FDA Committee Votes to Support Pegulicianine in Breast Cancer Surgery

“The MIDAC’s discussion underscored the need for better tools to achieve a more complete cancer resection and improve surgical outcomes,” according to Shelley Hwang, MD, MPH.

The FDA’s Medical Imaging Drugs Advisory Committee (MIDAC) has voted in support of pegulicianine (Lumisight)-based imaging for use in patients with breast cancer who undergo breast-conserving surgery, according to a press release from Lumicell.¹

The 16-to-2 vote from the MIDAC supports the use of the intracavity, fluorescence-guided surgical imaging tool plus the Lumicell^TM Direct Visualization System (DVS) to assist with real-time detection of residual cancer for the aforementioned population.

“The MIDAC’s discussion underscored the need for better tools to achieve a more complete cancer resection and improve surgical outcomes,” Shelley Hwang, MD, MPH, leader of the Breast Oncology Program at Duke University, said in the press release.¹ “The use of [pegulicianine] and Lumicell DVS, in the pivotal trial enabled real-time assessment of the breast cavity to remove residual cancer tissue that otherwise would have been missed, unlike any other surgical tool available on the market today.”

Supporting data for the MIDAC’s positive opinion on pegulicianine came from the phase 3 INSITE trial (NCT03686215). According to data published in NEJM Evidence, 406 patients with breast cancer received pegulicianine at 1.0 mg/kg intravenously prior to undergoing lumpectomy.² Based on per-margin analysis, the margin-level specificity with the agent was 85.2% (95% CI, 83.7%-86.6%), and the sensitivity level was 49.3% (95% CI, 37.0%-61.6%).

Investigators stopped administrating pegulicianine to 6 patients due to adverse effects (AEs). Additionally, 2 patients had grade 3 serious AEs that were associated with the agent.

“The results of the INSITE trial suggest that a more complete breast cancer resection may be achieved with the Lumicell DVS,” lead study author Barbara Smith, MD, PhD, director of the Breast Program at Massachusetts General Hospital and a professor of surgery at Harvard Medical School, said in a press release on these findings.³ “Given the low complication rate, minimal added operative time and, most importantly, the discovery of additional cancer left behind after a lumpectomy, the Lumicell DVS has the potential to be a critical adjunct to enhance standard practice for [patients with] breast cancer.”

In the prospective INSITE trial, investigators assessed 3 coprimary end points: the percentage of patients for whom pegulicianine-guided margins contained cancer left behind following standard lumpectomy, the sensitivity of pegulicianine-guided surgery, and the specificity of the procedure. Secondary end points included the positive margin rate after removing pegulicianine-guided margins and the impact of pegulicianine-guided margins on the volume of excised tissue.

Patients 18 years and older with histologically or cytologically confirmed primary invasive breast cancer, ductal carcinoma in situ (DCIS), or primary invasive breast cancer with a DCIS component were able to enroll on the trial.⁴ Additional eligibility criteria included having no uncontrolled serious medical conditions apart from a breast cancer diagnosis, adequate organ and marrow function, and an ECOG performance status of 0 or 1.

“This MIDAC vote, supported by more than 10 years of clinical evidence, is an exciting further validation of our work. We appreciate the valuable insights shared by the FDA, patients, and the advisory community about the need for surgical advances in breast-conserving surgery, and we look forward to working with the FDA as it completes its review of [pegulicianine’s] new drug application [NDA] and Lumicell DVS’ premarket approval [PMA] application,” Jorge Ferrer, chief scientific officer at Lumicell, said.¹

The FDA granted priority review to an NDA for pegulicianine in patients with breast cancer in May 2023.⁵ The regulatory agency also accepted a PMA for the Lumicell DVS for use in conjunction with pegulicianine.

References

1. Lumicell announces FDA Advisory Committee’s positive recommendation on the benefit-risk profile of LUMISIGHT™ in the detection of cancerous tissue during breast conserving surgery. News release. Lumicell, Inc. March 6, 2024. Accessed March 8, 2024. https://tinyurl.com/mucd64en
2. Smith BL, Hunt KK, Carr D, et al. Intraoperative fluorescence guidance for breast cancer lumpectomy surgery. NEJM Evid. 2023;2(7). doi:10.1056/EVIDoa2200333
3. Lumicell™ DVS pivotal trial results published in NEJM Evidence and to be presented at ASBrS assess safety and effectiveness of system for identifying residual breast cancer during lumpectomy. News release. Lumicell, Inc. April 27, 2023. Accessed March 8, 2024. https://tinyurl.com/3a86dyt6
4. Investigation of novel surgical imaging for tumor excision (INSITE). ClinicalTrials.gov. Accessed March 8, 2024. https://tinyurl.com/mc8js8vm
5. Lumicell announces FDA acceptance and priority review of new drug application for LUMISIGHT™ optical imaging agent for breast cancer. News release. Lumicell. May 22, 2023. Accessed March 8, 2024. https://yhoo.it/41YidAT