Camrelizumab plus Apatinib in patients with advanced cervical cancer: a phase II trial
Camrelizumab is a fully humanized, monoclonal antibody against PD-1. A study has assessed the efficacy and safety of Camrelizumab plus Apatinib, a tyrosine kinase inhibitor targeting VEGFR2, in patients with advanced cervical cancer.
In this open-label, single-arm, phase 2 study done at four centres in China, eligible patients were aged 18–70 years, had an ECOG performance status of 0 or 1, progressed after at least one line of systemic chemotherapy for metastatic, recurrent or persistent cervical cancer, and had measurable disease.
Patients received Camrelizumab 200 mg every 2 weeks and Apatinib 250 mg once daily. Treatment continued until disease progression, unacceptable toxicity, and withdrawal of consent.
The primary endpoint was the objective response rate ( ORR ) assessed by RECIST version 1.1.
An optimal Simon two-stage design was employed to test the null hypothesis of a 17% ORR versus 35% alternative ( 1-sided alpha 0.10, 80% power ), if more than 3 responses out of the first 16 patients were observed, then the study would continue to enroll a total of 44 patients.
In 2019, 45 patients were enrolled and received study treatment ( safety population ). The median age was 51 ( range, 33–67 ) years. Median previous treatment lines were 2 ( range, 1–4 ).
As of January 22, 2020, median follow-up was 9.2 months ( range, 2.4–12.2 ). 25 ( 59.5%; 95%: CI 44.7–74.4 ) of 42 patients who had at least one post-baseline tumor assessment ( efficacy evaluable population ) achieved an objective response, including two ( 4.8% ) complete response [ CR ], and 23 ( 54.8% ) partial response [ PR ].
Median duration of response was not reached.
The disease control rate was 88.1% ( 37/42 ).
Median progression-free survival ( PFS ) was 7.6 months ( 95% CI: 5.8–not reached ).
31 ( 68.9% ) patients had grade greater than or equal to 3 treatment-related adverse events ( TRAEs ). Grade greater than or equal to 3 TRAEs occurring in 5% or more of patients were hypertension ( 24.4% ), anemia ( 20.0% ), fatigue ( 15.6% ), γ-glutamyltransferase increased ( 13.3% ), neutropenia ( 6.7% ), and thrombocytopenia ( 6.7% ).
In post-hoc analyses, objective response was noted in 20 ( 69% ) of 29 patients with PD-L1-positive tumors, and in 5 ( 50.0% ) of 10 patients with PD-L1-negative tumors ( Chi-square test, P = 0.281 ). PFS was longer in patients with PD-L1-positive tumors than patients with PD-L1-negative tumors ( median PFS: 9.6 versus 5.3 months; log-rank test, P = 0.017 ).
In conclusion, Camrelizumab plus Apatinib showed promising antitumor activity and tolerable toxicities in patients with advanced cervical cancer. ( Xagena )
Source: American Society of Clinical Oncology ( ASCO ) Virtual Meeting, 2020
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