FDA Gives Fast Track Designation to VGT-309 for Lung Tumor Visualization

Efficacy findings from a phase 2 trial demonstrated that abenacianine visualized lung tumor tissue and was well tolerated when used during surgery.

The FDA has given fast track designation to the tumor-targeted fluorescent imaging agent abenacianine (VGT-309) as an adjunct for the intraoperative visualization of primary lung cancer, pulmonary lesions, lymph nodes containing cancer, and positive surgical margins in patients undergoing surgery for known or suspected lung cancer, according to a news release from the drug’s developer, Vergent Bioscience.¹

Previous efficacy results supporting the agent’s use came from a single-center phase 2 trial (NCT05400226) published in The Annals of Thoracic Surgery, which evaluated VGT-309 with intraoperative molecular imaging in patients undergoing surgical resection for known or suspected cancer in the lung.² A total of 17 of 40 (42.5%) patients who underwent pulmonary resection with VGT-309 had at least 1 clinically significant event (CSE), defined as the location of a difficult-to-find tumor, identification of positive margins, or discovery of previously undetected tumors otherwise missed using standard visual and palpitation measures.

Furthermore, near-infrared imaging identified lesions not found by standard surgical margins in 16 patients, additional cancers missed in preoperative imaging in 1 patient, and margins within 5 mm of the closest staple line in 2 patients.

“Receiving fast track designation from the FDA reinforces the potential of abenacianine to address existing deficits in lung cancer surgery by helping surgeons better visualize tumors in the lung during minimally invasive surgical procedures,” John Santini, PhD, president and chief executive officer at Vergent Bioscience, said in the news release on the FDA’s decision.¹ “We look forward to collaborating with the FDA to make abenacianine available to surgeons and their patients as quickly as possible.”

Patients undergoing resection for known or suspected cancer in the lung received preoperative intravenous VGT-309 at 0.32 mg/kg. Nodule localization and resection were performed using standard surgical techniques during the procedure. Then, near-infrared imaging was used to localize nodules, seek occult lesions, and assess resection margins.

The study’s primary end point was the incidence of CSEs.³ Secondary end points included sensitivity, specificity, and positive and negative predictive values of VGT-309.

Prior findings from the trial showed that VGT-309 appeared safe and well-tolerated across a range of primary and metastatic tumor types, including adenocarcinoma in situ, invasive adenocarcinoma, lymphoma, colorectal cancer, neuroendocrine cancers, sarcomas, and squamous cell carcinoma.⁴ No infusion reactions or drug-related serious adverse effects were observed with VGT-309.

Patients 18 to 85 years old with a nodule or mass suspected to be primary lung cancer or lung metastases who were scheduled to undergo standard surgical resection for said nodule or mass were eligible for study enrollment. Additional eligibility criteria included adequate kidney and liver functions at baseline, an ECOG performance status of 0 to 2, and meeting all standard surgical and general anesthesia requirements. Patients with comorbidities that may have precluded them from study protocol compliance or a known allergy or reaction to indocyanine green were ineligible for enrollment.

Developers announced that they received a Small Business Innovation Research (SBIR) grant of approximately $2 million from the National Cancer Institute (NCI) in November 2022 to support the phase 2 study assessing the intraoperative imaging capabilities of VGT-309 in lung cancer surgery.⁵

Furthermore, developers recently completed enrollment in another multi-center study, the phase 2 VISUALIZE study (NCT06145048), which is currently evaluating the efficacy and safety of VGT-309 in patients undergoing surgery for suspected or proven cancer in the lung. Enrollment for the phase 3 VISUALIZE-2 trial will begin in 2025.

References

1. Vergent Bioscience receives FDA fast track designation for abenacianine for injection (VGT-309) to help surgeons visualize tumors in the lung during surgery. News release. Vergent Bioscience. January 8, 2025. Accessed January 8, 2025. https://tinyurl.com/bdet8h2u
2. Bou-Samra P, Kennedy GT, Chang A, et al. Phase 2 clinical trial of VGT-309 for intraoperative molecular imaging during pulmonary resection. Ann Thorac Surg. Published online May 30, 2024. doi:10.1016/j.athoracsur.2024.05.019
3. Phase 2 study of VGT-309 in lung cancer. ClinicalTrials.gov. Updated October 17, 2024. Accessed January 8, 2025. https://tinyurl.com/2sey7w3y
4. Vergent Bioscience presents phase 2 data showing VGT-309 visualizes tumors in the lung during surgery. News release. Vergent Bioscience. January 28, 2024. Accessed January 8, 2025. https://tinyurl.com/ynsjbdxr
5. Vergent Bioscience awarded National Cancer Institute phase 2 grant to advance clinical development of VGT-309 in lung cancer. News release. Vergent Bioscience. November 29, 2022. Accessed January 8, 2025. http://tinyurl.com/rzndhhpx