Broad Range of Clinical Data Evaluating Celgene Therapies to Be Presented at ASCO

5/17/17

SUMMIT, N.J.--(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 American Society of Clinical Oncology Annual Meeting between June 2-6 in Chicago, Ill.

“We are part of an extremely exciting time in cancer research, where accelerating deep insights into the biology of disease and tumor microenvironment are leading to approaches that have the potential to make a major impact on patients’ lives,” said Michael Pehl, President, Hematology and Oncology for Celgene. “The studies being shared at ASCO this year reinforce our commitment to developing and delivering innovative treatment options to patients with cancer around the world.”

In multiple myeloma, abstracts will continue to support the role of Celgene’s IMiD® therapies as the foundation of multiple myeloma research, including in the maintenance setting. Additionally, data will be presented from the study evaluating the investigational R2 regimen (REVLIMID® (lenalidomide) and rituximab combination), in previously-treated follicular lymphoma. Updated data from two studies in the ABOUND program evaluating ABRAXANE® (nab-paclitaxel) in non-small cell lung cancer will also be presented. Finally, results from multiple studies highlighting key Celgene research collaborations of investigational compounds will be presented, including updated data from a phase I dose escalation and expansion study of IDHIFA® (enasidenib) in patients with mutant-IDH2 relapsed/refractory acute myeloid leukemia, updated data from the first clinical study of anti-BCMA CAR-T therapy bb2121 in multiple myeloma, and results from a study of CAR-T therapy JCAR017 in previously-treated aggressive b-cell non-Hodgkin’s lymphoma.

Selected abstracts include*:

Newly-diagnosed Multiple Myeloma

Abstract #8000; Oral; Sunday, June 4, 9:45 a.m., E354b, Daratumumab (DARA) in combination with carfilzomib, lenalidomide, and dexamethasone (KRd) in patients (pts) with newly diagnosed multiple myeloma (MMY1001): An open-label, phase Ib study (Jakubowiak)

Abstract #8001; Oral; Sunday, June 4, 9:57 a.m., E354b, Lenalidomide, adriamycin and dexamethasone versus bortezomib, lenalidomide and dexamethasone prior to scheduled stem cell transplant in newly diagnosed multiple myeloma (Knop)

Abstract #8002; Oral; Sunday, June 4, 10:09 a.m., E354b, An open-label, single arm, phase IIa study of bortezomib, lenalidomide, dexamethasone, and elotuzumab in newly diagnosed multiple myeloma (Laubach)

Abstract #8009; Poster Discussion; Monday, June 5, 3:00 p.m., E354b, Lenalidomide induction and maintenance therapy for myeloma: Results of the Myeloma XI Study (Jackson)

Abstract #8023; Poster; Monday, June 5, 8:00 a.m., Hall A, Impact of t(11;14) on outcomes in African American (AA) and non-AA (NAA) patients (Pts) with newly diagnosed multiple myeloma (NDMM): Connect® MM Registry (Gasparetto)

Relapsed/Refractory Multiple Myeloma

Abstract #8007; Oral; Sunday, June 4, 11:57 a.m., E354b, A phase Ib study of isatuximab in combination with pomalidomide (Pom) and dexamethasone (Dex) in relapsed/refractory multiple myeloma (RRMM) (Mikhael)

Abstract #8008; Oral; Sunday, June 4, 12:09 p.m., E354b, Phase I/II dose expansion of a trial investigating bendamustine and pomalidomide with dexamethasone (Ben-Pom-d) in patients with relapsed/refractory multiple myeloma (Sivaraj)

Abstract #8015; Poster Discussion; Monday, June 5, 3:00 p.m., E354b, Pembrolizumab (Pembro) plus lenalidomide (Len) and low-dose dexamethasone (Dex) for relapsed/refractory multiple myeloma (RRMM): Efficacy and biomarker analyses (Ocio)

Abstract #3010; Poster Discussion; Monday, June 5, 4:45 p.m., Hall D1, First-in-human multicenter study of bb2121 anti-BCMA CAR T-cell therapy for relapsed/refractory multiple myeloma: Updated results (Berdeja)

