Clinician Authors Reveal Positive Results, New Data for Occult Lesions and Histology from Company’s Phase 2 Trial and Phase 3 ELUCIDATE Trial
WEST LAFAYETTE, Ind., February 13, 2025 – As part of a strong fourth quarter of 2024, On Target was featured in two prominent oncology industry articles. Each highlighted clinically significant data from the company’s Phase 2 trial and Phase 3 ELUCIDATE trial and showcased the myriad capabilities of the company’s novel imaging agent, CYTALUX® (pafolacianine) injection.
“Intraoperative Molecular Imaging With Pafolacianine in Resection of Occult Pulmonary Malignancy in the ELUCIDATE Trial” was authored by David Rice, MBBS and colleagues and featured in The Annals of Thoracic Surgery, October 2024. Full text can be found HERE.
The authors concluded CYTALUX identifies occult malignant lesions during pulmonary resection despite thorough preoperative imaging and intraoperative assessment by experienced surgeons.
The results showed CYTALUX identified 29 occult lesions in 23 (23%) participants. Seventeen of 29 (58%) lesions were identified within the same lobe as known lesions; 12 of 29 (42%) were identified in a different lobe from the suspicious nodule known by preoperative assessment. Twenty-three of 29 (79%) of occult lesions were resected with an additional wedge resection. Ten of 29 (34%) lesions were malignant. There was no additional morbidity in participants with lesions resected. With CYTALUX, seven participants had a synchronous primary stage I lung cancer identified, and one participant had additional metastases identified.
“Intraoperative Molecular Imaging With Pafolacianine: Histologic Characteristics of Identified Nodules” was authored by Inderpal S. Sarkaria and colleagues and featured in Clinical Lung Cancer, November 2024. Full text can be found HERE.
The authors concluded, “Intraoperative Molecular Imaging (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.”
A total of 273 lesions resected from 191 patients were analyzed. The identification of primary and occult malignant lesions with CYTALUX in combination with standard practice was improved (P < .001) when compared to standard practice alone. A range of histologies were visualized 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, demonstrating the widespread applicability of CYTALUX targeting folate receptors expressed across multiple cancer types.
About On Target Laboratories, Inc.
On Target Laboratories discovers and develops targeted intraoperative molecular imaging agents to illuminate cancer during surgery. Their molecular imaging technology, based on the pioneering work of Philip S. Low, PhD, Purdue University’s Presidential Scholar for Drug Discovery and the Ralph C. Corley Distinguished Professor of Chemistry, is comprised of a near-infrared dye and a targeting molecule, or ligand, that binds to receptors overexpressed on cancer cells. The imaging agents illuminate the cancerous tissue, which may enable surgeons to detect more cancer that otherwise may have been left behind.
CYTALUX, the Company’s first product, received FDA approval of a New Drug Application for ovarian cancer in November 2021 and a supplemental New Drug Application for lung cancer in December 2022. CYTALUX targets the folate receptors commonly found on many cancers, binds to the cancerous tissue, and illuminates under near-infrared light. A single dose of the agent is administered via intravenous infusion prior to surgery and assists surgeons in visually identifying additional cancerous tissue to be removed during the operation. For more information and to view full Prescribing Information visit www.ontargetlabs.com and www.cytalux.com.
INDICATION AND USAGE
CYTALUX® is an FDA approved optical imaging agent indicated as an adjunct for intraoperative identification of:
- Malignant lesions in adult patients with ovarian cancer.
- Malignant and non-malignant pulmonary lesions in adult patients with known or suspected cancer in the lung.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Infusion-Related Reactions
Adverse reactions including nausea, vomiting, abdominal pain, flushing, hypersensitivity, elevation in blood pressure, dyspepsia, and chest discomfort were reported in patients receiving CYTALUX in clinical studies. A total of 17% of patients experienced reactions during administration of CYTALUX. Reactions typically occurred within 15 minutes of the start of infusion. CYTALUX infusion interruption or discontinuation due to adverse reactions occurred in 11% of all patients. Treatment with antihistamines and/or anti-nausea medication may be used. If an adverse reaction occurs during administration, the infusion can be interrupted and resumed after treatment of the reaction.Risk of
Misinterpretation
Errors may occur with the use of CYTALUX during intraoperative fluorescence imaging to detect ovarian cancer and lesions in the lung, including false negatives and false positives. Non-fluorescing tissue in the surgical field does not rule out the presence of ovarian cancer or lesions in the lung. Fluorescence may be seen in normal tissues including bowel, kidneys, lymph nodes, lungs, and inflamed tissue.
Embryo-Fetal Toxicity
Based on its mechanism of action, CYTALUX may cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential of the potential risk to a fetus. Verify pregnancy status of females of reproductive potential prior to initiating CYTALUX treatment.
Risk of Pafolacianine Aggregation and Infusion Reactions
Use of the incorrect diluent to prepare the CYTALUX infusion solution can cause the aggregation of pafolacianine; aggregation may induce infusion reactions such as nausea, vomiting, abdominal pain or rash. Use only 5% Dextrose Injection to prepare the CYTALUX infusion solution. Do not use other diluents.
DRUG INTERACTIONS
Use of folate, folic acid, or folate-containing supplements may reduce binding of pafolacianine to folate receptors and could reduce the detection of lesions with CYTALUX. Avoid administration of folate, folic acid, or folate-containing supplements within 48 hours before administration of CYTALUX
ADVERSE REACTIONS
The safety of CYTALUX was evaluated in four open label clinical studies, two studies (N = 44 and N = 150) in patients with ovarian cancer and two studies (N = 100 and N = 112) in patients with known or suspected cancer in the lung. A total of 406 patients received 0.025 mg/kg of CYTALUX via intravenous administration.
Adverse reactions that occurred in ≥ 1% of patients were: nausea (13%), vomiting (5%), abdominal pain (2%), flushing (2%), other infusion-related reactions (2%), hypersensitivity (2%), elevation in blood pressure (1%), dyspepsia (1%), and chest discomfort (1%). Adverse reactions occurred during the administration of CYTALUX in 17% of patients.
See full Prescribing Information to learn more.