(Cervical Cancer) Is Sintilimab Plus Anlotinib Effective? Phase 2 Trial Results
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- February 22, 2022
- 2 min read
On February 22, 2022, Qin Xu and colleagues from Fujian Medical University Cancer Hospital published results in the Journal of Clinical Oncology from a Phase 2 clinical trial evaluating the efficacy and safety of sintilimab (anti-PD-1 antibody) plus anlotinib (tyrosine kinase inhibitor) in previously treated, PD-L1-positive, recurrent/metastatic cervical cancer patients.
Trial Design:
This Phase 2 trial administered sintilimab (200 mg on Day 1) plus anlotinib (10 mg once daily, Days 1–14) on a 3-week cycle to previously treated, PD-L1-positive, recurrent/metastatic cervical cancer patients. The primary endpoint was objective response rate (ORR); secondary endpoints were PFS, OS, and disease control rate (DCR).
Results (N=42 enrolled; N=39 evaluable):
- Primary endpoint ORR: 59.0%
- Disease control rate (DCR): 94.9%
- Median PFS: 9.4 months
- Median OS: Not reached
Safety:
Overall adverse event rate: 85.8%. Most common adverse events: hypothyroidism 33.3%, AST elevation 21.4%, hypertension 19.0%.
Conclusion: Based on the Phase 2 trial results, Qin Xu and colleagues concluded that sintilimab plus anlotinib demonstrated favorable anti-tumor activity with an acceptable tolerability profile in previously treated, PD-L1-positive, recurrent/metastatic cervical cancer patients.
Source: https://ascopubs.org/doi/full/10.1200/JCO.21.02091
Cervical Cancer | Immunotherapy | Sintilimab | Anlotinib
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