Anlotinib for patients with recurrent or metastatic nasopharyngeal carcinoma: A phase II study.

e18020 Background: The prognosis of patients (pts) with recurrent or metastatic nasopharyngeal carcinoma (R/M NPC) is poor, especially for those who had failed two or more lines of prior systemic therapy. Anlotinib is a novel tyrosine kinase inhibitor that can inhibit tumor angiogenesis and proliferation by targeting VEGFR, FGFR, PDGFR, and c-Kit. A prospective, single-arm, phase 2 trial (NCT03906058) was performed to assess the efficacy and safety of single-agent anlotinib against R/M NPC and here we report the final results of this study. Methods: Eligible pts were aged 18-70 years old, diagnosed with histologically confirmed R/M NPC, had at least one measurable lesion and failed at least two lines of prior systemic treatments including chemotherapy, targeted therapy, or immunotherapy. Anlotinib was administered at 12 mg QD orally from day 1 to day 14 every 3 weeks until disease progression or intolerable toxicity. The primary endpoint was confirmed disease control rate (DCR). The second endpoints included confirmed objective response rate (ORR), progression-free survival (PFS), overall survival (OS) and safety. Tumor response was assessed according to RECIST 1.1 and adverse events were assessed according to NCI-CTCAE v5.0. Results: From April 2019 to March 2021, 39 pts were enrolled. 33 were male and 6 were female. The median age was 46.7 years (range, 20-64). 24 pts (61.5%) had liver metastasis. 29 pts (74.4%) had previously received 2 lines of systemic treatments and others received 3 or more. 19 pts (48.7%) pts had been exposed to anti-PD-1 immunotherapy. The median treatment duration of anlotinib was 4 cycles (range, 0.5-20). At the data cutoff date of Feb.1st 2022, 36 pts have underwent tumor response evaluation and the best response to anlotinib was partial response for 8 pts and stable disease for 20 pts. The DCR was 77.8% and ORR was 22.2%. 28 patients have progressed. For the intent-to-treat population, the median PFS was 5.7 months (95% CI: 4.7-6.7). 21 pts have died and the median OS was 23.9 months (95% CI: 5.3-42.5). The most common treatment-related adverse event (TRAE) of any grade was hand-foot syndrome (HFS) (24 pts). Grade 3 TRAEs included HFS (9 pts), mucositis (7 pts), hypertension (21 pts), liver dysfunction (2 pts) and pneumonia (1 pts). Only one grade 4 TRAE (mucositis) was reported and no treatment-related death was observed. 13 pts experienced hemorrhage, all were grade 1 or 2. Conclusions: Anlotinib monotherapy seemed to be a promising option for pts with R/M NPC who were heavily treated. The survival benefits were impressive and the toxicity was tolerable. Clinical trial information: NCT03906058.