Results of Halaven Phase III study in metastatic breast cancer presented at 2012 CTRC-AACR SABCS

Eisai Inc.Dec 7 2012

Results from the first large, global Phase III study of Halaven^® (eribulin mesylate) Injection in patients with early-stage metastatic breast cancer were presented today during the 2012 CTRC-AACR San Antonio Breast Cancer Symposium. 

The 1,102-patient, open-label, multi-center study compared Halaven versus capecitabine (Xeloda^®) in women with locally advanced or metastatic breast cancer. The majority of the patients received study treatment as their first or second-line chemotherapy for metastatic disease, a different population than what was studied for FDA approval.

The study did not meet the co-primary endpoints for overall survival or progression-free survival. However, the data showed a trend toward improved overall survival in patients treated with Halaven with a median survival of 15.9 months versus 14.5 months with capecitabine (HR 0.879; 95% CI 0.770, 1.003).

Additionally, pre-specified exploratory subgroup analyses suggested a potential overall survival advantage for Halaven over capecitabine in certain patient populations based on receptor status. Further study is warranted.

Adverse events (AEs) were consistent with the known side-effect profiles of both drugs. The most common AEs for eribulin and capecitabine (> 20% all grades) were neutropenia (54.2% vs. 15.9%), hand-foot syndrome (0.2% vs. 45.1%), alopecia (34.6% vs. 4.0%), leukopenia (31.4% vs. 10.4%), diarrhea (14.3 vs. 28.8%) and nausea (22.2% vs. 24.4%), respectively.

"Though the study did not reach the statistical threshold required to prove superiority compared to capecitabine – a commonly used treatment in earlier lines of metastatic breast cancer – trends observed in certain patient populations that were treated with Halaven merit additional research, especially considering the unmet need in metastatic breast cancer," said Peter A. Kaufman, MD, one of the lead investigators of the study and Associate Professor of Medicine, Geisel School of Medicine at Dartmouth and an oncologist and hematologist at the Norris Cotton Cancer Center in Lebanon, New Hampshire.