Presentations will cover a wide range of blood
diseases including multiple myeloma, lymphoma, chronic lymphocytic
leukemia, acute myeloid leukemia, myelodysplastic syndromes and
beta-thalassemia
First data read-out of pivotal Phase 3 MEDALIST
trial in patients with myelodysplastic syndrome (MDS) to be
highlighted during the ASH Plenary Session
Celgene Corporation (NASDAQ:CELG) today announced that data from
more than 100 abstracts, including a study being featured as a
plenary presentation and more than 40 selected for oral
presentations, evaluating Celgene investigational agents and
investigational uses of marketed products will be presented at the
60th American Society of Hematology Annual Meeting between Dec. 1-4
in San Diego, CA.
“Celgene is deeply committed to furthering our understanding of
blood cancers and encouraged by the promise of new innovations to
improve or extend the lives of patients living with these
intractable diseases,” said Dr. Alise Reicin, President, Global
Clinical Development for Celgene. “Importantly, this year’s ASH
data highlight the advancement of Celgene’s pipeline including
first-in-class compounds with the potential to transform treatment
across multiple blood cancers.”
Presentations will include data from Celgene investigational
agents in company-sponsored or investigator-initiated clinical
studies across the company’s approved and investigational
portfolio. Abstracts highlight some of the first results of key
pivotal data for the company’s pipeline assets, illustrating the
breadth and potential of the hematology portfolio. Of note, a first
look at the results from the MEDALIST trial in patients with
myelodysplastic syndrome (MDS) will be presented during the Plenary
Scientific Session, which honors the top six research papers
submitted for presentation at the meeting. Experts will also share
results from key approved therapies and investigational CAR T cell
therapies in non-Hodgkin's lymphoma, chronic lymphocytic leukemia,
beta thalassemia and multiple myeloma.
Key presentations include:
- First data of the pivotal, Phase 3,
MEDALIST trial featured in the Plenary Scientific Sessions,
highlighting the potential of luspatercept to address a significant
unmet need in patients with MDS;
- First data of the pivotal, Phase 3,
BELIEVE trial highlighting the potential for luspatercept to
address a significant unmet need in adult patients with beta
thalassemia;
- Data from the phase 1/2 TRANSCEND
CLL-004 trial evaluating liso-cel (JCAR017) in patients with
relapsed and/or refractory chronic lymphocytic leukemia (CLL);
- Initial results from a phase 1 trial of
bb21217, a next-generation anti-BCMA CAR T therapy, in patients
with relapsed and/or refractory multiple myeloma (RRMM);
- Data from the phase 1/2 EVOLVE trial
evaluating JCARH125 in patients with RRMM; and
- First data from the Phase 3, AUGMENT
trial, a chemotherapy-free regimen of REVLIMID® plus
rituximab (R2) in patients with relapsed and/or refractory indolent
non-Hodgkin’s lymphoma.
Selected abstracts include*:
Plenary Session
Abstract #1: Plenary; Sunday, Dec. 2, 2:00 p.m., Hall AB, The
MEDALIST Trial: Results of a Phase 3, Randomized, Double-Blind,
Placebo-Controlled, Randomized Study of Luspatercept to Treat
Anemia in Patients with Very Low-, Low-, or Intermediate-Risk
Myelodysplastic Syndromes (MDS) with Ring Sideroblasts (RS) Who
Require Red Blood Cell (RBC) Transfusions (List)
Beta Thalassemia
Abstract #163; Oral; Saturday, Dec. 1, 2:00 p.m., Room 30D, The
BELIEVE Trial: Results of a Phase 3, Randomized, Double-Blind,
Placebo-Controlled, Study of Luspatercept in Adult Beta-Thalassemia
Patients Who Require Regular Red Blood Cell (RBC) Transfusions
(Cappellini)
Myeloid Diseases
New data findings evaluate Celgene in-line and investigational
therapies in myeloid diseases.
Abstract #835; Oral; Monday, Dec. 3, 2:45 p.m., Room 25B,
Real-World Treatment Patterns and Comparative Effectiveness Among a
Population of Elderly Patients with Acute Myeloid Leukemia (AML)
(Medeiros)
Abstract #4731; Poster; Monday, Dec. 3, 6:00 p.m., Hall GH,
Factors Associated with Early Therapy Initiation in Patients (Pts)
with Myelodysplastic Syndromes (MDS) in the Connect® MDS/AML
Disease Registry (Cogle)
Chimeric Antigen Receptor T-cell therapy
(CAR T)
New data highlight growing base of research in cellular
immunotherapy across multiple blood cancers.
Abstract #319; Oral; Sunday, Dec. 2, 7:30 a.m., Room 25B,
Estimation of the Resource Utilization and Costs of Cytokine
Release Syndrome Observed in the TRANSCEND-NHL Clinical Trial: A
Micro-Costing Study (Siddiqi)
Abstract #300; Oral; Sunday, Dec. 2, 8:45 a.m., Marriott Marquis
San Diego Marina, Pacific Ballroom 20, Rapid MRD-negative Responses
in Patients with Relapsed/Refractory CLL Treated with Liso-cel, a
CD-19-directed CAR T-cell Product: Preliminary Results from
TRANSCEND CLL 004, a Phase 1/2 Study Including Patients with
High-Risk Disease Previously Treated with Ibrutinib (Siddiqi)
Abstract #488; Oral; Sunday, Dec. 2, 4:45 p.m., Room 6B, Initial
results from a phase 1 clinical study of bb21217, a next-generation
anti-BCMA CAR T therapy (Shah)
Abstract #957; Oral; Monday, Dec. 3, 5:00 p.m., Ballroom 20A,
JCARH125, Anti-BCMA CAR T-cell Therapy for Relapsed/Refractory
Multiple Myeloma: Initial Proof of Concept Results from a Phase 1/2
Multicenter Study (EVOLVE) (Mailankody)
Lymphoma/Chronic Lymphocytic Leukemia
(CLL)
Multiple studies evaluate novel chemotherapy-free combinations
in lymphoma and chronic lymphocytic leukemia.
