Celgene Corporation (NASDAQ:CELG) has recently unveiled the results from the randomized, Phase 2 tnAcity clinical trial evaluating Abraxane for injectable suspension as part of its presentation at the 2016 San Antonio Breast Cancer Symposium (SABCS) this week.
Phase 2 tnAcity Clinical Trial Results
The Phase 2 tnAcity clinical trial established that the investigational weekly combination of Abraxane and carboplatin as a first-line treatment for patients with metastatic triple negative breast cancer (mTNBC) had significantly improved progression-free survival (PFS) to 7.40 months compared to the weekly combination of either Abraxane and gemcitabine, which had demonstrated a PFS of 5.40 months; or carboplatin and gemcitabine, which had demonstrated a PFS of 6 months.
The Phase 2 tnAcity clinical trial has enrolled and randomized a total of 191 subjects.
Moving Forward?
“The findings of tnAcity are encouraging, illustrating that an ABRAXANE-containing regimen may have activity in a type of breast cancer with few viable treatments and these findings give researchers additional insight into how to treat metastatic triple negative breast cancer,” noted Michael Pehl, Celgene President of Hematology and Oncology.
Nonetheless, upon careful consideration of the rapidly changing nature of breast cancer treatments, Celgene has decided not to continue with a Phase 3 tnAcity clinical trial. Consequently, Abraxane is not directly nor indirectly indicated for the first-line treatment of mTNBC patients. It is currently indicated only for the treatment of breast cancer patients following the failure of combination chemotherapy for a metastatic condition or relapse within half a year of adjuvant chemotherapy.
With this, the company hopes to focus more on its breast cancer research support on Abraxane and other immunotherapy combinations. The encouraging results from the Phase 2 tnAcity clinical trial will play an important role in these future endeavors.
mTNBC is one of the most complicated cancer types. Patients with mTNBC have a huge, unmet demand for safe and efficient treatment options. Given this, Celgene believes that more extensive research work is required in order to meet the needs of these patients.
Celgene lost 4.03% on Wednesday, closing at $112.66.