Celgene Corporation
Jan 22, 2016
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Data Presented at ASCO GI Highlight the Feasibility of Second-Line Treatment in Patients with Metastatic Pancreatic Cancer Who Have Received First-Line Abraxane Plus Gemcitabine

Multiple analyses examined ABRAXANE (paclitaxel protein-bound particles for injectable suspension)(albumin-bound) and gemcitabine followed by 5-FU-based regimens

SUMMIT, N.J.--(BUSINESS WIRE)-- Celgene Corporation (NASDAQ: CELG) today announced that results from multiple analyses presented during the 2016 ASCO Gastrointestinal Cancers Symposium (ASCO GI) evaluated the outcomes of second-line treatments following ABRAXANE® (paclitaxel protein-bound particles for injectable suspension)(albumin-bound) and gemcitabine (AG) in first-line metastatic pancreatic cancer patients.

In particular, a post-hoc analysis of MPACT, the pivotal phase III study of AG compared with gemcitabine alone in first-line metastatic pancreatic cancer evaluated the outcomes of patients who received a second-line treatment during an observational extension of the study.

A total of 347 (40%) patients received second-line therapy in the extension, and of those patients, the majority (77%, including 132 who had received AG in the first line and 135 who had received gemcitabine alone) received 5-FU-based therapies or capecitabine combinations.

A post hoc analysis of overall survival (OS) was conducted and demonstrated that patients (n=170) who received AG, followed by second-line therapy had a median OS of 12.8 months, compared with 9.9 months for patients (n= 177) who received gemcitabine alone, followed by second-line therapy. Of patients receiving second-line therapies, the majority (n=132) received 5FU or capecitabine-containing regimens and had a median OS of 13.5 months. Patients receiving FOLFIRINOX (FFX) following AG (n=18) had the longest median overall survival at 15.7 months. OS was calculated using the Kaplan-Meier method.

The analysis provided data demonstrating the feasibility of second-line treatment in patients with MPC after first-line AG.

"As the body of research and approved options increase in pancreatic cancer, there is now evidence that second-line treatment is feasible and beneficial for certain patients with metastatic disease," said Dr. David Goldstein, medical oncologist at Prince of Wales Hospital in Sydney, Australia and the lead investigator of the analysis. "We are seeing an exciting evolution in the treatment of this disease and for patients and physicians, it is now time to consider a total treatment plan when choosing an initial therapy."

A retrospective cohort study performed using data U.S. community data from Navigating Cancer, an electronic medical record platform, sought to compare the time to treatment discontinuation and database persistence, used as a proxy for OS, between AG and FFX in the first-line setting.

The analysis showed that time to treatment discontinuation and database persistence for patients with first-line metastatic pancreatic cancer (n=202) were numerically similar (8.6 in each arm) between AG (n=122) and FFX (n=80). With the exception of the age of patients, which favored FFX (median age 67 for AG years vs. 61.4 years for FFX), baseline characteristics were generally similar between the groups.

There was a higher incidence of adverse events (all grades) with FFX compared with AG (95% vs. 84%). Most common AE's that led to discontinuation were anemia (8% for FFX and 2% for AG), neutropenia (6% for each), and dehydration (5% and 3%, respectively)

The analysis also evaluated various treatment plans including first-line AG, followed by second-line 5-FU-based therapies and first-line FFX, followed by second-line gemcitabine-based therapies. The duration of treatment for the AG arm was a median 8.7 months, compared with 8.4 months for the FFX arm (p=0.52). Further, the database persistence (proxy for OS) for patients receiving AG followed by 5-FU-based therapies (n=25) was a median 12.7 months, compared with 9.3 months for patients receiving FFX followed by gemcitabine-based therapies (n=41) (p=0.48).

There were four additional studies evaluating the sequence of AG followed by 5-FU-based therapies at the meeting:

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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