Elenagen, a p62/SQSTM1-encoding plasmid, improves overall survival in platinum-resistant ovarian cancer patients: a phase II trial
Bibliographic record
Abstract
Abstract Background Platinum-resistant ovarian cancer remains a major therapeutic challenge, with limited benefit from currently available cytotoxic agents. Elenagen is a newly developed plasmid DNA–based anticancer agent that encodes p62/SQSTM1 protein, a multifunctional adaptor protein involved in selective autophagy, signal transduction, and modulation of the inflammatory response. We previously reported the progression-free survival outcomes of patients with platinum-resistant ovarian cancer treated with Elenagen. We report the overall survival results from a phase II randomized controlled trial comparing Elenagen plus gemcitabine with gemcitabine alone. Methods This open-label, prospective, randomized, two-center study enrolled women with platinum resistant ovarian cancer. Patients were randomly assigned (1:1) to receive gemcitabine monotherapy (1,000 mg/m 2 on days 1 and 8 every 21 days) or gemcitabine plus Elenagen (2.5 mg intramuscularly weekly). The primary endpoint was OS; secondary endpoints included safety, post-progression outcomes, and time-dependent analyses of Elenagen exposure. Survival was analyzed using Kaplan–Meier and Cox proportional hazards models. Results Thirty patients (15 per arm) were evaluable for overall survival. Baseline demographic and clinical characteristics were balanced between groups. Among patients with elevated CA-125 levels (>35 U/mL), median overall survival was 13 months (95% CI, 10–27) in the gemcitabine arm and 25 months (95% CI, 17–not reached) in the Elenagen plus gemcitabine arm (log-rank p = .031). Treatment with Elenagen was associated with a 59% reduction in the risk of death (HR = 0.41; 95% CI, 0.18–0.94; p = .036). Time-dependent and landmark analyses demonstrated a positive association between longer Elenagen exposure and improved survival (p<.001). No additional safety signals were observed compared with gemcitabine alone. Post-progression survival and subsequent therapy patterns were comparable between arms. Conclusions The addition of Elenagen to gemcitabine significantly prolonged overall survival in patients with platinum-resistant ovarian cancer without increasing toxicity. Trial registration NCT05979298, 2023-08-07
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".