In an interim analysis of a Chinese phase III trial (CAPTAIN-1st) reported in The Lancet Oncology, Yang et al found that the addition of camrelizumab to gemcitabine and cisplatin significantly prolonged progression-free survival in the first-line treatment of recurrent or  metastatic nasopharyngeal carcinoma.

Study Details

In the multicenter double-blind trial, 263 patients were randomly assigned between November 2018 and November 2019 to receive camrelizumab at 200 mg (n = 134) or placebo (n = 129) on day 1 plus gemcitabine at 1,000 mg/m² on days 1 and 8 and cisplatin at 80 mg/m² on day 1 every 3 weeks for four to six cycles, followed by maintenance camrelizumab or placebo; treatment continued until disease progression or unacceptable toxicity. The primary endpoint was progression-free survival assessed by independent review committee. The significance threshold was P = .0086 for the prespecified interim analysis in June 2020.

Progression-Free Survival

Median follow-up at interim analysis was 10.2 months (interquartile range [IQR] = 7.7–12.7 months). Median progression-free survival was 9.7 months (95% confidence interval [CI] = 8.3–11.4 months) in the camrelizumab group vs 6.9 months (95% CI = 5.9–7.3 months) in the control group (hazard ratio [HR] = 0.54, 95% CI = 0.39–0.76, P = .0002).   

Objective response was observed in 87% (complete response in 5%) vs 81% of patients (complete response in 3%). Median duration of response was 8.5 months vs 5.6 months (HR = 0.54, 95% CI = 0.37–0.79).

At an updated analysis (December 2020), median follow-up was 15.6 months (IQR = 12.3–19.2 months). Median progression-free survival was 10.8 months (95% CI = 8.5–13.6 months) in the camrelizumab group vs 6.9 months (95% CI = 5.9–7.9 months) in the control group (HR = 0.51, 95% CI = 0.37–0.69), with 12- and 18-month rates of 45.8% vs 20.5% and 34.8% vs 12.7%. At the time of the updated analysis, overall survival data were not mature, with death having occurred in 21% vs 30% of patients; median overall survival was not reached in the camrelizumab group vs 22.6 months in the control group (HR = 0.67, 95% CI = 0.41–1.11).

Adverse Events

At the time of the updated analysis, grade ≥ 3 adverse events had occurred in 94% of the camrelizumab group vs 91% of the control group, with the most common being decreased white blood cell count (66% vs 70%), decreased neutrophils (64% vs 66%), anemia (40% vs 44%), and decreased platelets (40% vs 40%). Serious adverse events occurred in 44% vs 37% of patients and were considered related to treatment in 36% vs 29% (most common = decreased platelets in 14% vs 16%). Adverse events led to discontinuation of any study treatment in 10% vs 5%. Treatment-related death occurred in five patients (4%) in the camrelizumab group, due to an unknown cause in two patients, multiple organ dysfunction syndrome in one, pharyngeal hemorrhage in one, and arrhythmia in one; treatment-related death occurred in one patient (< 1%) in the control group, due to an unknown cause.

The investigators concluded: “Our findings suggest that camrelizumab plus gemcitabine and cisplatin could be a new standard of care for patients with recurrent or metastatic nasopharyngeal carcinoma in the first-line setting. Longer follow-up is needed to confirm this conclusion.”

Li Zhang, MD, of Sun Yat-Sen University Cancer Centre, Collaborative Innovation Center for Cancer Medicine, Guangzhou, is the corresponding author of The Lancet Oncology article.

Disclosure: The study was funded by Jiangsu Hengrui Pharmaceuticals. For full disclosures of the study authors, visit www.thelancet.com.