...Able to follow the procedures as required by the study protocol and must agree to provide tumor tissue for programmed cell death 1 (PD-L1) expression analyses, EGFR mutation status, and biomarker assessment....

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/m2. 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 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.