In a groundbreaking step forward for gastroesophageal cancer patients, Affibody AB has announced the successful enrollment and dosing of the first participants in their Phase 2 clinical basket study for the imaging agent 68Ga-ABY-025, known as “HER2 PET.” This agent, which non-invasively quantifies HER2 status in solid tumors, has the potential to transform how doctors assess and treat patients with gastroesophageal cancer. HER2, a protein associated with various forms of cancer, is often pivotal in determining treatment strategies. Affibody’s PET imaging agent harnesses the high affinity of their Affibody® molecules to HER2, enabling rapid and precise assessment within hours due to its swift clearance from normal tissues.
Affibody’s HER2 PET agent comes at a crucial time. Gastroesophageal cancer presents significant challenges worldwide, necessitating better non-invasive diagnostic tools. Innovations in HER2-targeted therapies have shown promising potential, but accurate diagnostics are essential to ensure effective treatments reach the right patients. Fredrik Frejd, Affibody’s Chief Scientific Officer, underscores the importance of this trial as it tests the HER2 PET agent’s ability to identify HER2 in gastroesophageal cancer, with the help of clinical experts at Karolinska Institutet and Karolinska University Hospital.
The Phase 2 basket trial aims to evaluate HER2 status in tumor lesions using 68Ga-ABY-025 on PET/CT scans, providing an innovative non-invasive approach compared to traditional biopsies. Previously published results have shown the agent’s ability to visualize low-HER2 expression metastases in breast cancer patients, and now the study seeks to replicate this success in gastroesophageal cancer.
Principal Investigator Rimma Axelsson, a Professor of Nuclear Medicine, emphasizes her excitement about extending this imaging agent’s utility to more patients. With up to 72 participants expected, this study will provide critical insights into how HER2 PET can improve diagnosis and treatment strategies for patients with gastroesophageal cancer.
Magnus Nilsson, Deputy Principal Investigator and Professor of Surgery, acknowledges the variability in HER2 expression across tumors, making it vital to accurately determine HER2 status to tailor targeted treatments effectively.
Involving experts from various disciplines, the study compares HER2 PET findings with biopsy specimens, correlating the results with survival data over a year of follow-up. This innovative approach could pave the way for broader acceptance of HER2 PET imaging as a vital tool in cancer diagnosis and patient management.
