BioCentury
ARTICLE | Clinical News

Panobinostat: Additional Phase III data

June 2, 2014 7:00 AM UTC

Additional data from the double-blind, international Phase III PANORAMA-1 trial in 768 patients with relapsed or relapsed and refractory MM showed that thrice-weekly 20 mg oral panobinostat plus Velcade bortezomib and dexamethasone led to a median PFS, the primary endpoint, of 12 months vs. 8.1 months for placebo plus Velcade and dexamethasone (HR=0.63, 95% CI: 0.52, 0.76, p<0.0001). On secondary endpoints, panobinostat plus Velcade and dexamethasone led to an ORR of 61% vs. 55% for placebo plus Velcade and dexamethasone; an nCR/CR rate of 28% vs. 16% for placebo plus Velcade and dexamethasone; and a duration of response of 13.1 months vs. 10.9 months for placebo plus Velcade and dexamethasone. OS data are not yet mature. Data were presented at the American Society of Clinical Oncology meeting in Chicago. Novartis previously reported that panobinostat plus Velcade and dexamethasone met the primary endpoint (see BioCentury, Dec. 9, 2013). ...