Shanghai Junshi Biosciences Co., Ltd. (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) and Coherus Biosciences, Inc. ((&ldquo, Coherus&rdquo, , NASDAQ:CHRS) announced today the completion of the rolling submission of the Biologics License Application (“BLA”) to the U.S. Food and Drug Administration (“FDA”) for toripalimab in combination with gemcitabine and cisplatin for first-line treatment for patients with advanced recurrent or metastatic nasopharyngeal carcinoma (“NPC”) and toripalimab monotherapy for second-line or above treatment of recurrent or metastatic NPC after platinum-containing chemotherapy.
The FDA recently granted Breakthrough Therapy Designation (“BTD”) for toripalimab in combination with chemotherapy (gemcitabine and cisplatin) for 1st line treatment of recurrent, locally advanced or primary metastatic non-keratinizing nasopharyngeal carcinoma (“NPC”) and earlier in 2020 granted BTD for toripalimab monotherapy for patients with recurrent or metastatic non-keratinizing NPC with disease progression on or after platinum-containing chemotherapy. BTD is intended to expedite the development and regulatory review of drugs where preliminary clinical evidence demonstrates substantial improvement over existing therapies for a severe or life-threating disease. Drugs with BTD will be granted more frequent FDA interaction and intensive guidance – including that from senior FDA officials – on the development program and ability to participate in various forms of expedited FDA review programs to provide patients with new therapy as soon as possible.
“Toripalimab was approved for marketing early this year in China as the world’s first immune checkpoint inhibitor to treat advanced NPC, an aggressive tumor with limited treatment options,” said Patricia Keegan, MD, Chief Medical Officer of Junshi Biosciences. “Toripalimab showed remarkable efficacy in the treatment of advanced NPC according to the results from POLARIS-02 and JUPITER-02 studies, as recognized by inclusion in plenary and other presentations at leading international medical professional conferences and publications in highly respected scientific journals. We look forward to working closely with the FDA in the review of this BLA and with our U.S. partner, Coherus, to bring this new treatment option forward as expeditiously as possible for patients in the U.S.”
“Toripalimab, the foundation stone of our emerging immuno-oncology franchise, demonstrated compelling efficacy in the pivotal studies supporting the BLA for nasopharyngeal carcinoma,” said Denny Lanfear, Coherus CEO. “As data read out from the extensive set of pivotal clinical trials potentially supporting a broad range of additional indications, we expect toripalimab to maintain a consistently strong efficacy profile. We will continue to work with our partner, Junshi Biosciences, to advance toripalimab through FDA approval."
The submission is supported by the results from “POLARIS-02” and “JUPITER-02”. The POLARIS-02 study is a multi-center, open-label, pivotal Phase II clinical study, results of which were published online in January 2021 in Journal of Clinical Oncology. The JUPITER-02 study is a randomized, double blind, placebo-controlled pivotal Phase 3 clinical trial, results of which were recently presented at the ASCO plenary session (#LBA2) and published in the August 2021 on-line edition of Nature Medicine.