OTL38 for Intra-operative Imaging of Folate Receptor Positive Ovarian Cancer

Summary

This is a phase 3, randomized, multi-center, single dose, open label, pivotal study in patients diagnosed with, or with high clinical suspicion of, ovarian cancer scheduled to undergo primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery.

Timeline

Start

2018-01-26

Primary completion

2020-04-16

Completion

2020-10-16

Outcome

Met primary endpoint

paper This phase III study of pafolacianine met its primary efficacy end point, identifying additional cancers not otherwise identified or planned for resection. PMID 36070540 ↗

Publications

• Tanyi JL, Randall LM, Chambers SK, Butler KA, Winer IS, Langstraat CL, Han ES, Vahrmeijer AL, Chon HS, Morgan MA, Powell MA, Tseng JH, Lopez AS, Wenham RM. A Phase III Study of Pafolacianine Injection (OTL38) for Intraoperative Imaging of Folate Receptor-Positive Ovarian Cancer (Study 006). J Clin Oncol. 2023 Jan 10;41(2):276-284. doi: 10.1200/JCO.22.00291. Epub 2022 Sep 7.

Drugs

Indications