Celgene Corporation
Jun 4, 2016
PDF
Add to Briefcase

Data Presented at ASCO 2016 Builds upon Foundation of Abraxane® Plus Gemcitabine as a First-Line Treatment in Patients with Metastatic Pancreatic Cancer

Multiple presentations evaluate the treatment sequence with ABRAXANE plus gemcitabine in the first line setting and as a foundation for investigational combinations

SUMMIT, N.J.--(BUSINESS WIRE)-- Celgene Corporation (NASDAQ:CELG) today announced that results from multiple sponsored and independent studies presented during the 52nd ASCO Annual Meeting evaluated the use of ABRAXANE® (paclitaxel protein-bound particles for injectable suspension)(albumin-bound) in combination with gemcitabine in first-line metastatic pancreatic cancer.

"This year's ASCO meeting continues to evaluate sequential therapy with ABRAXANE plus gemcitabine in the first-line and as a combination partner for investigational agents to treat metastatic pancreatic cancer," said Michael Pehl, President, Hematology and Oncology for Celgene. "The ABRAXANE plus gemcitabine combination is playing a key part in research designed to advance care for patients in this historically challenging disease."

Evaluating a Treatment Plan in Metastatic Pancreatic Cancer

For patients with metastatic pancreatic cancer, important considerations in defining a treatment plan include sequence, patient characteristics, comparative effectiveness and cost. At ASCO 2016 health outcomes analyses evaluating the treatment sequence with ABRAXANE plus gemcitabine as the first-line option are being presented.

An Italian multi-center real-life retrospective analysis highlighted outcomes of 122 patients who received first-line ABRAXANE plus gemcitabine followed by second-line treatment. (Abstract #4124 - Giordano). Second line treatments included FOLFOX/XELOX (45%). FOLFIRI (22%), FOLFIRINOX (18%), and other single agent therapies (15%). Median overall survival for patients receiving a second-line therapy following ABRAXANE plus gemcitabine was 13.5 months (95% CI 12.659-14.341), compared with 6.8 months for patients (99 patients) receiving BSC (95% CI 5.567-8.033), p < 0.0001. Also of note in the research presented at ASCO were two studies evaluating ABRAXANE plus gemcitabine in patients who exhibited elevated bilirubin levels, a common disease effect in metastatic pancreatic cancer. These studies provide insight into this patient population, which was excluded from the Phase III study of ABRAXANE plus gemcitabine.

In one observational interim analysis (Abstract #e15739 - zur Hausen), 20 (of 219) patients with a mean bilirubin level of 4.4 mg/dl (1.5-12.9) at baseline were followed for up to 4 cycles of ABRAXANE plus gemcitabine and methods of hyperbilirubinaemia were assessed. The mean bilirubin level of these patients dropped to 1.8 mg/dl (0.35-14.1; p=0.031) by the 2nd cycle. There were 14 (70%) patients that started treatment with a standard dosage and 6 (30%) that started with a reduced dose. Grade 3 or 4 toxicities were seen in 70 percent of patients with the most common being leukopenia, anemia and fever (each 20%).

An additional analysis of 29 patients (Abstract #e15717 - Pelzer) examined safety and survival with ABRAXANE/Gemcitabine in patients with elevated total bilirubin levels (≥ 1.2 to > 5 x ULN).

Administration of ABRAXANE in patients with hepatic impairment should be performed with caution. Patients with hepatic impairment may be at increased risk of toxicity, particularly from myelosuppression; such patients should be closely monitored for development of profound myelosuppression. According to the prescribing information, ABRAXANE is not recommended in patients who have total bilirubin > 5 x ULN or AST > 10 x ULN.

Multiple studies evaluated real-world comparative effectiveness and economic evaluations of first-line metastatic pancreatic treatments.

An independent, retrospective, Canadian comparative effectiveness analysis of ABRAXANE plus gemcitabine, FOLFIRINOX, and gemcitabine alone (Abstract #6561 - Wang) in five British Columbia cancer centers found the median overall survival of these treatments was 8.5 months for ABRAXANE plus gemcitabine (n=59), 7.8 months for FOLFIRINOX (n=59) and 3.1 months for gemcitabine alone. The analysis noted that patients receiving FOLFIRINOX were significantly younger (p < 0.001), had better performance status (p < 0.001) and had less disease burden at presentation (p=0.049), compared with ABRAXANE plus gemcitabine. Treatment discontinuation due to toxicities occurred in 36% of patients receiving FOLFIRINOX, 17% of patients receiving ABRAXANE plus gemcitabine and 23% of patients receiving gemcitabine alone.

A retrospective review of U.S. de-identified hospital data (Abstract #e15741 - Kim) evaluated the median time to treatment discontinuation and cost of ABRAXANE® plus gemcitabine and FOLFIRINOX in the first-line setting. In this analysis, patients treated with FOLFIRINOX had higher median total monthly treatment costs compared to ABRAXANE plus gemcitabine ($18,743 vs. $12,192; p < 0.05).

ABRAXANE plus gemcitabine as a foundation for investigational combinations in metastatic pancreatic cancer

Multiple studies presented at ASCO also evaluated ABRAXANE in combination with potential new agents in first-line metastatic pancreatic cancer. Agents being evaluated in combination with ABRAXANE plus gemcitabine in the first line include PEGPH20 (Abstract #4104 - Bullock), necuparanib (Abstract # 4117 - O'Reilly), indoximod (Abstract #3020 - Bahary) and napabucasin (Abstract #4128 - El-Rayes).

About ABRAXANE®

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.

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. We undertake 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 our Annual Report on Form 10-K and our other reports filed with the Securities and Exchange Commission.

For Celgene:
Investors:
908-673-9628
investors@celgene.com
or
Media:
908-673-2275
media@celgene.com

Source: Celgene Corporation

News Provided by Acquire Media