Greenwich LifeSciences has initiated the Phase III Flamingo-01 clinical trial of its immunotherapy, GLSI-100 (GP2 + GM-CSF), for preventing breast cancer recurrences in individuals who priorly underwent a surgical procedure.
Currently, multiple sites have commenced the screening and enrolment of subjects.
The trial will assess the safety and efficacy of GLSI-100 in patients with HER2/neu positive breast cancer with residual disease or increased-risk pathologic complete response at surgery.
These subjects should have previously received neoadjuvant and postoperative adjuvant trastuzumab-based treatment.
Baylor College of Medicine will lead the trial, which will have study centres from university-based hospitals and cooperative networks in the US and globally.
In the trial’s double-blinded arms, nearly 500 HLA-A*02 subjects will be randomised to receive either GLSI-100 or placebo while up to 100 subjects of other kinds of HLA will receive GLSI-100 in a third arm.
The trial will analyse a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be needed.
Furthermore, an interim assessment for superiority and futility will be carried out when a minimum of 14 such events are reported.
Greenwich LifeSciences CEO Snehal Patel said: “We are thrilled to begin what we hope will be a successful reproduction of our Phase IIb trial, in which GLSI-100 safely prevented metastatic breast cancer recurrences with 100% disease-free survival.
“We look forward to sharing more site contact information with patients and their clinicians in the future as we activate more sites and some of the largest oncology networks in the US and Europe, making Flamingo-01 available to as many patients as possible.”
With the trial initiation, the company has also begun pre-marketing activities, including talks with the US Food and Drug Administration to file Biologics License Application (BLA) and commercial launch.
In addition, the company will begin large-scale production, packaging and marketing of the immunotherapy.