TERN-701 Shows Unprecedented 75% Response Rate in Tough-to-Treat CML Patients—What Does This Mean for the Future of Leukemia Therapy?
Major Molecular Response at 75%—Twice as High as Comparable Phase 1 CML Trials
Terns Pharmaceuticals has announced data from its CARDINAL Phase 1 trial of TERN-701 that could signal a significant leap forward in chronic myeloid leukemia (CML) treatment, especially for patients who have run out of other options. The data, set for oral presentation at the American Society of Hematology (ASH) Annual Meeting in December, show an overall major molecular response (MMR) rate of 75% by 24 weeks in previously treated, heavily refractory CML patients—a figure that notably outpaces similar early-stage studies in the field.
Clinical Trial Highlights Reveal Strength in Hard-to-Treat Subgroups
The CARDINAL study enrolled 55 patients with a median of three prior tyrosine kinase inhibitor (TKI) therapies, a group considered difficult to treat. Subgroup analyses underscored TERN-701’s promise:
| Patient Group | MMR Rate by 24 Weeks | Number of Patients |
|---|---|---|
| Overall (Cumulative, Efficacy-Evaluable) | 75% | 32 |
| Lack of Efficacy to Last TKI | 69% | 16 |
| Prior Asciminib | 60% | 10 |
| Prior Asciminib / Ponatinib / Investigational TKI | 67% | 12 |
Impressively, none of the patients had lost their MMR at the time of data cutoff. Not only did TERN-701 outperform past therapies in these refractory cases, but the consistency across patient groups suggests broader potential for those who’ve exhausted multiple standard-of-care regimens.
Safety Remains Encouraging with Low Rates of Severe Side Effects
The safety profile also stands out. 87% of enrolled patients remained on TERN-701 at data cutoff. Most adverse events were mild (grade 1 or 2), such as diarrhea (22%), headache (18%), and nausea (16%). Serious (grade 3 or higher) events—including neutropenia (7%) and thrombocytopenia (4%)—occurred at rates well below 10%, with no dose-limiting toxicities observed, even at the trial’s maximum dose of 500mg. This may give the drug a clinical edge over other CML treatments known for harsh side effects or poor tolerability.
| Adverse Event | Occurrence (%) | Severity |
|---|---|---|
| Diarrhea | 22% | Grade 1–2 |
| Headache | 18% | Grade 1–2 |
| Nausea | 16% | Grade 1–2 |
| Neutropenia | 7% | Grade 3+ |
| Thrombocytopenia | 4% | Grade 3+ |
Investor Update and Next Steps—What to Watch as December Approaches
The company will release an updated dataset and hold an investor call on December 8th, directly following the ASH oral presentation. For those following cancer therapeutics and biotech investing, TERN-701 is quickly moving up the watchlist as its efficacy and safety data outshine typical early-phase oncology programs.
Key Details:
- ASH Oral Presentation: December 8, 2025
- Company Webcast: December 8, 4:30pm ET
Why This Matters for Investors and Patients
With a current share price of $17.64, TERN has grabbed investor interest based on the remarkable 75% MMR rate—approximately double the rates seen in comparable Phase 1 trials of other CML agents. For patients with relapsed/refractory disease, this may represent a genuine breakthrough.
As new clinical data and real-world results continue to emerge, both the investment community and those affected by CML will be watching closely. Could TERN-701 redefine treatment standards? December’s expanded dataset may provide further clues—and fuel even more discussion about what’s next in targeted oncology therapeutics.
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