Abstract #445; Oral; Sunday, Dec. 2, 4:30 p.m., Hall AB,
AUGMENT: A Phase III Randomized Study of Lenalidomide Plus
Rituximab (R2) vs. Rituximab/Placebo in Patients with
Relapsed/Refractory Indolent Non-Hodgkin’s Lymphoma (Leonard)
Abstract #446; Oral; Sunday, Dec. 2, 4:45 p.m., Hall AB, A Phase
II LYSA Study of Obinutuzumab Combined with Lenalidomide for
Advanced Front-Line Follicular B-Cell Lymphoma in Need of Systemic
Therapy (Morschhauser)
Abstract #999; Oral; Monday, Dec. 3, 6:45 p.m., Room 6F,
Lenalidomide in Combination with CHOP in Patients with
Angioimmunoblastic T Cell Lymphoma (AITL): Final Analysis of
Clinical and Molecular Data of a Phase 2 LYSA Study (Lemonnier)
Multiple Myeloma
New multiple myeloma data reinforces IMiD® therapies as a
foundation of myeloma research.
Abstract #112; Oral; Saturday, Dec 1, 10:15 a.m., Marriott
Marquis San Diego Marina, Grand Ballroom 7, Clinical Significance
and Transcriptional Profiling of Persistent Minimal Residual
Disease (MRD) in Multiple Myeloma (MM) Patients With Standard-Risk
(SR) and High-Risk (HR) Cytogenetics (Goicoechea)
Abstract #243; Oral; Saturday, Dec. 1, 4:30 p.m., Marriott
Marquis San Diego Marina, Grand Ballroom 7, Deep immunoprofiling of
the bone marrow microenvironment changes underlying the multistep
progression of multiple myeloma (Young)
Abstract #121; Oral; Sunday, Dec 2, 8:30 a.m., Marriott Marquis
San Diego Marina, Grand Ballroom 7, Efficacy and Feasibility of
Dose/Schedule-Adjusted Rd-R vs. Continuous Rd in Elderly and
Intermediate-Fit Newly Diagnosed Multiple Myeloma (NDMM) Patients:
RV-MM-PI-0752 Phase III Randomized Study (Larocca)
Abstract #474; Oral; Sunday, Dec 2, 5:45 p.m., Marriott Marquis
San Diego Marina, Grand Ballroom 7, Immunofixation (IF) in Urine is
Really Necessary to Define Complete Remission in Multiple Myeloma
(MM): A Subanalysis from the PETHEMA/GEM2012MENOS65 Phase III
Clinical Trial (Ubieto)
Abstract #716; Oral; Monday, Dec. 3, 10:45 a.m., Room 25B, The
Impact of Lenalidomide, Bortezomib, and Dexamethasone Treatment on
Health-Related Quality of Life in Transplant-Eligible Patients with
Newly-Diagnosed Multiple Myeloma: Results from the IFM/DFCI 2009
Trial (Roussel)
Abstract #1960; Poster; Saturday, Dec. 1, 6:00 p.m., Hall GH,
Health-Related Quality of Life among Patients with Relapsed or
Refractory Multiple Myeloma who Received Pomalidomide, Bortezomib,
and Low-Dose Dexamethasone Versus Bortezomib and Low-Dose
Dexamethasone – Results from the Phase 3 OPTIMISMM Study
(Weisel)
Abstract #2012; Poster; Saturday, Dec. 1, 6:15 p.m., Hall GH,
Immune Profiling of Relapsed or Refractory Multiple Myeloma
Patients Treated With Pomalidomide and Low-Dose Dexamethasone in
Combination With Daratumumab (Pierceall)
Abstract #2243; Poster; Saturday, Dec. 1, 6:15 p.m., Hall GH,
Real-World Outcomes for Transplant-Ineligible Patients With Newly
Diagnosed Multiple Myeloma (NDMM) Treated With Lenalidomide,
Bortezomib, and Dexamethasone (RVd) or Vd: An Enhanced Electronic
Health Records (EHR) Database Analysis (Chari)
Abstract #3271; Poster; Sunday, Dec. 2, 6:00 p.m., Hall GH,
Pomalidomide + Low-Dose Dexamethasone + Daratumumab in Relapsed
and/or Refractory Multiple Myeloma after Lenalidomide-Based
Treatment Failure (Siegel)
Abstract #3278; Poster; Sunday, Dec. 2, 6:00 p.m., Hall GH,
Pomalidomide + Bortezomib + Low-Dose Dexamethasone vs Bortezomib +
Low-Dose Dexamethasone as Second-Line Treatment in Patients with
Lenalidomide-Pretreated Multiple Myeloma: A Subgroup Analysis of
the Phase 3 OPTIMISMM Trial (Dimopoulos)
Abstract #3445; Poster; Sunday, Dec. 2, 6:00 p.m., Hall GH, The
Impact of RVD or VCD Induction on Response 3 Months after First
Line Autologous Transplant in Multiple Myeloma. A single-center
Retrospective Analysis (Moksnes)
Abstract #3232; Poster; Sunday, Dec. 2, 6:00 p.m., Hall GH
Treatment Choices and Outcomes for Patients with Multiple Myeloma
(MM) After Relapse on Lenalidomide (LEN) Maintenance Therapy (mt):
Results from the Connect® MM Registry (Jagannath)
Abstract # 3245; Poster; Sunday, Dec. 2, 6:00 p.m., Hall GH,
Integrated Analysis of Randomized Controlled Trials Evaluating
Bortezomib + Lenalidomide + Dexamethasone or Bortezomib +
