FDA Approves First Treatment for Nasopharyngeal Carcinoma

The FDA has approved Loqtorzi (toripalimab-tpzi) to treat patients with recurrent or metastatic nasopharyngeal carcinoma (NPC). It was approved 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. 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.

Loqtozi is an anti-PD-1 monoclonal antibody developed by Coherus BioSciences and Shanghai Junshi Biosciences. It is expected to be available in the first quarter of 2024.

Jong Chul Park, M.D.

“The FDA approval of Loqtorzi 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,” Jong Chul Park, M.D., assistant professor, Harvard Medical School and attending physician at the Center for Head and Neck Cancers at Massachusetts General Hospital Cancer Center, said in a press release. “Loqtorzi is a new treatment option that has demonstrated the ability to significantly improve progression free survival and overall survival and should quickly emerge as the new standard of care when used in combination with chemotherapy.”

The approval is supported by the results from clinical studies POLARIS-02 and JUPITER-02. 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.

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.

In May 2023, the FDA completed the required pre-licensing inspection of partner Shanghai Junshi Biosciences’s manufacturing site in China.

Toripalimab is also being studied to treat patients with non-small-cell lung cancer.