Pafolacianine Demonstrates Efficacy in Detection of Folate Receptor-Positive Ovarian Cancer

The use of a single infusion of pafolacianine exhibited promising efficacy in detecting folate receptor-positive ovarian cancer in a study published in The Journal of Clinical Oncology.

“It is well established that the extent of residual disease after surgery is negatively correlated with patient survival in ovarian cancer,” wrote Janos L Tanyi, Hospital of the University of Pennsylvania, Abramson Cancer Center, West Pavilion, Philadelphia, PA and co-authors, adding, “There is an important unmet need to improve the detection and resection of all lesions in ovarian cancer.”

In this phase 3, open-label study, 150 patients across 11 centers received a single infusion of pafolacianine with near-infrared imaging to detect the presence of folate-positive ovarian cancer not detected by white light assessment and palpation.

With 10% set as the study’s threshold for efficacy, pafolacianine identified additional cancer on tissue undetected by white light assessment and palpation, and therefore not planned for resection, in 33.0% (95% CI, 24.3 to 42.7; P < .001) of the 109 patients with folate receptor–positive ovarian cancer. Pafolacianine also yielded an efficacy rate of 39.7% (95% CI, 27.0 to 53.4; P < .001) in patients with folate receptor–positive ovarian cancer who had previously undergone interval debulking surgery.

Overall, pafolacianine with near-infrared imaging detected ovarian cancer at a rate of 83% vs a false positive rate of 24.8%, with complete R0 resection reported in 68 of 109 patients (62.4%). Among the 150 total patients who received an infusion of pafolacianine, none reported serious drug-related adverse events, though 30% (45) did experience adverse events such as nausea, vomiting and abdominal pain.

“Pafolacianine may offer an important real-time adjunct to current surgical approaches for ovarian cancer,” Dr Tanyi and colleagues concluded.

Source:

Tanyi JL, Randall LM, Chambers SK, et al. A Phase III Study of Pafolacianine Injection (OTL38) for Intraoperative Imaging of Folate Receptor-Positive Ovarian Cancer (Study 006) [published online ahead of print, 2022 Sep 7]. J Clin Oncol. 2022;JCO2200291. doi:10.1200/JCO.22.00291