Nasopharyngeal Carcinoma Treatment Loqtorzi Now Available

Loqtorzi (toripalimab-tpzi) is now available for the first-line treatment of adults with metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC) in combination with cisplatin and gemcitabine, and as a single agent for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after a platinum-containing chemotherapy. 

Loqtorzi is a programmed death receptor-1 (PD-1) monoclonal antibody. The approval was based on results from the phase 3 JUPITER-02 trial (ClinicalTrials.gov Identifier: NCT03581786), which included patients with metastatic or recurrent, locally advanced NPC who had not received previous systemic chemotherapy, and the phase 2 POLARIS-02 study (ClinicalTrials.gov Identifier: NCT02915432), which enrolled patients with previously treated unresectable or metastatic NPC. 

In JUPITER-02, statistically significant improvements in progression free survival (PFS), overall response rate, and overall survival (OS) were observed in patients who received Loqtorzi combined with chemotherapy compared with chemotherapy alone. Results from POLARIS-02 showed durable antitumor activity among Loqtorzi-treated patients with recurrent or metastatic NPC who failed previous chemotherapy.

Loqtorzi is supplied as a single-dose vial containing 240mg/6mL of toripalimab-tpzi. The recommended dosage of Loqtorzi for first-line NPC (in combination with cisplatin and gemcitabine) is 240mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months. For recurrent NPC, the recommended dosage is 3mg/kg every 2 weeks until disease progression or unacceptable toxicity. Dosage modifications are recommended to manage certain adverse reactions.

The most common adverse reactions with Loqtorzi as a single agent are fatigue, hypothyroidism, and musculoskeletal pain. The prescribing information also includes warnings and precautions related to severe and fatal immune-mediated adverse reactions (eg, pneumonitis, colitis, hepatitis, endocrinopathies, nephritis with renal dysfunction, and skin adverse reactions), infusion-related reactions, complications with allogeneic hematopoietic stem cell transplantation, and embryo-fetal toxicity. 

“We are proud to bring Loqtorzi to a patient population that has had no FDA-approved options available, and our mission is to establish Loqtorzi plus chemotherapy as the new standard of care for relapsed/metastatic NPC,” said Paul Reider, Chief Commercial Officer of Coherus. “Loqtorzi has demonstrated impressive clinical benefits, including PFS and OS, offering R/M NPC patients new hope for extended survival.”

Coherus has also launched the Loqtorzi Solutions™ program, which provides support services to prescribers and patients.

This article originally appeared on MPR