Rolling submission for Tuoyi to FDA completed for nasopharyngeal carcinoma.- Shanghai Junshi Biosciences/Coherus Biosciences

The FDA recently granted Breakthrough Therapy Designation for toripalimab in combination with chemotherapy (gemcitabine and cisplatin) for 1st line treatment of recurrent, locally advanced or primary metastatic non-keratinizing nasopharyngeal carcinoma 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.

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 III 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.