895P - Neoadjuvant PD-1 inhibitor combined with Nab-paclitaxel and cisplatin in resectable locally advanced head and neck squamous cell carcinoma (NCT05522985): A randomized, controlled, open label, phase II clinical trial

Background

Many previous clinical trials have confirmed that induction chemotherapy can improve the functional retention rate of head and neck squamous cell carcinoma (HNSCC) and improve the quality of life. However, pts have no long-term survival benefits from it. Immunotherapy has brought hope for long-term survival to pts with recurrent and metastatic HNSCC. The exploration of neoadjuvant immunotherapy in HNSCC is gradually being carried out.

Methods

This was a randomized, controlled, open label, phase II study. 122 pts were panned to enrolled. Key inclusion criteria: histologically or cytologically confirmed stage III or IV resectable HNSCC; without prior systemic anticancer therapy. Eligible pts were randomized 1:1 to A or B arm. A arm received 3 cycle of nab-paclitaxel (260 mg/m²，d1, q3w) and cisplatin (75mg/m², q3w); B arm received 3 cycle of toripalimab (240mg, D1, q3w), the rest of treatments were the same as A arm. Then surgery and pathological remission evaluation were performed. The primary endpoint was pathologic complete response (pCR) rate. Secondary endpoints were major pathological response (MPR), objective response rate (ORR), 2-year progression-free survival (PFS) rate, 2-year overall survival (OS) rate, and safety.

Results

Up to Dec. 2022, 99 pts were enrolled (A 47, B 52). Median age was 59 years (range: 34–76) and 83.8% were male. After neoadjuvant treatment, 68 pts underwent surgery (A 30,B 38). More pts achieved pCR (55.3% vs. 36.7%) and MPR (81.58% vs. 53.55%, p=0.01) in the B arm. Higher clinical downstage rate (36.54% vs. 25.53%) and pathologic tumor response-2 (pTR-2) rate (47.37% vs. 16.67% ,p=0.008) was observed in the B arms. Grade ≥3 treatment-related adverse events (TRAEs) were 14.29% in A arm, 27.91% in B arm. No new safety signals were observed and no TRAEs leading to death.

Conclusions

Compared with chemotherapy, neoadjuvant immunochemotherapy can significantly improve the MPR and pTR-2 rate of HNSCC. Moreover, adverse events are controllable. This study is ongoing. And we look forward to demonstrating that neoadjuvant immunochemotherapy is expected to improve the long-term survival of HNSCC.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

Hongling Wang.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.