Results of phase 3 trial of injection for ovarian cancer imaging published

Ovarian Cancer

An injection for intraoperative imaging of folate receptor positive ovarian cancer can identify more of the disease than is unable to be identified conventionally.

Biotech company On Target Laboratories announced that the results from its phase 3, 006 study of the Cytalux (pafolacianine) injection had been published in the Journal of Clinical Oncology yesterday (September 12).  

Research article

The research article reports that use of Cytalux during ovarian cancer surgery demonstrated identification of additional ovarian cancer that was not identified with conventional means and not otherwise planned for resection.

During the trial, 150 patients in the safety analysis set received a single infusion of Cytalux, resulting in 109 patients with folate receptor positive ovarian cancer comprising the full analysis set for efficacy.

Chris Barys, president and CEO of On Target Laboratories said: “This pivotal study indicates that Cytalux may offer an important real-time adjunct to current surgical approaches for ovarian cancer.

“We are grateful to the study participants and investigators for their important role in this research and are committed to continuing to pioneer the use and study of intraoperative molecular imaging to increase detection of malignant lesions during surgery.”

On Target Laboratories’ first product

Cytalux, the company’s first product, received FDA approval for ovarian cancer in November 2021. Cytalux targets folate receptors commonly found on many cancers, such as ovarian cancer. A single dose of the agent is administered via intravenous infusion prior to surgery to help the surgeon identify additional malignant tissue during the operation using a near-infrared imaging system.

Janos Tanyi, principal investigator of the phase 3 trial, said: “There are many limitations to current operative approaches of visual inspection and palpation, and I am encouraged that, in this clinical trial, near-infrared imaging with Cytalux identified additional lesions in 33% of participants which would have been left behind.

“These results further the evidence that intraoperative molecular imaging may help surgeons achieve complete surgical resection of cancer.”

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