Clinical trial supports adding ruxolitinib to tyrosine kinase inhibitors for chronic myeloid leukemia

Medical Xpress / SWOG Cancer Research Network / Conference on Chronic Myeloid Leukemia ^ | Sept. 23, 2024 | Kendra L. Sweet, MD

[ConservativeMind]

Researchers leading the SWOG S1712 clinical trial have found that adding ruxolitinib to standard tyrosine kinase inhibitor (TKI) treatment for patients with chronic-phase chronic myeloid leukemia (CP-CML) significantly increased the percentage of patients who had a molecular response deep enough to warrant discontinuing treatment.

CML is often treated with a class of drugs known as tyrosine kinase inhibitors. But leukemic stem cells can hide from TKIs in a patient's bone marrow. Preclinical data suggested that a drug called ruxolitinib can alter the bone marrow microenvironment to sensitize these stem cells to TKIs.

In clinical trial S1712, they randomized 75 eligible patients with CML whose disease was still molecularly detectable on current therapy and who had been undergoing treatment with a TKI for at least one year.

After 12 months of on-study treatment, all patients had their blood tested for molecular response (MR), a highly sensitive test for RNA from a gene specific to leukemic cells. A score of MR4.0—considered a deep molecular response—indicates a reduction in this RNA to 0.01% or less of the baseline level. A score of MR4.5 indicates that no such RNA has been detected and is considered a complete molecular response.

The rate of S1712 patients scoring MR4.0 by 12 months was significantly higher on the ruxolitinib arm—46% versus 26% on the TKI-only arm. The rate of patients scoring MR4.5 at 12 months was significantly higher on the ruxolitinib arm as well—14% versus 3% on the control arm.

The addition of ruxolitinib also moved more patients to a remission deep enough that they were able to go off treatment. Two years after randomization, the proportion of patients who met the National Comprehensive Cancer Network (NCCN) guidelines criteria for being able to discontinue treatment was 29% on the investigational arm versus 11% on the control arm.

[ConservativeMind]

There are big increases in the percentages of patients with no cancer, or effectively almost no cancer, with this drug pairing of a tyrosine kinase inhibitor and ruxolitinib.

[ConservativeMind]

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