In the Chinese phase II CLAP study reported in the Journal of Clinical Oncology, Lan et al found that the combination of the anti–PD-1 antibody camrelizumab and the VEGFR inhibitor apatinib produced high response rates in previously treated women with advanced cervical cancer.
The multicenter study included 45 patients (intent-to-treat population) whose disease had progressed after one or more lines of prior systemic treatment. Patients were enrolled between January and August 2019, and received camrelizumab at 200 mg every 2 weeks and apatinib at 250 mg once daily continuously in 4-week cycles up to a maximum of 24 months of camrelizumab treatment. A total of 41 patients were included in the efficacy-evaluable population. The primary endpoint was investigator-assessed objective response rate according to Response Evaluation Criteria in Solid Tumors version 1.1. A total of 57.8% of patients had previously received two or more lines of chemotherapy for recurrent or metastatic disease and 67% had PD-L1–positive disease (defined as having a combined positive score > 1).
Median follow-up was 11.3 months. Objective response was observed in 25 (55.6%) of 45 patients, including complete response in 2 (4.4%). An additional 12 patients (26.7%) had stable disease, yielding a disease control rate of 82.2%. Objective response was observed in 25 (61.0%) of 41 patients in the efficacy-evaluable population. Median duration of response was not reached (95% confidence interval [CI] = 5.6 months–not estimable). At time of analysis, 16 of 25 responses were ongoing, with 71.5% lasting ≥ 6 months and 66.8% lasting ≥ 12 months.
In the intent-to-treat population, median progression-free survival was 8.8 months (95% CI = 5.6 months–not estimable), with a 6-month rate of 57.0%. Median overall survival was not reached (95% CI = 11.6 months–not estimable), with a 9-month rate of 69.2%.
Objective response rates were 69.0% vs 50.0% (P = .281) among patients with PD-L1–positive vs PD-L1–negative tumors. Median progression-free survival was not reached vs 5.2 months (P = .034). Objective response rates were 77.8% in 30 patients with squamous cell carcinoma and 28.6% in 15 patients with adenocarcinoma.
Treatment-related grade 3 or 4 adverse events occurred in 71.1% of patients, with the most common being hypertension (24.4%), anemia (20.0%), and fatigue (15.6%). Serious treatment- related adverse events were observed in four patients (8.9%) and consisted of rash in two patients; pneumonitis in one; and neutropenia, anemia, and thrombocytopenia in one patient. Adverse events led to discontinuation of treatment in three patients (6.7%). No treatment-related deaths were observed.
The most common potential immune-related adverse events included grade 1 or 2 hypothyroidism (22.2%) and reactive cutaneous capillary endothelial proliferation (8.9%).
The investigators concluded, “Camrelizumab plus apatinib had promising antitumor activity and manageable toxicities in patients with advanced cervical cancer. Larger randomized controlled trials are warranted to validate our findings.”
Xin Huang, MD, of the Department of Gynecologic Oncology, Sun Yat-sen University Cancer Centre, Collaborative Innovation Center for Cancer Medicine, Guangdong, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by the Chinese National Natural Science Foundation. For full disclosures of the study authors, visit ascopubs.org.The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.