Cogent's New Stomach Cancer Treatment Cuts Progression Risk In Half, Gets Breakthrough Therapy Tag

On Monday, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to Cogent Biosciences, Inc.’s (NASDAQ:COGT) bezuclastinib in combination with sunitinib for patients with Gastrointestinal Stromal Tumors (GIST).

The trial included patients who received prior treatment with Novartis AG’s (NYSE:NVS) Gleevac (imatinib). 

Pfizer Inc. (NYSE:PFE) sells sunitinib under the brand Sutent.

Bezuclastinib’s Efficacy Outshines Current Standards

This Breakthrough Therapy Designation is based on results from the PEAK trial, which demonstrated a substantial and highly statistically significant clinical benefit on the primary endpoint of progression-free survival (PFS), reducing risk of disease progression or death compared to the current standard of care by 50%.

Median PFS was 16.5 months for the bezuclastinib combination ...