861P - Neo-TIME trial: Neoadjuvant tislelizumab combined with albumin-paclitaxel, cisplatin, and fluorouracil(APF) in patients with locally advanced oral squamous cell carcinoma (LA-OSCC)

Background

TPF (Docetaxel, Cisplatin, and 5-FU) is recommended as the preferred induction chemotherapy regimen for patients(pts) with locally advanced head and neck squamous cell carcinomas (LA-HNSCCs). PD-1 inhibitor monotherapy or combined with chemotherapy are recommended as standard treatment for advanced HNSCC and explored as neoadjuvant therapy in operable LA-HNSCC. This study aims to explore the efficacy and safety of anti-PD-1 Tislelizumab combined with modified APF as neoadjuvant treatment for LA-OSCC.

Methods

In this prospective single-arm phase II trial (NCT05862168), pts histologically confirmed OSCC staging III-IVB (AJCC 8th) were included and received 3 cycles induction therapy with tislelizumab combined modified APF (tislelizumab [day 1]: 200mg, nab-PTX [day 1/8]: 100 mg/m2, CDDP [day 1-3]: 20 mg/ m2, 5-FU [continuous infusion on days 1-5]: 600 mg/m2, every 3 weeks). Surgery was followed within 6 weeks and individual adjuvant therapy was performed according to neoadjuvant pathological response. The primary endpoint was pathological complete response (pCR) rate. The second endpoints consisted of safety, major pathological response (MPR) rate, R0 resection rate, non-surgery-delay rate, event-free survival, disease-free survival and overall survival.

Results

Between May. 2023, and May. 2024, 20 pts were enrolled, of whom 15 pts underwent surgical resection. The pCR rate was 73% (11/15) and 80% (12/15) pts achieved MPR. All pts received R0 resection. There were 1 pt suffered treatment-related surgical delay. No surgery-related or treatment-related death occurred. Treatment-related adverse events (TRAE) of any grade were reported in 11/20 (55%) pts, 3 (15%) had grade 3 and 4 TRAE and all come from chemotherapy-related white blood cell count decreased, neutropenia, thrombocytopenia, anaemia, diarrhea and hypokalemia.

Conclusions

Tislelizumab combined with modified APF is a promising neoadjuvant treatment for LA-OSCC with high pCR rate and manageable adverse events. However, long term follow-up is necessary to confirm the effects on survival-related endpoints.

Clinical trial identification

NCT05862168.

Editorial acknowledgement

Funding

BeiGene Co, Ltd. provided the study drug tislelizumab.

Disclosure

All authors have declared no conflicts of interest.