ELENAGEN combined with gemcitabine significantly improves overall survival in platinum resistant ovarian cancer, according to Phase two randomised data demonstrating a marked reduction in mortality risk without added toxicity.
Elenagen Improves Survival in Platinum Resistant Ovarian Cancer
Platinum resistant ovarian cancer remains a therapeutic challenge, with limited benefit from available cytotoxic agents. Elenagen is a plasmid deoxyribonucleic acid based anticancer agent encoding the p62 sequestosome one protein, a multifunctional adaptor involved in selective autophagy, signal transduction, and modulation of inflammatory responses.
In this open label, prospective, randomised two centre study, women with platinum resistant ovarian cancer were assigned in a one-to-one ratio to receive gemcitabine monotherapy at 1000 mg per square metre on Days one and eight every 21 days, or gemcitabine plus Elenagen at 2.5 mg administered intramuscularly weekly. The primary endpoint was overall survival, while secondary endpoints included safety, post progression outcomes, and time dependent analyses of Elenagen exposure. Survival analyses were conducted using Kaplan–Meier and Cox proportional hazards models.
Thirty patients, 15 per arm, were evaluable for overall survival. Baseline demographic and clinical characteristics were balanced between groups. Among patients with elevated cancer antigen 125 levels above 35 U per millilitre, median overall survival was longer in the combination arm: 25 months; 95% CI: 17–not reached versus 13 months; 95% CI: 10–27 in the gemcitabine arm, with log rank p=0.031. Treatment with Elenagen was associated with a reduced risk of death: hazard ratio: 0.41; 95% CI: 0.18–0.94; p=0.036.
Exposure Duration and Survival Benefit
Time dependent and landmark analyses demonstrated a positive association between longer Elenagen exposure and improved survival: p<0.001. These data are consistent with a potential duration response effect.
Safety And Post Progression Outcomes
No additional safety signals were observed with the addition of Elenagen compared with gemcitabine alone. Post progression survival and patterns of subsequent therapy were comparable between treatment arms.
With regard to clinical implications, the addition of Elenagen to gemcitabine prolonged overall survival in patients with platinum resistant ovarian cancer without increasing toxicity, supporting further investigation of this deoxyribonucleic acid based therapeutic strategy.
Reference
Krasny S 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. 2026:104456.
