Celgene details Abraxane pancreatic cancer data

Celgene Corp. (NASDAQ:CELG) reported detailed data from the Phase III MPACT trial evaluating Abraxane nab-paclitaxel for metastatic pancreatic cancer and said it now plans to submit regulatory applications for the indication in the U.S. and EU this half. The company, which previously said it planned to submit an application in the U.S. sometime this year, also plans to submit regulatory applications in other regions in 2H13. In 861 treatment-naive patients in the MPACT trial, Celgene said Abraxane plus gemcitabine led to a median overall survival (OS), the primary endpoint, of 8.5 months vs. 6.7 months for gemcitabine alone (p=0.000015). Abraxane plus gemcitabine also significantly improved one-year OS (35% vs. 22%, p=0.0002) and two-year OS rates (9% vs. 4%, p=0.02) vs. gemcitabine alone. The company reported in November that Abraxane met the OS endpoint, but did not disclose details. Data will be presented at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium on Friday.

The albumin stabilized nanoparticle formulation of paclitaxel is approved in the U.S. for first-line treatment of advanced non-small cell lung cancer (NSCLC), and in the U.S., EU and 12 other countries as second-line treatment of metastatic breast cancer. ...