A novel DNA-based therapy combined with gemcitabine chemotherapy has demonstrated encouraging survival outcomes in patients with platinum-resistant ovarian cancer, according to results from a randomised phase II study.
Platinum-resistant ovarian cancer remains difficult to treat, with limited effective treatment options and poor long-term outcomes. Investigators evaluated the addition of elenagen, a plasmid DNA therapy encoding the p62/SQSTM1 protein, to standard gemcitabine chemotherapy in women with advanced platinum-resistant disease.
CLINICAL SUMMARY
What was examined
A randomised phase II trial evaluated the addition of the plasmid DNA therapy elenagen to gemcitabine chemotherapy in patients with platinum-resistant ovarian cancer.
Key findings
-
Elenagen plus gemcitabine improved overall survival compared with gemcitabine alone
-
Among patients with elevated baseline CA-125 levels, median overall survival was approximately 25 months versus about 13 months
-
The combination therapy showed a safety profile comparable to gemcitabine alone
Clinical implications
-
DNA-based therapies may represent a novel treatment approach in platinum-resistant ovarian cancer
-
Combination therapy with elenagen may improve outcomes in a setting with limited treatment options
-
Larger studies are required to confirm clinical benefit
In this open-label, randomised phase II trial conducted at two centres, patients were assigned to receive gemcitabine alone or gemcitabine in combination with weekly intramuscular elenagen. Thirty patients were evaluable for overall survival, with 15 patients in each treatment arm.
Among patients with elevated baseline CA-125 levels, the addition of elenagen was associated with improved overall survival compared with gemcitabine alone. Median overall survival was approximately 25 months with the combination therapy compared with around 13 months with chemotherapy alone, representing a substantial survival improvement. The combination therapy was associated with an estimated 60% reduction in the risk of death compared with gemcitabine alone.
The combination was generally well tolerated, with no major increase in treatment-related toxicity observed compared with chemotherapy alone.
Elenagen is designed to influence tumour biology and immune signalling through expression of the multifunctional p62/SQSTM1 protein, representing a novel DNA-based therapeutic approach in oncology.
Although the study was small, the findings suggest that elenagen combined with gemcitabine may represent a potential new treatment strategy for platinum-resistant ovarian cancer and support further evaluation in larger clinical trials.
Paper: Krasny, Sergei et al. Elenagen, a p62/SQSTM1-encoding plasmid, improves overall survival in patients with platinum-resistant ovarian cancer: a phase II trial. International Journal of Gynecological Cancer, Access online here.
