Camrelizumab Plus Apatinib for Platinum-Refractory Nasopharyngeal Carcinoma

Camrelizumab plus apatinib demonstrated promising antitumor activity among patients with recurrent or metastatic nasopharyngeal carcinoma who were refractory to ≥1 systemic therapy, according to results from a phase 2 trial.

Xi Ding, MD, Sun Yat-Sen University Cancer Center, Guangzhou, China, and coauthors wrote, “There are limited effective options for patients with [recurrent/metastatic nasopharyngeal carcinoma] who suffer from progression after first-line chemotherapy."

This single-arm, open-label trial enrolled 58 patients with recurrent or metastatic nasopharyngeal carcinoma who had been treated with at least first-line systemic therapy but had not been exposed to immune checkpoint inhibitors. All patients received 200 mg camrelizumab once every three weeks and 250 mg apatinib once daily. The primary end point of the trial was objective response rate. Secondary end points included disease control rate, progression-free survival, duration of response, overall survival, and safety. 

With a median follow-up duration of 12.4 months, there were treatment responses evaluable from 52 patients. An objective response was confirmed in 38 patients (65.5%), with 13 complete responses and 25 partial responses. The disease control rate of 86.2%. The median progression free survival was 10.4 months, and the median duration of response was not reached.

The incidence of grade 3/4 treatment related adverse events was 58.6% with the most common (≥10%) being hypertension, nasopharyngeal necrosis, headache, AST elevation, and creatine phosphokinase elevation. There were 42 patients who experienced immune-related adverse events, 69% of which were grade 1/2. Treatment discontinuation of apatinib due to treatment-related adverse events occurred in 16 patients, most commonly due to nasopharyngeal lesions. Nasopharyngeal necrosis was associated with nasopharyngeal lesions and reirradiation.

Limitations to the study include the single-arm design, the small sample size, and the combination of apatinib and camrelizumab needing further validation.

Dr Ding et al concluded, “To our knowledge, this single-arm, Simon 2-stage trial is the first trial to demonstrate the activity and safety of camrelizumab…plus apatinib…in patients with recurrent/metastatic [nasopharyngeal carcinoma] who were refractory to at least 1 line of platinum-containing systemic therapy.”

Journal of Clinical Oncology associate editor Maura L. Gillison, MD, PhD, MD Anderson Cancer Center, Houston, TX, added, “In patients with platinum-refractory, recurrent or metastatic, endemic [nasopharyngeal carcinoma], the combination of a PD-1 immune checkpoint inhibitor (ie, camrelizumab) and an oral VEGFR2 inhibitor (ie, apatinib) demonstrated remarkable clinical activity.” 

Source:

Ding X, Zhang WJ, You R, et al. Camrelizumab plus apatinib in patients with recurrent or metastatic nasopharyngeal carcinoma: An open-label, single-arm, phase II study. J Clin Oncol. Published online: February 3, 2023. doi:10.1200/JCO.22.01450.