Celgene announces ABRAXANE plus gemcitabine, bevacizumab phase II trial data on breast cancer

Celgene International Sàrl (Nasdaq:CELG) today announced that results from an investigator-initiated phase II study of ABRAXANE (paclitaxel albumin-bound particles for injectable suspension), gemcitabine and bevacizumab as first-line treatment in metastatic breast cancer were presented at the 2011 American Society of Clinical Oncology Annual Meeting in Chicago, IL.

In the study, patients eligible for first-line chemotherapy were given ABRAXANE (125 mg/m2), followed by gemcitabine (1000 mg/m2) on days 1 and 8, followed by bevacizumab (15 mg/kg) on day 1 of each 21 day cycle. Forty-eight patients were evaluable for the study.

At a median follow-up of 10.6 months, the 6-month progression free survival rate was 81% (95% CI; 67%-91%). Median PFS was 11.7 months (95% CI: 8.7-13.1) and the median overall survival rate had not been reached. The 12-month overall survival rate was 84% (95% CI: 73%-97%). The confirmed complete response (CR) plus partial response (PR) rate was 69%, with two patients achieving CR and 31 achieving PR. The median duration of response was 9.9 months (95% CI: 7.3-12.6).

Grade 3 and higher adverse events occurred in 90% of patients in the study, with myelosuppression being the major toxicity experienced (75% grade 3 or higher).

Source: Celgene International Sàrl

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