Thalidomide + Dexamethasone Induction in Transplant-Eligible Newly
Diagnosed Multiple Myeloma (Rosinol)
Abstract #4744; Poster; Monday, Dec. 3, 6:00 p.m., Hall GH,
Relative Efficacy of Treatment Options in Newly Diagnosed Multiple
Myeloma (NDMM): Results from a Systematic Literature Review (SLR)
and Network Meta-Analysis (NMA) (Ramasamy)
Abstract #4737; Poster; Monday, Dec. 3, 6:00 p.m., Hall GH,
Survival Analysis from the CALGB Study of Lenalidomide Maintenance
Therapy in Newly Diagnosed Multiple Myeloma Post-Autologous Stem
Cell Transplantation Adjusted for Crossover (McCarthy)
The safety and efficacy of investigational agents and/or
investigational uses of approved marketed products have not been
established. There is no guarantee that the agents will receive
health authority approval or become commercially available in any
country for the uses being investigated.
A complete listing of abstracts can be found on the ASH Web site
at http://www.hematology.org/Annual-Meeting/Abstracts/.
*All times Pacific Standard Time
ABOUT REVLIMID
REVLIMID® (lenalidomide) in combination with
dexamethasone (dex) is indicated for the treatment of patients with
multiple myeloma (MM)
REVLIMID is indicated as maintenance therapy in patients with
MM following autologous hematopoietic stem cell transplantation
(auto-HSCT)
REVLIMID® is indicated for the treatment of
patients with transfusion-dependent anemia due to low-or
intermediate-1–risk myelodysplastic syndromes (MDS) associated with
a deletion 5q cytogenetic abnormality with or without additional
cytogenetic abnormalities
REVLIMID® is indicated for the treatment of
patients with mantle cell lymphoma (MCL) whose disease has relapsed
or progressed after two prior therapies, one of which included
bortezomib
REVLIMID is not indicated and is not recommended for the
treatment of patients with chronic lymphocytic leukemia (CLL)
outside of controlled clinical trials
Important Safety Information
WARNING: EMBRYO-FETAL TOXICITY,
HEMATOLOGIC TOXICITY, and VENOUS and ARTERIAL
THROMBOEMBOLISM
Embryo-Fetal Toxicity
Do not use REVLIMID during pregnancy. Lenalidomide, a
thalidomide analogue, caused limb abnormalities in a developmental
monkey study. Thalidomide is a known human teratogen that causes
severe life-threatening human birth defects. If lenalidomide is
used during pregnancy, it may cause birth defects or embryo-fetal
death. In females of reproductive potential, obtain 2 negative
pregnancy tests before starting REVLIMID treatment. Females of
reproductive potential must use 2 forms of contraception or
continuously abstain from heterosexual sex during and for 4 weeks
after REVLIMID treatment. To avoid embryo-fetal exposure to
lenalidomide, REVLIMID is only available through a restricted
distribution program, the REVLIMID REMS®
program.
Information about the REVLIMID REMS® program is
available at www.celgeneriskmanagement.com or by
calling the manufacturer’s toll-free number 1-888-423-5436.
Hematologic Toxicity (Neutropenia and
Thrombocytopenia)
REVLIMID can cause significant neutropenia and
thrombocytopenia. Eighty percent of patients with del 5q MDS had to
have a dose delay/reduction during the major study. Thirty-four
percent of patients had to have a second dose delay/reduction.
Grade 3 or 4 hematologic toxicity was seen in 80% of patients
enrolled in the study. Patients on therapy for del 5q MDS should
have their complete blood counts monitored weekly for the first 8
weeks of therapy and at least monthly thereafter. Patients may
require dose interruption and/or reduction. Patients may require
use of blood product support and/or growth factors.
Venous and Arterial
Thromboembolism
REVLIMID has demonstrated a
significantly increased risk of deep vein thrombosis (DVT) and
pulmonary embolism (PE), as well as risk of myocardial infarction
and stroke in patients with MM who were treated with REVLIMID and
dexamethasone therapy. Monitor for and advise patients about signs
and symptoms of thromboembolism. Advise patients to seek immediate
medical care if they develop symptoms such as shortness of breath,
chest pain, or arm or leg swelling. Thromboprophylaxis is
recommended and the choice of regimen should be based on an
assessment of the patient’s underlying risks.
