Release Details
Coherus and Junshi Biosciences Announce PD-1 Inhibitor Toripalimab Granted Orphan Drug Designation for Small Cell Lung Cancer in the United States
SCLC is an aggressive tumor characterized by rapid disease progression, low expression of PD-L1 and low levels of tumor infiltrating immune cells, as well as a high degree of immunosuppression. Efficacy of cancer immunotherapy has been limited in SCLC. No PD-1 inhibitors are currently approved in
The JUPITER-08 study (NCT04012606) is an ongoing, randomized, double-blind, placebo-controlled, multi-center Phase 3 clinical trial evaluating PD-1 inhibitor toripalimab in combination with chemotherapy (cisplatin or carboplatin + etoposide) compared to placebo in combination with chemotherapy as the first-line treatment of extensive stage SCLC. Enrollment in this trial has been completed. The co-primary endpoints of the study are overall survival and progression free survival as assessed by the investigator.
“Toripalimab in combination with chemotherapy has demonstrated robust antitumor immunity and survival benefit in multiple tumor types including in tumors with low PD-L1 expression. This differentiated clinical activity may result from toripalimab’s unique binding epitope and internalization properties,” said Dr.
“Lung cancer is the second most prevalent malignant tumor and has the highest mortality rate. However, there is a disparity in the development of new treatments for different subtypes of lung cancer, non-small cell lung cancer (“NSCLC”) and SCLC. For NSCLC without oncogenic mutations, multiple immuno-oncology drugs, including toripalimab, have been shown to improve survival when added to chemotherapy as compared to chemotherapy alone, whereas treatment options for SCLC patients are limited to chemotherapy with one of two PD-L1 inhibitors,” said Dr.
About Toripalimab
Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 promotes the immune system’s ability to attack and kill tumor cells.
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 four approved indications for toripalimab in China:
- unresectable or metastatic melanoma after failure of standard systemic therapy;
- recurrent or metastatic nasopharyngeal carcinoma 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 cisplatin and gemcitabine as the first-line treatment for patients with locally recurrent or metastatic NPC.
The first three indications have been included in the National Reimbursement Drug List (“NRDL”) (2021 Edition). Toripalimab is the only anti-PD-1 monoclonal antibody included in the NRDL for melanoma and NPC.
In addition, two supplemental New Drug Applications (“NDAs”) for toripalimab are currently under review by the National Medical Products Administration (“NMPA”) in China:
- in combination with chemotherapy as the first-line treatment of patients with advanced or metastatic ESCC.
- in combination with chemotherapy as the first-line treatment of patients with advanced or metastatic NSCLC without EGFR or ALK mutations.
In the
About Junshi Biosciences
Founded in
In the face of the COVID-19 pandemic, Junshi Biosciences responded swiftly and strongly, joining forces with Chinese and international scientific research institutions and enterprises to develop an arsenal of drug candidates to combat COVID-19, taking the initiative to shoulder the social responsibility of Chinese pharmaceutical companies by prioritizing and accelerating COVID-19 R&D. Among the many drug candidates is JS016 (etesevimab), China’s first neutralizing fully human monoclonal antibody against SARS-CoV-2 and the result of the combined efforts of Junshi Biosciences, the
Junshi Biosciences has more than 2,800 employees in
About
Coherus is a commercial stage biopharmaceutical company building a leading immuno-oncology franchise funded with cash generated by its commercial biosimilar business. In 2021, Coherus in-licensed toripalimab, an anti-PD-1 antibody, in
Coherus markets UDENYCA® (pegfilgrastim-cbqv), a biosimilar of Neulasta® in
Forward-Looking Statements
Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding Coherus’ ability to build its immuno-oncology franchise to achieve a leading market position; Coherus’ ability to generate cash; Coherus’ investment plans; Coherus’ expectations for the launch date of YUSIMRY™ and other products; Coherus’ plans to file additional BLAs for toripalimab; beliefs about toripalimab’s ability to enhance treatment of patients in combination with chemotherapy; beliefs about the need for new treatment options for SCLC; and expectations for the timing of any clinical data from the Phase 3 study evaluating toripalimab for SCLC.
Such forward-looking statements involve substantial risks and uncertainties that could cause Coherus’ actual results, performance or achievements to differ significantly from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the risks and uncertainties inherent in the clinical drug development process; risks relating to the COVID-19 pandemic; risks related to our existing and potential collaboration partners; risks of the drug development position of Coherus’ competitors; the risks and uncertainties of the regulatory approval process, including the speed of regulatory review, international aspects of Coherus’ business, the need to schedule inspections in
UDENYCA®, YUSIMRY™ and CIMERLI™, whether or not appearing in large print or with the trademark symbol, are trademarks of Coherus, its affiliates, related companies or its licensors or joint venture partners, unless otherwise noted. Trademarks and trade names of other companies appearing in this press release are, to the knowledge of Coherus, the property of their respective owners.
Coherus Contact Information: IR Contact:McDavid Stilwell Chief Financial OfficerCoherus BioSciences, Inc. IR@coherus.com Media Contact:Brian Grancagnolo Brian.Grancagnolo@hkstrategies.com +1 (212) 885-0449 Junshi Biosciences Contact Information IR Team: Junshi Biosciences info@junshipharma.com + 86 021-2250 0300 Goby GlobalBob Ai bai@gobyglobal.com + 1 646-389-6658 PR Team: Junshi BiosciencesZhi Li zhi_li@junshipharma.com + 86 021-6105 8800
Source: Coherus BioSciences, Inc.