On Target Laboratories Announces Publication in Journal of Thoracic and Cardiovascular Surgery Phase 3 ELUCIDATE Trial of CYTALUX® (pafolacianine) Injection for Intraoperative Imaging of Lung Cancer

WEST LAFAYETTE, Ind., March 27, 2023 /PRNewswire/ -- On Target Laboratories, Inc., a privately held biotechnology company developing intraoperative molecular imaging (IMI) agents to target and illuminate cancer during surgery, today announced publication of results from the ELUCIDATE Phase 3 Trial of CYTALUX (pafolacianine) injection for use of IMI for cancer in the lung. The results were published in the peer-reviewed Journal of Thoracic and Cardiovascular Surgery. In December 2022, the U.S. Food and Drug Administration expanded the indication of CYTALUX after previously granting approval for ovarian cancer in 2021, making it the first and only targeted molecular imaging agent that intraoperatively illuminates lung and ovarian cancers in real-time during surgery.

In the ELUCIDATE trial (n=112), patients with suspected or biopsy-confirmed cancer in the lung scheduled for lung resection were administered CYTALUX intravenously within 24 hours before surgery. The research article reports that, in patients randomized to receive IMI with CYTALUX, a clinically significant event (CSE) occurred in 53% of patients (N=53 out of 100, p < 0.0001).* CSEs included locating the primary lesion that the surgeon could not otherwise locate with conventional techniques in 19% of patients, discovery of one or more additional cancerous lesions which was previously unknown in 8% of patients, and identification of a close resection margin (10mm) in 38% of patients. Among additional cancerous lesions discovered with CYTALUX, 73% were outside the planned resection field. Overall, surgeons reported changing the scope of their surgical plan in 29% patients (22 increase, 7 decrease). No drug-related serious adverse events occurred.

"Identification of lesions during surgery can be challenging, especially if the lesions are small or deep below the surface of the lung," said Inderpal Sarkaria, MD, Thoracic Surgeon at the University of Pittsburgh Medical Center and lead author on the publication. "Our research confirmed that CYTALUX helps surgeons more easily visualize lesions and detect additional cancer at one of the most critical moments – during their operation."

"We're thrilled that this trial contributed to CYTALUX being available as a first-in-class agent to aid thoracic surgeons in visualizing otherwise undetectable cancerous lesions in the lung," said Chris Barys, President, Chief Executive Officer and Board Member of On Target Laboratories. "We believe that the adjunctive use of CYTALUX during lung cancer surgery will add significant value to surgeons, helping them make decisions in real-time that potentially lead to removing more cancer from their patient and improving outcomes."

* N=53 out of 100 patients with cancer in the lung. CYTALUX USPI describes a clinically significant event rate of 24% (N=24 out of 100) based on localization of the primary lesion (N=19 out of 100, 19%) and identification of a synchronous cancerous lesions (N=8 out of 100, 8%).

About the ELUCIDATE Trial

The ELUCIDATE (Enabling LUng Cancer IDentification Using FolATE Receptor Targeting) trial was a Phase 3, multi-center, single dose, open label trial and included 12 sites across the United States. The clinical trial (NCT04241315) investigated the use of CYTALUX (pafolacianine) injection in patients scheduled to undergo thoracic surgery for confirmed or suspected lung cancer. 

About Intraoperative Molecular Imaging

To date, there have been limited ways for surgeons to confidently assess the location and full extent of cancerous tissue while operating. Intraoperative Molecular Imaging (IMI) is an emerging category of technology for surgical oncology in which targeted imaging agents are injected into patients to highlight cancer cells making them visible during surgery.

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 for ovarian cancer in November 2021 and 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 visit www.ontargetlabs.com and www.cytalux.com.

What is CYTALUX?

CYTALUX is an FDA approved prescription medication that is given prior to surgery to adult patients who have ovarian cancer or known or suspected cancer in the lung. It helps surgeons visualize ovarian and lung cancer lesions during surgery.

Important Safety Information

Infusion-Related Reactions
Adverse reactions including nausea, vomiting, abdominal pain, flushing, allergic reaction, elevation in blood pressure, indigestion, and chest discomfort were reported during the administration of CYTALUX. Your doctor may treat you with antihistamines and/or anti-nausea medication.
Risk of Misinterpretation
Errors may occur with the use of CYTALUX. Sometimes cells may light up even if they are not cancerous or those that are cancerous may not light up. Also, non-cancerous cells from other areas may light up, such as areas of the bowel, kidneys, lymph nodes, lungs, and inflamed tissue.
Pregnancy
CYTALUX may cause fetal harm when administered to a pregnant woman. There are no available human data to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Contact your healthcare provider with a known or suspected pregnancy.
Folate Supplementation Usage
Folic acid may reduce the detection of cancerous tissue with CYTALUX. Patients should stop taking folate, folic acid, or folate-containing supplements 48 hours before administration of CYTALUX.
Adverse Reactions
The most common side effects of CYTALUX reported in clinical trials were nausea (13%), vomiting (5%), abdominal pain (2%), flushing (2%), other infusion-related reactions (2%), allergic reaction (2%), elevation in blood pressure (1%), indigestion (1%), and chest discomfort (1%) during administration.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of CYTALUX. For more information, ask your healthcare provider.
Call your doctor for medical advice about side effects. You may report side effects to On Target Laboratories at 1-844-434-9333 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

See full Prescribing Information for more details.

SOURCE On Target Laboratories, Inc.