Successful tnAcity trial of Abraxane (paclitaxel protein-bound particles for injectable suspension) + carboplatin for triple negative breast cancer. Celgene
Celgene Corporation announced that the results of its randomized phase II tnAcity trial of Abraxane for injectable suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) will be presented at the 2016 San Antonio Breast Cancer Symposium (SABCS) December 6-10, 2016.
The trial found that an investigational weekly combination regimen of Abraxane + carboplatin had significantly longer progression-free survival (PFS) (7.4 months) compared to weekly regimens of either Abraxane + gemcitabine (5.4 months) or of carboplatin + gemcitabine (6.0 months) as first-line treatment of patients with metastatic triple-negative breast cancer (mTNBC).
The phase II trial randomized 191 women with mTNBC to receive one of three weekly regimens (dosed 2 out of 3 weeks): Abraxane + carboplatin, Abraxane + gemcitabine, or carboplatin + gemcitabine as first-line treatment. The study findings demonstrated that Abraxane + carboplatin resulted in significantly longer PFS (7.4 months) than combination regimens with Abraxane + gemcitabine (5.4 months; P=0.02, HR 0.60 (95% CI, 0.39-0.93)) or carboplatin + gemcitabine (6.0 months; P= 0.03, HR 0.61 (95% CI, 0.39-0.94)). tnAcity also found that those treated with the Abraxane + carboplatin regimen experienced a longer median treatment duration (25 weeks) than those treated with Abraxane + gemcitabine (18.1 weeks) or carboplatin + gemcitabine (20.1 weeks).
After taking into consideration the rapidly changing breast cancer treatment landscape, which has a significant focus on immuno-oncology treatments, Celgene had determined not to move forward with the phase III portion of tnAcity. The Company will instead focus its breast cancer research support on Abraxane/Immunotherapy combinations and remains committed to applying the findings of tnAcity to ongoing and future research of Abraxane in breast cancer for patients with high unmet needs.
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