3653 - Tislelizumab Combined with Nimotuzumab and Chemotherapy without Concurrent Cisplatin for Local Advanced Nasopharyngeal Carcinoma

Purpose/Objective(s): We conducted this study to investigate the efficacy and safety of tislelizumab in combination with nimotuzumab and chemotherapy for induction treatment, followed by tislelizumab in conjunction with nimotuzumab and radiotherapy for high-risk, locally advanced nasopharyngeal carcinoma.

Materials/Methods: Patients with III-IVa (AJCC 8^th edition) NPC were recruited to receive tislelizumab and nimotuzumab plus taxanes-nedaplatin induction chemotherapy and concurrent tislelizumab plus nimotuzumab-radiotherapy (platin-free). Tislelizumab and nimotuzumab was administered once every 3 wks for up to 8 cycles, covering the induction (×3 cycles), radiotherapy (×2), and adjuvant (×3) phases. A total of 25 patients were intended to include. The primary endpoint is complete response rate after cocurrent chemoradiotherapy,and the secondary endpoints include ORR, PFS, OS and safety.

Results: Between April 2023 and Jul 2025, 23 patients (mean age 66 years, 56.5% male) were enrolled. As of Nov 5, 2025, the median follow-up duration was 15.6 months(range:4.0-29.5 months)and 20 patients had reached the primary endpoint. Long-term efficacy data are still response rate (ORR) after cocurrent chemoradiotherapy was 90.0% (95CI:68.3-98.8). The disease control rate(DCR) was 100%(95CI:83.2-100.0). The median PFS not reached(14.4 months -NR),with 24 month PFS rate 79.1 % (95% CI: 0.479-0.928)?The median OS not reached(NR -NR),with 24 month OS rate 87.1 % (95% CI: 0.573-0.966). The majority of treatment-emergent adverse events (TEAEs) were grade 1-2, with =grade 3 AEs occurring in 25% of cases, predominantly manifesting as hematologic toxicities. Immunotherapy-related adverse events were exclusively confined to grade 1-2.

Conclusion: Removing concurrent cisplatin and adding tislelizumab and nimotuzumab provides better response and lower toxicity for patients with LANPC.