Coherus Launches Loqtorzi for Nasopharyngeal Carcinoma

Coherus BioSciences has launched Loqtorzi (toripalimab-tpzi) to treat patients with recurrent or metastatic nasopharyngeal carcinoma (NPC). Loqtozi is an anti-PD-1 monoclonal antibody developed by Coherus and Shanghai Junshi Biosciences.

Loqtorzi is available for purchase through several specialty distributors including Cencora (formerly AmerisourceBergen), Cardinal and McKesson. Billing will occur under the medical benefit using an unclassified HCPCS code J3490 or J3590 with the NDC number of 70114-0340-01. Coherus expects a product-specific, permanent J-code to be assigned in mid-2024.

Loqtorzi has a list price of $8,892.03 per single-use vial. As a single agent, it is dosed every two weeks. When used in combination with chemotherapy, Loqtorzi is given every three weeks. Coherus provides patient assistance and copay assistance. Patients with insurance may be eligible for $0 copay, with a limit of $30,000 a year.

Coherus’s market access team has engaged with all top commercial payers and Medicare for coverage of Loqtorzi nationally and regionally, according to Paul Reider, Coherus’ chief commercial officer.

The FDA approved Loqtorzi in October 2023 to be used in combination with cisplatin and gemcitabine for first-line treatment and as monotherapy in patients with disease progression on or after platinum-containing chemotherapy. NPC is an aggressive cancer that starts in the nasopharynx, the upper part of the throat behind the nose and near the base of skull. It affects about 2,000 in the United States annually, and patients are treated primarily with radiation and chemotherapy. The five-year survival rate for all patients diagnosed with NPC is approximately 60%, however, those who are diagnosed with advanced disease have a five-year survival rate of approximately 49%.

The National Comprehensive Cancer Network classified Loqtozi as a preferred category 1 therapy, meaning there is a high level of evidence that the therapy is appropriate for this cancer.

Related: FDA Approves First Treatment for Nasopharyngeal Carcinoma

Loqtorzi was approved based on data from the POLARIS-02 and JUPITER-02 studies. In the JUPITER-02 phase 3 study, Loqtorzi combined with chemotherapy improved progression-free survival, reducing the risk of disease progression or death by 48% compared with chemotherapy alone. Loqtorzi also reduced the risk of death by 37% versus chemotherapy alone. Results from JUPITER-02 were published online in Journal of the American Medical Association.

In the POLARIS-02 phase 2 clinical study, Loqtorzi demonstrated durable antitumor activity in patients with recurrent or metastatic NPC who failed previous chemotherapy, with an objective response rate of 20.5%, a disease control rate of 40.0%, and a median overall survival of 17.4 months.

The safety profile of Loqtorzi was consistent with the PD-1 inhibitor class. Adverse events leading to discontinuation of Loqtorzi 11.6% compared with 4.9% with placebo. Immune-related adverse events of grade ≥3 were more frequent in the Loqtorzi arm.