On November 3, 2025 Terns Pharmaceuticals, Inc. (Terns or the Company) (Nasdaq: TERN), a clinical stage oncology company, reported that data from the ongoing CARDINAL trial of TERN-701, a novel investigational allosteric BCR::ABL1 inhibitor, in participants with previously treated chronic myeloid leukemia (CML) has been selected for oral presentation on December 8, 2025 at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition taking place in Orlando, FL. The company will host a conference call and webcast for investors at 4:30pm ET following the ASH (Free ASH Whitepaper) presentation.
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The abstract is now available on the ASH (Free ASH Whitepaper) website and details are summarized below. A more expansive and updated dataset from the CARDINAL trial will be presented at the ASH (Free ASH Whitepaper) Annual Meeting in December.
"We are pleased that data from our CARDINAL trial have been selected for oral presentation at ASH (Free ASH Whitepaper). These data further validate the potential of TERN-701 to be a new, game-changing therapy for CML. The 24 weeks MMR achievement rate with TERN-701 is unprecedented, trending at least two times higher than the rates reported in other Phase 1 studies of CML therapies that are approved or in development," said Amy Burroughs, chief executive officer of Terns.
"Importantly, TERN-701 also achieved consistently high overall (cumulative) MMR rates in key, difficult to treat patient subgroups while maintaining an encouraging safety profile. These emerging data strongly reinforce our conviction that TERN-701 has the potential to be a best-in-disease therapy, with broad opportunity across all CML treatment lines. We look forward to sharing additional data in December," added Ms. Burroughs.
The ASH (Free ASH Whitepaper) abstract published 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 June 30th, 2025, cutoff date, 55 patients were enrolled. Highlights include:
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Of 32 efficacy-evaluable patients:
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Overall (cumulative) major molecular response (MMR) rate of 75% (24/32) by 24 weeks, with 64% (14/22) achieving MMR and 100% (10/10) maintaining MMR
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Overall (cumulative) MMR by 24 weeks in difficult to treat patient subgroups:
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69% (11/16) in patients with lack of efficacy to last tyrosine kinase inhibitor (TKI)
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60% (6/10) in patients who had prior asciminib
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67% (8/12) in patients with prior asciminib / ponatinib / investigational TKI
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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
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35% had ≥4 prior TKIs
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56% 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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36% had prior asciminib treatment, 25% had prior ponatinib and/or an investigational TKI (olverembatinib / ELVN-001)
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13% with BCR::ABL1 mutations (9% with T315I and 4% with F317L)
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Encouraging safety profile:
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87% (48/55) patients remained on treatment as of the data cut-off; with discontinuations due to disease progression (n=4), adverse events (n=1), and consent withdrawal/lost to follow up (n=2)
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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 (74%) of treatment-emergent adverse events (TEAEs) were low grade with no apparent dose relationship
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Most common TEAEs were diarrhea (22%), headache (18%) and nausea (16%), all Grade 1 or 2
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Grade 3 or higher TEAEs were all less than 10%, most commonly neutropenia (7%) and thrombocytopenia (4%)
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TERN-701 exposures were approximately dose proportional across the dose range
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, MD Anderson Cancer Center
Session Name: 632. Chronic Myeloid Leukemia: Clinical and Epidemiological: Therapeutic agents to enhance patient outcomes
Session Date: December 8, 2025
Session Time: 2:45 – 4:15pm ET
Presentation Time: 2:45 – 3:00pm ET
Following the full presentation at the ASH (Free ASH Whitepaper) Annual Meeting, the presentation materials will be made available on the Terns website.
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 the TERN-701 data from CARDINAL and next steps in the development of TERN-701.
Webcasts can be accessed in the investor relations section of the Company’s website. A replay of the event will be 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 (CP) CML. The dose escalation portion of the CARDINAL trial completed in January 2025 with no dose limiting toxicities (DLTs) observed up to the maximum dose of 500 mg QD. Terns initiated the dose expansion portion of the trial in April 2025 with patients randomized to one of two dose cohorts (320 mg or 500 mg QD) with up to 40 patients per arm.
(Press release, Terns Pharmaceuticals, NOV 3, 2025, View Source [SID1234659283])