Amgen announces BLINCYTO five-year overall survival data
Amgen announced the five-year overall survival analysis from the single-arm, Phase 2 BLAST study that evaluated BLINCYTO in patients with minimal residual disease-positive acute lymphoblastic leukemia. The study found that with a median follow-up of 59.8 months, the median OS for BLINCYTO-treated patients was 36.5 months. More than half of patients who achieved a complete MRD response following the first cycle of BLINCYTO treatment were alive at five years. These results from the largest prospective trial ever conducted in MRD-positive ALL were presented during an oral presentation at the 24th Annual Congress of the European Hematology Association in Amsterdam. The Phase 2 open-label BLAST study enrolled 116 patients with MRD-positive Philadelphia chromosome-negative B-cell precursor ALL in first or subsequent complete hematologic remission after at least three intensive chemotherapy blocks of treatment. Of the 116 enrolled patients, OS was evaluated for 110 patients with less than five percent leukemic blasts, including 74 patients who received hematopoietic stem cell transplantation in continuous complete remission after BLINCYTO treatment. Results presented at EHA 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. Among patients with MRD in first complete remission, median OS was not reached for those who achieved a complete MRD response versus 10.6 months for those who did not achieve complete MRD response. Safety results among MRD-positive patients were consistent with the known safety profile of BLINCYTO.