Abraxane plus gemcitabine improves survival in phase III study of patients with advanced pancreatic cancer
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% 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.
ABRAXANE plus gemcitabine also demonstrated statistically significant improvements 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 ABRAXANE combination compared to gemcitabine alone [(median 5.1 vs. 3.6 months) (HR 0.70, P<0.0001)].
The most common grade ≥ 3 treatment-related adverse events in the study for ABRAXANE plus gemcitabine vs. gemcitabine alone were neutropenia (38% vs. 27%), fatigue (17% vs. 7%), and neuropathy (17% vs. 1%). In the ABRAXANE 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).
These results are from an investigational study. ABRAXANE is not approved for the treatment of advanced pancreatic cancer. Following TGA review and approval, STA will seek to have ABRAXANE included on the Pharmaceutical Benefits Scheme (PBS) for the reimbursement of ABRAXANE for advanced pancreatic cancer.
Most read news
Organizations
Other news from the department research and development
Get the life science industry in your inbox
From now on, don't miss a thing: Our newsletter for biotechnology, pharma and life sciences brings you up to date every Tuesday and Thursday. The latest industry news, product highlights and innovations - compact and easy to understand in your inbox. Researched by us so you don't have to.