We are pleased to announce our participation in ASCO 2019 was a great success; it was the perfect occasion to introduce our company and our first pipeline product, FES, a biomarker for targeted imaging in metastatic breast cancer (MBC), to the ASCO community. Our participation at ASCO 2019 was preceded by the announcement of the FDA acceptance of the New Drug Application (NDA) for FES.
The timing was of essence because a ASCO session took place on Sunday June 2nd entitled “Are we ready for prime time in molecular imaging of breast cancer?” The first presenter, Hannah Linden, MD FACP, Professor at the Department of Medicine in the Division of Oncology at the University of Washington, and specialist in breast cancer, spoke on the need for precision imaging in breast cancer. The second presentation by Dr. Carolien Schroder, MD, PhD, medical oncologist at the Department of Medical Oncology of the UMCG, the Netherlands, discussed FES (Fluoroestradiol F18) multi-center clinical trial experience and preliminary data.
Here are some of the key points from this ASCO session:
- The presenters indicated that “the time is right” for better diagnosis of estrogen receptors (ER) in MBC. Surface expression of ER may vary spatially within a single tumor, and from tumor to tumor, and with time over the course of a patient’s disease
- This spatial heterogeneity of ER+ metastatic disease cannot be assessed by any means other than whole body molecular imaging, but the decision to use or continue to use a targeted therapeutic approach is currently reliant upon measurement of ER expression sampled from a tumor at the time of diagnosis
- FES-PET delivers clinically meaningful functional diagnostic information about target expression throughout the entire body
- FES specifically measures functional presence and density of ER in the body to aid with staging, and potentially identifying addition sites of disease
- FES-PET methodology has been analytically validated regarding the reference method. The results can be trusted, and it is a non-invasive, specific and sensitive in vivo tool
- The clinical utility of FES-PET, providing actionable, clinically valuable information to optimize treatment decisions is hoped to be supported in multiple international prospective trials.
This ASCO session highlighted MBC as the most advanced stage of breast cancer, meaning it has spread beyond the breast to other parts of the body. More than 154,000 women in the United States alone have MBC.
FES (trademark EstroTep in Europe) from Zionexa, a biomarker for targeted diagnostic in MBC could provide a significant opportunity for oncologists to adapt and improve their patient’s pathway and quality of life.
We will update you as more information becomes available on our advancement, including final FDA approval.
 Susan G. Kommen