SurgiMab has announced that the first surgical procedure was carried out in a pivotal Phase 3 clinical trial of the company's lead product, SGM-101, in a patient with colorectal cancer (CRC). SGM-101 is a tumour-specific antibody conjugated to a dye (fluorophore) that fluoresces under near-infra-red light; it selectively targets a marker on the cancer cell surface known as carcinoembryonic antigen (CEA), which is overexpressed by more than 95% of colorectal cancer cells.
SGM-101 is being developed to provide cancer surgeons with a novel intraoperative imaging tool that enables them to visualise tumour tissues overexpressing CEA in real-time during surgery. This allows surgeons to more clearly delineate the margin between tumour tissue and healthy tissue, enabling a more accurate and complete resection of tumour tissue beyond what can currently be achieved with standard procedures. It also prevents removal of healthy tissue and allows for better preservation of functional outcomes.
"Cancer surgery can have a dramatic impact on a patient's prognosis and being able to identify and remove all malignant tissue is critical for the long-term success of their overall treatment and recovery," said Dr Alexander Vahrmeijer, Oncologic Surgeon from Leiden University Medical Center (Leiden - The Netherlands), and coordinating investigator of the SGM-101 Phase 3 trial. "Fluorescence-guided surgery (FGS) is an exciting new approach that allows the surgeon in real-time to differentiate between tumour tissue and healthy tissue, enabling detection of even small metastatic nodules that are invisible to the eye. With more than 400,000 new cases of CRC diagnosed every year in Europe, new approaches that can facilitate the detection of malignant tissue and potentially improve patient outcomes are greatly needed. We look forward to further evaluating the potential of SGM-101 in this study."
The randomised Phase 3 trial, designed following discussions with the FDA and other regulators, aims to enrol 300 CRC patients in ten clinical centres in Europe and US, and will assess the clinical benefit of using FGS with SGM-101 as the intraoperative imaging agent to identify cancer lesions during the surgical procedure. Patients will be injected with 10mg of SGM-101 four days prior to the scheduled CRC surgical procedure. Preliminary clinical data of the Phase 3 trial is expected in 2020.
SurgiMab is advancing SGM-101 into pivotal Phase 3 trials based on compelling results from a Phase 2 study (n=75) in which residual and otherwise invisible tumour tissue was detected using SGM-101 during FGS. The Phase 2 study, published in The Lancet Gastroenterology & Hepatology, has shown that the use of SGM-101 during surgery leads to a modification of surgery in 35% of patients with recurrent or peritoneal metastases of CRC by allowing either more aggressive resection of tumor tissue or by preserving healthy tissue.
"We are excited to initiate our pivotal Phase 3 clinical study with SGM-101. If the trial is successful, SGM-101 could become the first marketed product that combines the specificity of monoclonal antibodies and the sensitivity of fluorescent detection to facilitate the visualisation and resection of malignant tissue during cancer surgery,” said Dr Françoise Cailler, SurgiMab's CEO. “Our strategy is to develop and obtain regulatory approval in the US and Europe and ultimately to commercialise SGM-101 together with partners in selected markets. We look forward to reporting preliminary data in 2020.”