JCO publishes data from Celgene's ABRAXANE Phase II combination trial on pancreatic cancer

Celgene International Sàrl (Nasdaq:CELG) today announced that results from a clinical study of ABRAXANE (paclitaxel albumin-bound particles for injectable suspension) in combination with gemcitabine in 67 patients with previously untreated advanced pancreatic cancer were published in an online article by the Journal of Clinical Oncology ahead of print.

After the first phase of the study, the recommended Phase II dose was 125 mg/m2 of ABRAXANE followed by 1000 mg/m2 of gemcitabine on days 1, 8 and 15 of every 28-day cycle.

In Phase II, almost half of the patients responded (overall response rate was 48% (21/44)) and two-thirds experienced disease control (disease control rate was 68% (30/44)). The median progression-free survival was 7.9 months (95% CI: 5.8, 11.0) and the median overall survival (OS) was 12.2 months (95% CI: 8.9, 17.9). The one-year survival rate for patients was 48%.

http://www.w3.org/1999/xhtml">Furthermore, levels of secreted protein acidic and rich in crysteine (SPARC) were evaluated in 36 patients. These patients were classified as either “high-SPARC (average z-score ≥0, n=19) or “low-SPARC (average z-score <0, n=17). According to the study, a significant increase in OS was observed for patients in the high-SPARC group versus the low-SPARC group (median 17.8 vs. 8.1 months, p=0.0431). SPARC level remained a significant predictor of OS in a multivariate Cox regression model after adjusting for multiple clinical covariates including gender, race, age, treatment and baseline CA19-9 level (p=0.041). Of note, SPARC in the stroma correlated highly with OS (p=0.013), while SPARC in the tumor cells did not (p=0.15). This is particularly intriguing as SPARC expression in the stroma, but not in the tumor, has been associated with poor survival, suggesting that a unique mechanism of action of ABRAXANE may play a role in this reverse outcome.

The most common DLTs in the first phase of the study were sepsis and neutropenia. During the second phase, the most common grade 3 or higher ABRAXANE-related non-hematologic adverse events were fatigue (21%) and sensory neuropathy (15%). The most common grade 3 or higher treatment-related hematologic adverse events were neutropenia (67%), leukopenia (44%) and thrombocytopenia (23%).

These data are being confirmed in an ongoing, international, randomized phase III trial of Abraxane + gemcitabine vs. gemcitabine for patients with metastatic pancreatic cancer. 

These data are reported from an investigational study. ABRAXANE is not approved as a treatment for previously untreated advanced pancreatic cancer.

Source: Celgene International Sàrl