Junshi Biosciences on the Move with FDA Fast Track Designation for Toripalimab as First-Line Treatment for Mucosal Melanoma

Junshi Biosciences on the Move with FDA Fast Track Designation for Toripalimab as First-Line Treatment for Mucosal Melanoma

Shanghai China-based Junshi Biosciences (HKEX: 1877; SSE: 688180) announced the biotech venture received Fast Track designation by the U.S. Food and Drug Administration (FDA) for toripalimab, a first-line treatment of mucosal melanoma. Additionally, the FDA also approved their Investigational New Drug (IND) application for a global Phase 3 clinical trial of Toripalimab in combination with Axitinib versus Pembrolizumab for the first-line treatment of patients with advanced mucosal melanoma in a combination clinical trial.

TrialSite has reported a burst in Chinese biotech activity both in the world’s most populated nation and in activity in the United States, still the world’s largest economy and biopharmaceutical products market. A brief breakdown of this company and these investigational products ensures. 

What is Mucosal Melanoma?

This is a subtype of melanoma with mucosal origin. Compared with cutaneous melanoma, mucosal melanoma is less responsive to traditional chemotherapy and immunotherapy, and thus remains an unmet medical need. 

What is Toripalimab?

According to Junshi Biosciences this is the first domestic anti-PD-1 monoclonal antibody approved for marketing in China. They report that over 30 company-sponsored clinical trials covering more than 15 indications have been conducted worldwide, including China and the United States.

What about the Combination of Toripalimab & Axitinib?

Toripalimab and Axitinib combination was the world’s first clinical application of PD-1 checkpoint blockade with a VEGFR inhibitor for the treatment of mucosal melanoma in a Phase Ib study (NCT03086174). The results of the study were published in the Journal of Clinical Oncology in August 2019. The study showed that the combination of Toripalimab with Axitinib in the first-line setting achieved an ORR of 48.3% and a disease control rate (DCR) of 86.2% for advanced mucosal melanoma with a manageable safety profile. The median progression-free survival (mPFS) was 7.5 months. In March 2020, Toripalimab in combination with Axitinib for the treatment of mucosal melanoma was granted the Orphan-Drug Designation (ODD) by the FDA.

What is Toripalimab’s  timeline to date?

The company reports the following milestones and major activities with Toripalimab:

∙         By December 17, 2018 the drug was approved on a conditional basis by the Chinese National Medical Products Administration (NMPA) for the second-line treatment of unresectable or metastatic melanoma.

∙         By 2019 the drug was included in the 2019 and 2020 Guidelines of Chinese Society of Clinical Oncology (CSCO) for the Diagnosis and Treatment of Melanoma. 

∙         Two supplemental New Drug Applications (NDA) of the drug for A) the third-line treatment of recurrent/metastatic nasopharyngeal carcinoma and B) The second-line treatment of metastatic urothelial carcinoma was accepted by the NMPA in April and May 2020 respectively.   Note that both supplemental NDAs received priority review designations from the NMPA in July 2020.

∙         The U.S. FDA in September 2020 granted the drug Breakthrough Therapy Designation (BTD) for the treatment of recurrent/metastatic nasopharyngeal carcinoma.

∙         In 2020 Toripalimab was included in the updated National Reimbursement Drug List (NRDL) (2020 Edition)—China.

What about the Combination Clinical Trial?

This multi-center, randomized Phase 3 clinical trial is designed to evaluate the efficacy and safety of Toripalimab in combination with Axitinib versus Pembrolizumab as a first-line treatment in patients with unresectable, locally advanced or metastatic mucosal melanoma.  The sponsor plans on enrolling 220 patients who will be randomized at 1:1 ration into two study arms. The primary endpoint of the Combination Clinical Trial is a progression-free survival (PFS). The secondary endpoints include objective response rate (ORR), duration of response (DOR), overall survival (OS) and safety.

Junshi Biosciences Background

Founded in December 2012, Junshi Biosciences (HK: 1877; SH: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R & D pipeline comprising 27 innovative drug candidates and 2 biosimilars, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for anti-PD-1 monoclonal antibody in China. Its first-in-human anti-BTLA antibody for solid tumors was the first in the world to be approved for clinical trials by the FDA and NMPA and its anti-PCSK9 monoclonal antibody was the first in China to be approved for clinical trials by the NMPA. In early 2020, Junshi Biosciences joined forces with the Institute of Microbiology Chinese Academy of Science and Eli Lilly to co-develop JS016, China’s first neutralizing fully human monoclonal antibody against SARS-CoV-2, which has entered clinical trials and is now a part of their continuous innovation for disease control and prevention of the global pandemic. The company employs over 2,000 in the U.S. (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing, and Guangzhou).