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Bristol-Myers Squibb drug boasts strong overall survival in acute myeloid leukaemia

Published on 11/12/19 at 10:46am

Bristol-Myers Squibb took the opportunity at the 2019 American Society of Hematology (ASH) Annual Meeting to reveal new efficacy data on its candidate CC-486 in the maintenance treatment of front-line, newly diagnosed acute myeloid leukaemia (AML) in patients who have achieved remission with intensive induction chemotherapy.

The drug was tested in 472 patients at least 55 years old with de novo or secondary AML with intermediate or poor-risk cytogenetics who had achieved their first complete remission (CR) or complete remission with incomplete count recovery (CRi) after receiving intensive induction chemotherapy. Additionally, they had also undergone intensive induction chemotherapy, with or without consolidation chemotherapy and were not candidates for haematopoietic stem-cell transplant.

81% saw a complete remission (CR) while 19% achieved complete remission with incomplete count recovery (CRi) after receiving intensive induction chemo, while 80% had received at least one cycle of consolidation therapy.

At a median follow-up of 41.2 months, median overall survival benefit stood at 24.7 months compared to 14.8 months with placebo, while relapse-free survival benefit was measured as 10.2 months compared to 4.8 months with placebo, regardless of cytogenic risk category prior consolidation or CR/CRi status.

“Despite a number of recent advances in the treatment of AML, the prognosis remains poor, as most patients will relapse and ultimately die of their disease,” said Dr Andrew Wei of the Alfred Hospital and Monash University in Melbourne. “The role of maintenance therapy in AML has historically been a contentious issue. Based on the results of the QUAZAR study, we are excited about the clinical development of CC-486 and the potential to establish maintenance therapy as a new treatment paradigm for patients with AML in first remission.”

Dr Samit Hirawat, Chief Medical Officer of Bristol-Myers Squibb, remarked on the data: “We are extremely encouraged by the results of the QUAZAR AML-001 study as a part of our continuing commitment to both epigenetic research and myeloid diseases. We now look forward to taking the next steps to bring CC-486 to eligible AML patients in need.”

The drug candidate is not currently approved anywhere in the world, but BMS confirmed it will be submitting applications to regulatory authorities in the first half of next year.

Matt Fellows

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