Clinical trial results
Thirty-two patients at Peking Union Medical College Hospital (PUMCH) with histologically confirmed neuroendocrine tumours were recruited for a clinical trial with the new technology. The patients were randomly divided into three escalating dose groups. The treatments were planned for up to three cycles, repeated at eight-to 12-week intervals. Hematologic parameters, liver function, and kidney function were tested at baseline, one week, and four weeks after each cycle of treatment. The patients were scanned at the start of the trial, some days before the second and third cycles of treatment, and two to three months after their last PPRT cycle.
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The patients tolerated 177Lu-DOTA-EB-TATE well, with good tumor response with almost no side effects. The study was published in the 2021 March issue of the Journal of Nuclear Medicine .
"177Lu-DOTA-EB-TATE with longer circulation half-life and high tumor accumulation appears to have more potent anti-cancer efficacy than Lutathera, and at a much lower dose. We hope reversible albumin binding through Evans blue derivatives will create various novel therapeutic radiopharmaceuticals that can be effective for not only NET patients but also other types of cancer patients overexpressing different molecular targets," Prof Chen said.
Associate Professor Quek Swee Tian, Head, Department of Diagnostic Radiology at the National University Hospital, said PRRT has been shown to confer a longer progression-free survival and a significantly higher response rate in patients with advanced neuroendocrine cancers as compared to first line medical therapy. "The development of 177Lu-DOTA-EB-TATE, with its improved pharmacokinetics, has further advanced the PRRT therapeutic technology and holds promise for even better therapeutic efficacy and a more efficient workflow for our patients with a drug infusion time a fraction of standard PRRT."
The technology has been licensed to Molecular Targeting Technologies, Inc. (MTTI) and an Investigational New Drug (IND) application has been approved by the U.S. Food and Drug Administration (FDA).
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