NEJM publishes Celgene’s Abraxane phase III study results

Nab-paclitaxel plus gemcitabine demonstrated clinically meaningful results across primary and key secondary endpoints and patient subgroups compared with gemcitabine alone 

Published today 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 to patients receiving gemcitabine alone [(median of 8.5 vs. 6.7 months) (HR 0.72, P=0.000015)]. 

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 double the rate of survival at two years (9% vs. 4%, p=0.02) compared with gemcitabine alone.

“Today’s news of nab-paclitaxel plus gemcitabine demonstrating up to two 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 six 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 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)].

“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 vs. gemcitabine alone were neutropenia (38% vs. 27%), fatigue (17% vs. 7%), and neuropathy (17% vs. 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.