Phase III JUPITER-02 trial of Tuoyi shows improved PFS in nasopharyngeal carcinoma.- Shanghai Junshi Biosciences and Coherus BioSciences
Shanghai Junshi Biosciences and Coherus BioSciences announced the results of the prespecified final progression-free survival analysis and the interim overall survival analysis of the JUPITER-02 study (NCT03581786), a pivotal Phase III trial in first-line treatment of recurrent or metastatic nasopharyngeal carcinoma using Tuoyi (toripalimab).
In the final PFS analysis, results from JUPITER-02 demonstrated that toripalimab in combination with chemotherapy provided a statistically significant improvement in PFS assessed by the blinded independent review committee compared to chemotherapy plus placebo, with an improvement in median PFS of 13.2 months (21.4 versus 8.2 months). Furthermore, the addition of toripalimab to chemotherapy provided significant improvements in the secondary endpoints of PFS assessed by the investigator, objective response rate and duration of response, while maintaining a safety profile consistent with that in previously reported toripalimab clinical trials. Although the median OS was not yet mature in either arm, the interim OS analysis showed a trend favoring the toripalimab arm and will be formally tested in a prespecified final analysis. The JUPITER-02 results are summarized in a poster presentation at the annual meeting of the American Association for Cancer Research.