Celgene Corporation (NASDAQ: CELG) today announced updated Overall Survival (OS) results from a post-hoc analysis of its phase III MPACT ( Metastatic Pancreatic Adenocarcinoma Clinical Trial) study of ABRAXANE ® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in combination with gemcitabine in treatment-naïve patients with metastatic pancreatic cancer. A poster discussion of the analysis is scheduled for Sunday, June 1 st at 11:30 am CT at the 50 th American Society of Clinical Oncology (ASCO) annual meeting in Chicago, Ill.
The extended data cutoff occurred at final database lock in May 2013 and allowed for an OS analysis of mature data from 90% of the patients in the study. The extended analysis showed that ABRAXANE plus gemcitabine demonstrated an improvement in OS in the intent-to-treat population compared to patients that received gemcitabine alone [(median OS of 8.7 vs. 6.6. months) (HR0.72, P<0.0001), a difference of 2.1 months]. The analysis showed survival up to 3.5 years in the ABRAXANE plus gemcitabine group (3% of patients alive vs 0% with gemcitabine alone). One- and 2- year survival rates were consistent with the primary analysis.
The analysis also showed that the treatment effect on OS for pre-specified subgroups analyzed in the trial remained consistent across patient subgroups. Specifically, patients with Karnofsky Performance Status (KPS) KPS 90-100 had a higher median OS on ABRAXANE plus gemcitabine as compared to gemcitabine alone [median OS 9.7 months vs. 7.9 months (HR 0.77, P=0.0053)]. Patients with KPS 70-80 also maintained a benefit [median OS 7.6 months vs. 4.3 months (HR 0.59, P<0.0001)].
This updated analysis also evaluated the prognostic effects of CA19-9 and neutrophil-to-lymphocyte ratio (NLR). Both elevated CA19-9 and elevated NLR were associated with poorer survival. Further, treatment with ABRAXANE plus gemcitabine appeared to reduce the effect of CA19-9 as a poor prognostic factor, as similar overall survival was observed regardless of CA19-9 level.