FDA approves toripalimab-tpzi for nasopharyngeal carcinoma
Regulatory approval: On Oct 27, 2023, the FDA approved toripalimab-tpzi (LOQTORZI) for adults with nasopharyngeal carcinoma. It is approved with cisplatin and gemcitabine for first-line treatment of metastatic or recurrent, locally advanced disease, and as monotherapy for recurrent unresectable or metastatic disease progressing on or after platinum chemotherapy. Approval was supported by JUPITER-02 (PFS and OS benefit) and POLARIS-02 (ORR and DOR).
FDA approval: toripalimab-tpzi for nasopharyngeal carcinoma (NPC)
Type: Regulatory approval (FDA)
Date: 2023-10-27
The FDA approved toripalimab-tpzi (LOQTORZI; Coherus BioSciences, Inc.) for adults with NPC in two settings:
- With cisplatin + gemcitabine for first-line treatment of metastatic or recurrent, locally advanced NPC.
- As a single agent for recurrent unresectable or metastatic NPC with disease progression on or after platinum-containing chemotherapy.
Key efficacy evidence
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JUPITER-02 (NCT03581786): Randomized, multicenter, single-region, double-blind, placebo-controlled trial (n=289) in metastatic or recurrent, locally advanced NPC without prior systemic chemotherapy for recurrent/metastatic disease. Primary endpoint was BIRC-assessed PFS (RECIST v1.1).
- Median PFS: 11.7 vs 8.0 months (HR 0.52; 95% CI 0.36–0.74; p=0.0003).
- OS: Not reached vs 33.7 months (HR 0.63; 95% CI 0.45–0.89; p=0.0083).
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POLARIS-02 (NCT02915432): Open-label, multicenter, single-country trial (n=172) in unresectable/metastatic NPC previously treated with platinum-based therapy (or progression within 6 months of platinum).
- ORR: 21% (95% CI 15–28); median DOR: 14.9 months (95% CI 10.3–not estimable).
Safety and dosing highlights
Immune-mediated adverse reactions were reported (e.g., pneumonitis, colitis, hepatitis, endocrinopathies). Recommended dosing: 240 mg q3w with chemotherapy (up to 24 months) and 3 mg/kg q2w as monotherapy until progression or unacceptable toxicity.