Celgene Corporation
Jun 6, 2011
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Phase II Study Evaluating Clinical Benefits of ABRAXANE® Plus Gemcitabine and Bevacizumab as First-Line Treatment in Patients with Metastatic Breast Cancer Presented at ASCO

Achieved primary endpoint of study with 81% progression free survival rate at 6 months

BOUDRY, Switzerland, Jun 06, 2011 (BUSINESS WIRE) --

Celgene International Sàrl (Nasdaq:CELG) today announced that results from an investigator-initiated phase II study of ABRAXANE (paclitaxel albumin-bound particles for injectable suspension), gemcitabine and bevacizumab as first-line treatment in metastatic breast cancer were presented at the 2011 American Society of Clinical Oncology Annual Meeting in Chicago, IL.

In the study, patients eligible for first-line chemotherapy were given ABRAXANE (125 mg/m2), followed by gemcitabine (1000 mg/m2) on days 1 and 8, followed by bevacizumab (15 mg/kg) on day 1 of each 21 day cycle. Forty-eight patients were evaluable for the study.

At a median follow-up of 10.6 months, the 6-month progression free survival rate was 81% (95% CI; 67%-91%). Median PFS was 11.7 months (95% CI: 8.7-13.1) and the median overall survival rate had not been reached. The 12-month overall survival rate was 84% (95% CI: 73%-97%). The confirmed complete response (CR) plus partial response (PR) rate was 69%, with two patients achieving CR and 31 achieving PR. The median duration of response was 9.9 months (95% CI: 7.3-12.6).

Grade 3 and higher adverse events occurred in 90% of patients in the study, with myelosuppression being the major toxicity experienced (75% grade 3 or higher).

These results are from an investigational study. ABRAXANE is not approved as a treatment for first-line metastatic breast cancer.

About ABRAXANE®

ABRAXANE is a solvent-free chemotherapy treatment option for metastatic breast cancer which was developed using Celgene's proprietary nab® technology platform. This protein-bound chemotherapy agent combines paclitaxel with albumin, a naturally-occurring human protein. ABRAXANE is currently in various stages of investigation for the treatment of the following cancers: expanded applications for metastatic breast, non-small cell lung, malignant melanoma, pancreatic and gastric.

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

ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available.

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.

ADDITIONAL WARNINGS

Pregnancy-Teratogenic Effects: Pregnancy Category D

Use in Males:

Albumin (human):

PRECAUTIONS

Drug Interactions:

Hematology:

Nervous System:

Hepatic Impairment:

Injection Site Reaction:

Nursing Mothers:

Ability to Drive and Use Machines:

ADVERSE EVENTS

In the randomized metastatic breast cancer study, the most important adverse events included alopecia (90%), neutropenia (all cases 80%; severe 9%), sensory neuropathy (any symptoms 71%; severe 10%), asthenia (any 47%; severe 8%), myalgia/arthralgia (any 44%; severe 8%), anemia (all 33%; severe 1%), nausea (any 30%; severe 3%), diarrhea (any 27%; severe <1%) infections (24%), vomiting (any 18%; severe 4%), and mucositis (any 7%; severe <1%).

Other adverse reactions have included ocular/visual disturbances (any 13%; severe 1%), renal dysfunction (any 11%; severe 1%), fluid retention (any 10%; severe 0%), hepatic dysfunction (elevations in bilirubin 7%, alkaline phosphatase 36%, AST [SGOT] 39%), hypersensitivity reactions (any 4%; severe 0%), cardiovascular reactions (severe 3%), thrombocytopenia (any 2%; severe <1%), and injection site reactions (<1%). In clinical trials and during postmarketing surveillance, dehydration was common and pyrexia was very common. Rare occurrences of severe hypersensitivity reactions have also been reported during postmarketing surveillance.

Please see full Prescribing Information, including Boxed WARNINGS, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, and ADVERSE REACTIONS.

About Metastatic Breast Cancer

Metastatic breast cancer is a complex multi-step process involving the expansion of cancerous cells from the breast to other areas of the body. It is a serious complication of breast cancer, as metastatic disease in breast cancer is often fatal, with treatments mainly limited to palliation.

Breast cancer primarily metastasizes to the bone, lungs, regional lymph nodes, liver and to the brain, with the most common site being the bone. The typical environmental barriers in any metastatic event would include physical (basement membrane), chemical (Reactive oxygen species (ROS), hypoxia and low PH) and biological (immune surveillance, inhibitory cytokines and regulatory Extracellular Matrix (ECM) peptides) components. Organ-specific anatomic considerations can also influence metastasis; these include blood flow patterns from the primary tumor and the homing ability of cancer cells for certain tissues. The targeting by cancer cells of specific organs is likely regulated by chemoattractant factors and adhesion molecules, which are produced by the target organ along with the cell-surface receptors expressed by the tumor cells.

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.

This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company's control. The Company's actual results, performance, or achievements could be materially different from those projected by these forward-looking statements. The factors that could cause actual results, performance, or achievements to differ from the forward-looking statements are discussed in the Company's filings with the Securities and Exchange Commission, such as the Company's Form 10-K, 10-Q and 8-K reports. Given these risks and uncertainties, you are cautioned not to place undue reliance on the forward-looking statements.

SOURCE: Celgene International Sàrl

Celgene International Sàrl
Director of External Relations
Kevin Loth, +41 32 729 86 21