Abstract 564P
Background
There is limited treatment options for patients with metastatic or recurrent cervical cancer who progressed after standard first-line chemotherapy. Recently, immune checkpoint inhibitor (ICI) therapy has been approved as a second-line treatment for patients with advanced cervical cancer. However, only a small subset of patients responds to ICI therapy. ICI therapy combined with anti-angiogenic drugs may enhance cancer immunity and is a promising option for advanced cervical cancer.
Methods
In this open-label phase II study, a total 32 patients will be enrolled. All patients are given the intravenous infusion of tislelizumab 200 mg d1 and oral anlotinib 10 mg qd for 14 days every 3 weeks until disease progression or intolerable toxicity. The primary end point was investigator-confirmed objective response rate (ORR) per IRECIST v1.1. The secondary endpoints are disease control rate (DCR), duration of remission (DOR), median progression-free survival (PFS), median overall survival (OS), safety and tolerability.
Results
Until 31st March, 2022，seventeen patients have received at least four cycles of treatment. The ORR was 35.3% (95% CI, 17.3 to 58.7), the DCR was 94.1%(95%CI,73.0 to 98.9). The median PFS and OS was not reached. Furthermore, all patients experienced treatment-related adverse events (TRAEs). The most frequent TRAEs were hypertension (18.1%), Hand-foot syndrome (12.9%), and abdominal pain(9.3%). Grade ≥3 TRAEs occurred very rarely（0.06%）.
Conclusions
Available evidence showed that tislelizumab plus anlotinib had therapeutic efficacy and good tolerability in the treatment of advanced cervical cancer. No overlapping toxicity has been observed. Further results are expected.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.