Amgen’s Blincyto (blinatumomab) has been recommended by the National Institute for Health and Care Excellence (NICE) to treat certain cases of acute lymphoblastic leukaemia (ALL).
The health technology assessment agency has recommended in final draft guidance that the immunotherapy be used on the NHS in combination with chemotherapy to treat adults with Philadelphia chromosome-negative CD19-positive B-cell precursor ALL in the consolidation phase, a phase of frontline treatment for ALL which is aimed at killing any remaining leukaemia cells.
Eligible patients must also be minimal residual disease-negative, meaning they have responded well to initial therapy and have no detectable cancer cells.
NICE’s decision comes two months after the Medicines and Healthcare products Regulatory Agency (MHRA) approved the drug for the same indication. This was supported by positive results from the late-stage E1910 trial led by the ECOG-ACRIN Cancer Research Group.
The study showed that Blincyto added to multiphase consolidation chemotherapy was associated with superior overall survival (OS) and relapse-free survival (RFS) compared to chemotherapy alone.
With a median follow-up of 4.5 years, the five-year OS was 82.4% in the Blincyto plus chemotherapy cohort versus 62.5% in the chemotherapy group, while the five-year RFS was 77% in the Blincyto/chemotherapy arm versus 60.5% for chemotherapy alone.
Approximately 300 adults are diagnosed with ALL, a type of blood cancer that develops in the bone marrow, in the UK every year, with B-cell ALL accounting for the majority of cases.
Although up to 90% of adult patients will achieve an initial haematologic complete remission after front-line treatment, as many as 50% will experience relapse and need a second line of therapy.
Administered as an intravenous infusion and already approved in the UK to treat certain cases of B-ALL, Blincyto is a bispecific T-cell engager molecule designed to target CD19 surface antigens on B cells. This helps the body’s immune system recognise and destroy cancer cells that might be left behind after initial treatment.
Around 80 adults per year could benefit from the Blincyto combination treatment, which will be available to eligible patients immediately through the NHS.
Helen Knight, director of medicines evaluation at NICE, said: “This treatment could give patients precious extra months and potentially years with their loved ones. The evidence showing how well it works is really compelling.”