Celgene Announces Clinical Data Evaluating Broad Range of Blood Cancers to Be Presented at EHA 2017

Presentations highlight innovative research in multiple disease areas
including multiple myeloma, lymphoma, leukemia, myelodysplastic
syndromes and beta-thalassemia

BOUDRY, Switzerland–(BUSINESS WIRE)–Celgene Corporation (NASDAQ:CELG) today announced that data from a broad
range of company-sponsored and investigator-initiated studies evaluating
Celgene investigational agents and investigational uses of marketed
products will be presented at the 22nd European Hematology
Association annual meeting in Madrid, Spain, from June 22-25, 2017.

“Research into blood cancers is at a pivotal point, where we’re able to
apply insights into the biology of disease to help evolve the treatment
pathways, as well as continue to deepen our understanding of the disease
in ways that have the potential to positively impact patients’ lives,”
said Michael Pehl, President, Hematology and Oncology for Celgene. “The
studies being shared this year illustrate our ongoing commitment to
delivering innovative therapies to patients with serious and sometimes
underserved blood cancers.”

This year’s data presented at EHA will support the role of Celgene
therapies as the foundation of myeloma research, including data
evaluating REVLIMID® (lenalidomide) across a variety of
patient settings ranging from newly diagnosed to those receiving
maintenance treatment following autologous hematopoietic stem cell
transplant. The data also highlight the potential of Celgene treatments
across a range of blood cancers such as lymphoma, MDS and
beta-thalassemia. Findings from key Celgene research collaborations will
also be presented, including updated data from the Phase I dose
escalation and expansion study of IDHIFA® (enasidenib) in
patients with relapsed/refractory acute myeloid leukemia and an
isocitrate dehydrogenase-2 mutation.

Selected abstracts include:

Newly-Diagnosed Multiple Myeloma

Abstract #S102; Oral; Friday, June 23, 12:00 p.m., Hall A. Minimal
Residual Disease (MRD) by Multiparameter Flow Cytometry (MFC) in
Transplant Eligible Patients with Newly Diagnosed Multiple Myeloma (MM):
Results from the EMN02/HO95 Phase 3 Trial (Oliva)

Abstract #S407; Oral; Saturday, June 24, 11:30 a.m., Hall A. Quadruplet
vs. Sequential Triplet Induction Therapy for Multiple Myeloma Patients:
Results of the MYELOMA XI Study (Pawlyn)

Abstract #S410; Oral; Saturday, June 24, 12:15 p.m., Hall A.
Carfilzomib-Lenalidomide-Dexamethasone vs.
Carfilzomib-Cyclophosphamide-Dexamethasone Induction: Planned Interim
Analysis of the Randomized Forte Trial in Newly Diagnosed Multiple
Myeloma (Gay)

Abstract #P349; Poster Discussion; Friday, June 23, 5:15 p.m., Hall 7.
The Connect MM Registry: Impact of the Cytogenic Abnormality (11;14) on
Survival Outcomes in African American and non-African American Patients
with Newly Diagnosed Multiple Myeloma (Gasparetto)

Relapsed/Refractory Multiple Myeloma

Abstract #S142; Oral; Friday, June 23, 11:45 a.m., Room N109.
First-in-Human Multicenter Study of BB2121 Anti-BCMA CAR T Cell Therapy
for Relapsed/Refractory Multiple Myeloma: Updated Results (Lin)

Abstract #S456; Oral; Saturday, June 24, 4:00 p.m., Hall A. Phase 3
ELOQUENT-2 Study: Extended 4-Year Follow-up of Elotuzumab plus
Lenalidomide/Dexamethasone vs. Lenalidomide/Dexamethasone in
Relapsed/Refractory Multiple Myeloma (Dimopoulos)

Abstract #P343; Poster Presentation; Friday, June 23, 5:15 p.m., Hall 7.
MM-013 Phase 2 Multicenter Study of Pomalidomide (POM) plus Low-dose
Dexamethasone (LODEX) in Patients (PTS) with Relapsed/Refractory
Multiple Myeloma (RRMM) and Renal Impairment (RI) (Sonneveld)

Abstract #P680; Poster Presentation; Saturday, June 24, 5:30 p.m., Hall
7. Final Results of Phase (PH) 1/2 Study of Carfilzomib, Pomalidomide,
and Dexamethasone (KPD) in Patients (PTS) with Relapsed/Refractory
Multiple Myeloma (RRMM): A Multi-Center MMRC Study (Jakubowiak)

Maintenance in Multiple Myeloma

Abstract #S781; Oral; Sunday, June 25, 8:30 a.m., Hall D. Lenalidomide
Induction and Maintenance Therapy for Transplant Eligible Myeloma
Patients: Results of the MYELOMA XI Study (Pawlyn)

Abstract #P332; Poster Discussion; Friday, June 23, 5:15 p.m., Hall 7.
Lenalidomide Maintenance vs. Placebo After Stem Cell Transplant for
Patients with Multiple Myeloma: Overall Survival and Progression-free
Survival After Adjusting for Treatment Crossover in CALGB (McCarthy)

Acute Myeloid Leukemia

Abstract #S471; Oral; Saturday, June 24, 4:00 p.m., Hall D. Enasidenib
(AG-221) in Mutant-IDH2 Relapsed or Refractory Acute Myeloid Leukemia
(R/R AML): Results of a Phase 1 Dose-escalation and Expansion Study
(Stein)

Abstract #S791; Oral; Sunday, June 25, 8:30 a.m., Room N101. Molecular
Predictors of Response to Azacitidine Therapy: The Results of the UK
Trials Acceleration Programme RAVVA Study (Craddock)

Abstract #P208; Poster Discussion; Friday, June 23, 5:15 p.m., Hall 7.
Stable Disease with Hematologic Improvement is Clinically Meaningful for
Older Patients with Acute Myeloid Leukemia (AML) Treated with
Azacitidine (Schuh)

Abstract #P215; Poster Discussion; Friday, June 23, 5:15 p.m., Hall 7.
Differentiation Syndrome Associated with Enasidenib (AG-221), a
Selective Inhibitor of Mutant Isocitrate Dehydrogenase 2 (MIDH2) (Fathi)

Abstract #P555; Poster Discussion; Saturday, June 24, 5:30 p.m., Hall 7.
Response-adapted Azacitidine and Induction Chemotherapy in Patients >60
Years Old with Newly Diagnosed AML Eligible for Chemotherapy: Results of
the DRKS00004519 Study of the East German Study Group (Jaekel)

Lymphoma

Abstract #S467; Oral; Saturday, June 24, 4:15 p.m., Hall C. CC-122 in
Combination with Obinutuzumab (GA101): Phase IB study in Relapsed or
Refractory Patients with Diffuse Large B-cell Lymphoma, Follicular
Lymphoma or Marginal Zone Lymphoma (Michot)

Abstract #P634; Poster Discussion; Saturday, June 24, 5:30 p.m., Hall 7.
Phase IIIB Randomized Study of Lenalidomide plus Rituximab (R2) followed
by Lenalidomide vs. Rituximab Maintenance in Patients with
Relapsed/Refractory NHL: Analysis of Follicular Lymphoma Patients (Burke)

Myelodysplastic Syndromes

Abstract #P666; Poster Discussion; Saturday, June 24, 5:30 p.m., Hall 7.
Luspatercept Increases Hemoglobin and Reduces Transfusion Burden in
Patients with Lower-risk Myelodysplastic Syndromes (MDS): Long-term
Results from Phase 2 PACE-MDS Study (Giagounidis)

Beta-Thalassemia

Abstract #S129; Oral; Friday, June 23, 11:45 a.m., Room N105.
Luspatercept Increases Hemoglobin and Decreases Transfusion Burden in
Adults with B-Thalassemia. (Piga)

The safety and efficacy of the agents and/or uses under investigation
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 EHA Learning Center
Web site at https://learningcenter.ehaweb.org/eha/.

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

Allergic Reactions: REVLIMID is contraindicated in patients who
have demonstrated 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 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 Boxed 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

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

Allergic Reactions: Angioedema and serious dermatologic reactions
including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis
(TEN) have been reported. 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 or TEN is suspected and should not be resumed following
discontinuation for these reactions. REVLIMID capsules contain lactose;
risk-benefit of treatment should be evaluated in patients with lactose
intolerance

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

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 for patients on dialysis

Please see full Prescribing
Information
, including Boxed WARNINGS.

About POMALYST®

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.

Contacts

Celgene Corporation
Investors:
+1-908-673-9628
ir@celgene.com
or
Media:
+1-908-673-2275
media@celgene.com

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