Loqtorzi

Nasopharyngeal carcinoma (NPC) — metastatic or recurrent locally advanced, in combination with cisplatin and gemcitabine as first-line treatment; NPC — recurrent unresectable or metastatic following prior platinum-containing chemotherapy, as single agent.

NPC first-line (with chemo): 240 mg IV every 3 weeks for up to 6 cycles with cisplatin/gemcitabine, followed by 240 mg IV q3w as maintenance for up to 24 months
NPC monotherapy: 3 mg/kg IV every 2 weeks until progression or unacceptable toxicity
Infusion time: Over 60 minutes; may reduce to 30 minutes if no prior infusion reactions

Injection: 240 mg/6 mL (40 mg/mL) in single-dose vial

None listed.

• Immune-Mediated Adverse Reactions: Pneumonitis (3.7%), colitis (0.6%), hepatitis (2.3%), endocrinopathies (hypothyroidism 13%, hyperthyroidism 3.2%, adrenal insufficiency 0.6%, type 1 DM 0.2%), nephritis (1.2%), dermatologic (2.5%), myocarditis, myositis, encephalitis, Guillain-Barré.
• Infusion-Related Reactions: In 2.1%.
• Embryo-Fetal Toxicity

Nausea (42%), fatigue (35%), decreased appetite (27%), constipation (24%), musculoskeletal pain (22%), anemia (21%), rash (18%), vomiting (17%), cough (16%), hypothyroidism (13%), diarrhea (13%)

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

Consult the complete prescribing information for drug interactions, including effects on CYP enzymes, transporters, and concomitant medications that may require dose adjustments or monitoring.

Consult the full prescribing information for pregnancy-related considerations.

Refer to prescribing information for lactation guidance.

Pediatric safety and efficacy information is detailed in the full label.

Dose modifications for organ impairment are specified in the complete prescribing information.

Toripalimab is a humanized IgG4κ monoclonal antibody that binds to PD-1 and blocks its interaction with PD-L1 and PD-L2. By preventing PD-1 pathway-mediated inhibition of the immune response, toripalimab restores T-cell-mediated anti-tumor activity. It was the first anti-PD-1 antibody approved for nasopharyngeal carcinoma in the US.

Half-life: approximately 17 days at 240 mg q3w. Steady-state achieved by Cycle 4. Clearance: 0.24 L/day. Volume of distribution: approximately 5.3 L.

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

• JUPITER-02 — Toripalimab + gemcitabine/cisplatin vs. placebo + chemo in 1L nasopharyngeal carcinoma. Phase III, n=289.
  🔬 NCT03581786 ↗ 📄 Primary Publication ↗

Loqtorzi has FDA-approved indications across the following cancer types covered on PipelineEvidence: