Intraoperative Molecular Imaging With Pafolacianine: Histologic Characteristics of Identified Nodules.

Background: With increased early detection efforts, surgery for early-stage lung cancer is expected to rise. Pafolacianine is the first FDA approved targeted optical imaging agent indicated as an adjunct for intraoperative identification of malignant and nonmalignant pulmonary lesions in adult patients with known or suspected cancer in the lung.
Methods: This is a retrospective review of the malignant and nonmalignant lesions identified by pafolacianine with intraoperative molecular imaging (IMI) in the multi-center Phase 2 and Phase 3 ELUCIDATE clinical trials. All lesions meeting the intent to treat criteria from the combined studies were included. Histopathology for malignant and nonmalignant lesions and immunohistochemistry (ICH) for folate receptor alpha (FRα) and folate receptor beta (FRβ), which pafolacianine binds to, were assessed.
Results: A total of 273 lesions resected from 191 patients were analyzed. The identification of primary and occult malignant lesions with pafolacianine in combination with standard practice was improved (P < .001) when compared to standard practice alone. A range of histologies were demonstrated including adenocarcinoma (primary and metastatic), squamous cell carcinoma, adenoid cystic carcinoma, chordoma, lymphoma, and papillary thyroid cancer. Ninety-two percent (205 of 223) of lesions tested for folate expression were positive for FRα or FRβ expression.
Conclusions: While initially intended to identify adenocarcinoma, IMI with pafolacianine targets a broad histological cross-section of malignant and nonmalignant primary and metastatic lesions in the lung. As real-world use expands, additional insight will continue to inform utility of pafolacianine in clinical practice and may broaden clinical applicability.
Competing Interests: Disclosure The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Doctors Murthy, Singhal, Reddy, Martin, Rice, and Sarkaria were investigators in the sponsored trials and report financial support, administrative support, equipment, drugs, or supplies, provided by On Target Laboratories during the course of the clinical trials. No compensation was paid directly to the investigators from On Target Laboratories. Timothy Biro and Tina Barrett report a relationship with On Target Laboratories that includes employment and equity or stock. Dr. Gary Stevens is with Dynastat which was paid by the sponsor On Target Laboratories for statistical analysis work related to the publication. Dr. Lopez is an employee of Moffitt Cancer Center which was paid by the sponsor On Target Laboratories for IHC and pathology related services. Dr Murthy and Dr. Sarkaria report a relationship with On Target Laboratories. Dr Reddy, Dr Rice, Dr Martin, and Dr. Singhal report no further relationship with On Target Laboratories. This report includes data generated from a multi-center phase 2 trial and a randomized multi-center Phase 3 trial sponsored by On Target Laboratories.
(Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)