Updated on 23 January 2013
The trial involved 861 treatment naïve patients internationally
Singapore: A phase III clinical trial of world leading breast cancer drug ABRAXANE (nanoparticle albumin-bound paclitaxel) in combination with current standard of care gemcitabine by Australian biopharmaceutical company Specialised Therapeutics Australia in patients with advanced pancreatic cancer has demonstrated substantially improved survival times, with double the number of patients surviving two years.
The MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial) investigation involved 861 treatment naïve patients internationally.
Researchers found those patients treated with ABRAXANE plus gemcitabine had a statistically significant improvement in overall survival compared to patients receiving gemcitabine alone [(median of 8.5 vs. 6.7 months) (HR 0.72, P=0.000015)].
Moreover, ABRAXANE plus gemcitabine demonstrated a 59% increase in one-year survival (35 percent vs 22 percent, p=0.0002) and demonstrated double the rate of survival at two years (9 percent vs. 4 percent, p=0.02) as compared to gemcitabine alone.1
ABRAXANE plus gemcitabine also demonstrated statistically significant improvements in key secondary endpoints compared to gemcitabine alone, including a 31 percent reduction in the risk of progression or death with a median progression-free survival (PFS) of 5.5 vs. 3.7 months (HR 0.69, P=0.000024) and an overall response rate (ORR) of 23 percent compared to 7 percent (response rate ratio of 3.19, p=1.1 x 10-10). Another endpoint assessed included time to treatment failure, which was significantly improved with the ABRAXANE combination compared to gemcitabine alone [(median 5.1 vs. 3.6 months) (HR 0.70, P < 0.0001)].
"The past few decades have brought us very few treatment advances for patients with advanced pancreatic cancer, which is both deadly and incredibly difficult to treat with success," said Mr Daniel D Von Hoff, MD, FACP, lead principal investigator of the MPACT study and chief scientific officer for Scottsdale Healthcare's Virginia G Piper Cancer Centre Clinical Trials and Physician-In-Chief for TGen. "The fact that ABRAXANE plus gemcitabine demonstrated an overall survival benefit, and also did so at one and two years, is a significant step forward in offering potential new hope for our patients."