Vidaza and Enbrel Combination Therapy May Improve Response In Myelodysplastic Syndromes Patients
Myelodysplastic syndromes (MDS) patients show higher and prolonged response rates to Vidaza (azacitidine) in combination with Enbrel (etanercept) than to Vidaza alone, according to a Phase 2 study recently published in the British Journal of Haemotology.
However, the study authors point out that the improved responses were improved marrow responses rather than improvements in blood cell development.
Vidaza, approved by the US Food and Drug Administration in 2004, is a widely used therapy for MDS. However, many MDS patients either do not respond or only have limited or brief responses, leading researchers to investigate potential combination treatments with other drugs (see related Beacon news).
Enbrel, a drug already approved for rheumatoid arthritis and other autoimmune diseases, is currently investigated for the treatment of MDS. Response rates to Enbrel treatment as a single agent have been low.
For their study, researchers recruited 32 MDS and chronic myelomonocytic leukemia (CMML) patients. The patients received 75 mg/m2 Vidaza by intravenous or subcutaneous injection for seven consecutive days every four weeks in combination with 25 mg Enbrel by subcutaneous injection on days 8, 11, 15, and 18. Treatments were continued unless patients progressed toward acute myeloid leukemia, a more severe type of blood cancer.
At three months, 23 patients (72 percent) responded to the combination therapy, nine of whom achieved a complete response. Ten patients (31 percent) showed a bone marrow response. Bone marrow response is defined as having less than 5 percent blasts in the bone marrow.
The response rates observed in this study were higher than a 2006 Phase 3 collaborative clinical trial investigating the impact of Vidaza alone on MDS patients. In that study, researchers reported an overall response rate of 33-53 percent with 10-17 percent of patients achieving complete response.
The median duration of response had not been reached at the time of the data analysis. However, 12 patients showed bone marrow responses lasting more than one year, 92 percent of whom experienced more than two years of sustained improvement.
Twenty nine patients required dose reductions of Vidaza during the first three months of treatment because they experienced low white blood cell and platelet counts which were the most common severe side effects. However, the authors suggest that the combination therapy is still tolerable because 30 patients, or 94 percent, completed at least three cycles of treatment.
The researchers concluded that the Vidaza and Enbrel combination therapy should be investigated further in Phase 3 clinical trials.
For more information, please see the study in the British Journal of Haemotology (abstract).
Related Articles:
- Revlimid And Vidaza Combination May Be Effective In Treatment Of High-Risk MDS
- Vidaza and Thalidomide Combination Therapy Is Safe And At Least As Effective As Vidaza Alone In Myelodysplastic Syndromes Patients
- Vidaza and Thalidomide Combination Therapy Shows No Unexpected Side Effects In Myelodysplastic Syndromes Patients (ASH 2009)
- Vidaza Most Effective When First-Choice Treatment (ASCO 2009)
- MDS Patients’ Pretreatment Risk Level Predicts Outcome Of Vidaza Treatments (EHA 2009)
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