On December 8, 2025 Terns Pharmaceuticals, Inc. (Terns or the Company) (Nasdaq: TERN), a clinical-stage oncology company, reported that updated and expanded data from the ongoing CARDINAL trial of TERN-701, a novel investigational allosteric BCR::ABL1 inhibitor, in patients with previously treated chronic myeloid leukemia (CML) are being presented today at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition taking place December 6-9, 2025 in Orlando, FL. The company will host a conference call and webcast for investors at 4:30pm ET today following the ASH (Free ASH Whitepaper) presentation.
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The ASH (Free ASH Whitepaper) presentation will be made available on the Terns Pharmaceuticals website simultaneously with the oral presentation by Elias Jabbour, MD, Professor, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, and lead investigator on the TERN-701 Phase 1 CARDINAL study. Presentation details are summarized below.
"We are delighted that our investigators can share these unprecedented Phase 1 data for TERN-701 with patient groups and the broader hematology community at ASH (Free ASH Whitepaper). The 64% major molecular response (MMR) achievement rate reported in the abstract is maintained in the expanded dataset presented at ASH (Free ASH Whitepaper). The safety profile and higher MMR achievement rate of 75% over 24 weeks at doses of 320mg and above supports selection of 320mg and 500mg QD as the recommended phase 2 doses (RP2Ds) for expansion. Study enrollment has accelerated and surpassed 85 patients which supports rapidly advancing TERN-701 through dose expansion cohorts, dose selection, and the initiation of pivotal studies," said Amy Burroughs, chief executive officer of Terns.
"We are particularly encouraged to see unprecedented rates of MMR in a highly refractory population, including compelling response achievement in patients with lack of efficacy on prior asciminib, ponatinib, and/or other marketed and investigational TKIs. In the RP2D dose range, we see a 36% DMR achievement rate by 24 weeks, highlighting the fast response kinetics of TERN-701. Importantly, with a median treatment duration of six months, we continue to see a favorable safety and tolerability profile at all doses, further positioning TERN-701 as the potential best-in-disease therapy in 2L+ and 1L CML, where we intend to focus pivotal clinical development," stated Emil Kuriakose, MD, chief medical officer of Terns.
"While therapies for CML have come a long way since imatinib, there remains an unmet need for new drugs that achieve early, broad and deep responses with a safety/tolerability profile that allows long-term maintenance of response with improved quality of life for patients. Based on the data to date, TERN-701 represents an innovative treatment option that has the potential to achieve this important goal. I am excited to help advance this therapy for the benefit of CML patients," said Dr. Jabbour.
The ASH (Free ASH Whitepaper) oral presentation today reports data from the ongoing dose escalation and dose expansion parts of the CARDINAL study of TERN-701 in patients with previously treated CML. As of the September 13, 2025 cutoff date, 63 patients were enrolled.
Assessment of all dose cohorts (160mg – 500mg, n=63)
•
Of 38 efficacy-evaluable patients:
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Overall (cumulative) MMR rate of 74% (28/38) by 24 weeks, with 64% (18/28) achieving MMR and 100% (10/10) maintaining MMR
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MMR overall and achieved by 24 weeks in difficult to treat patient subgroups:
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Lack of efficacy to last tyrosine kinase inhibitor (TKI): 65% (13/20) overall; 63% (12/19) achieved
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Lack of tolerability to prior TKI: 88% (14/16) overall; 71% (5/7) achieved
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Prior asciminib: 60% (6/10) overall; 43% (3/7) achieved
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Prior asciminib, ponatinib and/or investigational TKI: 67% (8/12) overall; 50% (4/8) achieved
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Deep molecular response (DMR) achievement rate by 24 weeks of 29% (10/34)
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No patients had lost MMR at the time of data cutoff
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Enrolled patients had heavily pretreated, refractory disease:
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Median of 3 prior TKIs; 60% had ≥3 prior TKIs
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57% and 44% had baseline BCR::ABL1 >1% and >10%, respectively
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64% discontinued their last TKI due to lack of efficacy
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38% had prior asciminib treatment (75% had lack of efficacy and 25% had lack of tolerability)
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22% had prior ponatinib treatment (79% had lack of efficacy and 21% had lack of tolerability)
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15% with BCR::ABL1 mutations (10% with T315I and 5% with non-T315I mutations)
