Phase III CHOICE-01 study of Tuoyi showed improved survival in non-small cell lung cancer.
This interim analysis demonstrated a statistically significant improvement in overall survival, crossing the prespecified efficacy boundary, in patients treated with toripalimab plus chemotherapy. This treatment effect was observed notwithstanding the effects of active crossover to toripalimab at disease progression for patients in the control (placebo plus chemotherapy) arm. The addition of toripalimab to standard first-line chemotherapy in patients with advanced NSCLC showed a manageable safety profile with no new safety signals observed.
As previously reported at the 2021 World Conference on Lung Cancer (WCLC), the study also met the primary endpoint of progression free survival (PFS) per RECIST v1.1 for the toripalimab arm as compared to chemotherapy alone. Junshi Biosciences and Coherus plan to submit the CHOICE-01 results for publication and request a meeting with the FDA to discuss the submission of a Biologics License Application supplement for toripalimab in combination with chemotherapy for the first-line treatment of advanced NSCLC.
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