Celgene Corporation
Sep 8, 2017
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Data Presented at ESMO 2017 Further Evaluate Role of ABRAXANE® for Patients with Historically Challenging Cancers

Multiple presentations evaluate the investigational uses of ABRAXANE alone or as combination therapy to treat non-small cell lung cancer and as combination therapy for locally advanced pancreatic cancer

BOUDRY, Switzerland--(BUSINESS WIRE)-- Celgene Corporation (NASDAQ:CELG) today announced that data from multiple studies evaluating investigational uses of ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) will be presented during the European Society of Medical Oncology (ESMO) 2017 Annual Meeting between September 8-12 in Madrid, Spain.

"The data presented at ESMO highlight investigational uses of ABRAXANE to potentially treat patients with particularly challenging diseases, either alone or in combination with other agents," said Nadim Ahmed, President, Hematology and Oncology for Celgene. "Through these data, we are able to continue advancing our understanding and treatment of these cancers especially in patient populations with historically limited treatment options."

In advanced non-small cell lung cancer (NSCLC), abstracts from three studies in the ABOUND program continue to evaluate investigational uses of ABRAXANE. ABOUND 2L+ is a Phase II trial evaluating second-line monotherapy or combination treatment with an immune checkpoint inhibitor or epigenetic therapy. ABOUND.SQM is a Phase III study evaluating ABRAXANE as combination treatment with carboplatin as induction therapy for those with squamous disease. ABOUND 70+ is a Phase IV study evaluating the first-line treatment of ABRAXANE + carboplatin in patients 70 years and older.

Additionally, updated data from the Phase II LAPACT study evaluating the investigational use of ABRAXANE in patients with locally advanced, non-resectable pancreatic cancer will be presented.

Selected abstracts include*:

Non-Small Cell Lung Cancer

Abstract LBA48; Oral; Friday, September 8, 4:00 p.m., Madrid Auditorium, ABOUND.2L+: nab-paclitaxel (nap-P) +/- CC-486 or durvalumab in previously treated patients with advanced non-small cell lung cancer (NSCLC) (Morgensztern)

Abstract 1369P; Poster; Saturday, September 9, 1:15 p.m., Hall 8, nab-Paclitaxel/carboplatin (nab-P/C) induction therapy in squamous (SCC) non-small cell lung cancer (NSCLC): interim safety results from ABOUND.sqm (Gridelli)

Abstract 1366P; Poster; Saturday, September 9, 1:15 p.m., Hall 8, Effect of nab-paclitaxel/carboplatin (nab-P/C) induction therapy on quality of life (QoL) of patients with squamous (SCC) non-small cell lung cancer (NSCLC) (ABOUND.sqm) (Ponce Aix)

Abstract 1367P; Poster; Saturday, September 9, 1:15 p.m., Hall 8, Quality of Life (QoL) in Elderly NSCLC Patients (pts) Treated with nab-Paclitaxel/Carboplatin (nab-P/C) in the ABOUND.70+ Trial (Langer)

Pancreatic Cancer

Abstract 622PD; Poster Discussion; Monday, September 11, 4:30 p.m., Cordoba Auditorium, nab-Paclitaxel (nab-P) plus gemcitabine (G) for patients (Pts) with locally advanced pancreatic cancer (LAPC): Interim efficacy and safety results from the Phase 2 LAPACT Trial (Philip)

Abstract 730P; Poster; Saturday, September 9, 1:15 p.m., Hall 8, Interim Health-Related Quality of Life (QoL) From LAPACT, a Phase 2 Trial of nab-Paclitaxel (nab-P) Plus Gemcitabine (G) for Patients (pts) With Locally Advanced Pancreatic Cancer (LAPC) (Portales)

In advanced NSCLC, Abraxane is not approved for use as monotherapy or in combination with CC-486 or durvalumab. Abraxane is also not approved for use as a second-line therapy in advanced NSCLC. Abraxane is not approved for patients with locally advanced pancreatic cancer. 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.

*All times Central European Standard Time (CEST)

A complete listing of abstracts can be found on the ESMO website at http://194.224.142.195/slidecenter/esmo2017/confcal/?table.

About ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound)

ABRAXANE® is an albumin-based nanotechnology therapy approved for the treatment of metastatic breast cancer, advanced non-small cell lung cancer and metastatic pancreatic cancer in the United States, Europe and other markets around the world. It contains albumin-bound paclitaxel nanoparticles and is manufactured using patented nab® technology. ABRAXANE is formulated with albumin, a human protein, and is free of solvents.

ABRAXANE was first approved in January 2005 by the U.S. Food and Drug Administration (FDA) 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. In Europe, ABRAXANE was approved in January 2008 as monotherapy for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated. ABRAXANE is now approved in more than 50 countries for the treatment of metastatic breast cancer.

In October 2012, ABRAXANE was approved by the FDA for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC), in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy. ABRAXANE is also approved for the treatment of NSCLC in Argentina, Australia, Chile, Ecuador, Guatemala, Hong Kong, Japan, New Zealand and Singapore.

In September 2013, the FDA approved ABRAXANE as first-line treatment of patients with metastatic adenocarcinoma of the pancreas, in combination with gemcitabine. In December 2013, ABRAXANE in combination with gemcitabine was approved for first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas in EuropeABRAXANE is also approved for the treatment of metastatic pancreatic cancer in more than 40 countries.

Important Safety Information

 

WARNING - NEUTROPENIA

 

• Do not administer ABRAXANE therapy to patients who have baseline neutrophil counts of less than 1500 cells/mm3. In order to monitor the occurrence of bone marrow suppression, primarily neutropenia, which may be severe and result in infection, it is recommended that frequent peripheral blood cell counts be performed on all patients receiving ABRAXANE

 

• Note: An albumin form of paclitaxel may substantially affect a drug's functional properties relative to those of drug in solution. DO NOT SUBSTITUTE FOR OR WITH OTHER PACLITAXEL FORMULATIONS

 

CONTRAINDICATIONS

Neutrophil Counts

Hypersensitivity

WARNINGS AND PRECAUTIONS

Hematologic Effects

Nervous System

Sepsis

Pneumonitis

Hypersensitivity

Hepatic Impairment

Albumin (Human)

Use in Pregnancy: Pregnancy Category D

Use in Men

ADVERSE REACTIONS

Randomized Metastatic Breast Cancer (MBC) Study

Non-Small Cell Lung Cancer (NSCLC) Study

Pancreatic Adenocarcinoma Study

Postmarketing Experience With ABRAXANE and Other Paclitaxel Formulations

DRUG INTERACTIONS

USE IN SPECIFIC POPULATIONS

Nursing Mothers

Pediatric

Geriatric

Renal Impairment

DOSAGE AND ADMINISTRATION

Please see full Prescribing Information, including Boxed WARNING.

Please refer to the Summary of Product Characteristics for full European prescribing information.

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: @Celgene, Pinterest, LinkedIn, FaceBook and YouTube.

Forward-Looking Statements

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