Benzinga·2025-12-09 12:51Core Insights - Terns Pharmaceuticals presented updated data from the CARDINAL trial of TERN-701 for chronic myeloid leukemia (CML) patients, showing promising efficacy and safety results [1][3]. Efficacy Data - Among 38 efficacy-evaluable patients, the overall major molecular response (MMR) rate was 74% (28 out of 38) at 24 weeks, with 64% (18 out of 28) achieving MMR and 100% (10 out of 10) maintaining MMR [2][3]. - The deep molecular response (DMR) achievement rate was 29% by 24 weeks, with no patients losing MMR at the data cutoff [3][5]. - The reported MMR achievement rate of 64% is significantly higher than that of approved treatments like Scemblix and investigational agents, which reported rates of 24%-32% [8]. Safety Profile - The safety profile of TERN-701 was encouraging, with 87% (55 out of 63) of patients remaining on treatment as of the data cutoff [3]. - No dose-limiting toxicities were observed, and a maximum tolerated dose was not reached, indicating a favorable safety profile [3][4]. - The majority of treatment-emergent adverse events were low grade, with no apparent dose relationship [4]. Recommended Doses - The higher MMR achievement rate of 75% at doses of 320mg and above supports the selection of 320mg and 500mg QD as the recommended phase 2 doses for expansion [4][6]. Market Potential - Analysts believe TERN-701 has the potential to disrupt the CML treatment landscape, which has a global total addressable market (TAM) of approximately $5 billion [7]. - The consistency of efficacy data from the trial adds to the bullish sentiment among analysts regarding TERN-701's market prospects [9].