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– Toripalimab in combination with chemotherapy was associated with significant improvements in PFS and OS compared with chemotherapy alone in patients with advanced NSCLC without EGFR/ALK mutations, regardless of PD-L1 expression
– Supports combination development of toripalimab plus anti-TIGIT in NSCLC and other solid tumor indications
REDWOOD CITY, Calif. and SHANGHAI, China, Oct. 12, 2022 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (“Coherus”, Nasdaq: CHRS) and Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) today announced the publication of toripalimab plus chemotherapy for patients with treatment-naïve advanced non-small cell lung cancer: a multi-center randomized phase 3 trial (CHOICE-01) in the Journal of Clinical Oncology.
Toripalimab in combination with chemotherapy was associated with significant improvements in progression-free survival (PFS) (primary endpoint) and overall survival (OS) (secondary endpoint) compared with chemotherapy alone in patients with advanced non-small cell lung cancer ("NSCLC") without epidermal growth factor receptor (EGFR)/anaplastic lymphoma kinase (ALK) mutations, regardless of PD-L1 expression. No new safety signals were observed with toripalimab in this study.
“These data support our strategy for toripalimab in non-small cell lung cancer where we plan to evaluate toripalimab in combination with other immuno-oncology agents, including our TIGIT-targeted antibody, CHS-006/JS006, in patients with NSCLC as well as for other indications in the U.S.,” said Rosh Dias, MD, MRCP, Chief Medical Officer at Coherus.
A total of 465 patients with treatment-naïve, advanced NSCLC without EGFR/ALK mutations were randomized 2:1 to receive toripalimab 240 mg (n=309, “the toripalimab arm”) or placebo (n=156, “the placebo arm”) in combination with chemotherapy for 4-6 cycles, followed by the maintenance of toripalimab or placebo plus standard care. PFS was the primary endpoint.
Statistically significant improvements in both PFS and OS were detected in the toripalimab arm compared with the placebo arm, with similar rates of adverse events (AEs). At the final analysis, PFS was significantly longer in the toripalimab arm than in the placebo arm (median PFS 8.4 vs 5.6 months; 1-year PFS rates 36.7% vs 17.2%). At the interim OS analysis, the toripalimab arm had a significantly longer OS than the placebo arm (median OS not reached vs 17.1 months). OS rates at 2 years were 51.2% vs 33.9%, in the two arms. The incidence of Grade > 3 AEs was similar between the two arms (78.6% vs 82.1%).
About CHOICE-01The CHOICE-01 study was a multi-center, randomized double-blind, placebo-controlled phase 3 study conducted in 59 centers across China. 465 treatment-naïve advanced NSCLC patients without EGFR/ALK mutations were randomized to receive either toripalimab plus chemotherapy (n=309) or placebo plus chemotherapy (n=156). The primary endpoint was PFS assessed by the investigator. Secondary endpoints included PFS assessed by a blinded independent review committee (BIRC), OS, and safety. Patients from the placebo arm were actively crossed over to toripalimab treatment upon disease progression. The trial was conducted in full conformance with the ICH E6 guidelines for Good Clinical Practice and the principles of the Declaration of Helsinki.
As of October 31, 2021:
