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THOUSAND OAKS, Calif. (Dec. 8, 2014) – Amgen (NASDAQ:AMGN) announced today that new data from a pivotal Phase 2 study evaluating BLINCYTO™ (blinatumomab) for the treatment of adult patients with relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL) was presented at the 56th Annual Meeting and Exposition of the American Society of Hematology (ASH).
In one analysis from the ‘211 Study, 40 percent of patients treated with BLINCYTO who achieved a complete remission (CR) or complete remission with partial hematologic recovery (CRh) were enabled to proceed to allogeneic hematopoietic stem cell transplant (HSCT). Additionally, a secondary analysis from the study found that 82 percent of patients who had a CR or CRh also had a minimal residual disease (MRD) response, a measure used to predict disease recurrence in patients with ALL.
“The data from the ‘211 study expand the evidence of Amgen’s BiTE® immunotherapy as an advance in the management of this difficult-to-treat cancer, and importantly, served as the basis for the recent U.S. Food and Drug Administration (FDA) approval of BLINCYTO,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “In this study, BLINCYTO helped patients bridge to a stem cell transplant after achieving a remission, a key goal in the management of ALL, and achieved MRD response in patients, an important parameter in predicting relapse.”
In the study, the most frequent grade ≥3 AEs occurring in ≥5 percent of patients were febrile neutropenia (25 percent), neutropenia (16 percent), anemia (14 percent), pneumonia (9 percent), thrombocytopenia (8 percent), hyperglycemia (8 percent), leukopenia (8 percent), alanine aminotransferase increased (7 percent), hypokalemia (7 percent), pyrexia (7 percent), sepsis (6 percent), hypophosphatemia (5 percent). Grade ≥ 3 neurologic events occurred in 13 percent of patients, and Grade ≥ 3 cytokine release syndrome occured in 2 percent of patients.
In one analysis of the ‘211 Study, 40 percent of patients treated with BLINCYTO who achieved a CR or CRh were enabled to proceed to HSCT, including both patients who had received prior HSCT and patients who had not received prior HSCT. Additionally, the analysis found that responses to BLINCYTO were similar between patients who had received prior HSCT and patients who had not received HSCT (45 percent versus 42 percent, respectively).
A secondary analysis of the study demonstrated that, among patients receiving BLINCYTO who had a CR or CRh and had evaluable MRD data (n=73), 82 percent had an MRD response, with 70 percent of those patients achieving a complete MRD response. Median overall survival was longer among patients who had a CR or CRh and an MRD response compared to patients who didn’t have an MRD response (11.5 months [95 percent CI, 8.5 – not estimable] versus 6.7 months [95 percent CI, 2.0 – not estimable], respectively).
In the U.S., more than 6,000 cases of ALL will be diagnosed in 2014, and in the European Union, it is estimated that more than 7,000 cases of ALL are diagnosed each year.1,2 In adult patients with relapsed or refractory ALL, median overall survival is just three to five months.3
The single arm, open-label, multicenter Phase 2 trial evaluated the safety and efficacy of BLINCYTO in adult patients with Ph- B-precursor ALL who had relapsed or were refractory following treatment with standard front-line chemotherapy or allogeneic stem cell transplant. Patients received up to five four-week cycles of intravenous BLINCYTO treatment. The primary endpoint of the study was the rate of CR/CRh within the first two treatment cycles. Secondary endpoints include duration of CR and CRh, relapse-free survival, overall survival, HSCT realization rate, 100-day mortality rate and adverse events.
BLINCYTO is the first BiTE® antibody construct and the first single-agent immunotherapy to be approved by the U.S. Food and Drug Administration (FDA).4 BLINCYTO was granted breakthrough therapy and priority review designations by the FDA, and is now approved in the U.S. for the treatment of Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
Bispecific T cell engager (BiTE®) antibody constructs are a type of immunotherapy being investigated for fighting cancer by helping the body’s immune system to detect and target malignant cells. The modified antibodies are designed to engage two different targets simultaneously, thereby juxtaposing T cells (a type of white blood cell capable of killing other cells perceived as threats) to cancer cells. BiTE® antibody constructs help place the T cells within reach of the targeted cell, with the intent of allowing T cells to inject toxins and trigger the cancer cell to die (apoptosis). BiTE® antibody constructs are currently being investigated for their potential to treat a wide variety of cancers. For more information, visit www.biteantibodies.com.
BLINCYTO is indicated for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
This indication is approved under accelerated approval. Continued approval for this indication may be contingent upon verification of clinical benefit in subsequent trials.
IMPORTANT SAFETY INFORMATION
BLINCYTO™ is contraindicated in patients with a known hypersensitivity to blinatumomab or to any component of the product formulation.
Please see full Prescribing Information and medication guide for BLINCYTO at www.BLINCYTO.com.
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be the world's largest independent biotechnology company, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.
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Kristen Davis, 805-447-3008 (media)
Danielle Bertrand, 650-266-2114 (media)
Arvind Sood, 805-447-1060 (investors)