CRLX101: Interim Phase Ib/IIa data

Interim data from 12 patients with metastatic RCC in a dose-escalation, U.S. Phase Ib/IIa trial showed that CRLX101 plus Avastin bevacizumab led to a median progression-free survival (PFS) rate of 7.6 months, which Cerulean said exceeded the pre-specified threshold and triggered enrollment of 10-15 patients in a dose-expansion second stage of the trial. In 9 evaluable patients, CRLX101 plus Avastin led to 3 partial responses plus 4 cases of stable disease. The recommended Phase II dose is 15 mg/m 2 CRLX101 every 2 weeks plus Avastin. The trial is being sponsored by the University of Pennsylvania Abramson Cancer Center. Data were presented at the American Society of Clinical Oncology meeting in Chicago. Cerulean previously reported that there were no treatment discontinuations or dose reductions in 9 evaluable patients who were treated at their maximum tolerated doses (MTDs) of CRLX101 plus Avastin in the trial (see BioCentury, Oct. 14, 2013). ...