On September 1, 2021 Shanghai Junshi Biosciences Co., Ltd. ("Junshi Biosciences", HKEX: 1877; SSE: 688180) and Coherus Biosciences, Inc. ("Coherus", Nasdaq: CHRS) reported 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 (Press release, Coherus Biosciences, SEP 1, 2021, View Source [SID1234587084]).
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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 (Free ASCO Whitepaper) plenary session (#LBA2) and published in the August 2021 on-line edition of Nature Medicine.
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 is thought to recharge 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, 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 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 addition, two supplemental NDAs for toripalimab in combination with chemotherapy for the first-line treatment of patients with advanced, recurrent or metastatic NPC or for the first-line treatment of patients with advanced, or metastatic esophageal squamous cell carcinoma were accepted by the NMPA for review in February and July 2021 respectively.
In the United States, the first toripalimab BLA has been submitted to the FDA for the treatment of recurrent or metastatic NPC. The FDA has granted Breakthrough Therapy designation for toripalimab in combination with chemotherapy for the 1st line treatment of recurrent or metastatic NPC and also for toripalimab monotherapy in second or third line treatment of recurrent or metastatic NPC. There are currently no PD-1 blocking antibodies indicated for use in NPC in the United States. Additionally, FDA has granted Fast Track designation for 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 cancers and highly prevalent cancers.