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A Randomized, Double-blind, Multi-center Phase III Study of Penpulimab (AK105) Combined With Chemotherapy Versus Placebo Combined With Chemotherapy in the First-line Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma

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Trial Profile

A Randomized, Double-blind, Multi-center Phase III Study of Penpulimab (AK105) Combined With Chemotherapy Versus Placebo Combined With Chemotherapy in the First-line Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 06 Jun 2025

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At a glance

  • Drugs Carboplatin (Primary) ; Cisplatin (Primary) ; Gemcitabine (Primary) ; Penpulimab (Primary)
  • Indications Carcinoma; Liver metastases; Nasopharyngeal cancer
  • Focus Registrational; Therapeutic Use
  • Sponsors Akeso Biopharma

Most Recent Events

  • 30 Apr 2025 Results (as of 29 Apr 2024), reporting efficacy and safety data over median follow-up time 19 months presented at the 116th Annual Meeting of the American Association for Cancer Research
  • 24 Apr 2025 According to Akeso Biopharma media release, based on AK105-304 & AK105-202 study, U.S. FDA has approved penpulimab-kcqx, in combination with cisplatin/carboplatin & gemcitabine for first-line treatment of adult recurrent/metastatic non-keratinizing nasopharyngeal carcinoma (NPC). FDA also approved penpulimab-kcqx as single agent for adults with metastatic non-keratinizing NPC with disease progression on or after platinum-based chemotherapy and with least one other prior line of therapy.
  • 25 Feb 2025 Planned End Date changed from 15 Sep 2026 to 23 Dec 2026.

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