Abstract #8027; Poster; Monday, June 5, 8:00 a.m., Hall A, Phase II study of pomalidomide (POM) + low-dose dexamethasone (LoDEX) following second-line lenalidomide (LEN)-based treatment (Tx) in patients (Pts) with relapsed or refractory multiple myeloma (RRMM): An updated analysis of efficacy and safety (Siegel)

Maintenance in Multiple Myeloma

Abstract #8037; Poster; Monday, June 5, 8:00 a.m., Hall A, CALGB/ECOG 100104 (Alliance) study: Lenalidomide (LEN) vs placebo (PBO) maintenance (Maint) after stem cell transplant (SCT) for patients (Pts) with multiple myeloma: Overall survival (OS) and progression-free survival (PFS) adjusted for treatment (Tx) crossover (XO) (McCarthy)

Abstract #8040; Poster; Monday, June 5, 8:00 a.m., Hall A, Impact of post-autologous stem cell transplant (ASCT) maintenance therapy on outcomes in patients (Pts) with newly diagnosed multiple myeloma (NDMM) using the large prospective community-based Connect® MM Registry (Jagannath)

Acute Myeloid Leukemia

Abstract #7004; Oral; Tuesday, June 6, 10:57 a.m., E450ab, Enasidenib in mutant-IDH2 relapsed or refractory acute myeloid leukemia (R/R AML): Results of a phase I dose-escalation and expansion study (Stein)

Abstract #7015; Poster Discussion; Monday, June 5, 11:30 a.m., E354b, Differentiation syndrome associated with enasidenib, a selective inhibitor of mutant isocitrate dehydrogenase 2 (IDH2) (Fathi)

Abstract #7022; Poster; Monday, June 5, 8:00 a.m., Hall A, Molecular genetic testing patterns for patients with newly diagnosed acute myeloid leukemia (AML) enrolled in the CONNECT® MDS/AML Disease Registry (Pollyea)

Lymphoma/CLL

Abstract #7502; Oral; Saturday, June 3, 3:24 p.m., S100bc, Phase IIIb randomized study of lenalidomide plus rituximab (R2) followed by maintenance in relapsed/refractory NHL: Analysis of patients with double-refractory or early relapsed follicular lymphoma (FL) (Andorsky)

Abstract #7503; Oral; Saturday, June 3, 4:00 p.m., S100bc, A genetic risk-stratified, phase II study of fludarabine/antibody combinations in symptomatic, untreated chronic lymphocytic leukemia (CLL): Final results of Cancer and Leukemia Group B (CALGB) 10404 (Ruppert)

Abstract #7513; Poster Discussion; Monday, June 5, 1:15 p.m., E354b, CR rates in relapsed/refractory (R/R) aggressive B-NHL treated with the CD19-directed CAR T-cell product JCAR017 (TRANSCEND NHL 001) (Abramson)

Non-Small Cell Lung Cancer

Abstract #9058; Poster; Saturday, June 3, 8:00 a.m., Hall A, Safety and efficacy of nab-paclitaxel (nab-P)–based therapy in patients (pts) with non-small cell lung cancer (NSCLC) and performance status (PS) 2: Results from ABOUND.PS2 (Gajra)

Abstract #9059; Poster; Saturday, June 3, 8:00 a.m., Hall A, ABOUND.70+: Safety and efficacy of nab-paclitaxel/carboplatin (nab-P/C) in elderly patients (pts) with advanced non-small cell lung cancer (NSCLC) (Langer)

Abstract #9092; Poster; Saturday, June 3, 8:00 a.m., Hall A, Atezolizumab (atezo) plus platinum-based chemotherapy (chemo) in non-small cell lung cancer (NSCLC): Update from a phase Ib study (Liu)

Abstract #9095; Poster; Saturday, June 3, 8:00 a.m., Hall A, Nivolumab (nivo) + nab-paclitaxel (nab-P) + carboplatin (C) in patients (pts) with non-small cell lung cancer (NSCLC): Interim results from a multicenter phase I study (Waterhouse)

Biliary Tract Cancer

Abstract #9095; Poster; Saturday, June 3, 8:00 a.m., Hall A, A phase II trial of gemcitabine (G), cisplatin (C), and nab-paclitaxel (N) in advanced biliary tract cancers (aBTCs) (Shroff)

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 ASCO website at http://am.asco.org/program

*All times Central Time

About ABRAXANE®

ABRAXANE® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.

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