First Patient Enrolled in Pafolacianine Sodium Trial for Lung Cancer Lesions

On Target Laboratories has enrolled the first patient in the ELUCIDATE Trial, a Phase 3 clinical trial evaluating the efficacy and safety of pafolacianine sodium (formerly OTL38) in the intraoperative detection of lung cancer lesions.

"This pivotal study is pioneering the use of fluorescence guidance to intraoperatively identify lung cancer in real-time," said Sunil Singhal, M.D., Vice Chair, Translational Research and the William Maul Measey Associate Professor in Surgical Research in the Perelman School of Medicine at the University of Pennsylvania and a member of Penn's Abramson Cancer Center and principal investigator of the study. "Using a fluorescent imaging marker with high affinity and specificity for lung cancer allows surgeons to more effectively remove all the malignant tissue and have greater confidence in a complete resection."

The Phase 3 study will assess the efficacy, safety, and tolerability of pafolacianine sodium in patients with lung cancer. This multi-center trial is expected to enroll up to 130 patients. Top-line data from the trial are expected in 2021.

"Treating our first patient in the ELUCIDATE Phase 3 Trial is an enormous achievement for On Target Laboratories," said Chris Barys, CEO of On Target Laboratories. "We believe this transformational technology should become the standard of care and look forward to bringing it to market so more lung cancer patients can benefit from the improved outcomes associated with more complete tumor resections."

To date, there have been limited ways for surgeons to confidently assess the location and full extent of cancerous tissue while operating. On Target Laboratories' fluorescent markers are comprised of a near-infrared dye and a targeting molecule, or ligand, that binds to receptors overexpressed on cancer cells. These markers illuminate the cancerous lesions, lighting the way for the resection of malignant tissue and enabling surgeons to see and remove more diseased tissue.

On Target's first novel compound, pafolacianine sodium, targets folate receptors commonly found on many cancers, including lung and ovarian cancers. A small single dose of the compound is administered via intravenous infusion prior to surgery, allowing the surgeon to identify malignant tissue during the procedure using a near-infrared camera.