Junshi and Coherus Receive Complete Response Letter from U.S. FDA for Toripalimab

The U.S. Food and Drug Administration notified Shanghai Junshi Biosciences and Coherus BioSciences that it would not approve its combination of toripalimab with gemcitabine and cisplatin as a first-line treatment of patients with advanced recurrent or metastatic nasopharyngeal carcinoma and for toripalimab monotherapy in the second-line or later treatment of recurrent or metastatic NPC after platinum-containing chemotherapy.

In a letter to the company, the agency requested a quality process change that Junshi Biosciences and Coherus believe is readily addressable. Junshi Biosciences and Coherus plan to meet with the FDA directly and expect to resubmit the BLA by mid-summer 2022. The Agency also communicated in the letter that the review timeline for the application resubmission would be six months, as required onsite inspections have been hindered by travel restrictions related to the COVID-19 pandemic in China.

“The FDA has indicated that the existing toripalimab clinical data are supportive of the BLA submission, and we eagerly await scheduling and completion of the required inspections in China that have been impeded to date by COVID-related travel restrictions,” said Denny Lanfear, CEO of Coherus. “We believe toripalimab addresses an important unmet need for patients with NPC for whom there are currently no approved immunotherapies in the United States, and the FDA has stated that this indication warrants regulatory flexibility with respect to the sufficiency of single country clinical data.”

Nasopharyngeal carcinoma (NPC) is a type of aggressive cancer that starts in the nasopharynx, the upper part of the throat behind the nose and near the base of skull. Due to the location of the primary tumor, surgery is rarely an option, and patients with localized disease are treated primarily with radiation and chemotherapy. In the United States, there are presently no immunotherapies approved for the treatment of NPC.

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.

In the United States, the FDA granted Breakthrough Therapy designation for toripalimab in combination with chemotherapy for the first-line treatment of recurrent or metastatic NPC as well as for toripalimab monotherapy in the second or third-line treatment of recurrent or metastatic NPC.

Author: Rare Daily Staff