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

Background

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).

Methods

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).

Results

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: 912P

Baseline features

Conclusions

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.

Clinical trial identification

NCT04996758.

Editorial acknowledgement

Legal entity responsible for the study

Qingqing Cai.

Funding

This work was supported by grants from the Special Support Program of Sun Yat-sen University Cancer Center (PT19020401).

Disclosure

All authors have declared no conflicts of interest.