Coherus, Junshi Get FDA Approval for First Chinese PD-1 and NPC Treatment

Pictured: Exterior of an FDA building/iStock, Grandbrothers

Pictured: Exterior of an FDA building/iStock, Grandbrothers

The FDA has given the greenlight to Coherus BioSciences and Shanghai Junshi Biosciences’ Loqtorzi (toripalimab), the first and only approved treatment for nasopharyngeal carcinoma, the companies announced. The monoclonal antibody also has the distinction of being the first Chinese programmed death receptor-1 to gain the U.S. regulator’s approval.

The drug was approved in combination with cisplatin and gemcitabine for the first-line treatment of patients with metastatic or locally advanced nasopharyngeal carcinoma (NPC). Loqtorzi is expected to rapidly emerge as the new standard of care when used as a complement to chemotherapy.

Junshi BioSciences is the original developer of the drug, while Coherus BioSciences paid $150 million upfront in early 2021 for U.S. and Canadian rights. The antibody will be branded as Loqtorzi in the U.S., with an expected launch for the first quarter of 2024. Although its price has not yet been announced, Coherus said on an investor call on Friday that it will be pricing closer to the launch date.

“Loqtorzi’s first approval is a pivotal event for Coherus as an innovative oncology company. As a next generation PD-1 inhibitor it is the keystone of our I-O strategy to extend cancer patient survival as shown with the impressive results in NPC,” Coherus CEO Danny Lanfear said in a statement.

NPC is a rare tumor in the head and/or neck area that typically starts in the squamous cells that line the nasopharynx. Signs of NPC include trouble breathing, speaking, or hearing. Given the location of the primary tumor, surgery is not normally an option. Rather, patients are primarily treated with radiation and chemotherapy.

Jong Chul Park, an assistant professor at Harvard Medical School and attending physician at the Center for Head and Neck Cancers at Massachusetts General Hospital Cancer Center, added that Loqtorzi’s approval is “very encouraging for those living with NPC who currently have very limited treatment options and are in need of new therapies to treat this aggressive and life-threatening form of cancer.”

Loqtorzi is a monoclonal antibody that blocks PD-1 ligands PD-L1 and PD-L2 at a unique site on the PD-1 receptor, causing the immune system to activate and kill the tumor. It showed durable antitumor activity in patients with recurrent or metastatic NPC who had not previously benefitted from chemotherapy. In addition, the safety profile of Loqtorzi was consistent with the PD-1 inhibitor class.

Coherus supported its FDA application with data from the JUPITER-02 Phase III study. The trial  is the largest randomized, double-blind, placebo-controlled, international, multi-center clinical study to evaluate a checkpoint inhibitor and chemotherapy for a first-line treatment of recurrent or metastatic NPC.

Patients treated with Loqtorzi and chemotherapy exhibited significantly improved progression-free survival (PFS), with a reduced risk of disease progression or death by 48% compared to just chemotherapy alone. Loqtorzi  also showed a statistically significant and clinically meaningful improvement in overall survival (OS), as treatment resulted in a 37% reduction in the risk of death compared to chemotherapy alone.

The approval was also based on results from the POLARIS-02 Phase II study, in which Loqtorzi “demonstrated durable antitumor activity in patients with recurrent or metastatic NPC who failed previous chemotherapy,” according to the announcement. The mid-stage study showed an objective response rate of 20.5%, a disease control rate of 40.0% and a median OS of 17.4 months with an acceptable safety profile.

Matt Olszewski is a freelance writer based in Boston. Reach him on LinkedIn.

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