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 November 2009, the Company reported 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. While the data analysis showed that the study did not meet its primary endpoint of overall survival, the data suggest a potential trend toward a survival advantage in SCLC patients treated with picoplatin and best supportive care compared to best supportive care alone. An imbalance in the use of post-study chemotherapy was observed in favor or patients who received best supportive care alone compared to patients who received picoplatin plus best supportive care, and we believe that this may have been a significant factor contributing to the trial outcome. The intent-to-treat analysis was based on 321 patient deaths and showed a hazard ratio of 0.82 and a p value of 0.089.
The company is pursuing a process with the Food and Drug Administration to determine if there is a regulatory path forward for picoplatin in small cell lung cancer.
1American Cancer Society, Detailed Guide: Lung Cancer - Small Cell 2009, IntrinsiQ 2008
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