|The following article features coverage from the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting. Click here to read more of Cancer Therapy Advisor‘s conference coverage.|
Pafolacianine sodium injection could be a real-time adjunct to current surgical practice for ovarian cancer, allowing for more lesions to be removed at the time of surgery, according to a study presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.1
According to a press release2 from the manufacturer of pafolacianine sodium, many ovarian cancers overexpress folate receptors to enable uptake of folic acid. Pafolacianine sodium is a novel molecule that binds to folate receptors and illuminates intraoperatively under near-infrared light.
Pafolacianine sodium is given via a standard IV as little as 1 hour before the surgery. The U.S. Food and Drug Administration granted pafolacianine sodium priority review earlier this year.
Results of this phase 3 study of pafolacianine sodium (ClinicalTrials.gov Identifier: NCT03180307) were presented by Janos Laszlo Tanyi, MD, PhD, of the University of Pennsylvania Perelman School of Medicine in Philadelphia, and colleagues.
The study included 150 patients with ovarian cancer who were scheduled to undergo cytoreductive surgery, and 109 patients were included in the efficacy analysis.
The study was designed to confirm the efficacy and safety of pafolacianine sodium in combination with intraoperative near-infrared fluorescence (NIRF) imaging to detect lesions not detected by palpation and normal white light alone.
In 33% of patients, NIRF with pafolacianine sodium identified lesions that were not planned for surgical resection and were not detected by white light and palpation (P <.0001).
Roughly 40% of patients who underwent interval debulking surgery had additional lesions detected. NIRF with pafolacianine sodium had a sensitivity of 83% and a false positive rate of 32.7%. About two-thirds (62.4%) of the patients had complete resection.
Drug-related adverse events were reported in 30% of patients, with the most common events being nausea (18%), vomiting (5.3%), and abdominal pain (4.7%). There were no drug-related serious adverse events or deaths.
Disclosures: This research was supported by On Target Laboratory. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of the authors’ disclosures.
Read more of Cancer Therapy Advisor’s coverage of the 2021 ASCO Annual Meeting by visiting the conference page.
- Tanyi JL, Choon HS, Morgan MA, et al. Phase 3, randomized, single-dose, open-label study to investigate the safety and efficacy of pafolacianine sodium injection (OTL38) for intraoperative imaging of folate receptor positive ovarian cancer. J Clin Oncol. 2021;39:(suppl 15; abstr 5503). doi:10.1200/JCO.2021.39.15_suppl.5503
- On Target Laboratories announces U.S. FDA acceptance and priority review of new drug application for pafolacianine sodium injection for identification of ovarian cancer during surgery [press release]. West Lafayette, IN: BioSpace®; March 3, 2021.