Obatoclax to enter Phase III despite Phase II miss
Cephalon Inc. (NASDAQ:CEPH) plans to begin Phase III testing of obatoclax in 1Q12 despite data showing that the product missed the primary endpoint in a Phase II trial in 155 patients with extensive-stage small cell lung cancer (SCLC). Obatoclax plus carboplatin and etoposide did not significantly improve overall response rate 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 progression-free survival (6 vs. 5.4 months, p=0.08) and overall survival (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.
In a group of 141 patients with an Eastern Cooperative Oncology Group (ECOG) performance status of zero or one, 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). Cephalon said the Phase III trial will only enroll those types of patients. Data were presented at the American Society of Clinical Oncology meeting in Chicago. ...