Fluorescence-based product improves cancer detection during breast surgery
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Pegloprastide significantly improved cancer detection in real time during breast cancer surgery, according to topline results of a phase 2/phase 3 study released by the product’s manufacturer.
Achieving negative surgical margins — meaning no cancer cells are present at the edge of removed tissue — is a considerable challenge with breast-conserving surgery.
More than 260,000 women in the United States undergo lumpectomy each year, and approximately one-third of those are repeat surgeries intended to achieve negative margins. In addition, many women who choose mastectomy do so at least in part because of fear of incomplete initial lumpectomy.
Pegloprastide (AVB-620, Avelas Biosciences), a fluorescence-based clinical cancer detection product, is based on the science of activatable cell-penetrating peptides. It is designed to deliver a fluorescent marker to cancer cells to help surgeons identify cancerous tissue in real time, with the goal of reducing repeat surgeries and improving patient outcomes.
“Cancer recurrence and metastasis is more likely with positive margins, and the significant re-excision rate with standard of care for lumpectomies to try to obtain negative margins is driving women to get second lumpectomies, causing significant pain and physical limitations,” Sheldon Feldman, MD, director of breast services at Montefiore Medical Center, said in an Avelas Biosciences-issued press release. “Pegloprastide has the potential to greatly improve a breast surgeon’s ability to achieve negative margins and reduce the number of re-excisions, potentially improving outcomes for hundreds of thousands of women and saving thousands of lives.”
A pivotal registration study assessed the efficacy and safety of pegloprastide for women with primary, nonrecurrent breast cancer undergoing surgery.
The multicenter, open-label, single-arm study — conducted in two parts — included women with grade 1 to grade 3 ductal carcinoma in situ or stage I to stage III invasive carcinoma.
The first part of the study, which included 32 patients, demonstrated proof-of-concept that pegloprastide could sensitively visualize the primary tumor in the lumpectomy specimen. It also helped determine optimal dosing and imaging parameters.
The second part, which included 92 patients, prospectively assessed the potential of pegloprastide to identify malignant tissue at or close to the surface of excised tissue, as well as tissue that was not excised and otherwise would have required another operation to remove.
Patients received pegloprastide infusion either on the day before or the day of surgery.
Surgeons excised the tumor using standard methods, then performed interoperative imaging of the excised tissue and surgical site using pegloprastide and a fluorescent imaging camera manufactured for Avelas by Quest Medical Imaging.
The second part of the study met its primary endpoint, as pegloprastide detected cancer in margin specimens in real time among a sufficient number of patients (P < .001).
Pegloprastide correctly identified positive margins in about three-quarters of patients who otherwise would have been candidates for repeat surgery.
The planned re-excision rate for patients who underwent surgery with pegloprastide was 6%, compared with the typical re-excision rate of 20% to 40% (P < .001).
Researchers reported no serious adverse events or laboratory abnormalities related to pegloprastide infusion.
“With pegloprastide, we are removing the blindfold and helping surgeons see where the cancer is to make informed, real-time decisions in the operating room,” Jay Lichter, PhD, chairman, president and CEO of Avelas, said in the release. “This pivotal clinical data is a first in the field of fluorescence image-guided surgery for breast cancer and supports the use of pegloprastide to revolutionize surgical treatment with the goal of eliminating tens of thousands of repeat surgeries undertaken to address positive margins.”
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