Celgene Corporation
Jun 1, 2014
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Post-Hoc Analysis of Overall Survival in Phase III MPACT Study of Patients with Advanced Pancreatic Cancer Presented at ASCO 2014

SUMMIT, N.J.--(BUSINESS WIRE)-- Celgene Corporation (NASDAQ: CELG) today announced updated Overall Survival (OS) results from a post-hoc analysis of its phase III MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial) study of ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in combination with gemcitabine in treatment-naïve patients with metastatic pancreatic cancer. A poster discussion of the analysis is scheduled for Sunday, June 1st at 11:30 am CT at the 50th American Society of Clinical Oncology (ASCO) annual meeting in Chicago, Ill.

The extended data cutoff occurred at final database lock in May 2013 and allowed for an OS analysis of mature data from 90% of the patients in the study. The extended analysis showed that ABRAXANE plus gemcitabine demonstrated an improvement in OS in the intent-to-treat population compared to patients that received gemcitabine alone [(median OS of 8.7 vs. 6.6. months) (HR0.72, P < 0.0001), a difference of 2.1 months]. The analysis showed survival up to 3.5 years in the ABRAXANE plus gemcitabine group (3% of patients alive vs 0% with gemcitabine alone). One- and 2- year survival rates were consistent with the primary analysis.

The analysis also showed that the treatment effect on OS for pre-specified subgroups analyzed in the trial remained consistent across patient subgroups. Specifically, patients with Karnofsky Performance Status (KPS) KPS 90-100 had a higher median OS on ABRAXANE plus gemcitabine as compared to gemcitabine alone [median OS 9.7 months vs. 7.9 months (HR 0.77, P=0.0053)]. Patients with KPS 70-80 also maintained a benefit [median OS 7.6 months vs. 4.3 months (HR 0.59, P < 0.0001)].

This updated analysis also evaluated the prognostic effects of CA19-9 and neutrophil-to-lymphocyte ratio (NLR). Both elevated CA19-9 and elevated NLR were associated with poorer survival. Further, treatment with ABRAXANE plus gemcitabine appeared to reduce the effect of CA19-9 as a poor prognostic factor, as similar overall survival was observed regardless of CA19-9 level.

In the MPACT study, the most common grade ≥ 3 treatment-related adverse events in the study for ABRAXANE plus gemcitabine vs. gemcitabine alone were neutropenia, peripheral neuropathy and fatigue. In the ABRAXANE plus gemcitabine arm 17% of patients had grade 3 peripheral neuropathy (no cases of grade 4; 54% had any-grade peripheral neuropathy). Seven percent of patients on the ABRAXANE plus gemcitabine arm that received the average treatment duration experienced Grade 3 neuropathy. The median time to improvement of grade 3 peripheral neuropathy to grade ≤ 1 was 29 days, and 44% of patients resumed treatment with ABRAXANE. Grade ≥ 3 fatigue occurred in 18% of patients. The primary results of the MPACT study from the pre-specified analysis from September 2012 were published in the New England Journal of Medicine in the October 31st 2013 edition.

Details of the poster presentation at ASCO:

About the MPACT Study

In the MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial) study, a Celgene-sponsored, open-label, randomized, international study, a total of 861 patients were randomized 1:1 (431 patients to the ABRAXANE/gemcitabine group and 430 patients to the gemcitabine group). The primary endpoint for the study was overall survival. Secondary endpoints were progression-free survival and overall response rate determined by independent radiological review. Other endpoints included progression-free survival and overall response rate as determined by the investigator, and the safety and tolerability of the combination in this patient population.

About Pancreatic Cancer

Pancreatic cancer is the fourth-leading cause of cancer-related death in the U.S. and Europe. The pancreas is composed of two main cell types: exocrine and endocrine. Adenocarcinoma is a sub-type of exocrine tumors and accounts for about 95% of cancers of the pancreas. For all stages of pancreatic cancer combined, the five-year survival rate in U.S. is about 6% and 5.7% in the EU. For metastatic pancreatic cancer, the five-year survival is approximately 1% in the U.S.

About ABRAXANE®

ABRAXANE is an albumin-bound form of paclitaxel that is manufactured using patented nab® technology. ABRAXANE is formulated with albumin, a human protein, and is free of solvents.

In September 2013, the U.S. 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 Europe.

Important Safety Information Based on Approved U.S. Label

 

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

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 at http://abraxane.com/downloads/Abraxane_PrescribingInformation.pdf

About Celgene

Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit www.celgene.com. Follow us on Twitter @Celgene as well.

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. Celgene Corporation undertakes 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 Celgene Corporation's Annual Report on Form 10-K and its other reports filed with the Securities and Exchange Commission.

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Source: Celgene Corporation

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