On February 15, 2023 Shanghai Junshi Biosciences Co., Ltd ("Junshi Biosciences", HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS) reported positive results of a final analysis of overall survival ("OS") from the pivotal study JUPITER-02 (NCT03581786), a randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating toripalimab in combination with gemcitabine and cisplatin as the first-line treatment for patients with recurrent or metastatic nasopharyngeal carcinoma ("NPC") (Press release, Coherus Biosciences, FEB 15, 2023, View Source [SID1234627254]). This final analysis demonstrated a statistically significant and clinically meaningful improvement in OS in NPC patients treated with toripalimab plus chemotherapy compared to chemotherapy alone. These data are being submitted for presentation at an upcoming medical meeting.

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"In the pivotal JUPITER-02 trial, toripalimab has demonstrated a statistically significant and clinically meaningful overall survival benefit for patients with advanced NPC, an aggressive head and neck tumor with no current FDA-approved treatment options," said Rosh Dias, M.D., Coherus’ Chief Medical Officer. "These mature overall survival data continue to demonstrate the benefit of toripalimab in the treatment of NPC patients, further building upon the data published in Nature Medicine and presented at the 2021 plenary session at the ASCO (Free ASCO Whitepaper) annual meeting, and clearly show that toripalimab has the potential to become the new standard-of-care for NPC patients, once approved. We look forward to sharing these data with the oncology community at an upcoming medical meeting."

"With the ongoing accumulation of data from the JUPITER-02 trial, we are thrilled to observe toripalimab gain more ground for becoming the preferred treatment for advanced NPC," said Dr. Patricia Keegan, Chief Medical Officer of Junshi/TopAlliance Biosciences. "Compared to chemotherapy alone, a combination containing the immune checkpoint inhibitor, toripalimab, clearly has the potential to bring unprecedented changes to the extension of life in patients with NPC. We are looking forward to bringing this promising therapy to patients around the world."

The FDA has granted Breakthrough Therapy designations and priority review for the toripalimab Biologics License Application ("BLA") for use in combination with gemcitabine and cisplatin as first-line treatment for patients with advanced recurrent or metastatic NPC and for toripalimab monotherapy for the second-line or later treatment of recurrent or metastatic NPC after platinum-containing chemotherapy. Recurrent or metastatic NPC is an aggressive head and neck tumor which has no FDA-approved treatment options.

About toripalimab

Toripalimab is an anti-PD-1 monoclonal antibody that blocks PD-L1 binding to the PD⁠-⁠1 receptor at a unique site that minimizes opportunities for the tumor cell to evade the immune system and decreases PD-1’s expression on the T-cell as a second method of restoring the body’s immune response.

The FDA granted Breakthrough Therapy designation for toripalimab in combination with chemotherapy for the first-line treatment of recurrent or metastatic NPC in 2021 and as monotherapy for patients with progression following platinum-based chemotherapy in the treatment of recurrent or metastatic NPC in 2020. Additionally, the FDA has granted Fast Track designation for toripalimab for the treatment of mucosal melanoma and Orphan Drug designations for the treatment of esophageal cancer, mucosal melanoma, soft tissue sarcoma, and small cell lung cancer ("SCLC").

More than thirty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally by Junshi Biosciences, including in China, the United States, Southeast Asia, and European countries. Ongoing or completed pivotal clinical trials evaluating the safety and efficacy of toripalimab cover a broad range of tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin.

In China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI). Currently, there are six approved indications for toripalimab in China:

unresectable or metastatic melanoma after failure of standard systemic therapy;
in combination with cisplatin and gemcitabine as the first-line treatment for patients with locally recurrent or metastatic NPC.
recurrent or metastatic NPC after failure of at least two lines of prior systemic therapy;
locally advanced or metastatic urothelial carcinoma that failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy;
in combination with paclitaxel and cisplatin in first-line treatment of patients with unresectable locally advanced/recurrent or distant metastatic esophageal squamous cell carcinoma ("ESCC");
in combination with pemetrexed and platinum as the first-line treatment in EGFR mutation-negative and ALK mutation-negative, unresectable, locally advanced or metastatic non-squamous NSCLC.
The first three indications have been included in the National Reimbursement Drug List ("NRDL") (2022 Edition). Toripalimab is the only anti-PD-1 monoclonal antibody included in the NRDL for melanoma.