CONTRAINDICATIONS
Pregnancy: REVLIMID can cause fetal harm when
administered to a pregnant female and is contraindicated in females
who are pregnant. If this drug is used during pregnancy or if the
patient becomes pregnant while taking this drug, the patient should
be apprised of the potential risk to the fetus
Severe Hypersensitivity Reactions: REVLIMID is
contraindicated in patients who have demonstrated severe
hypersensitivity (e.g., angioedema, Stevens-Johnson syndrome, toxic
epidermal necrolysis) to lenalidomide
WARNINGS AND PRECAUTIONS
Embryo-Fetal Toxicity: See Boxed WARNINGS
- Females of
Reproductive Potential: See Boxed WARNINGS
- Males:
Lenalidomide is present in the semen of patients receiving the
drug. Males must always use a latex or synthetic condom during any
sexual contact with females of reproductive potential while taking
REVLIMID and for up to 4 weeks after discontinuing REVLIMID, even
if they have undergone a successful vasectomy. Male patients taking
REVLIMID must not donate sperm
- Blood
Donation: Patients must not donate blood during treatment
with REVLIMID and for 4 weeks following discontinuation of the drug
because the blood might be given to a pregnant female patient whose
fetus must not be exposed to REVLIMID
REVLIMID REMS® Program: See Boxed WARNINGS:
Prescribers and pharmacies must be certified with the REVLIMID REMS
program by enrolling and complying with the REMS requirements;
pharmacies must only dispense to patients who are authorized to
receive REVLIMID. Patients must sign a Patient-Physician Agreement
Form and comply with REMS requirements; female patients of
reproductive potential who are not pregnant must comply with the
pregnancy testing and contraception requirements and males must
comply with contraception requirements
Hematologic Toxicity: REVLIMID can cause significant
neutropenia and thrombocytopenia. Monitor patients with neutropenia
for signs of infection. Advise patients to observe for bleeding or
bruising, especially with use of concomitant medications that may
increase risk of bleeding. MM: Patients taking REVLIMID/dex or
REVLIMID as maintenance therapy should have their complete blood
counts (CBC) assessed every 7 days for the first 2 cycles, on days
1 and 15 of cycle 3, and every 28 days thereafter. MDS: Patients on therapy for del 5q
MDS should have their complete blood counts monitored weekly for
the first 8 weeks of therapy and at least monthly thereafter.
Patients may require dose interruption and/or dose reduction.
Please see the Black Box WARNINGS for further information.
MCL: Patients taking
REVLIMID for MCL should have their CBCs monitored weekly for the
first cycle (28 days), every 2 weeks during cycles 2-4, and then
monthly thereafter. Patients may require dose interruption and/or
dose reduction
Venous and Arterial Thromboembolism: See Boxed WARNINGS:
Venous thromboembolic events (DVT and PE) and arterial thromboses
(MI and CVA) are increased in patients treated with REVLIMID.
Patients with known risk factors, including prior thrombosis, may
be at greater risk and actions should be taken to try to minimize
all modifiable factors (e.g., hyperlipidemia, hypertension,
smoking). Thromboprophylaxis is recommended and the regimen should
be based on patient’s underlying risks. ESAs and estrogens may
further increase the risk of thrombosis and their use should be
based on a benefit-risk decision
Increased Mortality in Patients with CLL: In a clinical
trial in the first-line treatment of patients with CLL, single
agent REVLIMID therapy increased the risk of death as compared to
single agent chlorambucil. Serious adverse cardiovascular
reactions, including atrial fibrillation, myocardial infarction,
and cardiac failure, occurred more frequently in the REVLIMID arm.
REVLIMID is not indicated and not recommended for use in CLL
outside of controlled clinical trials
Second Primary Malignancies (SPM): In clinical trials in
patients with MM receiving REVLIMID, an increase of hematologic
plus solid tumor SPM, notably AML and MDS, have been observed.
Monitor patients for the development of SPM. Take into account both
the potential benefit of REVLIMID and risk of SPM when considering
treatment
Increased Mortality with Pembrolizumab: In clinical
trials in patients with multiple myeloma, the addition of
pembrolizumab to a thalidomide analogue plus dexamethasone resulted
in increased mortality. Treatment of patients with multiple myeloma
with a PD-1 or PD-L1 blocking antibody in combination with a
thalidomide analogue plus dexamethasone is not recommended outside
of controlled clinical trials
Hepatotoxicity: Hepatic failure, including fatal cases,
has occurred in patients treated with REVLIMID/dex. Pre-existing
viral liver disease, elevated baseline liver enzymes, and
concomitant medications may be risk factors. Monitor liver enzymes
periodically. Stop REVLIMID upon elevation of liver enzymes. After
return to baseline values, treatment at a lower dose may be
considered
Severe Cutaneous Reactions Including Hypersensitivity
Reactions: Angioedema and severe cutaneous reactions including
Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN),
and drug reaction with eosinophilia and systemic symptoms (DRESS)
have been reported. DRESS may present with a cutaneous reaction
(such as rash, or exfoliative dermatitis), eosinophilia, fever,
and/or lymphadenopathy with systemic complications such as
hepatitis, nephritis, pneumonitis, myocarditis, and/or
pericarditis. These events can be fatal. Patients with a prior
history of Grade 4 rash associated with thalidomide treatment
should not receive REVLIMID. REVLIMID interruption or
discontinuation should be considered for Grade 2-3 skin rash.
REVLIMID must be discontinued for angioedema, Grade 4 rash,
exfoliative or bullous rash, or if SJS, TEN, or DRESS is suspected
and should not be resumed following discontinuation for these
reactions
Tumor Lysis Syndrome (TLS): Fatal instances of TLS have
been reported during treatment with lenalidomide. The patients at
risk of TLS are those with high tumor burden prior to treatment.
These patients should be monitored closely and appropriate
precautions taken
Tumor Flare Reaction (TFR): TFR has occurred during
investigational use of lenalidomide for CLL and lymphoma.
Monitoring and evaluation for TFR is recommended in patients with
MCL. Tumor flare may mimic the progression of disease (PD). In
patients with Grade 3 or 4 TFR, it is recommended to withhold
treatment with REVLIMID until TFR resolves to ≤Grade 1. REVLIMID
may be continued in patients with Grade 1 and 2 TFR without
interruption or modification, at the physician’s discretion
Impaired Stem Cell Mobilization: A decrease in the number
of CD34+ cells collected after treatment (>4 cycles) with
REVLIMID has been reported. Consider early referral to transplant
center to optimize timing of the stem cell collection
Thyroid Disorders: Both hypothyroidism and
hyperthyroidism have been reported. Measure thyroid function before
start of REVLIMID treatment and during therapy
Early Mortality in Patients with MCL: In another MCL
study, there was an increase in early deaths (within 20 weeks),
12.9% in the REVLIMID arm versus 7.1% in the control arm. Risk
factors for early deaths include high tumor burden, MIPI score at
diagnosis, and high WBC at baseline (≥10 x 109/L)
ADVERSE REACTIONS
Multiple Myeloma
- In newly diagnosed: The most
frequently reported Grade 3 or 4 reactions included neutropenia,
anemia, thrombocytopenia, pneumonia, asthenia, fatigue, back pain,
hypokalemia, rash, cataract, lymphopenia, dyspnea, DVT,
hyperglycemia, and leukopenia. The highest frequency of infections
occurred in Arm Rd Continuous (75%) compared to Arm MPT (56%).
There were more Grade 3 and 4 and serious adverse reactions of
infection in Arm Rd Continuous than either Arm MPT or Rd18
- The most common adverse reactions
reported in ≥20% (Arm Rd Continuous): diarrhea (46%), anemia (44%),
neutropenia (35%), fatigue (33%), back pain (32%), asthenia (28%),
insomnia (28%), rash (26%), decreased appetite (23%), cough (23%),
dyspnea (22%), pyrexia (21%), abdominal pain (21%), muscle spasms
(20%), and thrombocytopenia (20%)
- Maintenance Therapy Post
Auto-HSCT: The most frequently reported Grade 3 or 4 reactions
in ≥20% (REVLIMID arm) included neutropenia, thrombocytopenia, and
leukopenia. The serious adverse reactions of lung infection and
neutropenia (more than 4.5%) occurred in the REVLIMID arm
- The most frequently reported adverse
reactions in ≥20% (REVLIMID arm) across both maintenance studies
(Study 1, Study 2) were neutropenia (79%, 61%), thrombocytopenia
(72%, 24%), leukopenia (23%, 32%), anemia (21%, 9%), upper
respiratory tract infection (27%, 11%), bronchitis (5%, 47%),
nasopharyngitis (2%, 35%), cough (10%, 27%), gastroenteritis (0%,
23%), diarrhea (55%, 39%), rash (32%, 8%), fatigue (23%, 11%),
asthenia (0%, 30%), muscle spasm (0%, 33%), and pyrexia (8%,
21%)
- After at least one prior
therapy: The most common adverse reactions reported in ≥20%
(REVLIMID/dex vs dex/placebo): fatigue (44% vs 42%), neutropenia
(42% vs 6%), constipation (41% vs 21%), diarrhea (39% vs 27%),
muscle cramp (33% vs 21%), anemia (31% vs 24%), pyrexia (28% vs
23%), peripheral edema (26% vs 21%), nausea (26% vs 21%), back pain
(26% vs 19%), upper respiratory tract infection (25% vs 16%),
dyspnea (24% vs 17%), dizziness (23% vs 17%), thrombocytopenia (22%
vs 11%), rash (21% vs 9%), tremor (21% vs 7%), and weight decreased
(20% vs 15%)
Myelodysplastic
Syndromes
- Grade 3 and 4 adverse events reported
in ≥ 5% of patients with del 5q MDS were neutropenia (53%),
thrombocytopenia (50%), pneumonia (7%), rash (7%), anemia (6%),
leukopenia (5%), fatigue (5%), dyspnea (5%), and back pain
(5%)
- Adverse events reported in ≥15% of del
5q MDS patients (REVLIMID): thrombocytopenia (61.5%), neutropenia
(58.8%), diarrhea (49%), pruritus (42%), rash (36%), fatigue (31%),
constipation (24%), nausea (24%), nasopharyngitis (23%), arthralgia
(22%), pyrexia (21%), back pain (21%), peripheral edema (20%),
cough (20%), dizziness (20%), headache (20%), muscle cramp (18%),
dyspnea (17%), pharyngitis (16%), epistaxis (15%), asthenia (15%),
upper respiratory tract infection (15%)
Mantle Cell Lymphoma
- Grade 3 and 4 adverse events reported
in ≥5% of patients treated with REVLIMID in the MCL trial (N=134)
included neutropenia (43%), thrombocytopenia (28%), anemia (11%),
pneumonia (9%), leukopenia (7%), fatigue (7%), diarrhea (6%),
dyspnea (6%), and febrile neutropenia (6%)
- Adverse events reported in ≥15% of
patients treated with REVLIMID in the MCL trial included
neutropenia (49%), thrombocytopenia (36%), fatigue (34%), anemia
(31%), diarrhea (31%), nausea (30%), cough (28%), pyrexia (23%),
rash (22%), dyspnea (18%), pruritus (17%), peripheral edema (16%),
constipation (16%), and leukopenia (15%)
DRUG INTERACTIONS
Periodic monitoring of digoxin plasma levels is recommended due
to increased Cmax and AUC with concomitant REVLIMID therapy.
Patients taking concomitant therapies such as erythropoietin
stimulating agents or estrogen containing therapies may have an
increased risk of thrombosis. It is not known whether there is an
interaction between dex and warfarin. Close monitoring of PT and
INR is recommended in patients with MM taking concomitant
warfarin
USE IN SPECIFIC POPULATIONS
- PREGNANCY: See Boxed WARNINGS:
If pregnancy does occur during treatment, immediately discontinue
the drug and refer patient to an obstetrician/gynecologist
experienced in reproductive toxicity for further evaluation and
counseling. There is a REVLIMID pregnancy exposure registry that
monitors pregnancy outcomes in females exposed to REVLIMID during
pregnancy as well as female partners of male patients who are
exposed to REVLIMID. This registry is also used to understand the
root cause for the pregnancy. Report any suspected fetal exposure
to REVLIMID to the FDA via the MedWatch program at 1-800-FDA-1088
and also to Celgene Corporation at 1-888-423-5436
- LACTATION: There is no
information regarding the presence of lenalidomide in human milk,
the effects of REVLIMID on the breastfed infant, or the effects of
REVLIMID on milk production. Because many drugs are excreted in
human milk and because of the potential for adverse reactions in
breastfed infants from REVLIMID, advise female patients not to
breastfeed during treatment with REVLIMID
- PEDIATRIC USE: Safety and
effectiveness have not been established in pediatric patients
- RENAL IMPAIRMENT: Adjust the
starting dose of REVLIMID based on the creatinine clearance value
and in patients on dialysis
Please see full Prescribing Information,
including Boxed WARNINGS.
About POMALYST/IMNOVID
POMALYST® (pomalidomide) is a thalidomide analogue indicated, in
combination with dexamethasone, for patients with multiple myeloma
who have received at least two prior therapies including
lenalidomide and a proteasome inhibitor and have demonstrated
disease progression on or within 60 days of completion of the last
therapy.
Important Safety Information
WARNING: EMBRYO-FETAL TOXICITY and
VENOUS AND ARTERIAL THROMBOEMBOLISM
Embryo-Fetal Toxicity
- POMALYST is contraindicated in pregnancy. POMALYST is a
thalidomide analogue. Thalidomide is a known human teratogen that
causes severe birth defects or embryo-fetal death. In females of
reproductive potential, obtain 2 negative pregnancy tests before
starting POMALYST treatment.
- Females of reproductive potential must use 2 forms of
contraception or continuously abstain from heterosexual sex during
and for 4 weeks after stopping POMALYST treatment.
POMALYST is only available through a
restricted distribution program called POMALYST
REMS®.
Venous and Arterial
Thromboembolism
- Deep venous thrombosis (DVT), pulmonary embolism (PE),
myocardial infarction, and stroke occur in patients with multiple
myeloma treated with POMALYST. Prophylactic antithrombotic measures
were employed in clinical trials. Thromboprophylaxis is
recommended, and the choice of regimen should be based on
assessment of the patient’s underlying risk factors.
CONTRAINDICATIONS
- Pregnancy: POMALYST can cause fetal
harm and is contraindicated in females who are pregnant. If
POMALYST is used during pregnancy or if the patient becomes
pregnant while taking this drug, the patient should be apprised of
the potential risk to a fetus.
WARNINGS AND PRECAUTIONS
- Embryo-Fetal
Toxicity & Females of Reproductive Potential: See Boxed
WARNINGS
- Males:
Pomalidomide is present in the semen of patients receiving the
drug. Males must always use a latex or synthetic condom during any
sexual contact with females of reproductive potential while taking
POMALYST and for up to 4 weeks after discontinuing POMALYST, even
if they have undergone a successful vasectomy. Males must not
donate sperm.
- Blood
Donation: Patients must not donate blood during treatment
with POMALYST and for 4 weeks following discontinuation of POMALYST
therapy because the blood might be given to a pregnant female
patient whose fetus must not be exposed to POMALYST.
- POMALYST
REMS® Program: See Boxed WARNINGS
- Prescribers and pharmacies must be
certified with the POMALYST REMS program by enrolling and
complying with the REMS requirements; pharmacies must only dispense
to patients who are authorized to receive POMALYST. Patients must
sign a Patient-Physician Agreement Form and comply with REMS
requirements; female patients of reproductive potential who are not
pregnant must comply with the pregnancy testing and contraception
requirements and males must comply with contraception
requirements.
- Further information about the
POMALYST REMS program is available at
www.CelgeneRiskManagement.com or by telephone at
1-888-423-5436.
- Venous and
Arterial Thromboembolism: See Boxed WARNINGS. Patients
with known risk factors, including prior thrombosis, may be at
greater risk, and actions should be taken to try to minimize all
modifiable factors (e.g., hyperlipidemia, hypertension, smoking).
Thromboprophylaxis is recommended, and the choice of regimen should
be based on assessment of the patient’s underlying risk
factors.
- Increased
Mortality with Pembrolizumab: In clinical trials
in patients with multiple myeloma, the addition of pembrolizumab to
a thalidomide analogue plus dexamethasone resulted in increased
mortality. Treatment of patients with multiple myeloma with a PD-1
or PD-L1 blocking antibody in combination with a thalidomide
analogue plus dexamethasone is not recommended outside of
controlled clinical trials.
