On April 29, 2021 Shanghai Junshi Biosciences Co., Ltd. ("Junshi Biosciences", HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS), reported that a late-breaking abstract detailing clinical data of anti-PD-1 antibody, toripalimab, in first-line treatment for recurrent or metastatic nasopharyngeal carcinoma will be featured at ASCO (Free ASCO Whitepaper) 2021 in the plenary session on Sunday, June 6, 2021 (Press release, Coherus Biosciences, APR 29, 2021, View Source [SID1234578802]). The abstract has also been selected for ASCO (Free ASCO Whitepaper)’s official press program.
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Details regarding the plenary session and abstract publication are as follows:
Title: JUPITER-02: Randomized, double-blind, phase 3 study of toripalimab or placebo plus gemcitabine and cisplatin as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma (NPC)
Abstract #: LBA2
Presentation: Plenary Session, June 6, 2021, 1:00 p.m. – 4:00 p.m. Eastern Daylight Time
Publication: June 3, 2021, 5:00 p.m. Eastern Daylight Time
"We are excited that results of JUPITER-02, a Phase 3 clinical trial evaluating toripalimab plus chemotherapy for the first-line treatment of recurrent or metastatic nasopharyngeal carcinoma, have been selected for presentation during ASCO (Free ASCO Whitepaper)’s plenary session, which traditionally features high-impact studies," said Dr. Patricia Keegan, Chief Medical Officer of Junshi Biosciences. "Treatment of nasopharyngeal carcinoma, a specific type of head-and-neck cancer, is challenging, as the diagnosis usually occurs when the cancer is in an advanced stage and treatment options are limited."
In addition to the JUPITER-02 late-breaking abstract, ASCO (Free ASCO Whitepaper) accepted for publication or presentation more than two dozen additional abstracts, primarily investigator-sponsored studies, that evaluate the utility of toripalimab in a variety of cancer types including lung cancer, melanoma, urothelial carcinoma, gastroesophageal cancer, and hepatobiliary malignancies.
About Toripalimab
More than thirty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally, including in China and the United States. Pivotal clinical trials are ongoing or completed evaluating the safety and efficacy of toripalimab for 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). On December 17, 2018, Toripalimab was granted a conditional approval from the National Medical Products Administration (NMPA) for the second-line treatment of unresectable or metastatic melanoma. In December 2020, Toripalimab was successfully included in the updated National Reimbursement Drug List. In February 2021, the supplemental NDA for Toripalimab in combination with chemotherapy for the first-line treatment of patients with advanced, recurrent or metastatic nasopharyngeal carcinoma was accepted by the NMPA. In the same month, the NMPA granted a conditional approval to toripalimab for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy. In April, NMPA granted a conditional approval to toripalimab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.
In the United States, a rolling submission of the first toripalimab Biologics License Application (BLA) is underway for the treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC). The U.S. Food and Drug Administration (FDA) has granted toripalimab Breakthrough Therapy Designation for this indication. There are currently no PD-1 blocking antibodies indicated for use in NPC in the United States. Additionally, FDA has granted Fast Track status for the development of toripalimab for the treatment of mucosal melanoma and orphan drug designation for NPC, mucosal melanoma and soft tissue sarcoma. Earlier in 2021 Coherus in-licensed rights to develop and commercialize toripalimab in the United States and Canada. Coherus and Junshi Biosciences plan to file additional toripalimab BLAs with the FDA over the next three years for multiple rare cancers and highly prevalent cancers.