Loqtorzi^™ (toripalimab-tpzi) injection was approved by the U.S. Food and Drug Administration (FDA) on Oct. 27, 2023. It is the first drug specifically indicated to treat nasopharyngeal carcinoma (NPC), a rare but aggressive cancer that is difficult to treat. A new type of programmed death receptor-1 (PD-1) monoclonal antibody, it fastens to both PD Ligands 1 (PD-L1) and 2 (PD-L2). It is administered as intravenous (IV) infusions. For patients who have not had previous drug therapy for NPC, Loqtorzi will be given at a dose of 240mg once every three weeks along with the chemotherapy (chemo) drugs cisplatin and gemcitabine. Treatment lasts for two years or until the cancer spreads or the patient can no longer endure the therapy. For patients whose NPC has returned or worsened while or after they were undergoing chemo that included a platinum-based drug, Loqtorzi can be used alone at a dose of 3mg/kg once every two weeks until it stops controlling NPC or its side effects become too severe. Coherus BioSciences and its partner, Shanghai Junshi Biosciences, plan to introduce Loqtorzi to the U.S. market in the first quarter of 2024. Arrangements for its cost and distribution are not yet available. Complete prescribing information is here.

At a Glance

• Brand (Generic) Name: Loqtorzi (toripalimab-tpzi)
• Manufacturer: Coherus BioSciences and Junshi Bioscience
• Date Approved: Oct. 27, 2023
• Indication: for first-line treatment, in combination with cisplatin and gemcitabine, of adults who have metastatic or recurrent locally advanced NPC and for treatment, as a single agent, for adults who have recurrent unresectable or metastatic NPC with disease progression on or after platinum-containing chemo
• Dosage Forms Available: single-dose vials that contain 240mg/6mL
• Launch Date: First quarter of 2024
• Estimated Annual Cost: Unavailable
• NPC is located at the top of the throat behind the nose. Because it is in a small, restricted area close to the base of the brain, it usually cannot be removed by surgery.
• The American Cancer Society (ACS) estimates that only one case of NPC is diagnosed for every 100,000 people in the United States – roughly 3,300 each year.
• With up to 75% of cases diagnosed among men, NPC tends to be discovered during the late teens and early twenties or in patients aged 65 years and older.
• By attaching at a site that is different from other PD inhibitors, Loqtorzi targets PD-1 ligands 1 and 2 to boost the immune response to NPC tumors.
• For patients in one clinical trial, the risk of worsened cancer or death was reduced by 48% and the overall survival (OS) rate increased by 37% among those receiving Loqtorzi plus chemo versus participants using only chemo.
• A second study – of Loqtorzi by itself for recurrent or refractory NPC – showed a response rate of 20.4% and OS averaged 17.4 months.
• In clinical studies, some patients experienced life-threatening immune reactions and/or infusion reactions. More common side effects from Loqtorzi alone included fatigue, low thyroid function, and pain in the joints and muscles. 
• Currently, NPC is treated primarily with radiation and various chemo regimens. The epidermal growth factor receptor (EGFR) blocker, Erbitux^® (cetuximab) injection, and PD-1 blockers, such as Keytruda® (pembrolizumab) and Opdivo® (nivolumab), are FDA-approved to treat head and neck cancers, but Loqtorzi is the first drug specifically indicated for NPC.
• Loqtorzi has Orphan Drug status for treating NPC.