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18 Oct 2013

Abraxane (Nab-Paclitaxel) Demonstrates Survival Advantage in Metastatic Pancreatic Cancer in Study

Published in the New England Journal of Medicine (NEJM), a Phase III clinical trial of Abraxane (paclitaxel formulated as albumin-bound nanoparticles) in combination with gemcitabine in treatment-naive patients with metastatic pancreatic cancer demonstrated a statistically significant improvement in overall survival compared with patients receiving gemcitabine alone [(median of 8.5 versus 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 1-year survival (35% versus 22%, p=0.0002) and double the rate of survival at 2 years (9% versus 4%, p=0.02) compared with gemcitabine alone.1


“Today’s news of nab-paclitaxel plus gemcitabine demonstrating up to 2 years' survival in some patients represents a major new advance in the treatment of metastatic pancreatic cancer,” commented Dr Harpreet Wasan, Consultant Oncologist & Reader, who runs a pancreatic cancer research programme. “At the moment, treatment options for patients with metastatic pancreatic cancer are very limited, with average life expectancy around 6 months, therefore these results potentially offer crucial new hope in the battle against this intractable disease.”


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 versus 3.7 months (HR 0.69, P=0.000024) and an overall response rate (ORR) of 23% compared with 7% (response rate ratio of 3.19, p=1.1 x 10-10).1 Another endpoint assessed included time to treatment failure, which was significantly improved with the nab-paclitaxel combination compared with gemcitabine alone [(median 5.1 versus 3.6 months) (HR 0.70, P<0.0001)].1

“We are excited by the results of the MPACT study published in the NEJM, and the potential this treatment combination may bring to UK patients with metastatic pancreatic cancer,” said Dr David Gillen, Medical Director, Celgene UK and Ireland. “As the largest Phase III clinical trial in metastatic 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 areas of high unmet need.” 

The most common grade ≥ 3 treatment-related adverse events in the study for nab-paclitaxel plus gemcitabine versus gemcitabine alone were neutropenia (38% versus 27%), fatigue (17% versus 7%), and neuropathy (17% versus 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).

Based on the strength of this data, Celgene has applied to the European Medicines Agency (EMA) for a licence in metastatic pancreatic cancer. 

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