Small Cell Lung Cancer (SCLC) SCLC is the most aggressive form of lung cancer and tends to be widespread by the time of diagnosis. According to the American Cancer Society, SCLC accounts for about 10 to 15 percent of all lung cancers. An estimated 32,000 new cases of SCLC were expected to be diagnosed in the United States in 2009, and 52,000 SCLC patients were projected to be treated in the United States in 2008.1 The prognosis for patients with SCLC that have progressed despite chemotherapy is exceedingly poor. Effective second-line treatment for SCLC is a major unmet need. There is no standard chemotherapy for SCLC patients that do not respond to initial platinum-based treatment. In June 2010, the Company reported full results from the Phase 3 SPEAR (Study of Picoplatin Efficacy After Relapse) trial, which enrolled 401 patients and evaluated intravenous picoplatin in patients who were refractory to, or who progressed within six months following initial treatment with a platinum-based therapy. The data analysis showed a statistically significant difference in favor of the picoplatin arm for progression free survival (PFS) in the intent-to-treat population, with a PFS of 9.0 weeks compared to 6.6 weeks in the best supportive care (BSC) alone arm (p-value=0.0281; Hazard Ratio=0.783). There was a statistically significant difference in favor of the picoplatin arm for time to progression in the intent-to-treat population, with a median time to progression of 11.3 weeks versus 6.7 weeks in the BSC alone arm (p-value=0.0002; Hazard Ratio=0.610). Overall survival in the intent-to-treat population, the primary endpoint of the study, which was based on 320 evaluable events, showed a median overall survival of 20.6 weeks in the picoplatin arm compared to 19.7 weeks in the BSC alone arm (p-value=0.0895, Hazard Ratio= 0.817). As previously reported, the primary endpoint of the study was not met, potentially due to an imbalance in the use of post-study chemotherapy between the picoplatin and BSC alone arms: 27.6 percent of patients in the picoplatin arm received post-study chemotherapy, compared to 40.6 percent in the BSC alone arm (p-value, 0.012). Among 273 patients that did not receive post-study chemotherapy, the picoplatin arm (n=194) demonstrated a statistically significant improvement in overall survival compared to the BSC alone arm (n=79). In this population, the picoplatin arm demonstrated a median survival of 18.3 weeks compared to 14.4 weeks in the BSC arm (p-value, 0.0345, Hazard Ratio=0.730). Among 294 patients who were refractory or relapsed within 45 days of first-line platinum-based therapy, the picoplatin arm (n=202) demonstrated a statistically significant improvement in overall survival as compared to the BSC alone arm (n=92). In this patient population, the picoplatin arm demonstrated a median overall survival of 21.3 weeks compared to 18.4 weeks in the BSC arm (p-value=0.0173, Hazard Ratio=0.717). In the SPEAR trial, picoplatin was well-tolerated and demonstrated a safety profile consistent with prior clinical experience. The most common adverse events were hematological, and included thrombocytopenia, anemia and neutropenia. These events were well managed without clinical sequelea. Adverse events associated with bleeding were mild and did not include any Grade 3/4 events. The incidence of neurotoxicity, a common adverse event among platinum agents, was low, with 0.8 percent of patients reporting grade 3 neuropathy and no incidences of grade 4 neuropathy. Based on the clinical activity picoplatin demonstrated in the SPEAR trial, Poniard, in collaboration with the FDA and its clinical advisory board, is developing a regulatory strategy for picoplatin in small cell lung cancer. More information on picoplatin in small cell lung cancer » 1American Cancer Society, Detailed Guide: Lung Cancer - Small Cell 2009, IntrinsiQ 2008