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ABRAXANE oncology milestones spelled out


CALGB 40502 advances understanding of optimal dosing and scheduling of nab-paclitaxel in metastatic breast cancer


Celgene International Sarl, a subsidiary of Celgene Corporation, has announced a series of milestones related to the development of ABRAXANE (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in metastatic pancreatic cancer, advanced non-small cell lung cancer, metastatic breast cancer and metastatic melanoma.


The company completed enrollment in the largest phase III study of metastatic pancreatic cancer to date (NCI clinical trial reference number NCT00844649). 


In this global study, 861 patients were randomized to receive either nab-paclitaxel plus gemcitabine or gemcitabine alone. Results from the study with a primary endpoint of overall survival are expected during the second half of 2012. 


The design of the study is based on the promising results of a phase I/II study in 67 patients published in the Journal of Clinical Oncology in December 2011 (Von Hoff et al, 2011 JCO).


In advanced non-small cell lung cancer, additional regulatory submissions were filed in Japan, Australia and New Zealand, which were based on the positive randomized phase III study reported online in the Journal of Clinical Oncology (Socinski et al, 2012 JCO (epub)). 


In the United States, the Food and Drug Administration (FDA) has set a PDUFA date of Oct. 12, 2012.


At the American Society of Clinical Oncology (ASCO) 2012 annual meeting, results of Cancer and Leukemia Group B (CALGB) study 40502 were presented evaluating bevacizumab in combination with nab-paclitaxel administered weekly at a dose of 150 mg/m2, which is significantly higher than the approved dose intensity*(Abstract #CRA1002). 


The study reported that bevacizumab plus nab-paclitaxel was not superior to bevacizumab plus paclitaxel and was associated with increased toxicity and earlier treatment discontinuations in patients receiving first-line therapy for metastatic breast cancer (MBC).


The data presented at ASCO does not impact the body of breast cancer data for nab-paclitaxel monotherapy which has demonstrated significantly superior efficacy and an acceptable safety profile compared to paclitaxel in a randomized Phase III clinical study** that was the basis for nab-paclitaxel approvals in more than 40 countries for the treatment of MBC.


Celgene will use the CALGB 40502 efficacy and safety data to inform the next stage of development of nab-paclitaxel across all stages of breast cancer. The company continues to explore how the molecular characteristics of tumours can be utilised to optimise therapy for patients.


The company plans to support studies that will enroll more than 4000 patients in the potentially curative, neo-adjuvant treatment setting. 


The company will work with study investigators to incorporate recent U.S. Food and Drug Administration Guidance for Industry on pathological complete response (pCR) as the endpoint in neoadjuvant (preoperative) treatment of breast cancer to support accelerated approval. 


This process is intended to incorporate therapies into standard treatment for early-stage breast cancer as rapidly as possible to provide greatest benefit to the most patients.


As a result of the recent changes in the treatment landscape of metastatic melanoma, Celgene is incorporating correlative analyses into its ongoing randomized phase III study of nab-paclitaxel (150 mg/m2 weekly) single-agent versus dacarbazine, including BRaF mutational status (NCI clinical trial reference number NCT00864253). This study completed enrollment in the second quarter of 2011.

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