Belinostat: Phase II data
Top-line data from the open-label, international Phase II PXD101-CLN-17 in 89 patients with previously untreated CUP showed that belinostat plus carboplatin and paclitaxel missed the primary endpoint of PFS vs. carboplatin and paclitaxel alone (5.4 vs. 5.3 months, p=0.5526). Belinostat plus chemotherapy did meet the secondary endpoint of improving ORR vs. chemotherapy alone (43.2% vs. 22.2%, p=0.0252), but non-significantly improved OS (p=0.2906). Topotarget did say that evaluation of the OS endpoint indicated a separation of the survival curves after about 8 months with a benefit for the belinostat arm. The combination was generally well tolerated. Patients received carboplatin and paclitaxel with or without 1,000 mg/m 2 IV belinostat on days 1-3 and 2,000 mg oral belinostat on days 4 and 5 of a 21-day cycle for up to 6 cycles. Topotarget said it is still analyzing the data and has not yet determined next steps. ...