– Toripalimab plus chemotherapy met both primary endpoint of progression free survival and prespecified secondary endpoint of overall survival compared to chemotherapy alone–

- Data support the use of toripalimab with chemotherapy as first-line treatment for advanced NSCLC patients without EGFR/ALK mutations -

SHANGHAI, China, and REDWOOD CITY, Calif., March 15, 2022 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd. (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. (“Coherus”, Nasdaq: CHRS), today announced the presentation of positive results and biomarker analyses from the pivotal study “CHOICE-01” (clinicaltrials.gov identifier# NCT03856411), a randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating toripalimab plus chemotherapy as first-line treatment of advanced squamous or non-squamous non-small cell lung cancer (“NSCLC”). The final progression-free survival (“PFS”) analysis confirms the finding of the previous interim PFS analysis, demonstrating a statistically significant and clinically meaningful improvement in PFS per RECIST v1.1 compared to chemotherapy alone. The study also demonstrated an improvement in overall survival (“OS”) in a prespecified interim OS analysis. These results will be summarized later today during the ASCO Plenary Series, in an oral presentation by Professor Jie Wang, MD, PhD, from the National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College. The abstract is now available on the ASCO website.

“We are excited about the consistently strong clinical evidence that toripalimab has displayed across multiple tumor types,” said Dr. Patricia Keegan, Chief Medical Officer at Junshi Biosciences. “The addition of toripalimab to chemotherapy in patients with advanced NSCLC provided superior PFS and OS compared to chemotherapy alone with a manageable safety profile. These results support the use of toripalimab with chemotherapy as first-line therapy for advanced NSCLC patients without EGFR/ALK mutations.”

“In the CHOICE-01 study in patients with non-small cell lung cancer, toripalimab has once again demonstrated the potential to delay disease progression and help patients live longer,” said Theresa LaVallee, PhD, Chief Development Officer at Coherus. “The study investigators also reported interesting biomarker data with toripalimab plus chemotherapy having activity independent of PD-L1 expression as well as a statistically significant overall survival advantage in NSCLC patients who have alterations in the focal adhesion-PI3K-AKT signaling pathway, a finding which may inform the design of future toripalimab clinical trials.”

About CHOICE-01A total of 465 treatment-naïve advanced NSCLC patients without EGFR/ALK mutations were randomized (2:1): 309 to toripalimab plus chemotherapy (the “toripalimab arm”) and 156 to placebo plus chemotherapy (the “placebo arm”). 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.

As of October 31, 2021:

• At the final analysis, a significant improvement in PFS was detected in the toripalimab arm over the placebo arm (hazard ratio (“HR”)=0.49; 95% confidence interval (“CI”): 0.39-0.61, P