Study of gynecological cancer therapy moving fast in summer slowdown
Enrollment in large, late-stage trial remains ahead of schedule, per developer
Written by |
A large, late-stage clinical trial testing an immunotherapy in people with gynecological cancers is recruiting participants ahead of schedule, even amid the typically slower summer months, according to an update from treatment developer Imunon.
The Phase 3 study, dubbed OVATION-3 (NCT06915025), is testing the safety and effectiveness of the injection treatment IMNN-001, given alongside chemotherapy. It aims to recruit 500 people with newly diagnosed ovarian, fallopian tube, or peritoneal cancer. Participants will be treated with standard-of-care chemotherapy, with or without IMNN-001.
The trial’s main goal is to determine whether adding IMNN-001 will extend survival among individuals with these gynecological cancers. Recruitment is ongoing at eight sites in the U.S.
When Imunon planned the study, the company expected that each trial site would enroll one new participant, on average, every three months. This predicted rate was based on recruitment in prior studies. But Imunon reports that most trial sites are enrolling faster, averaging one new patient every two months.
“The early momentum we are seeing in OVATION 3 reflects the strength of our clinical data, the quality of our sites and the commitment of the investigators and patients participating in the trial,” Stacy Lindborg, PhD, president and CEO of Imunon, said in a company press release. “We’ve seen enrollment build quarter after quarter, including through the early summer months when trials typically slow down, a trend we view as a strong signal of investigator and patient engagement.”
Based on this faster than expected enrollment, Imunon now expects that the trial will be fully enrolled by mid-2029. The company noted that it is planning multiple interim analyses. If those meet prespecified criteria, Imunon hopes to use the interim data as a basis to file for approval of IMNN-001 in the U.S., according to the release.
DNA-based therapy aims to treat ovarian, fallopian tube cancers
IMNN-001 is a DNA-based immunotherapy designed to be administered by injection into the abdominal cavity. The therapy aims to trigger cells to produce interleukin-12 (IL-12), a signaling molecule that can rally cancer-fighting immune cells to more effectively attack tumors.
Imunon said the therapy has so far shown a good safety profile, with safety data comparable between patients receiving IMNN-001 and those receiving standard of care alone.
“The consistent safety profile we’ve now observed across multiple studies further [reinforces] our confidence in IMNN-001, uniquely designed to safely exploit the pluripotent capability of IL-12 to recruit the entirety of the patient’s own immune system to fight cancer, as we continue to advance our pivotal Phase 3 OVATION 3 trial,” Lindborg said.
According to Imunon, the speedy enrollment in OVATION-3 is at least partly attributable to positive data from the Phase 2 OVATION 2 trial (NCT03393884), an earlier study that suggested IMNN-001 may extend survival in people with newly diagnosed advanced ovarian cancer.
OVATION-3 is now testing the therapy in people with a range of gynecological cancers, including those affecting the ovaries and fallopian tubes, a pair of ducts in the female reproductive system that connect the ovaries to the uterus. People with peritoneal cancer, which affects the thin membrane lining the inside of the abdomen and pelvis, are also being recruited.
More than 70% of the trial sites are meeting or exceeding the expected average enrollment rate, per the company.
Leave a comment
Fill in the required fields to post. Your email address will not be published.