TERN-701 Phase 1 CARDINAL earns ASH oral; no DLTs to 500 mg
Rhea-AI Filing Summary
Terns Pharmaceuticals (TERN) announced that updated Phase 1 CARDINAL trial data for TERN-701 in relapsed/refractory chronic myeloid leukemia has been selected for an oral presentation at the 67th ASH Annual Meeting on December 8, 2025.
The dose escalation phase completed in January 2025 with no dose-limiting toxicities observed up to 500 mg once daily. Dose expansion began in April 2025 with patients randomized to 320 mg or 500 mg once daily, with up to 40 patients per arm. As of June 30, 2025, 55 patients were enrolled. The company highlighted consistently high cumulative major molecular response (MMR) rates in difficult-to-treat subgroups and an encouraging safety profile in the abstract.
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Insights
Oral ASH slot and Phase 1 safety at 500 mg with 55 patients.
Terns reports its TERN-701 Phase 1 CARDINAL data will be presented orally at ASH. The dose-escalation phase completed with no DLTs up to 500 mg QD, and expansion is randomizing between 320 mg and 500 mg.
As of June 30, 2025, 55 patients were enrolled. The company cites consistently high cumulative MMR in hard-to-treat subgroups with an encouraging safety profile. These are early-phase signals and come from the abstract highlights.
The presentation on December 8, 2025 will provide more detail. Actual impact depends on the depth of efficacy and safety results disclosed at that session.
8-K Event Classification
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