Benzinga | Dec 13, 2021 07:04AM EST

Junshi Biosciences and Coherus Announce Interim Overall Survival Results Of CHOICE-01, A Phase 3 Clinical Trial Evaluating Toripalimab In Combination With Chemotherapy As First-Line Treatment For Non-Small Cell Lung Cancer

Shanghai Junshi Biosciences Co., Ltd. ("Junshi Biosciences", HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. (("Coherus", NASDAQ:CHRS), today announced positive results of an interim analysis of overall survival from the pivotal study "CHOICE-01" (NCT03856411), a randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating toripalimab plus standard-of-care chemotherapy as the first-line treatment of advanced squamous or non-squamous non-small cell lung cancer ("NSCLC"). 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. 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 United States Food and Drug Administration ("FDA") to discuss the submission of a Biologics License Application ("BLA") supplement for toripalimab in combination with chemotherapy for the first-line treatment of advanced NSCLC. The BLA for toripalimab in combination with gemcitabine and cisplatin for the first-line treatment for patients with advanced recurrent or metastatic nasopharyngeal carcinoma ("NPC") and toripalimab monotherapy for the second-line or above treatment of recurrent or metastatic NPC after platinum-containing chemotherapy is currently under priority review by the FDA.

"The results of CHOICE-01, demonstrating improvements in overall survival, confirm that toripalimab can deliver significant benefits to patients receiving first-line treatment for non-small cell lung cancer," said Dr. Patricia Keegan, Chief Medical Officer of Junshi Biosciences. "With a consistently strong record of positive efficacy and safety accumulating as data read out from studies across multiple tumor types, we are working to register toripalimab for a broad array of indications in China and the United States. In 2022, we look forward to clinical data from additional Phase 3 studies in NSCLC, small cell lung cancer, triple negative breast cancer, and hepatocellular cancer."

"The achievement of an overall survival benefit in non-small cell lung cancer patients by toripalimab is a watershed event in the strategic transformation of Coherus and validates the role of toripalimab as the foundation of our immuno-oncology pipeline," said Denny Lanfear, CEO of Coherus. "Toripalimab has once again delivered positive progression free survival and overall survival clinical data in a first-line setting. We will now work closely with our partners at Junshi Biosciences to engage the FDA on BLA supplement filing strategies for first-line treatment of non-small cell lung cancer. We also look forward to initiating future studies combining toripalimab with a series of complementary immuno-oncology agents to advance patient care and outcomes in oncology."