On April 27, 2023 Shanghai Junshi Biosciences Co., Ltd ("Junshi Biosciences", HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS) reported that data presentations of four toripalimab pivotal clinical studies will be presented at the upcoming ASCO (Free ASCO Whitepaper) Annual Meeting, which is being held from June 2-6, 2023 at McCormick Place in Chicago (Press release, Coherus Biosciences, APR 27, 2023, View Source [SID1234630598]).
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Presentations
Abstract #6009/Poster #1: "Final Overall Survival Analysis of JUPITER-02: a Phase 3 study of Toripalimab versus Placebo in Combination with Gemcitabine and Cisplatin as First-line Treatment for Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)"
Principal Investigator: Prof. Rui-hua XU, Sun Yat-sen University Cancer Center
Poster Discussion Session: Head and Neck Cancer
Date: Monday, June 5, 2023, 4:30 p.m. Central Daylight Time
Abstract #9003: "Final overall survival and biomarker analyses of CHOICE-01: A double-blind randomized phase 3 study of toripalimab versus placebo in combination chemotherapy for advanced NSCLC without EGFR/ALK mutations"
Principal Investigator: Prof. Jie WANG, Cancer Hospital, Chinese Academy of Medical Sciences
Oral Abstract Session: Lung Cancer-Non-Small Cell Metastatic
Date and Time: Tuesday, June 6, 2023, 9:45 a.m. Central Daylight Time
Abstract #8501: "Perioperative toripalimab + platinum-doublet chemotherapy vs chemotherapy in resectable stage II/III non-small cell lung cancer (NSCLC): Interim event-free survival (EFS) analysis of the phase III NEOTORCH study"
Principal Investigator: Prof. Shun LU, Shanghai Chest Hospital
Oral Abstract Session: Lung Cancer-Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Date and Time: Saturday, June 3, 2023, Session: 3:00-6:00 p.m., Presentation: 3:12 p.m. Central Daylight Time
Abstract #LBA1013: "TORCHLIGHT: a randomized, double-blind, phase III trial of toripalimab versus placebo, in combination with nab-paclitaxel (nab-P) for patients with metastatic or recurrent triple-negative breast cancer (TNBC)"
Principal Investigator: Prof. Zefei JIANG, Chinese PLA General Hospital
Rapid Abstract Session: Breast Cancer-Local/Regional/Adjuvant
Date and Time: Saturday, June 3, 2023, Session: 4:30-5:30 p.m., Presentation: 4:54 p.m. Central Daylight Time
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.
The FDA granted Breakthrough Therapy designations 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. The BLA for toripalimab in combination with chemotherapy as treatment for recurrent or metastatic nasopharyngeal carcinoma is currently under review by the FDA. 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.
More than forty 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.
In Europe, marketing authorization applications (MAA) were accepted by the European Medicines Agency (EMA) and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) for 1) toripalimab combined with cisplatin and gemcitabine for the first-line treatment of patients with locally recurrent or metastatic NPC and 2) toripalimab combined with paclitaxel and cisplatin for the first-line treatment of patients with unresectable locally advanced/recurrent or metastatic ESCC, in December 2022 and February 2023.