- Clinical Trials
- Research News
- Industry Trends
- Agency Actions
- Drug Safety Issues
- Approvals, Launches, & New Indications
- Health Care Reform
Positive Phase III Results Reported for Abraxane (Paclitaxel) in Metastatic Pancreatic Cancer
Nab-paclitaxel/gemcitabine is more effective than gemcitabine alone (October 16)
Positive results have been reported from the phase III Metastatic Pancreatic Adenocarcinoma Clinical Trial (MPACT) of Abraxane (paclitaxel protein-bound particles for injectable suspension, albumin-bound [nab-paclitaxel]; Celgene International Sàrl) in combination with gemcitabine (Gemzar, Eli Lilly). The new findings were reported online in the New England Journal of Medicine.
The MPACT trial was an open-label randomized study of 861 previously untreated patients with metastatic pancreatic cancer in North America, Europe, and Australia.
The patients were randomly assigned to treatment with nab-paclitaxel and gemcitabine (n = 431) or gemcitabine alone (n = 430). Patients in the nab-paclitaxel/gemcitabine group received nab-paclitaxel as an intravenous (IV) infusion over 30 to 40 minutes at a dose of 125 mg/m2 followed by gemcitabine as an IV infusion over 30 to 40 minutes at a dose of 1,000 mg/m2 given on days 1, 8, and 15 of each 28-day cycle. In the comparator treatment group, gemcitabine monotherapy was administered at a dose of 1,000 mg/m2 given weekly for 7 weeks followed by a 1-week rest period in cycle 1. In cycle 2 and onwards, gemcitabine was administered on days 1, 8, and 15 of a 28-day cycle. The study’s primary endpoint was overall survival (OS).
The median OS was 8.5 months in the nab-paclitaxel/gemcitabine group compared with 6.7 months in the gemcitabine group (hazard ratio [HR] for death, 0.72; P < 0.001). The survival rate was 35% in the nab-paclitaxel/gemcitabine group versus 22% in the gemcitabine group at 1 year, and 9% versus 4%, respectively, at 2 years. The median progression-free survival was 5.5 months in the nab-paclitaxel/gemcitabine group compared with 3.7 months in the gemcitabine group (HR for disease progression or death, 0.69; P < 0.001). The response rates were 23% versus 7% in the two groups (P < 0.001).