Celgene Corporation
Jan 22, 2016
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Investigational Combinations Using an ABRAXANE and Gemcitabine Foundation Lead ASCO GI Pancreatic Cancer Research

10 abstracts including AG as an investigational foundation in first-line metastatic pancreatic cancer research being presented during the meeting

SUMMIT, N.J.--(BUSINESS WIRE)-- Celgene Corporation (NASDAQ:CELG) today announced that 10 studies highlighting combinations that include a foundation of ABRAXANE® (paclitaxel protein-bound particles for injectable suspension)(albumin-bound) and gemcitabine are being presented during the 2016 ASCO Gastrointestinal Cancers Symposium (ASCO GI), establishing the therapy as the foundation for research in first-line metastatic pancreatic cancer.

"ABRAXANE is the only chemotherapy approved in combination with gemcitabine based on an improvement in overall survival for first line metastatic pancreatic cancer patients and is fast becoming the standard of care in this extremely difficult to treat disease," said Jacqualyn A. Fouse, Ph.D., President, Hematology/Oncology for Celgene. "We are excited that ABRAXANE plus gemcitabine is serving as the foundation for a new wave of potential treatments that may further improve the treatment paradigm in this disease and are fully committed to continuing to serve these patients."

Studies evaluating new combinations added to ABRAXANE plus gemcitabine being presented at the meeting include:

- Results from a phase 1b study of the anti-cancer stem cell agent demcizumab and gemcitabine +/- nab-paclitaxel in patients with PC (Abstract 341) - Hidalgo

- Results from a phase 1b study of cancer stem cell pathway inhibitor BBI-608 in combination with gemcitabine and nab-paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma (Abstract 284) - Shahda

- Results of the phase 1b portion of a phase 1/2 trial of the indoleamine 2,3-dioxygenase pathway (IDO) inhibitor indoximod plus gemcitabine/nab-paclitaxel for the treatment of metastatic pancreatic cancer. (Abstract 452) - Bahary

- A trial in progress update on nab-paclitaxel (nab-P) + nivolumab (Nivo) ± gemcitabine (Gem) in patients (pts) with advanced pancreatic cancer (PC). (Abstract TPS475) - Firdaus

- A trial in progress update on a randomized, multicenter, double-blind, placebo-controlled study of the Bruton tyrosine kinase inhibitor, ibrutinib, v. placebo in combination with nab-paclitaxel and gemcitabine in first-line mPC (Abstract TPS483) - Tempero

- Interim results of a randomized phase 2 study of PEGPH20 added to nab-paclitaxel/gemcitabine in patients with stage 4 previously untreated pancreatic cancer. (Abstract 439) - Hingorani

- Trial in progress update on a multicenter phase 2 study of istiratumab (MM-141) plus nab-paclitaxel (A) and gemcitabine (G) in metastatic pancreatic cancer (MPC). (TPS481) - Ko

- Trial in progress update on a phase 1 trial with cohort expansion of BYL719 in combination with gemcitabine and nab-paclitaxel in locally advanced and mPC (TPS467) - Soares

- Results from a trial "Synergy of water soluble prodrug triptolide (minnelide) with gemcitabine and nab-paclitaxel in pancreatic cancer. (Abstract 259) - Dudeja

- Results from the RAINIER trial: A randomized, double-blinded, placebo-controlled phase 2 trial of gemcitabine plus nab-paclitaxel combined with apatorsen or placebo in patients with metastatic pancreatic cancer (Abstract 419)- Ko

Abraxane plus gemcitabine is not approved in the combinations identified above.

Indications

ABRAXANE® is indicated for the first-line treatment of patients with metastatic adenocarcinoma of the pancreas, in combination with gemcitabine.

Important Safety Information

WARNING - NEUTROPENIA

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

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.

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. FollowCelgene on Social Media: @CelgenePinterestLinkedInFaceBook and YouTube.

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Source: Celgene Corporation

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