A pilot phase II trial of neoadjuvant camrelizumab plus nab-paclitaxel and cisplatin (NeoCPC) for locoregionally advanced, resectable squamous cell carcinoma of the head and neck.

• DOI: 10.1200/jco.2023.41.16_suppl.6069
• Publication Date: 2023-06-04T15:58:27Z
• Authors: Di Wu; Yong Li; Peng-Fei Xu; Xinrui Zhang; Hongsheng Lin; Yin Li; Qi Fang; Fei Cao; Yong Su; Li-Xia Lu; Yizhuo Li; Zheng Zhao; Xiaoyu Hong; Guohong Li; Honghong Yan; Yunyun Fan; Lei Chen; Zhiming Li; Xuekui Liu
• Keywords: Clinical endpoint; Chemoradiotherapy; Neoadjuvant Therapy

6069 Background: For resectable squamous cell carcinoma of the head and neck (HNSCC), novel therapeutic approaches are still needed to improve outcomes. Neoadjuvant immunochemotherapy (NICT) is considered as a potentially effective strategy. We therefore conducted pilot phase II trial explore efficacy safety neoadjuvant camrelizumab plus nab-paclitaxel cisplatin (NeoCPC) in patients with locoregionally advanced, HNSCC. Methods: In this open-label trial, untreated HNSCC (T2‒T4, N0‒N3b, M0; AJCC, 8th Edition) received NICT (200 mg), (260 mg/m 2 ) (60 on day 1 each 21-day cycle for three cycles, followed by radiotherapy or surgery. The primary endpoint was objective response rate (ORR) per RECIST version 1.1. Secondary endpoints included pathologic complete (pCR), major (MPR), safety, disease-free survival (DFS), overall (OS). Genomic biomarkers (genetic mutations, tumour mutational burden [TMB] immune microenvironment) baseline tumor samples were explored. Results: Between April 2021 January 2022, 48 enrolled (median age, 59 years [range 27–73]; 42 men [87.5%]). After completion therapy, underwent surgery (27, 56.3%), chemoradiotherapy (15, 31.2%), (five, 10.4%) continued maintenance therapy (one, 2.1%). At median follow-up time 415 days, ORR 89.6% (43/45). Of 27 who had surgery, 17 (63.0%) an MPR, including 15 (55.6%) pCR. Patients more likely achieve One patient died lung metastasis 6 months after treatment. 1-year OS DFS rates both 97.9%. Only 3 (6.3%) grade treatment-related adverse events (AEs): one pneumonitis two neurotoxicity. No unexpected immune-related AEs observed. genetic analysis, most frequently mutated genes TP53 (77.1%), CDKN2A, FAT1, CCND1 NOTCH1. lower radiographic regression percentage observed TP53-altered ( p= 0.01) TERT-altered 0.002) patients, whereas higher HPV-positive patients. TMB 3.15 mutations/MB. significant difference between non-ORR (stable disease). There correlation density M1-like macrophage cells, CD8+ T cells area 0.009, 0.0005, respectively). Conclusions: NeoCPC showed promising high HNSCC, acceptable profile. Clinical information: NCT04826679 .