So now let's get into product specifics. What it's like for tivozanib outside of RCC? The BATON-CRC (colorectal cancer) Phase II trial completed accrual of 252 patients earlier this year, and we expect to see results in the second half of next year.
This is a randomized 2:1 trial, comparing tivozanib plus FOLFOX to the standard of care of avastin plus FOLFOX in first-line colorectal cancer. In addition to the ITT analysis, there are multiple pre-specified biomarker-driven subgroups defined, consistent with our approach of identifying patients who may see a significant clinical benefit beyond that of the broader population.
The BATON-BC Phase II trial in triple negative breast cancer was initiated by AVEO late last year. This is 2:1 randomized trial of approximately 158 patients, comparing tivozanib plus paclitaxel to placebo paclitaxel. Triple negative breast cancer represents a significant unmet medical need, and the scientific rationale for the potential of tivozanib is based on the relatively high occurrence of hypoxia in ER/PR and HER2 negative breast cancer. The hypoxia signature identified using our Human Response Platform has the potential to be a predictive biomarker of tivozanib response.
"We expect both the colorectal and the breast cancer trials to read out by the latter part of 2014."
AV-203, our clinical stage ERBB3 inhibitory antibody candidate, is in Phase I development, with expansion cohorts in specific biomarker-defined patient populations to evaluate the preliminary efficacy in patients with advanced solid tumors. ERBB3 is believed to be an important biologic pathway for multiple solid tumors. We expect results from this biomarker-driven study in 2014. As a reminder, Biogen Idec has the option to develop and commercialize AV-203 for the territory outside of North America, option to be exercised upon demonstration of proof of concept. AVEO retains full rights within North America.
Ficlatuzumab, for which we have worldwide rights, is a potent hepatocyte growth factor inhibitory antibody that binds to the HGF ligand, with high affinity and specificity to inhibit the HGF/c-Met biological activities. Last year, we announced results from our Phase II trial in lung cancer, where activity was observed in certain patient subpopulations that require further analysis. We believe this signals merit for the investigation, and indeed, we have initiated discussions with multiple opinion leaders for further clinical studies of ficlatuzumab.