- Cogent Biosciences' lead asset, **bezuclastinib**, a selective KIT inhibitor, achieved **positive data** from the **Summit study** in non-advanced systemic mastocytosis in **July 2025**, with an **FDA submission and approval expected in 2026**.  **[1622229_tx_379734_0]** 
- In the Summit Part II data, bezuclastinib demonstrated a **clear statistical win** against placebo, showing **faster, deeper, and more pronounced symptom resolution** and a **~90% response rate** (greater than 50% reduction in serum tryptase) at 24 weeks in non-advanced systemic mastocytosis.  **[1622229_tx_379734_4]** 
- Bezuclastinib's safety profile is favorable, with **no true liver toxicity** observed in the Summit study and **very low rates of severe adverse events** compared to competitor avapritinib, enabling higher therapeutic dosing.  **[1622229_tx_379734_6]** **[1622229_tx_379734_8]** 
- Upcoming pivotal trial readouts for bezuclastinib include the **APEX study** (advanced mastocytosis) and the **PEAK study** (gastrointestinal stromal tumors), both expected **later in 2025**.  **[1622229_tx_379734_0]** 
- For gastrointestinal stromal tumors, Cogent is pursuing a **combination therapy of bezuclastinib with sunitinib** in the second line, a strategy enabled by bezuclastinib's selective profile, aiming to cover all known KIT secondary resistance mutations.  **[1622229_tx_379734_10]**

Cogent Biosciences (COGT)