Study data published in the Lancet Gastroenterology & Hepatology support the efficacy and safety of camrelizumab combined with apatinib as a second-line treatment option for patients with advanced esophageal squamous cell carcinoma.

This single-arm, open-label, phase 2 trial was conducted at 8 medical centers in China. Eligible patients had unresectable, locally advanced, locally recurrent, or metastatic esophageal squamous cell carcinoma and were intolerant to first-line chemotherapy. Enrollees received intravenous camrelizumab 200 mg once every 2 weeks combined with once-daily oral apatinib 250 mg in 28-day cycles until disease progression, unacceptable adverse events, or study withdrawal.

The primary endpoint was objective treatment response rate, determined by investigators per the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. Secondary endpoints included disease control rate, progression-free survival, and overall survival. Objective response rate and disease control rate were reported, with 95% confidence intervals [CIs] calculated by the Clopper-Pearson method. Overall and progression-free survival was determined using Kaplan-Meier curves.


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A total of 52 patients were enrolled between 2019 and 2021, among whom 42 (81%) were men and 10 (19%) were women. Median age was 63 (IQR, 58-67) years. Median follow-up time was 7.5 (IQR, 4.0-11.2) months. A total of 18 patients (34.6%; 95% CI, 22.0-49.1) had confirmed objective response to treatment. Forty-one patients had disease control (78.8%; 95% CI, 65.3-88.9). Median time to response was 3.4 months (95% CI, 2.1-4.0). Median progression-free survival was 6.8 months (95% CI, 3.8-10.4); median overall survival was 15.8 months (95% CI, 8.4-16.2). A total of 22 patients died during the study.

Adverse events occurred in 85% of patients; 44% experienced grade 3 or higher treatment-related adverse events. Treatment-related adverse events led to dose interruption of apatinib in 27% of patients and dose interruption of camrelizumab in 17% of patients. The most common reactions of grade 3 or higher were increased aspartate aminotransferase (19%), increased gamma-glutamyltransferase (19%), and increased alanine aminotransferase (10%). No treatment-related deaths were observed.

Results from this study suggest that camrelizumab combined with apatinib may be an appropriate second-line treatment option for patients with advanced esophageal squamous cell carcinoma. Study limitations include the small sample size, single-arm design, and exclusion of patients with prior exposure to immunotherapy. Further investigation in patients previously treated with first-line immunotherapy is warranted.

“In conclusion, camrelizumab plus apatinib showed promising antitumour activity with a manageable safety profile in patients with advanced oesophageal squamous cell carcinoma,” investigators wrote. “This combination could be a potential second-line treatment option for patients with advanced oesophageal squamous cell carcinoma and warrants phase 3 trials to validate the potential benefits of this regimen.”

Disclosure: This research was supported by Jiangsu Hengrui Pharmaceuticals. Please see the original reference for a full list of disclosures

Reference

Meng X, Wu T, Hong Y, et al. Camrelizumab plus apatinib as second-line treatment for advanced oesophageal squamous cell carcinoma (CAP 02): a single-arm, open-label, phase 2 trial. Lancet Gastroenterol Hepatol. 2022;7(3):245-253. doi: 10.1016/S2468-1253(21)00378-2