A reolutionary drug that prevents relapse long term and maintains remission of people with acute myeloid leukaemia has been launched.
Trials of the treatment, called Ceplene, have shown that it prolongs remission and prevents relapse in patients under the age of 60.
Ceplene has been shown to avert an additional 20 per cent of relapses during the three years after chemotherapy.
It is the first and only treatment proven to extend first remission in acute myeloid leukaemia (AML), the most common form of acute leukaemia in the UK. Without therapy to sustain remission, most patients relapse within 12-18 months.
The study, presented by the University of Gothenburg, Sweden, involved 320 AML patients from eleven countries worldwide. Sufferers were put on repeated courses of the treatment over 18 months after chemotherapy to protect them from relapse.
The trial demonstrated that the combination treatment, which contains histamine dihydrochloride (Ceplene) and the immune system molecule Interleukin-2, significantly improved relapse protection rates for three years. The efficacy of Ceplene to prevent relapse was also observed after a separate analysis at six years.
Initial treatment of AML is aimed at producing complete remission by eradicating leukaemic cells through chemotherapy. Once remission is achieved, the standard approach has been to give no treatment and wait for relapse to occur – or hope that relapse will not occur.
For a small number of patients, stem cell transplant is an option but at a high cost to the NHS.
However, because AML patients who relapse have a poor prognosis for survival, there is a critical unmet medical need for maintenance therapy to prolong remission time and prevent relapse.
The drug Ceplene is the only approved treatment that has been shown to prolong remission of AML patients of whom the majority will die within 6-9 months should a relapse occur.
Professor Kristoffer Hellstrand of the University of Gothenburg, says: “This is a new therapeutic option for AML patients that has the potential to improve the outcome in one of the deadliest forms of cancer.”
Each dose of Ceplene, which patients can self administer at home without medical supervision, is injected subcutaneously over 5-15 minutes where it is rapidly absorbed into the body.
Ceplene works by facilitating the anti-leukaemic functions of lymphocytes. This allows the natural killer cells and T cells in the immune system to destroy any remaining cancer cells. The drug costs from £3,500 per treatment cycle.
Leukaemia is a blood cancer which affects white blood cells, which are a really important part of the immune system that fights infection.
Acute myeloid leukaemia (AML) is an acute leukaemia, meaning that it progresses quickly. It affects a type of white blood cell called myeloid cells. It can affect people of any age, including children and young adults.
Around 2,200 adults are diagnosed with AML in the UK every year and it is the second most common leukaemia in children.
Normally, blood cells are made in the bone marrow in an orderly and controlled way. In AML, this process gets out of control and many abnormal leukaemia cells are made. These immature cells (blast cells) are not able to develop into normal functioning blood cells.
The immature cells fill up the bone marrow, taking up space that is needed to make normal blood cells. Some leukaemia cells ‘spill over’ into the blood and circulate around the body in the bloodstream. These leukaemia cells don’t mature, and so don’t work properly.
This leads to an increased risk of infection as well as symptoms such as anaemia and bruising caused by fewer healthy red blood cells and platelets being made. Without chemotherapy treatment, AML results in death within months of diagnosis.
Over the past decade, significant progress has been made in understanding the disease. Progress in therapy, however, has only been gradual and most of this progress is limited to improved treatment in the early phase of the disease.
Tony Gavin, spokesman for Leukaemia CARE says: ‘It would be nice to think that there are new drugs coming through which can be used to prevent relapse in acute myeloid leukaemia .”
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