NMPA(China) approves Tuoyi + chemotherapy to treat NSCLC without EGFR mutations or ALK fusions
The China National Medical Products Administration has approved the supplemental new drug application seeking the approval of toripalimab (Tuoyi) plus pemetrexed and platinum as a frontline treatment in patients with unresectable, locally advanced or metastatic, nonsquamous non–small cell lung cancer (NSCLC) who do not harbor EGFR mutations or ALK fusions
The application is supported by findings from the phase III CHOICE-01 trial (NCT03856411), in which the toripalimab combination was found to significantly improve progression-free survival (PFS) and overall survival (OS) over chemotherapy alone in this patient population, irrespective of PD-L1 expression status
As of October 31, 2021, the median PFS achieved with the addition of toripalimab to chemotherapy was 9.7 months vs 5.5 months with chemotherapy alone, translating to a 52% reduction in the risk of disease progression or death in 245 patients with nonsquamous NSCLC (HR, 0.48; 95% CI, 0.35-0.66; P < .0001) 1 The median OS with toripalimab/chemotherapy was not yet reached; the toripalimab resulted in a 52% reduction in the risk of death (HR, 0.48; 95% CI, 0.32-0.71).
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