Celgene UK and Ireland, a subsidiary of Celgene Corporation (NASDAQ: CELG), today announced that its phase III clinical trial of ABRAXANE® (nab-paclitaxel) in combination with gemcitabine in treatment-naïve patients with metastatic pancreatic cancer demonstrated 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)].(1)
In the MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial) study, nab-paclitaxel plus gemcitabine demonstrated a 59% increase in one-year survival (35% vs. 22%, p=0.0002) and demonstrated double the rate of survival at two years (9% vs. 4%, p=0.02) as compared to gemcitabine alone.(1)
Nab-paclitaxel plus gemcitabine also demonstrated a statistically significant improvement in key secondary endpoints compared to gemcitabine alone, including a 31% 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% compared to 7% (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 nab-paclitaxel combination compared to gemcitabine alone [(median 5.1 vs. 3.6 months) (HR 0.70, p<0.0001)].(1)
“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 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 Center Clinical Trials and Physician-In-Chief for TGen. “The fact that nab-paclitaxel 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.”
Dr Pippa Corrie, Consultant Medical Oncologist at Addenbrooke’s Hospital, Cambridge, emphasises the importance of this new data. “At the moment, treatment options for patients with advanced pancreatic cancer are very limited, with average life expectancy around six months. The announcement of the MPACT study results showing significant improvements in overall survival when combining nab-paclitaxel with standard gemcitabine, lasting up to two years in some cases, is a major step forward in the battle against pancreatic cancer.”
The most common grade ≥ 3 treatment-related adverse events in the study for nab-paclitaxel plus gemcitabine vs. gemcitabine alone were neutropenia (38% vs. 27%), fatigue (17% vs. 7%), and neuropathy (17% vs. 1%).(1) In the nab-paclitaxel plus gemcitabine arm, the median time to neuropathy improvement was 29 days. There was no difference in serious life threatening toxicity (4% in each arm).(1)
“We are excited by the results of the nab-paclitaxel MPACT study and the potential this treatment combination may bring to patients with advanced pancreatic cancer,” said Jean-Pierre Bizzari, MD, Executive Vice President, Global Head Haematology & Oncology Clinical Research, Celgene Corporation. “As the largest phase III real-world clinical trial in advanced pancreatic cancer, the clinically meaningful findings seen across key study endpoints and patient subgroups are a reflection of our ongoing commitment to develop innovative new therapies in critical areas of need.”
Further details of the study will be highlighted in a late-breaking oral presentation by Dr. Daniel D. Von Hoff:
- Abstract: LBA #148: Final results of a randomised phase III study of weekly nab-paclitaxel plus gemcitabine versus gemcitabine alone in patients with metastatic adenocarcinoma of the pancreas. Friday, January 25th between 2:00 to 3:30 pm PST at the American Society of Clinical Oncology’s (ASCO) 2013 Gastrointestinal Cancers Symposium in San Francisco, CA.(1)
Based on the results of the MPACT study, Celgene plans to submit dossiers for registration in the US and Europe during the first half of 2013 followed by submissions in other countries/regions during the second half of 2013.
These results are from an investigational phase III study. Nab-paclitaxel is not currently approved for the treatment of advanced pancreatic cancer.
- Randomized phase 3 study of weekly nab-paclitaxel plus gemcitabine versus gemcitabine alone in patients with metastatic adenocarcinoma of the pancreas (MPACT). Phase 3 metastatic pancreatic cancer, D Von Hoff. ASCO GI, Jan 24-26, 2013 San Francisco, CA; Late-breaking abstract.