Avid Bioservices Inc (CDMO)

[freethemice]

News of a phase 3 trial of Abraxane + gemcitabine in advanced pancreatic cancer (APC) will be coming
out tomorrow. I thought I would do a little review of the drug and trials for NSCLC and APC. Abraxene is a version
of paclitaxel which is bound to the protein albumin to increase efficacy and decrease toxicity.
http://en.wikipedia.org/wiki/Abraxane

Abraxane is owned by Celegene, which bought out Abraxis BioScience in 2010 for $2.9 billion.
http://www.nytimes.com/2010/07/01/health/01drug.html?_r=0

NSCLC:
Results of phase 3 trial which led to the approval in first-line NSCLC on October 12, 2012.
Weekly nab-paclitaxel in combination with carboplatin versus solvent-based paclitaxel plus carboplatin as first-line therapy in patients with advanced non-small-cell lung cancer: final results of a phase III trial
http://www.ncbi.nlm.nih.gov/pubmed/22547591
The drug was approved for first-line NSCLC based on a significantly improved ORR, the primary endpoint.
PFS and MOS were not increased significantly. sb-paclitaxel is the usual solvent-based paclitaxel for injection.
Both arms also got carboplatin. About 70% of the patients were from Russia/Ukraine.

There was an approximately 10% improvement in progression-free survival (median, 6.3 v 5.8 months; hazard ratio [HR], 0.902; 95% CI, 0.767 to 1.060; P = .214) and overall survival (OS; median, 12.1 v 11.2 months; HR, 0.922; 95% CI, 0.797 to 1.066; P = .271) in the nab-PC arm versus the sb-PC arm, respectively.

Here is the survival curve from that study.


NEXT: Abraxane in APC.