The P-I study evaluates the safety, tolerability, PK characteristics & recommended dosing of ELVN-001 (10mg to 120mg, QD) to treat CML patients (n=27) with & without T315I mutations and those who are relapsed, refractory or intolerant to TKIs
The study, as of Mar 2024 among 16 evaluable patients, demonstrated a cumulative MMR rate of 44% & 40% in post-asciminib as well as TKI-resistant patients, respectively along with an improvement in BCR::ABL1 transcript levels among response-evaluable patients by 12wks.
Furthermore, the PK profile favored QD dosing & the target coverage of ELVN-001 at dosing level ≥40mg QD was superior over 2nd generation TKIs while it was similar to asciminib at 80mg QD
Ref: Terns Pharmaceuticals | Image: Terns Pharmaceuticals
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