Celgene Corporation
Nov 21, 2017
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Results from 282 Abstracts Including Celgene Therapies and Pipeline Compounds to Be Presented at the American Society of Hematology Annual Meeting (ASH)

Presentations will focus on a wide range of disease areas including multiple myeloma, lymphoma, acute myeloid leukemia, myelodysplastic syndromes and beta-thalassemia and novel technologies such as CAR-T cell therapy

SUMMIT, N.J.--(BUSINESS WIRE)-- Celgene Corporation (NASDAQ:CELG) today announced that data from 282 abstracts, including more than 60 oral presentations, evaluating Celgene investigational agents and investigational uses of marketed products will be presented at the 59th American Society of Hematology Annual Meeting between Dec. 9-12 in Atlanta, GA.

Presentations will include investigational data from Celgene agents in company-sponsored or investigator-initiated studies.

"Disease altering advances in hematology are coming at a more rapid pace than ever and we are looking forward to new insights into the treatment of deadly blood cancers and other serious diseases," said Nadim Ahmed, President, Hematology and Oncology for Celgene. "Presentations highlighting data from more than 150 studies in multiple myeloma utilizing the foundation of IMiD® therapies in investigational uses continue to grow the body of evidence for these treatments. We are also excited about results from novel technologies such as CAR-T cell therapy and other pipeline candidates across multiple disease areas that demonstrate our commitment to patients with life-threatening hematologic diseases."

Selected abstracts include*:

Multiple Myeloma

Data will be presented from the immunotherapy-focused collaboration between Celgene and bluebird bio demonstrating significant potential in multiple myeloma research:

Abstract #740; Oral; Monday, Dec. 11. 3 p.m., Hall C1, Durable clinical responses in heavily pretreated patients with relapsed/refractory multiple myeloma: Updated results from a multicenter study of bb2121 anti-BCMA CAR T cell therapy (Kochenderfer)

Among the more than 150 studies including IMiD-based regimens, including investigational combinations, there are presentations across the myeloma continuum. Some of these include:

Abstract #1811; Poster; Saturday, Dec. 9, 5:30 p.m., Hall A2, Safety and Efficacy of Pomalidomide (POM) + Low-Dose Dexamethasone (LoDEX) + Daratumumab (DARA) As Second- or Third-Line Therapy in Patients with Relapsed and/or Refractory Multiple Myeloma (RRMM) after Lenalidomide (LEN)-Based Treatment (Tx) Failure (Siegel)

Abstract #400; Oral; Sunday, Dec. 10, 10:15 a.m., C101, Response-Adapted Lenalidomide Maintenance in Newly Diagnosed, Transplant-Eligible Multiple Myeloma: Results from the Multicenter Phase III GMMG-MM5 Trial (Goldschmidt)

Abstract #402; Oral; Sunday, Dec. 10, 10:45 a.m., C101, Curative Strategy for High-Risk Smoldering Myeloma (GEM-CESAR): Carfilzomib, Lenalidomide and Dexamethasone (KRd) As Induction Followed By HDT-ASCT, Consolidation with Krd and Maintenance with Rd (Mateos)

Abstract #436; Oral; Sunday, Dec. 10, 12:45 p.m., Hall C4, Lenalidomide maintenance significantly improves outcomes compared to observation irrespective of cytogenetic risk: Results of the Myeloma XI trial (Jackson)

Abstract #739; Oral; Monday, Dec. 11, 2:45 p.m., Hall C1, Daratumumab, Lenalidomide, and Dexamethasone (DRd) Versus Lenalidomide and Dexamethasone (Rd) in Relapsed or Refractory Multiple Myeloma (RRMM): Updated Efficacy and Safety Analysis of Pollux (Dimopoulos)

Abstract #743; Oral; Monday, Dec. 11, 3:45 p.m., Hall C1, Overall Survival (OS) of Patients with Relapsed/Refractory Multiple Myeloma (RRMM) Treated with Carfilzomib, Lenalidomide, and Dexamethasone (KRd) Versus Lenalidomide and Dexamethasone (Rd): Final Analysis from the Randomized Phase 3 Aspire Trial (Stewart)

Abstract #837; Oral; Monday, Dec. 11 5 p.m., Hall C1, A Multicenter Open Label Phase II Study of Pomalidomide, Cyclophosphamide and Dexamethasone in Relapse Multiple Myeloma Patients Initially Treated with Lenalidomide, Bortezomib and Dexamethasone (Garderet)

Abstract #904; Oral; Monday, Dec. 11, 7 p.m., Hall C4, Minimal Residual Disease in the Maintenance Setting in Myeloma: Prognostic Significance and Impact of Lenalidomide (de Tute)

Abstract #905; Oral; Monday, Dec. 11, 7:15 p.m., Hall C4, Impact of Next-Generation Flow (NGF) Minimal Residual Disease (MRD) Monitoring in Multiple Myeloma (MM): Results from the Pethema/GEM2012 Trial (Paiva)

Lymphomas/Chronic Lymphocytic Leukemia (CLL)

Updated data from the CAR-T program JCAR-017 in partnership with Juno Therapeutics will be presented in multiple studies:

Abstract #193; Oral; Saturday, Dec. 9, 2 p.m., C101, Auditorium Patient Characteristics and Pre-Infusion Biomarkers of Inflammation Correlate with Clinical Outcomes after Treatment with the Defined Composition, CD19-Targeted CAR T Cell Product, JCAR017 (Siddiqi)

Abstract #194; Oral; Saturday, Dec. 9, 2:15 p.m., C101, Auditorium Predicting Clinical Response and Safety of JCAR017 in B-NHL Patients: Potential Importance of Tumor Microenvironment Biomarkers and CAR T-Cell Tumor Infiltration (Swanson)

Abstract #581; Oral; Monday, Dec. 11, 8 a.m., A411-A412, High Durable CR Rates in Relapsed/Refractory (R/R) Aggressive B-NHL Treated with JCAR017 (TRANSCEND NHL 001): Defined Composition CD19-Directed CAR T Cell Product Allows for Dose Finding and Definition of Pivotal Cohort (Abramson)

Several studies presented focus on investigational chemotherapy-free treatment approaches in indolent lymphoma and CLL, including R2 (REVLIMID® + rituximab), while further data from Celgene's pipeline demonstrates our commitment to new lymphoma research.