- Hematologic
Toxicity: Neutropenia (46%) was the most
frequently reported Grade 3/4 adverse reaction in patients taking
POMALYST in clinical trials, followed by anemia and
thrombocytopenia. Monitor complete blood counts weekly for the
first 8 weeks and monthly thereafter. Patients may require dose
interruption and/or modification.
- Hepatotoxicity: Hepatic failure,
including fatal cases, has occurred in patients treated with
POMALYST. Elevated levels of alanine aminotransferase and bilirubin
have also been observed in patients treated with POMALYST. Monitor
liver function tests monthly. Stop POMALYST upon elevation of liver
enzymes. After return to baseline values, treatment at a lower dose
may be considered.
- Severe
Cutaneous Reactions Including Hypersensitivity
Reactions: Angioedema and severe cutaneous
reactions including Stevens-Johnson Syndrome (SJS), toxic epidermal
necrolysis (TEN), and drug reaction with eosinophilia and systemic
symptoms (DRESS) have been reported. DRESS may present with a
cutaneous reaction (such as rash or exfoliative dermatitis),
eosinophilia, fever, and/or lymphadenopathy with systemic
complications such as hepatitis, nephritis, pneumonitis,
myocarditis, and/or pericarditis. Discontinue POMALYST for
angioedema, skin exfoliation, bullae, or any other severe cutaneous
reactions such as SJS, TEN or DRESS, and do not resume
therapy.
- Dizziness and
Confusional State: In patients taking POMALYST in
clinical trials, 14% experienced dizziness (1% Grade 3 or 4) and 7%
a confusional state (3% Grade 3 or 4). Instruct patients to avoid
situations where dizziness or confusional state may be a problem
and not to take other medications that may cause dizziness or
confusional state without adequate medical advice.
- Neuropathy: In patients taking
POMALYST in clinical trials, 18% experienced neuropathy (2% Grade 3
in one trial) and 12% peripheral neuropathy.
- Second Primary
Malignancies: Cases of acute myelogenous leukemia
have been reported in patients receiving POMALYST as an
investigational therapy outside of multiple myeloma.
- Tumor Lysis
Syndrome (TLS): TLS may occur in patients treated
with POMALYST. Patients at risk are those with high tumor burden
prior to treatment. These patients should be monitored closely and
appropriate precautions taken.
ADVERSE REACTIONS
The most common adverse reactions for POMALYST (≥30%) included
fatigue and asthenia, neutropenia, anemia, constipation, nausea,
diarrhea, dyspnea, upper-respiratory tract infections, back pain,
and pyrexia.
In the phase III trial, nearly all patients treated with
POMALYST + low-dose dex experienced at least one adverse reaction
(99%). Adverse reactions (≥15% in the POMALYST + low-dose dex arm
and ≥2% higher than control) included neutropenia (51.3%), fatigue
and asthenia (46.7%), upper respiratory tract infection (31%),
thrombocytopenia (29.7%), pyrexia (26.7%), dyspnea (25.3%),
diarrhea (22%), constipation (21.7%), back pain (19.7%), cough
(20%), pneumonia (19.3%), bone pain (18%), edema peripheral
(17.3%), peripheral neuropathy (17.3%), muscle spasms (15.3%), and
nausea (15%). Grade 3 or 4 adverse reactions (≥15% in the POMALYST
+ low-dose dex arm and ≥1% higher than control) included
neutropenia (48.3%), thrombocytopenia (22%), and pneumonia
(15.7%).
DRUG INTERACTIONS
Avoid concomitant use of POMALYST with strong inhibitors of
CYP1A2. Consider alternative treatments. If a strong CYP1A2
inhibitor must be used, reduce POMALYST dose by 50%.
USE IN SPECIFIC POPULATIONS
- Pregnancy: See
Boxed WARNINGS. If pregnancy does occur during
treatment, immediately discontinue the drug and refer patient to an
obstetrician/gynecologist experienced in reproductive toxicity for
further evaluation and counseling. There is a POMALYST pregnancy
exposure registry that monitors pregnancy outcomes in females
exposed to POMALYST during pregnancy as well as female partners of
male patients who are exposed to POMALYST. This registry is also
used to understand the root cause for the pregnancy. Report any
suspected fetal exposure to POMALYST to the FDA via the MedWatch
program at 1-800-FDA-1088 and also to Celgene Corporation at
1-888-423-5436.
- Lactation: There is no information
regarding the presence of pomalidomide in human milk, the effects
of POMALYST on the breastfed child, or the effects of POMALYST on
milk production. Pomalidomide was excreted in the milk of lactating
rats. Because many drugs are excreted in human milk and because of
the potential for adverse reactions in a breastfed child from
POMALYST, advise women not to breastfeed during treatment with
POMALYST.
- Pediatric
Use: Safety and effectiveness have not been
established in pediatric patients.
- Geriatric
Use: No dosage adjustment is required for
POMALYST based on age. Patients >65 years of age were more
likely than patients ≤65 years of age to experience pneumonia.
- Renal
Impairment: Reduce POMALYST dose by 25% in
patients with severe renal impairment requiring dialysis. Take dose
of POMALYST following hemodialysis on hemodialysis days.
- Hepatic
Impairment: Reduce POMALYST dose by 25% in
patients with mild to moderate hepatic impairment and 50% in
patients with severe hepatic impairment.
