Terns Highlights Additional Positive Phase 1 Clinical Data Supporting TERN-701's Best-in-Disease Potential in Relapsed/Refractory CML at the 67th ASH Annual Meeting

Core Insights - Terns Pharmaceuticals announced updated data from the CARDINAL trial of TERN-701, showing a 64% major molecular response (MMR) achievement by 24 weeks across all efficacy evaluable patients and a 75% MMR achievement at doses greater than 320mg QD [1][3][4] - The safety and tolerability profile of TERN-701 has been encouraging, with no dose-limiting toxicities observed and a majority of patients remaining on treatment [11][18] - The company will host an investor update call to discuss the findings further [1][16] Study Results - The CARDINAL trial has reported a cumulative MMR rate of 74% (28/38) by 24 weeks, with 100% of those achieving MMR maintaining it [7][12] - In difficult-to-treat patient subgroups, the MMR rates were 65% for those with prior lack of efficacy to the last TKI and 88% for those with prior tolerability issues [7][11] - The deep molecular response (DMR) achievement rate by 24 weeks was 29% (10/34) [11] Patient Cohorts - The study enrolled 63 patients as of the cutoff date, with a median of 3 prior TKIs and a significant portion having discontinued their last TKI due to lack of efficacy [6][11] - Among patients at doses ≥ 320mg QD, the overall MMR rate was 80% (24/30) by 24 weeks, with a DMR achievement rate of 36% [12][18] Safety Profile - 87% of patients remained on treatment as of the data cutoff, with discontinuations primarily due to disease progression or adverse events [11] - Most treatment-emergent adverse events were low grade, with common non-hematologic TEAEs including diarrhea (21%), headache (19%), and nausea (19%) [11][12] Future Development - Terns Pharmaceuticals plans to focus on pivotal clinical development for TERN-701 in chronic myeloid leukemia (CML) [4][5] - The company aims to advance TERN-701 as a potential best-in-disease therapy for both second-line and first-line CML treatments [4][19]