Celgene Corporation
Jun 2, 2012
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Multiple Analyses Evaluating ABRAXANE® (Nab-Paclitaxel) in Non-Small Cell Lung Cancer Presented at ASCO

Overall survival nearly doubled for elderly patients

Response rate significantly improved in squamous-cell histology

Trend toward overall survival demonstrated in squamous-cell compared to non-squamous-cell disease

PDUFA date scheduled for Oct. 12, 2012

BOUDRY, Switzerland--(BUSINESS WIRE)--Jun. 2, 2012-- Celgene International Sàrl, a subsidiary of Celgene Corporation (NASDAQ:CELG) today announced results from multiple presentations evaluating ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in combination with carboplatin in patients with advanced non-small cell lung cancer during the 48th American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Ill.

The two reports presented data from retrospective analyses of CA-031, the phase III, multi-center, randomized study where patients received either nab-paclitaxel (100mg/m2) weekly plus carboplatin (AUC=6) every three weeks (n=521) or paclitaxel (200mg/m2) every three weeks plus carboplatin (AUC=6) (n=531) as first-line therapy for advanced non-small cell lung cancer.

Based on the data from CA-031, Celgene submitted an sNDA for ABRAXANE® for the first-line treatment of patients with advanced non-small cell lung cancer with the U.S. Food and Drug Administration in December 2011. The current PDUFA date for the submission is Oct. 12, 2012.

Results of this study published ahead of print on April 30, 2012 in the Journal of Clinical Oncology demonstrated a higher overall response rate (ORR), the approved primary end-point of the study based on a Special Protocol Assessment (SPA), for patients in the nab-paclitaxel arm compared to those in the paclitaxel arm (33% vs. 25%, p=0.005).

The first sub-analysis evaluated elderly patients in the study (age ≥70, n=156) and patients under 70 (n=896). In both groups, ORR was higher in patients receiving nab-paclitaxel, though in elderly patients this difference was not significant. In elderly patients, progression-free survival (PFS) favored nab-paclitaxel (median 8.0 vs. 6.8 months, HR: 0.687, p=0.134) and overall survival was significantly improved (median 19.9 vs. 10.4 months, HR 0.583, p=0.009). For patients under 70, there was no significant difference in PFS or OS between the arms of the study.

In elderly patients, less grade 3/4 neutropenia (54% vs. 74%) and neuropathy (7% vs. 23%) and increased thrombocytopenia (23% vs. 14%) and anemia (23% vs. 10%) in the nab-paclitaxel arm vs. the paclitaxel arm.

The second report evaluated patients with squamous-cell histology (n=450) and non-squamous cell patients (n=602).

In squamous-cell histology patients, the nab-paclitaxel arm demonstrated a significantly higher ORR (41% vs. 24%, p<0.001), similar PFS (5.6 vs. 5.7 months, HR: 0.865) and a slight improvement in OS (10.7 vs. 9.5 months, HR:0.890), compared to the paclitaxel arm. Non-squamous-cell histologies including adenocarcinoma (ADENO), large-cell carcinoma (LC) and not otherwise specified (NOS) were characterized individually for ORR. In these histologies, the ORR in patients receiving nab-paclitaxel compared to paclitaxel was the nab-paclitaxel arm, respectively, was 26% vs. 27% in ADENO, 33% vs. 15% in LC and 24% vs. 15% in NOS. PFS in non-squamous cell histology patients who received nab-paclitaxel compared to those who received paclitaxel, respectively, was 6.9 vs. 6.5 months (HR: 0.933, p=0.532). By histology, median PFS measures for nab-paclitaxel patients compared to paclitaxel patients, respectively, were 6.9 vs. 6.9 months in ADENO, NR (not reached) vs. 3.8 months in LC and 6.4 vs. 4.3 months in NOS. OS by histology for patients receiving nab-paclitaxel compared to those receiving paclitaxel, respectively was 13.9 vs. 13.6 months in ADENO, 12.4 vs. 10.6 months in LC and 10.4 vs. 11.2 months in NOS.

In squamous-cell histology patients, nab-paclitaxel demonstrated produced lower rates of grade 3/4 neuropathy (3% vs. 11%) and neutropenia (43% vs. 51%), and higher rates of anemia (27% vs. 4%) and thrombocytopenia (21% vs. 7%) compared to paclitaxel. In non-squamous-cell histology patients, patients receiving nab-paclitaxel versus paclitaxel, respectively demonstrated lower rates of grade 3/4 neuropathy (3% vs. 12%) and neutropenia (50% vs. 63%), and higher rates of anemia (28% vs. 9%) and thrombocytopenia (16% vs. 11%).

These results are from an investigational study. ABRAXANE is not indicated for the treatment of non-small cell lung cancer.

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

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 Corporation

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