Cogent Hits Unprecedented Efficacy in Rare Stomach Cancer, Clearing Path to FDA

Cogent Biosciences reported 'unprecedented' efficacy with its tyrosine kinase inhibitor bezuclastinib in patients with gastrointestinal stromal tumors (GIST), a rare form of stomach cancer37.

The pivotal study showed the bezuclastinib combination reduced the risk of disease progression or death by 50% compared to the standard of care (sunitinib), with a hazard ratio (HR) of 0.50 and a statistically significant P value (<.0001)3.

Objective response rate (ORR) with the bezuclastinib combination was 46%, versus 26% for sunitinib alone, signaling a 20% improvement in responses3.

Median progression-free survival (mPFS) improved by more than 7 months for patients on the bezuclastinib combination compared to standard therapy3.

Safety profile was favorable:
the most common grade ≥3 adverse events were hypertension (29.4%), neutropenia (15.2%), and ALT/AST elevations (10.8%), with all grade 3 liver enzyme elevations resolved by the data cutoff3.

Treatment discontinuation due to drug-related adverse events occurred in 7.8% of patients on combination therapy, compared to 3.8% on standard care3.

Based on these results, Cogent plans to submit a New Drug Application (NDA) for bezuclastinib in GIST to the FDA in the first half of 202614.

Cogent also launched an expanded access program allowing immediate use of the bezuclastinib combination for eligible GIST patients3.

Sources:

1. https://www.bioworld.com/articles/726095-a-second-win-for-cogent-pushes-the-company-toward-two-ndas

3. https://www.targetedonc.com/view/bezuclastinib-combo-yields-promising-efficacy-in-2l-gist-poised-for-nda-submission

4. https://firstwordpharma.com/story/6522499

7. https://www.biospace.com/fda/fda-stalwart-pazdur-named-tidmarshs-replacement-as-cder-director