A phase III trial of Abraxane extended overall survival in metastatic pancreatic cancer, with some patients surviving longer than three years, when used in combination with gemcitabine.
The updated OS data from the Metastatic Pancreatic Adenocarcinoma Clinical Trial was presented at the American Society of Clinical Oncology Gastrointestinal Conference in San Francisco.
According to researchers, 4 percent of patients taking Abraxane (nanoparticle albumin-bound paclitaxel) and gemcitabine were alive after three years, compared to zero patients in the gemcitabine-alone arm.
The median survival benefit in the updated analysis was extended in the combination arm with a 2.1 month improvement in OS compared to gemcitabine alone (median 8.7 months vs. 6.6 months; HR=0.72; p<0.0001). This compares favorably with the 1.8 months improvement previously reported in the New England Journal of Medicine (median 8.5 months vs. 6.7 months; HR=0.72; p<0.00001).
The MPACT study was an open-label, randomized, international study of 861 patients with metastatic pancreatic cancer. Patients were randomized to receive either Abraxane plus gemcitabine (125 mg/m(2) followed by 1000 mg/m(2) gemcitabine for 3 weeks followed by a week of rest) or gemcitabine alone (1000 mg/m(2) administered weekly for 7 weeks followed by a week of rest followed by cycles of weekly administration for 3 weeks followed by one week of rest).
The primary endpoint for the study was overall survival. Secondary endpoints were progression-free survival and overall response rate determined by independent radiological review. Other endpoints included progression-free survival and overall response rate determined by investigator, and the safety and tolerability of this combination in this patient population.
Abraxane is approved for metastatic breast cancer in over 40 countries including the U.S., the European Union, Japan, and China, and is currently in various stages of investigation for the treatment of metastatic melanoma, adjuvant pancreatic cancer, bladder cancer, ovarian cancer, and expanded applications for breast cancer.
Abraxane combines paclitaxel with albumin, a naturally-occurring human protein, to deliver the drug and eliminates the need for solvents in the administration process. Nanoparticle technology allows it to deliver a 49 percent higher dose compared to regular solvent-based paclitaxel without compromising safety and tolerability. Abraxane is a registered trademark of Celgene Corporation.
