Onyx
Pharmaceuticals, Inc. ONXX today highlighted the
presentation of three studies, among several, from its proteasome
inhibitor franchise at the 14th International Myeloma Workshop (IMW),
April 3-7, 2013, in Kyoto, Japan. New data will be presented on
carfilzomib in high-risk-smoldering myeloma and on oprozomib in
hematologic malignances.
"The results being presented at the IMW continue to build our
clinical understanding of carfilzomib, a second-generation proteasome
inhibitor, and oprozomib, an oral proteasome inhibitor in early
development," said Pablo Cagnoni, M.D., Executive Vice President,
Global Research & Development and Technical Operations, Onyx
Pharmaceuticals. "Onyx is committed to the continued development of both these proteasome inhibitors in multiple myeloma, as well as
other hematologic malignancies and to bringing these therapies to
patients globally as quickly as possible."
Carfilzomib
Clinical and
Correlative (Phase II) Pilot Study - Carfilzomib (CFZ), Lenalidomide
(LEN), and Dexamethasone (Dex) in High Risk Smoldering Multiple
Myeloma ("Early Myeloma")
-- Dr. Ola Landgren, National Cancer Institute (NCI)
-- Saturday, April 6, 8:00-8:12 a.m. JST (Friday, April 5, 7:00-7:12 p.m.
ET)
-- Plenary Session 1
Treatment (tx) with CRd -- carfilzomib (CFZ), lenalidomide (LEN) and
low-dose dexamethasone (dex) -- for elderly patients (pts) with newly
diagnosed multiple myeloma (NDMM) enrolled in a phase (Ph) 1/2 study
-- Dr. Andrzej Jakubowiak, University of Chicago Medical Center
-- Saturday, April 6, 8:48-9:00 a.m. JST (Friday, April 5, 7:48-8:00 p.m.
ET)
-- Plenary Session 1
Oprozomib
Oprozomib Treatment in Patients With Hematologic Malignancies: Updated
Results From a Phase 1b/2 Trial
-- Dr. Jonathan Kaufman, Winship Cancer Institute
-- Thursday, April 4, 5:00-9:00 p.m., Friday-Saturday, April 5-6 10:00
a.m.-4:00 p.m. JST (Thursday, April 4 4:00-8:00 a.m. ET,
Thursday-Friday, April 4-5 9:00 p.m.-3:00 a.m. ET)
-- Poster # P-225
-- Abstract #
427
Important Indication and Safety Information Regarding Kyprolis(R)
(carfilzomib) for Injection
On July 20, 2012, the U.S. Food and
Drug Administration (FDA) granted accelerated approval of Kyprolis(R)
(carfilzomib) for Injection for the treatment of patients with
multiple myeloma who have received at least two prior therapies
including bortezomib and an immunomodulatory agent (IMiD), and have
demonstrated disease progression on or within 60 days of completion of the last therapy. Approval was based on response rate. Clinical
benefit, such as improvement in survival or symptoms, has not been
verified.
Safety data have been evaluated in 526 patients with relapsed and/or
refractory multiple myeloma who received single-agent Kyprolis. There
were 37 deaths in the phase 2 studies, or 7% of patients. The most
common causes of death, other than disease progression, were cardiac
(5 patients), end-organ failure (4 patients), and infection (4
patients). Important warnings and precautions include cardiac arrest,
congestive heart failure, myocardial ischemia; pulmonary
hypertension, pulmonary complications, infusion reactions, tumor
lysis syndrome, thrombocytopenia, hepatic toxicity and embryo-fetal
toxicity.
Death due to cardiac arrest has occurred within a day of Kyprolis
administration. Patients with New York Heart Association Class III
and IV heart failure, myocardial infarction in the preceding 6
months, and conduction abnormalities uncontrolled by medications were not eligible for the clinical trials. These patients may be at
greater risk for cardiac complications.
Pulmonary arterial hypertension (PAH) was reported in 2% of patients
treated with Kyprolis and was Grade 3 or greater in less than 1% of
patients. Dyspnea was reported in 35% of patients enrolled in
clinical trials. Grade 3 dyspnea occurred in 5%; no Grade 4 events,
and 1 death (Grade 5) was reported.
Infusion reactions, characterized by a spectrum of systemic symptoms
including fever, chills, arthralgia, myalgia, facial flushing, facial
edema, vomiting, weakness, shortness of breath, hypotension, syncope,
chest tightness, or angina can occur immediately following or up to
24 hours after administration of Kyprolis. Administration of
dexamethasone prior to Kyprolis reduces the incidence and severity of
reactions. Tumor lysis syndrome (TLS) occurred following Kyprolis
administration in < 1% of patients. Patients with multiple myeloma
and a high tumor burden should be considered to be at greater risk
for TLS.
Thrombocytopenia following Kyprolis administration resulted in a dose
reduction in 1% of patients and discontinuation of treatment with
Kyprolis in < 1% of patients.
Cases of hepatic failure, including fatal cases, have been reported
(< 1%). Kyprolis can cause elevations of serum transaminases and
bilirubin.
There are no adequate and well-controlled studies in pregnant women
using Kyprolis. Females of reproductive potential should be advised
to avoid becoming pregnant while being treated with Kyprolis. The
most common serious adverse reactions were pneumonia, acute renal
failure, pyrexia, and congestive heart failure. The most common
adverse reactions (incidence of 30% or greater) observed in clinical
trials of patients with multiple myeloma were fatigue, anemia,
nausea, thrombocytopenia, dyspnea, diarrhea, and pyrexia. Serious
adverse reactions were reported in 45% of patients.
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