Business
Amgen Announces BLINCYTO® (blinatumomab) Five-Year Overall Survival Data At EHA 2019
THOUSAND OAKS, Calif., June 15, 2019 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the five-year overall survival (OS) analysis from the single-arm,
About this update from Amgen Inc.
[{"type":"text","content":"THOUSAND OAKS, Calif., June 15, 2019 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the five-year overall survival (OS) analysis from the single-arm, Phase 2 BLAST study that evaluated BLINCYTO® (blinatumomab) in patients with minimal residual disease (MRD)-positive acute lymphoblastic leukemia (ALL). The study found that with a median follow-up of 59.8 months, the median OS for BLINCYTO-treated patients was 36.5 months (95 percent CI: 22 months - not estimable [NE]). 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 today during an oral presentation at the 24th Annual Congress of the European Hematology Association (EHA) in Amsterdam.\n\"As the only CD19-targeted immuno-oncology therapy with five-year survival data, BLINCYTO continues to demonstrate compelling results for ALL patients,\" said David M. Reese, M.D., executive vice president of Research and Development at Amgen. \"We are proud of the science behind our BiTE® technology. 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.\" \nThe Phase 2 open-label BLAST study enrolled 116 patients with MRD-positive Philadelphia chromosome-negative (Ph-) 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 (HSCT) in continuous complete remission (CCR) after BLINCYTO treatment. \nResults presented at EHA showed that in 84 patients who achieved a complete MRD response (had no measurable MRD), median OS was not reached (95 percent CI: 29.5 months - NE) compared to 14.4 months for those who had measurable MRD (n=23; 95 percent CI: 3.8 - 32.3 months). Among patients with MRD in first complete remission (CR1), median OS was not reached for those who achieved a complete MRD response (95 percent CI: 29.5 months - NE) versus 10.6 months (95 percent CI: 2.7 - 39.7 months) for those who did not achieve complete MRD respon...