912MO - A single-arm, open-label, multicenter phase II study of camrelizumab in patients with recurrent or metastatic (R/M) nasopharyngeal carcinoma (NPC) who had progressed on ≥2 lines of chemotherapy: CAPTAIN study

Background

The management of R/M NPC remains a challenge worldwide due to its poor prognosis and limited treatment option after prior chemotherapy. Camrelizumab, a humanized anti–PD-1 antibody, had shown favorable anti-tumor activity and manageable toxicities in R/M NPC in previous phase I trial (Fang et al. Lancet Oncol 2018). We conducted this phase II trial (CAPTAIN) to further assess the efficacy and safety of camrelizumab in R/M NPC.

Methods

Patients with histologically confirmed R/M NPC (stage IVb) who had progressed on ≥2 lines of chemotherapy were enrolled and received camrelizumab at 200 mg IV q2w. The primary endpoint was ORR assessed by independent review committee (IRC) per RECIST v1.1.

Results

From Aug 14, 2018 to Dec 30, 2019, 156 eligible patients were enrolled and received camrelizumab treatment. As of data cutoff on Mar 31, 2020, the median follow-up time was 9.2 months (range 0.7–19.1). Of the 156 patients, 44 (28.2%, 95% CI 21.3–36.0) patients had an objective response assessed by IRC, including one complete response and 43 partial responses. Median DoR was not reached (95% CI 7.4–not estimable), and the 12-month DoR rate was 53.7% (95% CI 30.9–72.0). Median PFS per IRC was 3.7 months (95% CI 2.0–3.9) and median OS was 17.1 months (95% CI 15.2–not estimable). Treatment-related adverse events (TRAEs) of any grade were observed in 151 (96.8%) of the 156 patients. TRAEs of ≥3 grade occurred in 22 (14.1%) patients, with the most common ones being increased gamma-glutamyl transferase (3.2%) and anaemia (3.2%). Treatment interruption and discontinuation due to TRAEs occurred in 18 (11.5%) and one (0.6%) patients, respectively. Seventeen (10.9%) patients had serious TRAEs, and one death was considered as drug-related. Plasma Epstein-Barr virus DNA and evaluable tumor samples for biomarker analysis were obtained and the result will be presented at the meeting.

Conclusions

Camrelizumab demonstrated promising anti-tumor activity and favorable safety profile in patients with R/M NPC who had progressed on ≥2 lines of chemotherapy, thus could represent a novel treatment option for this patient population.

Clinical trial identification

NCT03558191; CTR20180865.

Editorial acknowledgement

Legal entity responsible for the study

Jiangsu Hengrui Medicine Co., Ltd.

Funding

Jiangsu Hengrui Medicine Co., Ltd.

Disclosure

Q. Yang, B. Zhang: Full/Part-time employment: Jiangsu Hengui Medicine Co., Ltd. All other authors have declared no conflicts of interest.