Cephalon Presents Encouraging Results of Obatoclax, in Extensive-Stage Small Cell Lung Cancer at ASCO Annual Meeting

Today, Cephalon CEPH presented new phase 2 data on an investigational compound, obatoclax, at the 47th Annual Meeting of the American Society of Clinical Oncology in Chicago, Ill. The data show that patients with extensive-stage small cell lung cancer receiving obatoclax in addition to standard chemotherapy demonstrated a trend toward improved overall response rate, progression-free survival and overall survival (OS) when compared to chemotherapy alone. This is the first presentation of solid tumor data for the Company following its acquisition of Gemin X in March 2011, which developed the drug. Obatoclax expands the Cephalon portfolio in oncology beyond hematologic malignancies. “Small cell lung cancer is a deadly and fast-growing tumor type. Approximately 65 percent of patients with this type of lung cancer have extensive disease at presentation and new approaches to treatment are needed,” said Lesley Russell, Chief Medical Officer at Cephalon. “The results of this study, suggest that obatoclax could be a new treatment option for patients if these treatment effects are replicated in a larger phase 3 study.” The phase 2 randomized open-label obatoclax study was conducted in 80 trial sites across 10 countries with 155 patients receiving treatment with carboplatin and etoposide (C/E) (n=78) or obatoclax in combination with C/E (n=77). The primary endpoint was ORR as defined by the Response Evaluation Criteria In Solid Tumors criteria. Secondary endpoints included PFS, survival at 12 months, OS and safety. Patients receiving obatoclax combination therapy experienced a 64.9 percent ORR (single-sided P=0.11) compared to 53.8 percent in those receiving C/E alone. Obatoclax combination therapy was associated with a median improvement in PFS from 5.4 to six months (HR=0.795, single-sided P=0.08) and an improvement in median OS from 9.8 to 10.5 months (HR=0.724, single-sided P=0.05) over C/E alone. For the sub-population of patients planned for the phase 3 study with a performance status of 0-1, the median OS was improved from 10 to 11.7 months (HR=0.711, single-sided P=0.05). Overall, obatoclax combination therapy was found to be generally well tolerated. Adverse events found more commonly in the obatoclax arm included transient central nervous system events (such as somnolence and euphoria) during obatoclax infusion, diarrhea and anorexia.