Shanghai Junshi Biosciences Co., Ltd. (1877.HK) on Wednesday said its phase III study of toripalimab combined with platinum-containing doublet chemotherapy as perioperative treatment for resectable stage II-III non-small cell lung cancer met the primary endpoint.
The primary endpoints were event-free survival and major pathological response rate in the stage II-III population, as well as major pathological response rate in the stage III population.
The study showed that compared with perioperative chemotherapy alone, toripalimab combined with chemotherapy significantly improved event-free survival, with median event-free survival not reached versus 15.1 months in the chemotherapy group. The combination therapy reduced the risk of disease recurrence, progression or death by 60%.
Overall survival in the toripalimab plus chemotherapy group also showed a clear trend toward improvement.
The company said toripalimab combined with chemotherapy increased the pathological complete response rate to 24.8% from 1%, while the major pathological response rate rose to 48.5% from 8.4%.
Toripalimab combined with chemotherapy is already approved for perioperative treatment of resectable stage III non-small cell lung cancer, and the company plans to submit a supplemental new drug application to expand the indication to stage II-III disease.
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