Coherus and Junshi Biosciences to Present Positive Progression Free Survival and Overall Survival Results from JUPITER-06, a Phase 3 Clinical Trial Evaluating Toripalimab in Combination with Chemotherapy as First-Line Treatment for Advanced Esophageal Squ - Seite 2

“With JUPITER-06, toripalimab has once again exhibited compelling efficacy in a first-line setting,” said Denny Lanfear, CEO of Coherus. “The significant PFS and similarly robust overall survival data demonstrate that toripalimab in combination with chemotherapy could provide significant clinical benefits to patients with advanced or metastatic esophageal squamous cell carcinoma. We plan to work closely with our partner, Junshi Biosciences, to pursue a BLA supplement for this new indication expeditiously.”

About JUPITER-06
A total of 514 treatment-naive advanced or metastatic patients were randomized (1:1) to receive toripalimab or placebo in combination with paclitaxel plus cisplatin chemotherapy followed by toripalimab or placebo maintenance. The primary endpoints were PFS as assessed by a blinded independent central review (BICR) and overall survival (OS).

• At a prespecified interim analysis on March 22, 2021, with median follow-up of 7.4 and 7.3 months in the two arms, there was a significant improvement in OS for the toripalimab-chemotherapy arm compared to the placebo-chemotherapy arm (HR=0.58 [95% CI: 0.43-0.78], P=0.00037) with median OS of 17.0 vs. 11.0 months;
  
  
• One-year OS rates were 66.0% vs.43.7% for the toripalimab-chemotherapy arm compared to the placebo-chemotherapy arm, respectively;
  
  
• A significant improvement in PFS assessed by BICR was also detected for the toripalimab-chemotherapy arm compared to the placebo-chemotherapy arm (HR=0.58 [95% CI: 0.46-0.74], P<0.00001);
  
  
• The OS and PFS benefits were observed across key subgroups, including all PD-L1 expression subgroups;
  
  
• The incidence of Grade ≥3 adverse events (AEs) (73.2% vs 70.0%) and fatal AEs (8.2% vs 8.2%) were similar between the two arms. No new safety signals were observed.
  

Junshi Biosciences and Coherus are planning in 2022 to submit a biologics license application supplement to the United States Food and Drug Adminstration for toripalimab for first-line treatment, in combination with platinum-based chemotherapy, of advanced or metastatic ESCC. In China, the supplemental New Drug Application of this indication has been accepted by the National Medical Products Administration (NMPA) in July, 2021.

About Toripalimab
Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 is thought to recharge the immune system’s ability to attack and kill tumor cells. More than thirty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally, including in China and the United States. Ongoing or completed pivotal clinical trials are evaluating the efficacy and safety of toripalimab for a broad range of tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin.