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- Toripalimab plus chemotherapy demonstrates improvement in co-primary endpoints of PFS and OS in patients with advanced ESCC -
- PFS and OS benefits were observed across all PD-L1 expression subgroups, including in patients with low PD-L1 expression -
REDWOOD CITY, Calif., and SHANGHAI, China, March 04, 2022 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (“Coherus”, Nasdaq: CHRS) and Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) today announced the online publication in Cancer Cell of Toripalimab plus chemotherapy in treatment-naïve, advanced esophageal squamous cell carcinoma (JUPITER-06): a multi-center randomized phase 3 trial. The manuscript publication was accompanied by a Cancer Cell editorial preview entitled Jupiter-06 establishes immune checkpoint inhibitors as essential first-line drugs for the treatment of advanced esophageal squamous cell carcinoma.
JUPITER-06 achieved the co-primary endpoints of progression free survival (“PFS”) and overall survival (“OS”) with statistically significant and clinically meaningful improvements for patients treated with the toripalimab and chemotherapy combination compared to chemotherapy alone. The study results were first presented in a mini-oral session during the European Society for Medical Oncology (“ESMO”) Congress 2021.
“The clinically meaningful results of JUPITER-06, as published in this internationally recognized, peer-reviewed journal, demonstrate toripalimab's ability to deliver significant benefits to patients receiving first-line treatment of advanced or metastatic esophageal squamous cell carcinoma,” said Dr. Patricia Keegan, Chief Medical Officer of Junshi Biosciences.
“Toripalimab interacts with PD-1 through a differentiated domain on the PD-1 surface, the FG loop, and has strong receptor internalization upon binding, resulting in a consistent reduction of PD-1 from the T-cell surface. We have hypothesized that this unique feature could enable a more robust response to antigen stimulation, and in our clinical trials, including JUPITER-06, we are closely monitoring PD-L1 expression as well as clinical efficacy in both PD-L1 high and PD-L1 low patient populations,” commented Dr. Sheng Yao, Senior Vice President of Junshi Biosciences.
“The robust results from the JUPITER-06 study add to the emerging body of clinical evidence of toripalimab’s clinical activity across multiple tumor types. Importantly, ESCC patients with low PD-L1 expression represent a high unmet need, and we are encouraged by these results in patients with ESCC and the potential of toripalimab plus chemotherapy to offer improved clinical outcomes for these patients,” said Denny Lanfear, CEO of Coherus. “We are working closely with our partners at Junshi Biosciences to make toripalimab and additional complementary immuno-oncology agents available to patients in the U.S. as part of our mission to advance patient care and outcomes in oncology.”
Highlights from the peer-reviewed manuscript are summarized below. A total of 514 treatment-naive advanced or metastatic patients were randomized (1:1) to receive toripalimab in combination with paclitaxel plus cisplatin (”TP”) chemotherapy (the “toripalimab arm”) or placebo in combination with TP chemotherapy (the “placebo arm”), followed by toripalimab or placebo maintenance. The co-primary endpoints were PFS as assessed by a blinded independent central review (“BICR”) and OS.
