FDA Approves Toripalimab for Recurrent/Metastatic Nasopharyngeal Carcinoma


Data from the phase 3 JUPITER-02 study and phase 2 POLARIS-02 study support the FDA approval of toripalimab-tpzi alone and in combination with gemcitabine and cisplatin in nasopharyngeal carcinoma.

Supporting data for the approval came from the phase 3 JUPITER-02 study (NCT03581786) and the phase 2 POLARIS-02 trial (NCT02915432).

Supporting data for the approval came from the phase 3 JUPITER-02 study (NCT03581786) and the phase 2 POLARIS-02 trial (NCT02915432).

The FDA has granted approval to frontline toripalimab-tpzi (Loqtorzi) plus cisplatin and gemcitabine for adult patients with metastatic or locally advanced nasopharyngeal carcinoma (NPC), as well as single-agent toripalimab for recurrent, unresectable, or metastatic disease that has progressed on or following prior chemotherapy, according to a press release from Coherus Biosciences, Inc and Shanghai Junshi Biosciences Co., Ltd.

The agency approved toripalimab in combination with chemotherapy at a recommended dose of 240 mg every 3 weeks for up to 24 months or unacceptable toxicity or disease progression. The recommended dose for single-agent toripalimab in previously treated patients is 3 mg/kg every 2 weeks.

Supporting data for the approval came from the phase 3 JUPITER-02 study (NCT03581786), in which toripalimab plus chemotherapy yielded a 48% reduction in the risk of disease progression or death with respect to progression-free survival (PFS) compared with chemotherapy on its own. Investigators also reported 37% reduction in the risk of death with respect to overall survival (OS) among patients receiving the experimental regimen.

The approval was also based on findings from the phase 2 POLARIS-02 trial (NCT02915432), in which patients with recurrent or metastatic NPC experienced an objective response rate (ORR) of 20.5%, a disease control rate of 40.0%, and a median OS of 17.4 months when treated with toripalimab. Investigators reported that the agent was tolerable.

“Today’s FDA approval of [toripalimab] 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, MD, assistant professor at Harvard Medical School and attending physician at the Center for Head and Neck Cancers at Massachusetts General Hospital Cancer Center, said in the press release. “[Toripalimab] is a new treatment option that has demonstrated the ability to significantly improve PFS and OS and should quickly emerge as the new standard of care when used in combination with chemotherapy.”

According to data from the JUPITER-02 study, the rate of grade 3 or higher adverse effects (AEs) was 89.7% in patients receiving toripalimab plus chemotherapy compared with 90.2% among patients treated with chemotherapy alone. Additionally, 11.6% and 4.9% of patients in each respective arm experienced AEs leading to treatment discontinuation, and 54.1% and 21.7% had any grade immune-related AEs (IRAEs); high-grade AEs occurred in 9.6% vs 1.4% of patients, respectively.


Coherus and Junshi Biosciences announce FDA approval of LOQTORZI™ (toripalimab-tpzi) in all lines of treatment for recurrent or metastatic nasopharyngeal carcinoma (NPC). News release. Coherus Biosciences. October 27, 2023. Accessed October 27, 2023. https://shorturl.at/rwCDL

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