Experts reveal pafolacianine sodium may offer a novel real-time adjunct to current surgical imaging practice in ovarian cancer surgery, according to a phase 3 study being presented at the virtual 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.
A phase 3, randomized, multicenter single dose, open-label pivotal trial, evaluated patients with ovarian cancer to confirm efficacy and safety of pafolacianine sodium in combination with intraoperative near-infrared fluorescence (NIRF) imaging to detect additional lesions not detected by palpation and normal white light alone.
Pafolacianine sodium was administered to 150 total patients who were scheduled to undergo cytoreductive surgery from March 2018 through April 2020. Patients had primarily serous adenocarcinoma (n = 72; 68.6%) and advanced stage disease (n = 83; 76.1%). To note, in 33% of patients, NIRF imaging with pafolacianine sodium identified additional lesions that were not planned for resection and were not detected by both normal white light and palpation.
Moreover, among the patients who underwent interval debulking surgery, the rate was higher (39.7% of patients. At the individual lesion level, the accuracy of pafolacianine sodium with NIRF to detect ovarian cancer is reflected by sensitivity of 83%.
Dr. Tanyi and co-investigators reported achieving complete resection (R0) in 62.4% of patients. Drug-related adverse events (AEs) included nausea, vomiting, and abdominal pain. Overall, no drug-related serious AEs or deaths were reported.
“Since complete resection (R0) is the strongest predictor of overall survival, methods to enhance detection of lesions are expected to benefit patient outcomes,”- explained Janos L. Tanyi, Hospital of the University of Pennsylvania, alongside his co-investigators.
“This phase 3 trial of pafolacianine sodium with NIRF imaging met its primary endpoint, intraoperatively identifying additional cancer not planned for resection in a statistically significant number of patients. Therefore, pafolacianine sodium may offer a novel real-time adjunct to current surgical imaging practice in ovarian cancer surgery,”- concluded Dr. Tanyi. –Alexis Hyams
Janos Laszlo Tanyi, Hye Sook Chon, Mark Aloysuis Morgan, 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. Presented at: the 2021 ASCO Annual Meeting; June 4-8, 2021; virtual. Abstract 5503.
This article was published by Oncology Learning Network.