On September 12, 2022 On Target Laboratories, Inc., a privately-held biotechnology company developing intraoperative molecular imaging agents to target and illuminate cancer during surgery, reported publication of results from the Phase 3 006 Study of CYTALUX (pafolacianine) injection for intraoperative imaging of folate receptor positive ovarian cancer in the peer-reviewed Journal of Clinical Oncology (Press release, On Target Laboratories, SEP 12, 2022, View Source [SID1234619466]).

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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. 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. In 33% of patients*, near-infrared imaging with CYTALUX identified additional lesions which would have been left behind (P < 0.001, 95% CI [0.243, 0.427]). The rate was higher, at 39.7%, among patients who underwent interval debulking surgery (95% CI [0.270, 0.534]).

"This pivotal study indicates that CYTALUX may offer an important real-time adjunct to current surgical approaches for ovarian cancer," said Chris Barys, President and Chief Executive Officer of On Target. "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."

"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," said Janos L. Tanyi, MD, PhD, an associate professor of Obstetrics and Gynecology in the Perelman School of Medicine at the University of Pennsylvania and principal investigator of the Phase 3 trial. "These results further the evidence that intraoperative molecular imaging may help surgeons achieve complete surgical resection of cancer."

* N=36 out of 109 folate receptor positive ovarian cancer patients. CYTALUX USPI describes the proportion of patients in which CYTALUX identified additional lesions in the "intent-to-image set" regardless of ovarian cancer status (N=36 out of 134, 27%)