FDA approves Loqtorzi for advanced nasopharyngeal cancer
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The FDA approved toripalimab-tpzi for two indications as treatment for nasopharyngeal carcinoma, making it the first approved therapy for this malignancy.
One indication authorizes the agent to be used in combination with cisplatin and gemcitabine as first-line treatment for adults with metastatic or recurrent locally advanced disease.
The other authorizes the agent to be used as monotherapy for treatment of adults with recurrent, unresectable or metastatic nasopharyngeal carcinoma whose disease progressed on or after platinum-containing chemotherapy.
Toripalimab-tpzi (Loqtorzi; Coherus BioSciences Inc., Shanghai Junshi Biosciences Co.) is an anti-PD-1 monoclonal antibody. The indications apply regardless of patients’ PD-L1 status.
The FDA based the combination therapy approval on results of the randomized phase 3 JUPITER-02 study. Results showed toripalimab-tpzi with chemotherapy reduced risk for disease progression or death by 48% compared with chemotherapy alone. Researchers also reported a 37% reduction in risk for death with the combination vs. chemotherapy alone.
Results showed comparable rates of grade 3 or higher adverse events (89.7% vs. 90.2%) and fatal adverse events (3.4% vs. 2.8%) between the combination and chemotherapy-alone groups; however, a higher percentage of patients treated with the combination discontinued treatment (11.6% vs. 4.9%), developed immune-related adverse events (54.1% vs. 21.7%) and developed grade 3 or higher immune-related adverse events (9.6% vs. 1.4%).
The FDA based the monotherapy indication on results of the phase 2 POLARIS-02 study, which showed toripalimab-tpzi induced a 20.5% objective response rate and 40% disease control rate among patients with recurrent or metastatic nasopharyngeal carcinoma who failed prior chemotherapy. Researchers reported median OS of 17.4 months and characterized the safety profile as acceptable.
“[This approval] is very encouraging for those living with nasopharyngeal carcinoma 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 Center for Head and Neck Cancers at Massachusetts General Hospital Cancer Center, said in a press release issued by Coherus Biosciences and Shanghai Junshi Biosciences. “[This] 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.”
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