Hello, my name is Dr. David Andorsky. I’m a hematologist at the Rocky Mountain Cancer Center in Boulder, Colorado, and part of the Serotonin Research Institute.
This year at ASH, I am a coauthor on our presentation of the CARDINAL study, which is evaluating a new treatment for chronic myeloid leukemia (CML) called TERN-701.
The field of CML has evolved tremendously over the past 20 years. Previously, patients often needed a bone marrow transplant to survive. Now, we have multiple oral medications that can effectively put the disease into remission, allowing patients to live normal lives as long as they continue their treatment.
Despite these advances, we continue to seek better therapies—especially for patients who struggle with side effects or whose disease is resistant to current treatments.
TERN-701 is a new molecule in this space. Unlike most other tyrosine kinase inhibitors, which bind to the ATP binding site, TERN-701 binds to a different location, potentially improving effectiveness and safety.
So far, we have treated 55 patients in this phase 1/2 study. The first portion involved dose escalation from 160 mg up to 500 mg, and we are now comparing 320 mg versus 500 mg in the second phase.
In the dose escalation phase, TERN-701 was very well tolerated. Only one patient discontinued due to side effects. Most side effects were mild, such as diarrhea, nausea, or headache, and low blood counts were rarely seen.
In terms of effectiveness, the primary benchmark in CML studies is the major molecular response (MMR), meaning PCR levels of leukemia are below 0.1% on an international scale. In this study, 75% of patients achieved MMR at 24 weeks, which compares very favorably with other therapies in this field.
In conclusion, these early data suggest TERN-701 is a very promising new treatment for CML. We plan to enroll approximately 80 more patients at the selected doses to gather further data, which we hope to present at ASH in the next year or two.
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HealthTree • December 26, 2025