Toripalimab: the First Domestic Anti-Tumor PD-1 Antibody in China

Abstract

Toripalimab (Tuoyi™) is a selective, recombinant, humanized monoclonal antibody against programmed death protein 1 (PD-1) developed by Shanghai Junshi Bioscience Co., Ltd. Toripalimab is able to bind to PD-1 and block the interaction with its ligands. The binding of toripalimab to PD-1 is mainly attributed to the heavy chain of the former and the FG loop of the latter. Toripalimab received a conditional approval in China for the treatment of melanoma (second-line) in December, 2018. It has also received approvals to treat nasopharyngeal carcinoma (first-line and third-line) and urothelial carcinoma (second-line) in 2021. Additionally, several orphan drug designations were granted to toripalimab by the US Food and Drug Administration. Toripalimab has exhibited primary anti-tumor effects in tumors such as melanoma, lung cancer, digestive tract tumors, hepatobiliary and pancreatic tumors, neuroendocrine neoplasms, nasopharyngeal carcinoma and urothelial carcinoma. It showed a satisfactory anti-tumor effect and long-term survival benefits in Chinese melanoma patients, while the combination of axitinib with toripalimab exhibited an impressive result in metastatic mucosal melanoma. As a checkpoint inhibitor, toripalimab was generally well-tolerated in the enrolled patients. Due to different study populations, comparisons could not be made directly between toripalimab and other drugs in most cases. Nevertheless, the introduction of toripalimab may offer a valuable choice for decision-making in the treatment of tumors in the future.

Neoadjuvant toripalimab combined with gemcitabine and cisplatin in resectable locally advanced head and neck squamous cell carcinoma (NeoTGP01): An open label, single-arm, phase Ib clinical trial

“…Toripalimab, a PD-1 inhibitor, has been approved for the treatment of NPC, esophageal carcinoma, melanoma, and soft tissue sarcoma in China [ 16 ]. Here, we report the results of a phase Ib clinical trial that investigated the safety and efficacy of neoadjuvant toripalimab combined with GP in resectable locally advanced HNSCC.…”

Long-Term Survival of FOLFIRINOX +toripalimab in a Patient with Metastatic Pancreatic Ductal Adenocarcinoma: A Case Report

“…Unlike other PD-1 inhibitors, it binds to the FG loop of the PD-1 receptor identified via unconventional three-dimensional structure analysis. 25 Increasing studies have shown that Toripalimab alone or combined with chemotherapy exhibits promising effects and favourable tolerability in various malignancies and the adverse reactions to Toripalimab are acceptable and generally manageable. 26,27 In recent years, an evergrowing number of efforts have been made to explore chemo-immunotherapy, with encouraging results in its ability to overcome primary resistance to PDAC.…”

Immune-Related Uncommon Adverse Events in Patients with Cancer Treated with Immunotherapy

“…Immune-related cystitis may be suspected in patients treated with ICI who develop symptoms of urinary tract irritation (such as dysuria, pollakiuria, or urinary urgency), leukocyturia or erythrocyturia in urine samples, and after infective etiologies have been ruled out by consecutive urinary cultures or antibiotic failure. We have found eight cases described in the literature [ 219 ] in patients receiving pembrolizumab, nivolumab, and to-ripalimab (a monoclonal anti PD-1 antibody approved in China [ 220 ]). Using data from the FDA adverse database, 19 reports were identified by He et al [ 219 ].…”