- Smoking
Tobacco: Advise patients that smoking may reduce
the efficacy of POMALYST. Cigarette smoking reduces the AUC of
pomalidomide by 32% by CYP1A2 induction.
Please see full Prescribing Information,
including Boxed WARNINGS.
About IDHIFA
IDHIFA (enasidenib) is indicated for the treatment of adult
patients with relapsed or refractory acute myeloid leukemia with an
isocitrate dehydrogenase-2 mutation as detected by an FDA-approved
test.
Important Safety Information
WARNING: DIFFERENTIATION
SYNDROME
Patients treated with IDHIFA have
experienced symptoms of differentiation syndrome, which can be
fatal if not treated. Symptoms may include fever, dyspnea, acute
respiratory distress, pulmonary infiltrates, pleural or pericardial
effusions, rapid weight gain or peripheral edema, lymphadenopathy,
bone pain, and hepatic, renal, or multi-organ dysfunction. If
differentiation syndrome is suspected, initiate corticosteroid
therapy and hemodynamic monitoring until symptom
resolution.
WARNINGS AND PRECAUTIONS
Differentiation Syndrome: See Boxed WARNING. In the
clinical trial, 14% of patients treated with IDHIFA experienced
differentiation syndrome, which may be life-threatening or fatal if
not treated. Differentiation syndrome has been observed with and
without concomitant hyperleukocytosis, as early as 10 days and at
up to 5 months after IDHIFA initiation. Symptoms in patients
treated with IDHIFA included acute respiratory distress represented
by dyspnea and/or hypoxia and need for supplemental oxygen;
pulmonary infiltrates and pleural effusion; renal impairment;
fever; lymphadenopathy; bone pain; peripheral edema with rapid
weight gain; and pericardial effusion. Hepatic, renal, and
multi-organ dysfunction have also been observed. If differentiation
syndrome is suspected, initiate systemic corticosteroids and
hemodynamic monitoring until improvement. Taper corticosteroids
only after resolution of symptoms. Differentiation syndrome
symptoms may recur with premature discontinuation of
corticosteroids. If severe pulmonary symptoms requiring intubation
or ventilator support and/or renal dysfunction persist for more
than 48 hours after initiation of corticosteroids, interrupt IDHIFA
until signs and symptoms are no longer severe. Hospitalization for
close observation and monitoring of patients with pulmonary and/or
renal manifestation is recommended.
Embryo-Fetal Toxicity: Based on animal embryo-fetal
toxicity studies, IDHIFA can cause embryo-fetal harm when
administered to a pregnant woman. Advise females of reproductive
potential and males with female partners of reproductive potential
to use effective contraception during treatment with IDHIFA and for
at least 1 month after the last dose. Pregnant women, patients
becoming pregnant while receiving IDHIFA, or male patients with
pregnant female partners should be apprised of the potential risk
to the fetus.
ADVERSE REACTIONS
- The most common adverse reactions
(≥20%) included total bilirubin increased (81%), calcium decreased
(74%), nausea (50%), diarrhea (43%), potassium decreased (41%),
vomiting (34%), decreased appetite (34%), and phosphorus decreased
(27%)
- The most frequently reported ≥Grade 3
adverse reactions (≥5%) included total bilirubin increased (15%),
potassium decreased (15%), phosphorus decreased (8%), calcium
decreased (8%), diarrhea (8%), differentiation syndrome (7%),
non-infectious leukocytosis (6%), tumor lysis syndrome (6%), and
nausea (5%)
- Serious adverse reactions were reported
in 77.1% of patients. The most frequent serious adverse reactions
(≥2%) were leukocytosis (10%), diarrhea (6%), nausea (5%), vomiting
(3%), decreased appetite (3%), tumor lysis syndrome (5%), and
differentiation syndrome (8%). Differentiation syndrome events
characterized as serious included pyrexia, renal failure acute,
hypoxia, respiratory failure, and multi-organ failure
LACTATION
Many drugs are excreted in human milk and because of the
potential for adverse reactions in breastfed infants, advise women
not to breastfeed during treatment with IDHIFA and for at least 1
month after the last dose.
Please see full Prescribing Information,
including Boxed WARNING
About Celgene
Celgene Corporation, headquartered in Summit, New Jersey, is an
integrated global biopharmaceutical company engaged primarily in
the discovery, development and commercialization of innovative
therapies for the treatment of cancer and inflammatory diseases
through next-generation solutions in protein homeostasis,
immuno-oncology, epigenetics, immunology and neuro-inflammation.
For more information, please visit www.celgene.com.
Follow Celgene on Social Media: Twitter, Pinterest, LinkedIn,
Facebook and YouTube.
Forward-Looking Statements
This press release contains forward-looking statements, which
are generally statements that are not historical facts.
Forward-looking statements can be identified by the words
"expects," "anticipates," "believes," "intends," "estimates,"
"plans," "will," "outlook" and similar expressions. Forward-looking
statements are based on management's current plans, estimates,
assumptions and projections, and speak only as of the date they are
made. We undertake no obligation to update any forward-looking
statement in light of new information or future events, except as
otherwise required by law. Forward-looking statements involve
inherent risks and uncertainties, most of which are difficult to
predict and are generally beyond our control. Actual results or
outcomes may differ materially from those implied by the
forward-looking statements as a result of the impact of a number of
factors, many of which are discussed in more detail in our Annual
Report on Form 10-K and our other reports filed with the Securities
and Exchange Commission.
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purposes only. Celgene bears no responsibility for the security or
content of external websites or websites outside of its
control.
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