SOFIE Biosciences Advances Phase 3 Trials for Cancer Imaging with FDA Support

What's Happening?

SOFIE Biosciences has announced the successful completion of an end-of-phase 2 meeting with the U.S. Food and Drug Administration (FDA), paving the way for two Phase 3 studies of [18F]FAPI-74, a radiopharmaceutical targeting Fibroblast Activation Protein (FAP). The trials, named FAPI-GO and FAPI-PRO, will focus on gastroesophageal and pancreatic cancers, respectively. The studies aim to evaluate the diagnostic accuracy of [18F]FAPI-74 PET in detecting metastatic disease. The Phase 2 study demonstrated a 100% positive predictive value for detecting FAP-expressing cells and a 94% value for detecting gastrointestinal malignancies.

Why It's Important?

The advancement of [18F]FAPI-74 into Phase 3 trials represents a significant step in cancer diagnostics, particularly for gastroesophageal and pancreatic cancers, which have high mortality rates and limited diagnostic options. The use of FAPI PET imaging could improve the accuracy of cancer staging, potentially leading to better treatment decisions and outcomes. This development could also reduce the number of futile surgeries and early recurrences, addressing a critical unmet need in oncology.

What's Next?

SOFIE Biosciences will proceed with the Phase 3 trials, focusing on the performance of [18F]FAPI-74 PET in detecting metastatic disease. The trials will be conducted at multiple centers and are expected to provide further evidence of the efficacy of FAPI PET imaging in precision oncology. The results could lead to broader adoption of this imaging technology in clinical practice, pending successful trial outcomes.