VA CFU Criteria Formulary Advisor Reference
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TORIPALIMAB-TPZI INJ,SOLN

Generic Name
TORIPALIMAB-TPZI INJ
Brand Names
LOQTORZI
Drug Class
ANTINEOPLASTIC,OTHER
Formulary Status
PA-F
Copay Tier
3
Last Updated
2023-12-07

Clinical Criteria Summary

Document 640

Exclusion Criteria

  • Autoimmune disease
  • Immunosuppression requiring a corticosteroid equivalent to >10 mg per day of prednisone
  • Primary immunodeficiency
  • History of allogeneic hematopoietic stem cell or solid organ transplant
  • Pregnancy
  • Lactating

Inclusion Criteria

  • Indication is FDA-approved
  • Care is provided by a VA/VA Community Care oncology provider
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Goals of care and role of Palliative Care consult have been discussed and documented

Reproductive Health & Contraception Requirements

  • Female patients of child-bearing potential: Counseling provided on contraception and risks vs. benefits of treatment; use effective contraception during therapy and for 4 months after the last dose
  • Male patients with female partners of child-bearing potential: Counseling provided on contraception and risks vs. benefits of treatment; use effective contraception during therapy and for 4 months after the last dose

Document 658

Indications

  • First-line treatment in combination with cisplatin and gemcitabine for metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC)
  • Single agent for recurrent unresectable or metastatic NPC with progressive disease on or after platinum-containing chemotherapy

Dosing & Administration

  • In combination with cisplatin and gemcitabine: 240 mg IV every 3 weeks
  • As a single agent: 3 mg/kg IV every 2 weeks
  • Dosage form: Injection 240 mg/6 mL [40 mg/mL] solution as a single-dose vial

Patient Eligibility / Inclusion Criteria

  • Metastatic or recurrent, locally advanced NPC
  • First-line setting: No prior systemic therapy for recurrent or metastatic disease; if recurrent disease, last treatment (radiotherapy or chemotherapy) > 6 months from last treatment
  • Subsequent-line setting: Refractory to standard chemotherapy including >2 lines of systemic chemo; first line must have included a platinum-based regimen; neoadjuvant, adjuvant, or concurrent chemoradiotherapy counts as a line of therapy only if progressive disease occurs; intolerance to chemotherapy is not considered a line of therapy
  • ECOG Performance Status 0-1

Exclusion Criteria

  • Autoimmune conditions (other than stable hypothyroidism or Type I diabetes mellitus within 6 months after end of treatment)
  • Requirement for systemic immunosuppression
  • Active CNS metastases

Clinical Guidelines & VA Pathway Alignment

  • VA Head & Neck Oncology Pathway: Recommended as first-line therapy in patients with recurrent or metastatic NPC who are candidates for immunotherapy and cisplatin
  • NCCN Guidelines v4.2024 (Preferred 1L): Cisplatin/gemcitabine; cisplatin/gemcitabine + toripalimab; cisplatin/gemcitabine + other PD-1 inhibitor
  • NCCN Guidelines v4.2024 (Preferred Subsequent Line): Toripalimab for disease progression on or after platinum-containing therapy

Safety & Monitoring Considerations

  • No boxed warnings or contraindications listed
  • Monitor for immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic hematopoietic stem cell transplantation, and embryo-fetal toxicity
  • Prednisone-equivalent >10 mg/day may diminish immune checkpoint inhibitor effect

Source Documents

Document 640 Document 658