Elenagen, a p62/SQSTM1-encoding plasmid, improves overall survival in patients with platinum-resistant ovarian

Sergei Krasny1, Yauheni Baranau2, Evgeny Bakin3

  • 1N. N. Alexandrov National Cancer Centre of Belarus, Minsk, Belarus.

Abstract

Insights

Adding Elenagen to gemcitabine significantly improved overall survival for patients with platinum-resistant ovarian cancer. This novel plasmid DNA therapy demonstrated enhanced efficacy without increasing toxicity, offering a promising new treatment option.

Area of Science:

  • Oncology
  • Pharmacology
  • Molecular Biology

Background:

  • Platinum-resistant ovarian cancer presents a significant therapeutic challenge with limited effective treatments.
  • Elenagen, a plasmid DNA-based agent encoding p62/SQSTM1, targets selective autophagy and signal transduction.
  • Previous studies reported progression-free survival outcomes for Elenagen in this patient population.

Purpose of the Study:

  • To evaluate the overall survival results of a phase II randomized controlled trial comparing Elenagen plus gemcitabine versus gemcitabine alone.
  • To assess the safety and efficacy of Elenagen in combination with gemcitabine for platinum-resistant ovarian cancer.

Main Methods:

  • An open-label, prospective, randomized, 2-center study enrolled women with platinum-resistant ovarian cancer.
  • Patients were randomized (1:1) to receive gemcitabine monotherapy or gemcitabine plus Elenagen (2.5 mg IM weekly).
  • Overall survival was the primary endpoint, analyzed using Kaplan-Meier and Cox proportional hazards models.

Main Results:

  • Median overall survival was 25 months (Elenagen + gemcitabine) vs. 13 months (gemcitabine alone) in patients with elevated CA-125 levels (p = .031).
  • Elenagen addition showed a 59% reduction in the risk of death (HR 0.41, p = .036).
  • No additional safety concerns were identified with Elenagen combination therapy.

Conclusions:

  • The combination of Elenagen and gemcitabine significantly prolonged overall survival in patients with platinum-resistant ovarian cancer.
  • Elenagen represents a safe and effective therapeutic option, enhancing gemcitabine's efficacy without increasing toxicity.

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