immunotherapy and antiangiogenic therapy have been investigated in exclusively programmed death-ligand 1 (PD-L1)–positive advanced cervical cancer (CA). We investigated the efficacy and safety of sintilimab plus anlotinib as second-line or later therapy for PD-L1–positive recurrent or metastatic (R/M) CA.
PATIENTS AND METHODS:
Patients with PD-L1–positive (Combined Positive Score ≥ 1) R/M CA who progressed after at least one prior systemic chemotherapeutic regimen or could not tolerate chemotherapy were eligible for the phase II trial. The patients received 200 mg sintilimab once on day 1 and 10 mg anlotinib once daily on days 1-14 every 3 weeks. The primary end point was investigator-confirmed objective response rate (ORR) per RECIST v1.1. Secondary end points included progression-free survival (PFS), overall survival, and disease control rate. Biomarkers were explored.
RESULTS:
Forty-two patients were enrolled. The ORR was 54.8% (95% CI, 38.7 to 70.2). In 39 efficacy-evaluable patients, the ORR was 59.0% (95% CI, 42.1 to 74.4); the disease control rate was 94.9% (95% CI, 82.7 to 99.4). The median PFS was 9.4 months (95% CI, 8.0 to 14.6). The median overall survival was not reached. Furthermore, 85.8% of the patients experienced treatment-related adverse events. The most frequent treatment-related adverse events were hypothyroidism (33.3%), elevated aspartate aminotransferase levels (21.4%), and hypertension (19.0%). Patients with altered PIK3CA, PI3K-AKT signaling, or KMT2D had a higher ORR, whereas those with altered STK11 and/or JAK2 had a significantly shorter PFS.
CONCLUSION:
Sintilimab plus anlotinib as second-line or later therapy is efficacious and safe for patients with advanced CA who have failed prior chemotherapy.
Description
Citation
Xu, Q., Wang, J., Sun, Y., Lin, Y., Liu, J., Zhuo, Y., Huang, Z., Huang, S., Chen, Y., Chen, L., Ke, M., Li, L., Li, Z., Pan, J., Song, Y., Liu, R., & Chen, C. (2022). Efficacy and Safety of Sintilimab Plus Anlotinib for PD-L1-Positive Recurrent or Metastatic Cervical Cancer: A Multicenter, Single-Arm, Prospective Phase II Trial. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 40(16), 1795–1805. https://doi.org/10.1200/JCO.21.02091
Publisher
Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology