WEST LAFAYETTE, Ind., May 20, 2021 /PRNewswire/ -- On Target Laboratories, Inc., a privately held biotechnology company developing fluorescent markers to target and illuminate cancer during surgery, today announced results of the 006 Study, a Phase 3, randomized, multi-center, prospective, open-label study to investigate the safety and efficacy of pafolacianine sodium injection (OTL38) for intraoperative imaging of folate receptor positive ovarian cancer.
In 33% of patients (36 of 109), near-infrared imaging with pafolacianine sodium injection identified additional lesions which would have been left behind (P < 0.001, 95% CI [0.243, 0.427]). Among patients who underwent interval debulking surgery, the rate was higher, at 39.7% of patients (23 of 58; 95% CI [0.270, 0.534]).
"We are proud to share the results of the Phase 3 trial for pafolacianine sodium injection in ovarian cancer, which demonstrated identification of additional cancer that was not planned for resection," said Chris Barys, Chief Executive Officer of On Target Laboratories. "These results get us closer to realizing our mission to make cancer visible during surgery so it can be removed more completely."
The data will be presented on June 7 during the virtual scientific program of the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract # 5503).
"The surgeon's ability to achieve a complete resection in ovarian cancer patients impacts their long-term prognosis," said Dr. Janos L. Tanyi, MD, PhD, an Assistant Professor of Obstetrics and Gynecology in the Perelman School of Medicine at the University of Pennsylvania and Principal Investigator of the trial. "The trial results add to the body of evidence supporting the potential of pafolacianine sodium injection as an adjunct to identify malignant lesions that may otherwise be missed."
About the Phase 3 006 Study
In the Phase 3, randomized, multi-center, open-label study, patients with ovarian cancer who were scheduled to undergo cytoreductive surgery were recruited from 11 sites in the US and Netherlands from March 2018 through April 2020. The primary endpoint was the percent of patients in which ≥1 folate receptor positive ovarian cancer lesion was detected by intraoperative fluorescence imaging on tissue not planned for resection and not detected by normal white light or palpation.
This phase 3 trial of pafolacianine sodium injection with near-infrared imaging met its primary endpoint, intraoperatively identifying additional cancer not planned for resection in a statistically significant number of patients.
The safety profile observed was consistent with the Phase 2 trial published in 2019.1 The most frequently reported drug-related adverse events (AEs) were nausea (18.0%), vomiting (5.3%), and abdominal pain (4.7%). The majority (97%) of drug-related AEs were mild or moderate in severity and were transient in nature. No drug-related serious AEs or deaths were reported.
About Ovarian Cancer
Ovarian cancer ranks fifth in cancer deaths among women, accounting for more deaths than any other cancer of the female reproductive system. The American Cancer Society estimates that in 2021 over 21,000 women in the United States will receive a new diagnosis of ovarian cancer and nearly 14,000 women will die from ovarian cancer.2
About pafolacianine sodium injection (OTL38)
Pafolacianine sodium injection is a targeted fluorescent marker which is under investigation as an adjunct to visual inspection and palpation by providing intraoperative imaging of folate receptor positive ovarian cancer.
Over 95% of ovarian cancers overexpress folate receptors to increase folate uptake for tumor growth.3 Pafolacianine sodium injection is shown to bind to folate receptors and illuminate intraoperatively under near-infrared light. It is administered by standard IV in as little as one hour before surgery.
Earlier this year, On Target Laboratories announced the U.S. Food and Drug Administration has granted Priority review to its New Drug Application for pafolacianine sodium injection in identifying ovarian cancer during surgery.
About On Target Laboratories, Inc.
On Target Laboratories discovers and develops fluorescent markers to target and illuminate cancer with a mission to make cancer visible during surgery so it can be removed more completely. Their intraoperative molecular imaging technology is based on the pioneering work of Philip S. Low, PhD at Purdue University. Pafolacianine sodium injection, the Company's first product, is currently under Priority review with the FDA for ovarian cancer and is being studied in the Phase 3 ELUCIDATE Trial for lung cancer in the US. It is not yet approved. For more information visit www.ontargetlabs.com.
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- L.M. Randall, R.M. Wenham, P.S. Low, et al., A phase II, multicenter, open-label trial of OTL38 injection for the intraoperative imaging of fola..., Gynecologic Oncology, https://doi.org/10.1016/j.ygyno.2019.07.010
- American Cancer Society. 2021. Key Statistics for Ovarian Cancer. Accessed May 2021. https://www.cancer.org/cancer/ovarian-cancer/about/key-statistics.html.
- Markert S, et al. Alpha-folate receptor expression in epithelial ovarian carcinoma and non-neoplastic ovarian tissue. Anticancer Res. 2008 (28): 3568-3572.
SOURCE On Target Laboratories, Inc.