Treatment - Free Remission (TFR)
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Terns Pharmaceuticals (NasdaqGS:TERN) FY Conference Transcript
2026-03-02 21:52
Summary of Terns Pharmaceuticals FY Conference Call Company Overview - **Company**: Terns Pharmaceuticals (NasdaqGS:TERN) - **Event**: 46th Annual TD Cowen Healthcare Conference - **Date**: March 02, 2026 Industry Context - **Industry**: Chronic Myeloid Leukemia (CML) treatment landscape - **Key Competitors**: Gleevec (first generation), second-generation TKIs, asciminib, Scemblix Core Insights and Arguments 1. **CML Treatment Landscape**: CML has evolved into a chronic disease since Gleevec's approval in 2001, with multiple therapies available, including first and second-generation TKIs and allosteric inhibitors. Despite these options, there remains a significant unmet need in terms of both efficacy and safety [4][5][6] 2. **Safety Concerns**: Young CML patients may require lifelong treatment with TKIs, raising safety concerns such as arterial occlusive events and pleural effusion. Allosteric inhibitors like TERN-701 are noted for their better safety profiles [5][6] 3. **Treatment-Free Remission (TFR)**: Currently, only 15%-20% of patients achieve TFR, which is a goal for young patients. Faster and deeper responses could increase TFR rates, making it a critical focus for Terns Pharmaceuticals [6][8] 4. **Market Share of Asciminib**: Asciminib has captured approximately 25% of the market share due to its improved safety profile compared to older therapies [10][11] 5. **Efficacy of TERN-701**: In the CARDINAL phase 1 trial, TERN-701 showed promising results with a 75% major molecular response (MMR) and a 36% deep molecular response (DMR) in expansion cohorts [20][23] 6. **FDA Engagement**: Terns plans to engage with the FDA mid-year regarding pivotal trial designs for TERN-701, aiming to move directly into second-line and first-line pivotal trials [24][32] 7. **Resistance Mutations**: Resistance mutations are not the primary driver of treatment failure in CML. TERN-701 has shown efficacy against certain mutations, such as F317L, which are resistant to asciminib [14][81] 8. **Differentiation from Competitors**: TERN-701 is expected to offer better safety and efficacy compared to active site inhibitors, positioning it favorably in the market [71][72] 9. **Adverse Events**: The most common adverse events reported were hematologic, significantly lower than those seen with other therapies. Only one patient was lost due to an adverse event [74][80] 10. **Pipeline and Partnerships**: Terns is focusing on oncology and is looking to license its metabolic portfolio, including TERN-501 and TERN-801, while actively working on discovery for oncology small molecule targets [88][89] Additional Important Points - **Market Dynamics**: The shift in physician preferences towards newer therapies like asciminib indicates a growing acceptance of advanced treatments in frontline settings [85] - **Future Data Releases**: Terns anticipates releasing more comprehensive data later in the year, which will include a larger patient cohort beyond the initial 85 patients enrolled [67][70] - **Combination Therapies**: While there is potential for combining TERN-701 with active site molecules, it is not a current priority due to cost and toxicity concerns [66] This summary encapsulates the key points discussed during the conference call, highlighting Terns Pharmaceuticals' strategic positioning and the evolving landscape of CML treatment.