Amgen 2015 Annual Report Download - page 25

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17
BLINCYTO®
BLINCYTO® is an anti-CD19 x anti-CD3 (BiTE®) bispecific antibody construct.
In February 2016, we announced that the phase 3 TOWER study evaluating the efficacy of BLINCYTO® versus standard
of care in adult patients with Ph- relapsed or refractory B-cell precursor ALL, met its primary endpoint of improved OS based on
the results of a prespecified interim analysis.
A phase 3 study in pediatric patients with high-risk first relapse B-precursor ALL is ongoing. Phase 2 studies in adult patients
with relapsed/refractory Philadelphia chromosome-positive (Ph+) and minimal residual disease of ALL are ongoing. A phase 2
study in adult patients with DLBCL is ongoing.
Denosumab
Denosumab is a human monoclonal antibody that inhibits RANKL.
Prolia®
A phase 3 study of Prolia® for the treatment of glucocorticoid-induced osteoporosis is ongoing.
XGEVA®
Phase 3 studies for the delay or prevention of bone metastases in patients with adjuvant breast cancer and prevention of SREs
in patients with multiple myeloma are ongoing. A phase 2 study in NSCLC is ongoing.
ENBREL
ENBREL is a fusion protein that inhibits tumor necrosis factor.
A phase 3 study to evaluate ENBREL as a monotherapy for psoriatic arthritis treatment is ongoing. A phase 3 study to evaluate
ENBREL as a monotherapy in maintaining remission in rheumatoid arthritis is ongoing.
IMLYGIC™
IMLYGIC™ is an oncolytic immunotherapy derived from HSV-1.
A phase 1b/3 study to evaluate IMLYGIC™ in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab),
in patients with mid- to late-stage metastatic melanoma is ongoing.
Kyprolis®
Kyprolis® is a proteasome inhibitor.
In December 2015, we announced that we submitted to the EMA a Variation to the MAA to expand the indication for
Kyprolis® in combination with dexamethasone for the treatment of adult patients with multiple myeloma who have received at
least one prior therapy based on the data from the ENDEAVOR trial.
A phase 3 study, CLARION, evaluating Kyprolis® in combination with melphalan and prednisone compared to bortezomib,
melphalan and prednisone in newly diagnosed multiple myeloma is ongoing. A phase 3 study, ARROW (RAndomized, Open-
label, Phase 3 Study in Subjects with Relapsed and Refractory Multiple Myeloma Receiving Carfilzomib in Combination with
Dexamethasone, Comparing Once-Weekly versus Twice-weekly Carfilzomib Dosing), with weekly dosing in relapsed and
refractory multiple myeloma is also underway.
A phase 1b/2 study in small-cell lung cancer is ongoing.
Parsabiv™
Parsabiv™ is a peptide agonist of the human cell surface CaSR. It is being evaluated as an intravenously administered treatment
of SHPT.
In September 2015, we announced that we submitted an MAA to the EMA for Parsabiv™, for the treatment of SHPT in adult
patients with CKD on hemodialysis.
In November 2015, we announced that the FDA has accepted for review our NDA for Parsabiv™ for the treatment of SHPT
in adult patients with CKD on hemodialysis.