Camrelizumab plus famitinib in patients with recurrent or metastatic nasopharyngeal carcinoma: Data from an open-label, multicenter phase II basket study.

Abstract

e18031 Background: Immune-checkpoint inhibitor (ICI) in combination with antiangiogenic therapy have the potential for synergistic activity. We report the results of camrelizumab plus famitinib for the treatment of recurrent or metastatic, ICI-resistant nasopharyngeal carcinoma (NPC) from an open-label, multicenter, phase II basket trial. Methods: Patients (pts) with histologically confirmed recurrent or metastatic NPC (nonkeratinizing carcinoma, WHO type II-III), who had been treated with platinum-based chemotherapy and ICIs (≤2 lines of systemic treatment), were enrolled to receive camrelizumab (200 mg intravenously every 3 weeks) and famitinib (20 mg orally once daily). Primary endpoint was objective response rate (ORR) per RECIST version 1.1, and secondary endpoints included duration of response (DoR), disease control rate (DCR), time to response (TTR), progression-free survival (PFS), overall survival (OS) and safety. Results: Between Oct 23, 2020, and Sep 24, 2021, 15 recurrent or metastatic NPC pts were enrolled. Among them, 12 (80.0%) and 3 (20.0%) pts had received their prior 1st-line and 2nd-line treatment, respectively. All pts were pretreated with anti-PD-1/PD-L1 immunotherapy (toripalimab, n = 9; tislelizumab, n = 4; sintilimab, n = 1; pembrolizumab, n = 1). As of Nov 30, 2021, median time from enrollment to data cutoff was 6.3 months (range, 2.2-13.3). No pt had a complete response, 5 (33.3%) pts had a confirmed partial response, 7 (46.7%) pts had stable disease, 2 (13.3%) pts had progressive disease and 1 (6.7%) pt was not evaluable. The ORR was 33.3% (95% confidence interval [CI], 11.8-61.6), the DCR was 80.0% (95% CI, 51.9-95.7). Most pts (73.3%) experienced reduction in target lesion size from baseline, with a median change of -36.0%. The median DoR was 4.2 months (95% CI, 2.1-not reached [NR]), median PFS was 6.3 months (95% CI, 4.1-NR), and median OS has not been reached. Treatment-related adverse events (TRAEs) of grade 3 or higher were reported in 7 (46.7%) pts, mainly decreased platelet count (13.3%), decreased neutrophil count (13.3%) and palmar-plantar erythrodysaesthesia syndrome (13.3%). Treatment interruption and discontinuation due to TRAEs occurred in 11 (73.3%) and 1 (6.7%) pts, respectively. Five (33.3%) pts had serious TRAEs (grade 2 platelet count decreased, grade 2 pharyngeal necrosis, grade 2 pulmonary tuberculosis, grade 3 left ventricular dysfunction, grade 3 pharyngeal hemorrhage; n = 1 for each), and no treatment-related death was reported. Conclusions: Camrelizumab plus famitinib showed encouraging antitumor activity in recurrent or metastatic NPC patients who were resistant to ICI treatment, with an acceptable and manageable safety profile. This combination might provide a novel alternative treatment strategy in this challenging disease setting and support further investigation. Clinical trial information: NCT04346381.