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Published on 19 June 2014

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Vidaza® in acute myeloid leukaemia study results

Celgene has announced that results from AML-001, its phase III study of VIDAZA® (azacitidine), compared with conventional care regimens (CCR) in elderly patients with newly diagnosed acute myeloid leukaemia (AML – >30% blasts)
 

Celgene has announced that results from AML-001, its phase III study of VIDAZA® (azacitidine), compared with conventional care regimens (CCR) in elderly patients with newly diagnosed acute myeloid leukaemia (AML – >30% blasts)
 
In the global, multi-centre, randomised, open-label pivotal study, patients at least 65 years old with newly diagnosed AML with >30% bone marrow blasts were pre-selected to receive one of three regimens from intensive chemotherapy (standard 7+3 regimen), low-dose Ara-C (20 mg SC twice per day for 10 days of each 28-day cycle) or best supportive care only. Patients were then randomised to receive either azacitidine (n=241) (75 mg/m2/d SC for 7 days of each 28-day cycle) or their predetermined CCR (n=247).
 
Median overall survival (OS), the primary endpoint of the study, was 10.4 months (range 8.0–12.7 months) for patients receiving azacitidine compared with 6.5 months (5.0–8.6) for patients receiving CCR (unstratified hazard ratio [HR]=0.84 [95% confidence interval (CI) 0.69, 1.02]; p=0.0829).(1)
 
Additionally, a pre-specified sensitivity analysis for overall survival that censored patients at the start of subsequent AML therapy was conducted. Results of this analysis showed a significantly longer median overall survival for patients receiving azacitidine (median 12.1 months 95% CI, range 9.2–14.2 months) compared with patients receiving CCR (median 6.9 months 95% CI range 5.1–9.6 months) (stratified HR=0.76 [95% CI 0.60, 0.96]; p=0.019).(1) One-year survival was 47% for patients receiving azacitidine compared with 34% for patients receiving CCR.(1)
 
Commenting on the results, Professor Jamie Cavenagh, Consultant Haematologist at Barts Health NHS Trust, London, said “AML can affect people of any age but is more common in people over 65. While some patients over 60 are offered intensive chemotherapy to try to cure the leukaemia, not everyone is fit enough to go through this and the majority are given lower doses of chemotherapy instead, which means that the chances of going into remission are also lower. However, results from the AML-001 study showed that patients aged 65 and over, who received azacitidine, reached the longest median overall survival seen to date with a low-intensity therapy suggesting a potential future treatment option.”
 
Grade 3-4 anaemia, neutropenia, febrile neutropenia and thrombocytopenia rates, respectively, were 16%, 26%, 28%, and 24% with azacitidine; 5%, 5%, 28%, 5% with best supportive care; 23%, 25%, 30%, 28% with low-dose Ara-C; and 14%, 33%, 31%, 21% with intensive chemotherapy.(1)

The results were presented in a late-breaking abstract oral session at the 19th Congress of the European Hematology Association.
 
 

  1. Dombret H, et al. Results of a phase 3, multicenter, randomized, open-label study of azacitidine (AZA) vs conventional care regimens (CCR) in older patients with newly diagnosed acute myeloid leukemia (AML). Abstract presented at the 19th Congress of the European Hematology Association (EHA). 12–15 June 2014; Milan, Italy.


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