Obatoclax: Phase II data

An open-label, international Phase II trial in 155 patients showed that IV obatoclax plus carboplatin and etoposide missed the primary endpoint of significantly improving ORR vs. carboplatin and etoposide (64.9% vs. 53.8%, p=0.11). On secondary endpoints, Cephalon said obatoclax plus chemotherapy showed a trend for improved median PFS (6 vs. 5.4 months, p=0.08) and OS (10.5 vs. 9.8 months, p=0.05) vs. chemotherapy alone, but that the trial was not powered to detect statistical significance on these endpoints. The 12-month OS rate for obatoclax plus chemotherapy was 45.5% vs. 37.2% for chemotherapy alone (p=0.19).

In a subgroup of patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (n=141), obatoclax plus chemotherapy also missed the primary endpoint vs. chemotherapy alone (p=0.116), but did improve median OS (11.7 vs. 10 months, p=0.05). Obatoclax plus chemotherapy was generally well tolerated with transient CNS events during infusion, diarrhea and anorexia reported as adverse events found more commonly in the obatoclax arm. Patients received an IV infusion of obatoclax for 3 consecutive days as part of a 3-week cycle for up to 6 cycles as combination therapy, then alone as maintenance therapy. Data were presented at the American Society of Clinical Oncology meeting in Chicago. ...