Giotrif fails two Phase III trials for Breast Cancer- Boehringer
In the Phase III LUX-BREAST 1 study Giotrif (afatinib) plus vinorelbine (The Boehringer combination) showed a similar progression free survival and objective response rate and shorter overall survival compared to Herceptin (trastuzumab) and vinorelbine in HER-2 positive metastatic Breast Cancer patients after failure of prior Herceptin therapy.The Boehringer combination was less well tolerated with higher rates of treatment discontinuation.
In the Phase III LUX-BREAST 3 study in HER 2 positive Breast Cancer progressing with Brain Cancer metastases the Giotrif, Boehringer combination data after prior trastuzumab and/or lapatinib ( Tyver/Tykerb) based therapy showed no benefit for Giotrif or the Boehringer combination over investigators choice as measured by patient benefit at 12 weeks,progression free survival or overall survival.