Results from Celgene’s ABRAXANE plus gemcitabine clinical study on resectable pancreatic cancer

Jun 5 2012

Celgene International Sàrl, a subsidiary of Celgene Corporation (NASDAQ: CELG) today announced results from a study of ABRAXANE^® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in combination with gemcitabine in patients with resectable pancreatic cancer. These results were reported during the 48^th American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Ill.

In the study, patients with resectable or borderline resectable pancreatic cancer were treated with nab-paclitaxel (125 mg/m² days 1, 8 and 15) and gemcitabine (1000 mg/m² days 1,8 and 15) for two cycles prior to surgery. Response was assessed by FDG-PET scan, CA19.9 levels and elastography, an investigational non-invasive assessment of pancreatic tumor stroma.

Of 16 patients enrolled, 12 have received operations and 11 achieved a complete resection. Based on CT scan assessment, of the 16 enrolled patients, 3 had progressive disease while 13 achieved stable disease or partial response. The median value for PET SUVmax decreased from 7.2 pre-treatment to 4.5 post-treatment (p=0.005), including 8 patients with a partial metabolic response. Mean CA19.9 level decreased from 2588 to 1056 (p=0.001) with 50% of patients (8/16) experiencing at least a 70% decrease in tumor marker level. Additionally, the elastography ratio value diminished from 36 pre-treatment to 18 post-treatment (p=0.002) and correlated with improvement in SUVmax (p=0.494) and CA19.9 response (p=0.019). Immunohistochemistry analysis showed the addition of nab-paclitaxel alters the collagen structure surrounding pancreatic tumors.   

The most common grade 3-4 toxicities were neutropenia (18%, no febrile neutropenia), thrombocytopenia (12.5%), infections (12.5%) and transaminases elevation (6.2%).

These results are from an investigational study. ABRAXANE^® is not indicated for the treatment of resectable pancreatic cancer. ABRAXANE^® is currently being evaluated in the MPACT trial, a randomized Phase III study comparing the combination of nab-paclitaxel and gemcitabine to gemcitabine alone in metastatic pancreatic cancer patients. The study has completed accrual with results expected in late 2012.