Penpulimab-kcqx FDA Approval History

Last updated by Judith Stewart, BPharm on April 28, 2025.

FDA Approved: Yes (First approved April 23, 2025)
Generic name: penpulimab-kcqx
Dosage form: Injection
Company: Akeso, Inc.
Treatment for: Nasopharyngeal Carcinoma

Penpulimab-kcqx is a programmed death receptor-1 (PD-1)-blocking antibody for use in the treatment of nasopharyngeal carcinoma.

• Penpulimab-kcqx is indicated:
  - in combination with either cisplatin or carboplatin and gemcitabine for the first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC)
  - as a single agent for the treatment of adults with metastatic non-keratinizing NPC with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.
• Nasopharyngeal carcinoma is an aggressive type of squamous cell carcinoma of the epithelial tissue of the nasopharynx.
• Penpulimab-kcqx is a PD-1 blocking antibody that works to decrease NPC tumor growth by binding to PD-1 and blocking its interaction with PD-L1 and PD-L2.
• FDA approval of penpulimab-kcqx was based on the results of the international Phase III clinical trial AK105-304 and the pivotal AK105-202 study, both of which demonstrated the drug’s clinical benefits and favorable safety profile across two stages of treatment for metastatic NPC.
  - AK105-304 (NCT04974398) was a randomized, double-blind, multi-center trial in 291 patients with recurrent or metastatic NPC who had not received previous systemic chemotherapy. Median progression-free survival was 9.6 months (95% CI: 7.1, 12.5) in the penpulimab-kcqx arm and 7.0 months (95% CI: 6.9, 7.3) in the placebo arm, with 31% and 11% of patients alive and progression-free after 12 months of follow-up in the penpulimab-kcqx and placebo arms, respectively.
  - AK105-202 (NCT03866967) was an open-label, multicenter, single-arm trial of 125 patients with unresectable or metastatic non-keratinizing NPC who had disease progression after platinum-based chemotherapy and at least one other line of therapy. The objective response rate was 28% (95% CI: 20, 37) and median duration of response was not reached (95% CI: 9.2, not estimable).
• Penpulimab-kcqx is administered by intravenous injection over 60 minutes. It is administered every three weeks when used in combination with either cisplatin or carboplatin and gemcitabine, and every two weeks when used as a single agent. Treatment continues until disease progression or a maximum of 24 months. 
• Warnings and precautions associated with penpulimab-kcqx include immune-mediated adverse reactions (pneumonitis, colitis, hepatitis and hepatotoxicity, endocrinopathies, nephritis and renal dysfunction, dermatologic adverse reactions and solid organ transplant rejection), infusion-related reactions, complications of allogeneic HSCT, and embryo-fetal toxicity.
• Common adverse reactions (≥20%):
  - when used in combination with either cisplatin or carboplatin and gemcitabine include nausea, vomiting, hypothyroidism, constipation, decreased appetite, decreased weight, cough, COVID-19 infection, fatigue, rash, and pyrexia.
  - when used as a single agent include anemia and hypothyroidism.

Development timeline for penpulimab-kcqx

Further information

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