Interim results of a clinical trial evaluating Celsion’s GEN-1 combined with preoperative chemotherapy to treat patients with advanced ovarian cancer were recently presented at the American Society of Clinical Oncology (ASCO) 2017 Annual Meeting.
The Phase 1b OVATION study (NCT02480374) is a dose-escalating trial that is currently evaluating the safety and effectiveness of GEN-1 (injected into the peritoneum) combined with chemotherapy in patients with newly diagnosed advanced ovarian cancer who will undergo surgery after chemo. The study includes four dose groups designed to include three to six patients per group to identify a maximum-tolerated dose.
GEN-1 is a lipid vesicle containing the DNA of the IL-12 gene. IL-12 is an immune-stimulatory molecule that activates the immune system. By delivering IL-12 directly into cancer cells, GEN-1 reduces the adverse effects caused by increased inflammatory activity in other regions of the body.
According to Celsion, the last patient in this trial has been dosed. Now there will be a safety evaluation by the company’s Data Safety Monitoring Board.
Results showed that, of the 14 treated patients, two achieved a complete response, 10 achieved partial response, and two patients maintained stable disease. Researchers observed a disease control rate (DCR) and an objective response rate (ORR) of 100% and 86%, respectively.
Also, of the five patients in the group treated with the highest dose, four achieved partial response and one was completely treated.
“We have seen promising clinical findings including objective responses [complete and partial] in all patients at the highest dose cohort, along with an 87.5% rate of R0 (margin-negative) resections in the two highest dose cohorts and a 100% rate of R0 resections in the highest dose cohort at [the] time of [cancer] surgery,” Nicolas Borys, senior vice president and chief medical officer at Celsion, said in a news release.
“Additionally, translational research data presented at ASCO demonstrates that GEN-1 is biologically active, producing beneficial cytokines and positively impacting T-cell population in the tumor,” he said.
“We believe that GEN-1 may be stimulating the immune system to improve tumor control in these patients,” Borys added. “We are currently evaluating the most cost-effective development program to continue our clinical evaluation of GEN-1 in subsequent ovarian cancer studies.”
Of the seven patients treated with GEN-1 over a year ago and who are still being followed, one patient saw cancer return after 11.7 months. This result was similar to the 12-month median progression-free survival (PFS) seen in other newly diagnosed patients with stage 3 and 4 ovarian cancer treated with preoperative chemotherapy and cancer surgery.
“This progression-free survival trend adds to the impressive clinical findings seen across a number of meaningful measures used to assess ovarian cancer, like an overall 86% objective tumor response rate and a greater than 60% R0 (margin-negative) surgical resection rate,” said Michael H. Tardugno, Celsion’s president and CEO.
“The consistency and robust nature of the data across all four cohorts and the encouraging clinical responses underscore the potential of GEN-1 to serve as an effective, safe IL-12 immunotherapy in ovarian cancer,” he added.