Elenagen Plus Gemcitabine Demonstrates Overall Survival Benefit in Platinum-Resistant Ovarian Cancer
Clinical Summary:
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Design/Population: This randomized phase 2 trial evaluated elenagen, a plasmid DNA–based immunomodulatory agent encoding p62/SQSTM1, plus gemcitabine versus gemcitabine alone in patients with platinum-resistant ovarian cancer.
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Key Outcomes: Adding elenagen to gemcitabine significantly prolonged overall survival compared with gemcitabine alone, reducing the risk of death by 59%. Time-dependent analyses demonstrated an association between longer elenagen exposure and improved survival, while the safety profile remained comparable between treatment groups.
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Clinical Relevance: These findings support further investigation of elenagen in combination with chemotherapy as a potential treatment strategy for platinum-resistant ovarian cancer.
Results from a randomized phase 2 trial demonstrated that adding elenagen to gemcitabine significantly improved overall survival (OS) compared with gemcitabine alone in patients with platinum-resistant ovarian cancer.
"Platinum-resistant ovarian cancer remains a major therapeutic challenge, with limited benefit from currently available cytotoxic agents," stated Sergei Krasny, MD, Alexandrov National Cancer Centre of Belarus, Minsk, Belarus, and coauthors. "Elenagen is a newly developed plasmid DNA-based anti-cancer agent that encodes p62/SQSTM1 protein, a multi-functional adapter protein involved in selective autophagy, signal transduction, and modulation of the inflammatory response."
In this study, 30 patients were randomized 1:1 to receive 1000 mg/m² of gemcitabine on days 1 and 8 either alone (n = 15) or with 2.5 mg of once weekly intramuscular elenagen (n = 15) in 21-day cycles. The primary end point was OS. Secondary end points included progression-free survival (PFS) and time-dependent analyses of elenagen exposure.
Median OS was 13 months with gemcitabine compared with 25 months with elenagen plus gemcitabine (P = .031). Treatment with elenagen was associated with a 59% reduction in the risk of death compared with gemcitabine alone (hazard ratio [HR], 0.41; 95% CI, 0.18 to 0.94; P = .036).
Time-dependent and landmark analyses demonstrated a significant association between longer elenagen exposure and improved survival (P < .001). The safety profile was similar between treatment groups, with no new toxicity signals observed, and post-progression survival did not differ between the study arms.
“The addition of elenagen to gemcitabine chemotherapy is effective in patients with platinum-resistant ovarian cancer, increasing [OS] without elenagen-associated side effects," concluded Dr Krasny et al. “Future studies of elenagen with various tumors and chemotherapy regimens, especially gemcitabine, are warranted.”
Source:
Krasny S, Baranau Y, Bakin E, et al. Elenagen, a p62/SQSTM1-encoding plasmid, improves overall survival in patients with platinum-resistant ovarian cancer: A phase II trial. Int J Gynecol Cancer. Published online: January 7, 2026. doi: 10.1016/j.ijgc.2025.104456
