ICHNO-ECHNO 2022 - Abstract Book

S90

ICHNO-ECHNO 2022

Purpose or Objective The neutrophil-to-lymphocyte ratio (NLR), and the platelet-to-lymphocyte ratio (PLR) may be useful for drawing conclusions about the survival of head and neck squamous cell carcinoma (HNSCC) patients. Materials and Methods Clinical data of 156 patients managed for HNSCC at two head and neck surgery centres were analyzed retrospectively. We studied the relationships between survival and PLR as well as NLR. Results With regard to 5-year survival, the difference between the two groups with PLR values lower or higher than the threshold was statistically significant (p=0.004), and we found the same for disease-free survival (p=0.05), and tumour-specific mortality (p=0.009). Concerning NLR, the difference in tumour-specific survival was statistically significant (p=0.006). According to the multivariate analysis, NLR values higher than the threshold indicated enhanced risk for overall as well as for tumour-specific mortality.

Conclusion In HNSCC patients, a high NLR may be considered as an independent risk factor for 5-year overall survival.

PO-0144 A phase 2 study of serplulimab plus HLX07 in patients with advanced head and neck tumours

Y. Guo 1 , W. Wang 2 , G. Cao 3 , S. Wang 4 , Y. Sun 5 , D. Peng 6 , Q. Wang 6 , J. Zhu 7

1 Shanghai East Hospital, Department of Oncology , Shanghai, China; 2 Hunan Cancer Hospital, Department of Medical Oncology, Changsha, China; 3 Jiangsu Cancer Hospital, Department of Oncology, Nanjing, China; 4 Peking University Shenzhen Hospital, Department of Medical Oncology , Shenzhen, China; 5 Beijing Cancer Hospital, Department of Radiotherapy, Beijing, China; 6 Shanghai Henlius Biotech, Inc., Clinical Development, Shanghai, China; 7 Shanghai Henlius Biotech, Inc., Global Product Development, Shanghai, China Purpose or Objective Historical data indicate that the combination of PD-1 antibodies and EGFR inhibitors show synergistic effect in recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC). This study aimed to determine the efficacy and safety of serplulimab (a novel recombinant humanized anti-PD-1 monoclonal antibody) plus HLX07 (a novel anti-EGFR antibody) in patients with R/M HNSCC who had failed platinum-based chemotherapy. Materials and Methods This is an ongoing, open-label, multicentre, two-stage phase 2 study (NCT04297995). Patients with PD-L1 positive (combined positive score ≥ 1, as determined by immunohistochemistry) and histologically-proven R/M HNSCC who had previously failed platinum-based chemotherapy were recruited. In stage 1, 13 eligible patients were planned to be enrolled and given intravenous infusion of serplulimab 3 mg/kg (every two weeks) in combination with HLX07 600 mg (every week). Treatment responses were evaluated every 6 weeks after the first infusion of study drugs, and statistical analyses were performed 12 weeks after the first infusion in the last patient. If four or more patients respond, this study will proceed to stage 2 (N=30, with the same dose regimen as stage 1) following Simon's Two-stage Optimal Design. Otherwise, an additional 13 patients will be enrolled in stage 1 to receive 3 mg/kg of serplulimab (every two weeks) in combination with HLX07 800 mg (every week). The primary endpoints were objective response rate (ORR, assessed by independent radiological review committee [IRRC] per RECIST v1.1) 18 weeks after the first infusion of study drugs and the proportion of patients suffered from drug related toxicities. Results Here we mainly report the results in stage 1. By cut-off date August 25, 2021, 13 eligible Chinese patients were enrolled, with a median age of 52.0 (range: 34.0–68.0) years and a median BMI of 20.4 (range: 13.9–24.6) kg/m 2 . Of the 13 patients, four were non-smokers, eight were ex-smokers and one was a smoker at the time of enrolment; while six were non-drinkers, five were former-drinkers and two were drinkers at the time of enrolment. The ORR assessed by IRRC and investigators were both 38.5% (n=5; 95% CI: 13.9%–68.4%). The DCR assessed by IRRC and investigators were both 76.9% (n=10; 95% CI: 46.2%–95.0%). The median PFS and median OS were not reached. Nine (69.2%) patients experienced grade 3 or worse treatment-emergent adverse events (TEAEs), most commonly hypomagnesaemia (n=4, 30.8%) and rash (n=2, 15.4%). No TEAEs leading to permanent discontinuation of study drugs or death were reported. Conclusion The results above demonstrated a manageable safety profile and encouraging efficacy of serplulimab plus HLX07 in patients with R/M HNSCC who had failed platinum-based chemotherapy, supporting a new treatment option that warrants further investigations.

PO-0145 NLR and SUVmax of Nodal Metastases Predict Outcome in Head and Neck Cancer Before Chemoradiation

J. Werner 1 , K. Strobel 2 , D. Lehnick 3 , G. Rajan 1,4

1 Cantonal Hospital Lucerne, Department of Otorhinolaryngology - Head and Neck Surgery, Lucerne, Switzerland; 2 Cantonal Hospital Lucerne, Department of Radiology and Nuclear Medicine, Lucerne, Switzerland; 3 University of Lucerne,