In a Chinese phase II trial reported in the Journal of Clinical Oncology, Ding et al found that camrelizumab plus apatinib produced durable objective responses in most patients with recurrent or metastatic nasopharyngeal carcinoma.
The multicenter trial enrolled 58 patients between October 2020 and December 2021 who were refractory to at least first-line systemic therapy and had received no prior immune checkpoint inhibitor therapy. Patients were treated with camrelizumab at 200 mg every 3 weeks and apatinib at 250 mg once daily; treatment continued until disease progression or unacceptable toxicity. The primary endpoint was objective response rate.
At data cutoff (in June 2022), median follow-up was 12.4 months (range = 2.1–19.9 months). Objective response was observed in 38 patients (65.5%, 95% confidence interval [CI] = 51.9%–77.5%), with complete response seen in 13 (22.4%). The disease control rate was 86.2%. Median duration of response was not reached (95% CI = not evaluable to not evaluable); 68.4% of responses lasted ≥ 6 months and 65.8% were ongoing at the time of analysis.
Median progression-free survival was 10.4 months (95% CI = 7.2–13.6 months), with a 12-month rate of 44.3%. Media overall survival was not reached (95% CI = not evaluable to not evaluable), with an 18-month rate of 85.7%.
With use of combined positive score ≥ 10 as a cutoff, objective response rates were 65.6% among 32 PD-L1–positive patients vs 66.7% among 15 PD-L1–negative patients (P = .944).
PD-L1–positive patients had a significantly longer duration of response (hazard ratio [HR] = 0.20, 95% CI = 0.05–0.73, P = .015), and median progression-free survival was 16.7 months vs 9.0 months (HR = 0.50, 95% CI = 0.22–1.13, P = .095).
Grade ≥ 3 treatment-related adverse events occurred in 58.6% of patients, most commonly hypertension (in 19.0%), nasopharyngeal necrosis (in 15.5%), headache (in 12.1%), aspartate aminotransferase elevation (in 10.3%), and creatine phosphokinase elevation (in 10.3%). No treatment-related deaths occurred.
Apatinib was discontinued in 16 patients (27.6%) due to treatment-related adverse events, most commonly due to nasopharyngeal necrosis in 9 patients (15.5%). Factors associated with nasopharyngeal necrosis were recurrent nasopharyngeal lesions (odds ratio [OR] = 5.94, 95% CI = 1.45–24.24) and reirradiation (OR = 5.33, 95% CI = 1.15–24.79).
Immune-related adverse events of any grade occurred in 72.4% of patients, with 69.0% being grade 1 or 2. Grade 3 events occurred in two patients (3.4%; rash and fever) and grade 4 events occurred in two (pneumonia and hyperglycemia).
The investigators concluded, “Camrelizumab plus apatinib had promising antitumor activity in patients with refractory recurrent/metastatic nasopharyngeal carcinoma who failed first-line therapy. Moderate to severe treatment-related adverse events were experienced by 58.6% [of patients], including nasopharyngeal necrosis associated with local recurrence and a history of reirradiation.”
Ming-Yuan Chen, MD, PhD, of the Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by the National Natural Science Foundation of China, Key-Area Research and Development of Guangdong Province, and others. For full disclosures of the study authors, visit ascopubs.org.