Abstract #154; Oral; Saturday, Dec. 9, 12:45 p.m., A411-A412, Initial Treatment with Lenalidomide Plus Rituximab for Mantle Cell Lymphoma: 5-year Follow-up and Correlative Analysis from a Multi-center Phase II Study (Ruan)

Abstract #192; Oral; Saturday, Dec. 9, 3:15 p.m., A411-A412, A Phase I, Open-Label, Multicenter Trial of Oral Azacitidine (CC-486) Plus R-CHOP in Patients with High-Risk, Previously Untreated Diffuse Large B-Cell Lymphoma, Grade 3B Follicular Lymphoma, or Transformed Lymphoma (Martin)

Abstract #411; Oral; Sunday, Dec. 10, 12:30 p.m., Hall C1, CC-122, a Novel Cereblon Modulating Agent, in Combination with Obinutuzumab (GA101) in Patients with Relapsed and Refractory (R/R) B-cell Non-Hodgkin Lymphoma (NHL) (Michot)

Abstract #482; Oral; Sunday, Dec. 10, 4:45 p.m., Hall C1, A 3-Arm Randomized Phase II Trial with Bendamustine/Rituximab Therapy in Untreated High Risk (HR) Follicular Lymphoma (FL): Bortezomib Induction or Novel IMiD Continuation (BIONIC) Study from the ECOG-ACRIN Cancer Research Group (Evens)

Abstract #729; Oral; Monday, Dec. 11, 3:15 p.m., C101 Auditorium, Lenalidomide Treatment Restores In Vivo T Cell Activity in Relapsed/Refractory FL and DLBCL (Menard)

Myeloid Diseases

In acute myeloid leukemia (AML), new data for investigational uses of IDHIFA® (enasidenib) in patients in the relapsed/refractory and front-line settings in combinations, as well as new phase II data for CC486 in post-transplant maintenance for AML and in patients with MDS will be presented.

Abstract #1299; Poster; Saturday, Dec. 9, 5:30 p.m., Hall A2, Continuing Enasidenib Treatment for Patients with Mutant-IDH2 (mIDH2) Relapsed or Refractory Acute Myeloid Leukemia (R/R AML) with Stable Disease May Result in Improved Survival and Responses over Time (Stein)

Abstract #638; Oral; Monday, Dec. 11, 10:45 a.m., Murphy Ballroom 1-2, Enasidenib Monotherapy Is Effective and Well-tolerated in Patients with Previously Untreated Mutant-IDH2 (mIDH2) Acute Myeloid Leukemia (AML) (Pollyea)

Abstract #639; Oral; Monday, Dec. 11, 11 a.m., Murphy Ballroom 1-2, Mutant Isocitrate Dehydrogenase (mIDH) Inhibitors, Enasidenib or Ivosidenib, in Combination with Azacitidine (AZA): Preliminary Results of a Phase 1b/2 Study in Patients with mIDH Newly Diagnosed Acute Myeloid Leukemia (AML) (DiNardo)

Abstract #726; Oral; Monday, Dec. 11, 4 p.m., Murphy Ballroom 1-2, A phase 1 trial of ivosidenib and enasidenib combined with standard induction chemotherapy in newly diagnosed AML patients with an IDH1 and/or IDH2 mutation (Stein)

Abstract #751; Oral; Monday, Dec. 11, 2:45 p.m., C211-C213, Quality of Life in Patients with β-Thalassemia: Transfusion Dependent Versus Non-Transfusion Dependent (Cappellini)

Abstract #4512; Poster; Monday, Dec. 11, 6 p.m., Hall A2, Final Analysis of the Phase I/II Study of CC-486 (Oral Azacitidine) Maintenance Therapy after Allogeneic Stem Cell Transplantation (Allo-SCT) in Patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS) (de Lima)

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 Eastern Standard Time

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


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.


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


Embryo-Fetal Toxicity: See Boxed WARNINGS

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 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

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


Multiple Myeloma

Myelodysplastic Syndromes

Mantle Cell Lymphoma


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


Please see full Prescribing Information, including Boxed WARNINGS.



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


Embryo-Fetal Toxicity

POMALYST is only available through a restricted distribution program called POMALYST REMS®.

Venous and Arterial Thromboembolism




Nearly all patients treated with POMALYST + low-dose dex experienced at least one adverse reaction (99%). The most common adverse reactions 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 included neutropenia (48.3%), thrombocytopenia (22%), and pneumonia (15.7%).


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%.


Please see full Prescribing Information, including Boxed WARNINGS.


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


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.


Differentiation Syndrome: See Boxed WARNING. In the clinical trial, 14% of patients treated with IDHIFA experienced differentiation syndrome. Differentiation syndrome has been observed with and without concomitant hyperleukocytosis, as early as 10 days and at up to 5 months after IDHIFA initiation. 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.



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: @CelgenePinterestLinkedInFacebook 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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Source: Celgene Corporation

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