UK MHRA approves Blincyto for specific leukemia

“B-cell precursor leukaemia acute lymphoblastic leukaemia (B-ALL) is a rare life-threatening blood cancer. Patients treated with standard of care chemotherapy alone in consolidation, can relapse despite initial responses and hence the E1910 trial investigated whether adding blinatumomab to the standard of care chemotherapy regimen could prolong survival and reduce relapse rates. The consolidation phase is a period of intense treatment and can be a worrying time for patients and their loved ones. This licence allows us to reach even more patients in the UK who are in need of frontline treatments that reduce the risk of disease relapse,” said Tony Patrikios, Amgen UK & Ireland Medical Director.

“B-cell precursor leukaemia acute lymphoblastic leukaemia (B-ALL) is a rare life-threatening blood cancer. Patients treated with standard of care chemotherapy alone in consolidation, can relapse despite initial responses and hence the E1910 trial investigated whether adding blinatumomab to the standard of care chemotherapy regimen could prolong survival and reduce relapse rates. The consolidation phase is a period of intense treatment and can be a worrying time for patients and their loved ones. This licence allows us to reach even more patients in the UK who are in need of frontline treatments that reduce the risk of disease relapse,” said Tony Patrikios, Amgen UK & Ireland Medical Director.

The extended indication is based on the Phase III E1910 clinical trial, led by ECOG-ACRIN Cancer Research Group. This randomised-controlled trial studied adult patients with newly diagnosed Philadelphia chromosome-negative B-ALL receiving post-induction consolidation treatment. “In the E1910 study, blinatumomab added to consolidation chemotherapy, demonstrated significantly improved survival compared to chemotherapy alone in patients who met the threshold of MRD negativity below 10-4,” said Dr Richard Burt, Cancer Research UK Clinician Scientist at Imperial College London and Honorary Haematology Consultant at University College London Hospital. “This licence could provide a more effective treatment option compared to standard of care chemotherapy alone for minimal residual disease negative adult patients with B-ALL, by reducing likelihood of relapse and improving survival.

Results from the study demonstrated that in adult patients with Philadelphia chromosome negative CD19-positive B-ALL who are MRD negative (threshold below 10-4), blinatumomab added to multiphase consolidation chemotherapy showed improved overall survival (OS, primary endpoint) and relapse free survival (RFS, secondary endpoint) versus consolidation chemotherapy alone. With a median follow-up of 4.5 years, the 5-year OS was 82.4% in the blinatumomab plus chemotherapy arm and 62.5% in the chemotherapy arm, with the hazard ratio for OS of 0.44 (95% confidence interval 0.25 - 0.76) (p=0.003). The 5-year RFS was 77% in the blinatumomab plus chemotherapy arm versus 60.5% in the chemotherapy arm, with a hazard ratio for RFS of 0.53 (95% CI, 0.32 - 0.88).