Camrelizumab plus apatinib in patients with recurrent and/or metastatic nasopharyngeal carcinoma: A single-arm, multicenter, phase 2 trail.

e18025 Background: Our previous study demonstrated that apatinib has preliminary clinical benefit in recurrent and/or metastatic nasopharyngeal carcinoma (RM-NPC). Preclinical studies showed the combination of immune checkpoint inhibitors and antiangiogenic drugs produces a synergistic effect in anti-tumor activity. This phase 2 trail evaluated the efficacy and safety of camrelizumab combined with apatinib in patients with RM-NPC. Methods: In this study, patients with RM-NPC received 250 mg apatinib orally once per day plus 200 mg camrelizumab by intravenous infusion every 2 weeks until disease progression or unacceptable toxicity. The primary endpoint was objective response rate (ORR) assessed according to RECIST version 1.1. The key secondary endpoints included progression-free survival (PFS), overall survival (OS) and safety. The study is registered with. Results: From January 14, 2021 to September 15, 2021, 26 patients with RM-NPC were enrolled in this clinical study with median follow-up duration of 8 months (range:4-12 months). The ORR was 38.5% (10/26), and the DCR was 61.5% (16/26). Median PFS (mPFS) was 6 months. Median OS was not reached. Of the 26 patients, 6 patients (23.1%) had treatment-related grade 3 or 4 adverse events, including anemia(7.7%), stomatitis(3.8%), headache(3.8%), pneumonia(3.8%) and myocarditis(3.8%). No treatment-related deaths occurred in this trial. Conclusions: Camrelizumab plus apatinib had promising antitumor activity and manageable toxicities in patients with RM-NPC, and the mPFS by this combination regimen was longer than our previously reported mPFS by apatinib monotherapy. Larger randomized trials to evaluate this new combination strategy are warranted. Clinical trial information: NCT04350190. [Table: see text]