Cogent Biosciences (COGT) Jefferies Global Healthcare Conference summary

Lead program and clinical pipeline

• Lead drug bezuclastinib is in three registration-directed studies: SUMMIT (non-advanced systemic mastocytosis), APEX (advanced systemic mastocytosis), and PEAK (GIST resistant to imatinib).

• The company also has a strong small molecule research team working on additional pipeline programs.

PEAK study and GIST data

• PEAK Phase III is a global, randomized trial comparing bezuclastinib plus sunitinib to sunitinib alone in second-line GIST, with nearly 400 patients and a primary endpoint of median progression-free survival.

• Lead-in data showed the combination is well tolerated, with a median progression-free survival of over 10 months in a refractory population and 19.4 months in the second-line subset.

• Objective response rates were 28% overall and 33% in the second-line group, both higher than historical controls.

• The combination covers all major KIT resistance mutations, offering pan-mutant coverage not achieved by sunitinib alone.

• Enrollment for PEAK is ahead of schedule, now expected to complete in Q3 2024, with top-line data anticipated by end of 2025.

Systemic mastocytosis programs

• SUMMIT targets non-advanced systemic mastocytosis, aiming to improve quality of life by addressing the underlying KIT D816V mutation.

• A new patient-reported outcome tool (MS2D2) was developed for SUMMIT due to proprietary restrictions on the competitor's tool; regulatory feedback is expected imminently.

• SUMMIT Part 2 began in February 2024, with enrollment through Q2 2025 and top-line results expected by end of 2025.

• Physician and patient awareness of bezuclastinib is high, and there is strong trial participation even where a competitor is available.