Amgen’s Phase 2 data supports safety, efficacy of BLINCYTO in ALL patients with minimal residual disease

Dec 8 2015

Amgen (NASDAQ:AMGN) today announced that new data from three Phase 2 trials support the efficacy and safety of BLINCYTO® (blinatumomab) in adults with acute lymphoblastic leukemia (ALL). These data were presented today in oral sessions at the 57th Annual Meeting and Exposition of the American Society of Hematology (ASH) in Orlando, Fla.

In a Phase 2 confirmatory multicenter single-arm trial (BLAST), adult patients with B-cell precursor ALL with minimal residual disease (MRD) who received BLINCYTO monotherapy demonstrated clinically meaningful relapse-free survival (RFS), as measured in the key secondary endpoint (abstract #680). Median RFS was 18.9 months following initiation of BLINCYTO. MRD refers to the presence of leukemia blast cells below the limits of detection available with standard assessment. Results from the Phase 2 BLAST trial were nominated for inclusion in the Best of ASH Session on Tuesday, Dec. 8 from 11:30 a.m. - 1 p.m. ET.

Other presentations demonstrate BLINCYTO’ s potential in a high risk subpopulation of patients with relapsed or refractory Philadelphia chromosome-positive (Ph+) B-precursor ALL (abstract #679) and confirm BLINCYTO’s efficacy in a subset of patients with relapsed or refractory Philadelphia chromosome-negative (Ph-) ALL after an allogeneic hematopoietic stem cell transplantation (alloHSCT), who typically have poor outcomes with current therapies (abstract #861).

“A key goal in the treatment of blood cancers is to prevent relapse from occurring,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “Achieving a complete minimal residual disease, or MRD response, is important because having no detectable MRD places ALL patients at a lower risk for relapse when compared to patients with persistent or recurrent MRD. The data presented are highly encouraging because they support the potential of BLINCYTO in a broader spectrum of ALL patients, including those at an earlier stage of disease.”

ALL is a rare and rapidly progressing cancer of the blood and bone marrow. In adult patients with relapsed or refractory ALL, median overall survival (OS) is just three to five months. Currently, there is no broadly accepted standard treatment regimen for adult patients with relapsed or refractory ALL beyond chemotherapy. Around 15-30 percent of adult ALL patients are Ph+ and these patients typically have a poor response to standard therapy, short remission duration and low survival rates.

Abstracts are currently available on the ASH website.

ASH Abstract #680: Long-Term Outcomes After Blinatumomab Treatment: Follow-up of a Phase 2 Study in Patients With Minimal Residual Disease (MRD) Positive B-cell Precursor ALL

• In this long-term follow up from the Phase 2 ‘203 study of 116 patients with B-precursor ALL and persistent or recurrent MRD after first-line chemotherapy, patients who achieved an MRD complete response with BLINCYTO had a longer OS, RFS and duration of remission (DOR) compared with those not achieving an MRD complete response, with a median OS in MRD-negative patients of 40.4 months. In data reported at ASH 2014, treatment with BLINCYTO resulted in complete MRD response in cycle 1 in 78 percent of patients.
• The most clinically relevant adverse events (AEs) were neurologic events, including tremor (30 percent), aphasia (13 percent), dizziness (8 percent), ataxia and paresthesia (6 percent each), and encephalopathy (5 percent). Rates decreased over time (cycles 1, 2, 3 and 4) for any neurologic event (47 percent, 24 percent, 15 percent and 15 percent) and any grade 3 or higher neurologic event (10 percent, 4 percent, 0 percent and 0 percent).

ASH Abstract #679: Complete Molecular and Hematologic Response in Adult Patients with R/R Philadelphia Chromosome-positive B-precursor ALL following Treatment with Blinatumomab: Results from a Phase 2 Single-arm, Multicenter Study (ALCANTRA)

• In the Phase 2 ALCANTARA study, BLINCYTO showed antileukemic activity in very poor prognosis patients with relapsed or refractory Ph+ B-precursor ALL after failure of at least one second-generation tyrosine kinase inhibitor (TKI) therapy, with 36 percent of patients achieving complete remission or complete remission with partial hematological recovery (CR/CRh) during the first two treatment cycles. Of patients who achieved CR/CRh, 88 percent achieved a complete MRD response. Equivalent response rates were observed in patients with kinase-domain mutations in BCR-ABL such as T315I (four achieved CR/CRh; all four also achieved a complete MRD response).
• Patient incidence of grade 3 or higher treatment-emergent AEs was 82 percent, most commonly febrile neutropenia (27 percent), thrombocytopenia (22 percent), anemia (16 percent), pyrexia (11 percent), and neurologic events (7 percent). There were no episodes of grade 3 or higher cytokine release syndrome.

ASH Abstract #861: Treatment with anti-CD19 BiTE® Blinatumomab in Adult Patients with Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (r/r ALL) PostAllogeneic Hematopoietic Stem Cell Transplantation

• In this analysis from the pivotal Phase 2 ‘211 trial, BLINCYTO induced a CR/CRh rate of 45 percent in a subset of 64 heavily pretreated patients with Ph- ALL who had relapsed or were refractory after an alloHSCT.
• In total, 88 percent of patients had grade 3 or higher treatment-emergent AEs, with the most frequent including neutropenia (22 percent), febrile neutropenia (20 percent), anemia (17 percent), and thrombocytopenia (14 percent). Six patients reported treatment-emergent graft vs. host disease (GvHD), two of which were grade 3 or higher.

Amgen Webcast Investor Meeting

Amgen will host a webcast investor meeting at ASH on Monday, Dec. 7, 2015, at 7 p.m. ET. Sean E. Harper, M.D., executive vice president of Research and Development at Amgen, along with members of Amgen’s clinical development team and clinical investigators will participate to discuss data presented at ASH and Amgen’s broader oncology portfolio of products.

Live audio of the conference call will be simultaneously broadcast over the Internet and will be available to members of the news media, investors and the general public.