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Encouraging safety profile:
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87% (55/63) of patients remained on treatment as of the data cutoff; with discontinuations due to disease progression (n=4), adverse events (n=1), and physician / patient decision or lost to follow up (n=3)
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No dose-limiting toxicities (DLTs) were observed in dose escalation, and a maximum tolerated dose (MTD) was not reached
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The majority of treatment-emergent adverse events (TEAEs) were low grade with no apparent dose relationship
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Rates of cytopenia were generally low with less than 10% Grade 3 thrombocytopenia and neutropenia
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Most common non-hematologic TEAEs were diarrhea (21%), headache (19%) and nausea (19%), all Grade 1 or 2
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Grade 3 or higher TEAEs were all less than 10%, most commonly neutropenia (8%) and thrombocytopenia (8%)
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TERN-701 exposures were approximately dose proportional across the dose range
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Encouraging MMR achievement rates in patients with lack of efficacy to prior asciminib:
Subgroup Baseline Characteristics MMR achieved by 24 weeks
Prior asciminib (n=10) No MMR at baseline 7/10 (70%) 3/7 (43%)
Prior lack of efficacy 6/7 (86%) 2/6 (33%)
Prior intolerance only 1/7 (14%) 1/1 (100%)
Assessment of patient cohorts at doses ≥ 320mg QD (n=53)
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Similar overall baseline characteristics to the full study population:
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Median of 3 prior TKIs
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56% and 47% had baseline BCR::ABL1 >1% and >10%, respectively
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38% had prior asciminib treatment, 21% had prior ponatinib treatment
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68% discontinued their last TKI due to efficacy
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In 30 efficacy evaluable patients, overall MMR rate of 80% (24/30) by 24 weeks, with 75% (18/24) achieving MMR and 100% maintaining MMR (6/6)
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DMR achievement rate by 24 weeks of 36% (10/28)
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Molecular responses observed across full spectrum of baseline BCR::ABL1 transcripts
Baseline BCR::ABL1 (Patients at doses ≥ 320 mg QD)
MR5
(n=0)
MR4.5
(n=1)
MR4
(n=1)
MR3
(n=4)
MR2
(n=11)
MR1
(n=4)
>10%
(n=9)
LOGO
MR5 (DMR) 1 1 1 1 1 1
MR4.5 (DMR) 3
MR4 (DMR) 1 1 1
MR3 (MMR) 2 6 4
MR2 1
MR1 1 1
BCR::ABL >10% 3
Note: Table includes response evaluable non-T315Im patients that have ≥1 baseline assessment with at least six months of treatment at visit cutoff, achievement of MMR or better prior to six months or treatment discontinuation prior to six months for any reason (n=30). Diagonal, bolded cells represent stable disease. Up/right of diagonal, bolded cells represents improvement in molecular response (MR) category, while down/left represents loss of efficacy. MR represents a decrease in the number of cells in the blood with the BCR::ABL1 gene and is quantified as a percentage. MR5: ≤0.001%, MR4.5: >0.001 to 0.0032%, MR4: >0.0032 to 0.01%, MR3: >0.01 to 0.1%, MR2: >0.1 to 1%, MR1: >1 to 10%.
Details for the ASH (Free ASH Whitepaper) oral presentation are as follows:
Title: CARDINAL: A Phase 1 study of TERN-701, a novel investigational allosteric BCR::ABL1 inhibitor for patients with previously treated CML
Presenter: Elias Jabbour, MD, Professor, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center
Session Name: 632. Chronic Myeloid Leukemia: Clinical and Epidemiological: Therapeutic agents to enhance patient outcomes
Session Date: December 8, 2025 at 2:45pm ET
Company Conference Call and Webcast Information
Terns will host a conference call and webcast for investors at 4:30pm ET on December 8, 2025 following the oral presentation at the ASH (Free ASH Whitepaper) Annual Meeting. Members of the Terns management team will discuss additional TERN-701 data from CARDINAL, including patient vignettes, benchmarking comparisons and next steps for the development of TERN-701. The conference call will conclude with a Q&A session.
The webcast can be accessed in the investor relations section of the Company’s website. A replay of the event will be archived and available for a limited time.
About TERN-701 and CARDINAL Clinical Trial
TERN-701 is currently being evaluated in the CARDINAL trial (NCT06163430), a global multi-center dose escalation and dose-expansion clinical trial to assess safety, tolerability and efficacy in patients with previously treated chronic phase CML. The dose escalation portion of the CARDINAL trial completed in January 2025 with no DLTs observed up to the maximum dose of 500mg QD. Terns initiated the dose expansion portion of the trial in April 2025 with patients randomized to one of two dose cohorts (320mg or 500mg QD) with up to 40 patients per arm.
(Press release, Terns Pharmaceuticals, DEC 8, 2025, View Source [SID1234661274])