Amgen has revealed “compelling” long-term survival data for its acute lymphoblastic leukemia (ALL) drug Blincyto (blinatumomab).
The five-year overall survival (OS) analysis – based on data from the Phase II BLAST study, which included patients with minimal residual disease (MRD)-positive ALL – found the median OS for Blincyto-treated patients to be 36.5 months at a median follow-up of 59.8 months.
Also, more than half of patients who achieved a complete MRD response following the first cycle of treatment were alive at five years, the firm noted.
“As the only CD19-targeted immuno-oncology therapy with five-year survival data, Blincyto continues to demonstrate compelling results for ALL patients,” said David Reese, executive vice president of Research and Development at Amgen.
“These data in an MRD-positive ALL patient population give us increased confidence in the clinical benefit of Blincyto, especially when these patients are treated earlier.”
Results from the trial presented at the 24th Annual Congress of the European Hematology Association (EHA) in Amsterdam also showed that in 84 patients who achieved a complete MRD response, median OS was not reached compared to 14.4 months for those who had measurable MRD.
“The presence of MRD is a strong predictor of relapse in patients with B-cell precursor ALL,” said Nicola Gökbuget, principal investigator for the BLAST study and head of the German Multicenter Study Group for Adult ALL in Frankfurt, Germany.
“Results from the final follow-up of the BLAST trial at five years demonstrate that early achievement of complete molecular remission with Blincyto is associated with prolonged survival.”
Blincyto, a bispecific CD19-directed CD3 T cell BiTE (bispecific T cell engager) molecule, is the first approved molecule from Amgen’s BiTE immuno-oncology platform, and the first and only therapy to receive regulatory approval globally for the treatment of MRD.