Celgene Corporation
Jun 4, 2012
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Data Evaluating Clinical Potential of ABRAXANE® (Nab-Paclitaxel) in Combination with Gemcitabine in Resectable Pancreatic Cancer Presented at ASCO

50% of patients experienced at least a 70% decrease in tumor marker level CA19.9 after 2 cycles of neo-adjuvant treatment with ABRAXANE® and gemcitabine

11 of 12 resected patients achieved a complete resection, and 13 of 16 patients achieved stable disease or partial response

BOUDRY, Switzerland--(BUSINESS WIRE)--Jun. 4, 2012-- Celgene International Sàrl, a subsidiary of Celgene Corporation (NASDAQ: CELG) today announced results from a study of ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in combination with gemcitabine in patients with resectable pancreatic cancer. These results were reported during the 48th American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Ill.

In the study, patients with resectable or borderline resectable pancreatic cancer were treated with nab-paclitaxel (125 mg/m2 days 1, 8 and 15) and gemcitabine (1000 mg/m2 days 1,8 and 15) for two cycles prior to surgery. Response was assessed by FDG-PET scan, CA19.9 levels and elastography, an investigational non-invasive assessment of pancreatic tumor stroma.

Of 16 patients enrolled, 12 have received operations and 11 achieved a complete resection. Based on CT scan assessment, of the 16 enrolled patients, 3 had progressive disease while 13 achieved stable disease or partial response. The median value for PET SUVmax decreased from 7.2 pre-treatment to 4.5 post-treatment (p=0.005), including 8 patients with a partial metabolic response. Mean CA19.9 level decreased from 2588 to 1056 (p=0.001) with 50% of patients (8/16) experiencing at least a 70% decrease in tumor marker level. Additionally, the elastography ratio value diminished from 36 pre-treatment to 18 post-treatment (p=0.002) and correlated with improvement in SUVmax (p=0.494) and CA19.9 response (p=0.019). Immunohistochemistry analysis showed the addition of nab-paclitaxel alters the collagen structure surrounding pancreatic tumors.

The most common grade 3-4 toxicities were neutropenia (18%, no febrile neutropenia), thrombocytopenia (12.5%), infections (12.5%) and transaminases elevation (6.2%).

These results are from an investigational study. ABRAXANE® is not indicated for the treatment of resectable pancreatic cancer. ABRAXANE® is currently being evaluated in the MPACT trial, a randomized Phase III study comparing the combination of nab-paclitaxel and gemcitabine to gemcitabine alone in metastatic pancreatic cancer patients. The study has completed accrual with results expected in late 2012.

ABRAXANE® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) is indicated 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.

Important Safety Information

       
   

WARNING - NEUTROPENIA

 

 

ABRAXANE therapy should not be administered to patients with metastatic breast cancer who have baseline neutrophil counts of less than 1,500 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

Hepatic Impairment

Albumin (Human)

Use in Pregnancy: Pregnancy Category D

Use in Men:

ADVERSE REACTIONS - Randomized Metastatic Breast Cancer Study

Post-Marketing 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, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, and ADVERSE REACTIONS.

About Celgene International Sàrl

Celgene International Sàrl, located in Boudry, in the Canton of Neuchâtel, Switzerland, is a wholly owned subsidiary and international headquarters of Celgene Corporation. 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 the Company's website at www.celgene.com.

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.

Source: Celgene International Sàrl

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