912P Toripalimab in combination with anlotinib in previously treated recurrent or metastatic nasopharyngeal carcinoma: The interim analysis of the single-arm, phase II TORAL study

The immune checkpoint inhibitors (ICIs) have been recommended as the second-line or beyond treatment for recurrent or metastatic (R/M) nasopharyngeal carcinoma (NPC), however, the overall response rate (ORR) was only approximately 20%. Anlotinib, an anti-angiogenetic multi-targeted TKI, showed an ORR of 17.6% as third-line or beyond treatment for R/M NPC in our previous study (ESMO 2020, #2502). Here, we reported the interim results of the phase II TORAL study (NCT04996758). Patients aged 18-70 years with R/M NPC who failed the first-line platinum-based chemotherapy were treated with toripalimab (240mg, iv drip, d1) plus anlotinib (12mg QD, P.O., d1-14) every 3 weeks until disease progression or intolerable toxicity. The primary endpoint was ORR. The secondary endpoints included disease control rate (DCR), progression-free survival (PFS), and adverse events (AEs). Between October 2021 and January 2023, a total of 30 patients were enrolled. Sixteen patients had received previous ICI treatment. Baseline characteristics were listed in Table. The median cycle was 8 (2-25), and 14 patients received 10 or more cycles. The ORR and DCR were 36.7% (11/30) and 90.0% (27/30), respectively. For patients with or without previous ICI treatment, the ORR were 25.0% and 50.0%, respectively. With a median follow-up of 10.3 months, the median PFS was 9.5 months. Most patients (96.7%) patients had AEs at any grade. The most common (≥20%) grade 3/4 AEs were mucositis (26.7%,) and hand-foot syndrome (23.3%). Dose reductions of anlotinib occurred in 14 patients due to AEs (hand-foot syndrome, n=7; mucositis, n=5; proteinuria, n=1; joint effusion, n=1). Table: 912PBaseline featuresCharacteristicsPatients (N=30)Age (years)Median46.5Range31.0-67.0GenderFemale6 (20.0%)Male24 (80.0%)ECOG PS010 (33.3%)120 (66.7%)Previous curative radiotherapyYes15 (50.0%)No15 (50.0%)Previous ICI treatmentYes16 (53.3%)No14 (46.7%)Prior chemotherapy regimen(s)119 (63.3%)29 (30.0%)32 (6.7%)EBV DNA level (copies/mL)≥400012 (40.0%)＜400018 (60.0%) Open table in a new tab The combination of toripalimab and anlotinib showed encouraging efficacy and acceptable safety for R/M NPC. The efficacy and toxicity data with larger sample size will be further evaluated at the completion of this trial.