TY - JOUR
T1 - A Phase III Study of Pafolacianine Injection (OTL38) for Intraoperative Imaging of Folate Receptor-Positive Ovarian Cancer (Study 006)
AU - Tanyi, Janos L.
AU - Randall, Leslie M.
AU - Chambers, Setsuko K.
AU - Butler, Kristina A.
AU - Winer, Ira S.
AU - Langstraat, Carrie L.
AU - Han, Ernest S.
AU - Vahrmeijer, Alexander L.
AU - Chon, Hye Sook
AU - Morgan, Mark A.
AU - Powell, Matthew A.
AU - Tseng, Jill H.
AU - Lopez, Alexis S.
AU - Wenham, Robert M.
N1 - Funding Information:
The authors thank the patients and their families for participation in this study, as well as all investigators and clinical study site staff who supported the study. The authors also wish to acknowledge clinical study conduct support from Synteract Inc (Carlsbad, CA), pathology services of Moffitt Cancer Center Tissue Core and the Total Cancer Care program with special thanks to Michelle Fournier and the histology team, and manuscript writing and editing support from Kerri Pierz, PhD (Elucidate Health, LLC) and H.B. Slade, MD (Chisholm Clinical Research Services, LLC). Moffitt Cancer Center is an NCI-designated Comprehensive Cancer Center under grant number P30-CA076292.
Publisher Copyright:
© American Society of Clinical Oncology.
PY - 2023/1/10
Y1 - 2023/1/10
N2 - PURPOSEThe adjunctive use of intraoperative molecular imaging (IMI) is gaining acceptance as a potential means to improve outcomes for surgical resection of targetable tumors. This confirmatory study examined the use of pafolacianine for real-time detection of folate receptor-positive ovarian cancer.METHODSThis phase III, open-label, 11-center study included subjects with known or suspected ovarian cancer, scheduled to undergo cytoreductive surgery. The objectives were to confirm safety and efficacy of pafolacianine (0.025 mg/kg IV), given ≥ 1 hour before intraoperative near-infrared imaging to detect macroscopic lesions not detected by palpation and normal white light.RESULTSFrom March 2018 through April 2020, 150 patients received a single infusion of pafolacianine (safety analysis set); 109 patients with folate receptor-positive ovarian cancer comprised the full analysis set for efficacy. In 33.0% of patients (95% CI, 24.3 to 42.7; P <.001), pafolacianine with near-infrared imaging identified additional cancer on tissue not planned for resection and not detected by white light assessment and palpation, exceeding the prespecified threshold of 10%. Among patients who underwent interval debulking surgery, the rate was 39.7% (95% CI, 27.0 to 53.4; P <.001). The sensitivity to detect ovarian cancer was 83%, and the patient false-positive rate was 24.8%. Investigators reported achieving complete R0 resection in 62.4% (68 of 109) of patients. Drug-related adverse events were reported by 30% of patients (45 of 150) and most commonly included nausea, vomiting, and abdominal pain. No drug-related serious adverse events or deaths were reported.CONCLUSIONThis phase III study of pafolacianine met its primary efficacy end point, identifying additional cancers not otherwise identified or planned for resection. Pafolacianine may offer an important real-time adjunct to current surgical approaches for ovarian cancer.
AB - PURPOSEThe adjunctive use of intraoperative molecular imaging (IMI) is gaining acceptance as a potential means to improve outcomes for surgical resection of targetable tumors. This confirmatory study examined the use of pafolacianine for real-time detection of folate receptor-positive ovarian cancer.METHODSThis phase III, open-label, 11-center study included subjects with known or suspected ovarian cancer, scheduled to undergo cytoreductive surgery. The objectives were to confirm safety and efficacy of pafolacianine (0.025 mg/kg IV), given ≥ 1 hour before intraoperative near-infrared imaging to detect macroscopic lesions not detected by palpation and normal white light.RESULTSFrom March 2018 through April 2020, 150 patients received a single infusion of pafolacianine (safety analysis set); 109 patients with folate receptor-positive ovarian cancer comprised the full analysis set for efficacy. In 33.0% of patients (95% CI, 24.3 to 42.7; P <.001), pafolacianine with near-infrared imaging identified additional cancer on tissue not planned for resection and not detected by white light assessment and palpation, exceeding the prespecified threshold of 10%. Among patients who underwent interval debulking surgery, the rate was 39.7% (95% CI, 27.0 to 53.4; P <.001). The sensitivity to detect ovarian cancer was 83%, and the patient false-positive rate was 24.8%. Investigators reported achieving complete R0 resection in 62.4% (68 of 109) of patients. Drug-related adverse events were reported by 30% of patients (45 of 150) and most commonly included nausea, vomiting, and abdominal pain. No drug-related serious adverse events or deaths were reported.CONCLUSIONThis phase III study of pafolacianine met its primary efficacy end point, identifying additional cancers not otherwise identified or planned for resection. Pafolacianine may offer an important real-time adjunct to current surgical approaches for ovarian cancer.
UR - http://www.scopus.com/inward/record.url?scp=85141460569&partnerID=8YFLogxK
U2 - 10.1200/JCO.22.00291
DO - 10.1200/JCO.22.00291
M3 - Article
C2 - 36070540
AN - SCOPUS:85141460569
SN - 0732-183X
VL - 41
SP - 276
EP - 284
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 2
ER -