Poniard Announces Final Data From Phase 3 SPEAR Trial Of Picoplatin In Small Cell Lung Cancer
SOUTH SAN FRANCISCO, June 5 /PRNewswire-FirstCall/ -- Poniard Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical company focused on innovative oncology therapies, today announced the full efficacy and safety data from its Phase 3 SPEAR (Study of Picoplatin Efficacy After Relapse) trial of picoplatin in the second-line treatment of small cell lung cancer (SCLC). Dr. Tudor Eliade Ciuleanu, M.D., Ph.D., of Institute of Oncology, Cluj-Napoca, Romania and an investigator for the SPEAR trial, presented the data during an oral session at the American Society of Clinical Oncology (ASCO) 2010 Annual Meeting in Chicago, IL.
"Results from this important study show that picoplatin is an active compound, with a demonstrated survival benefit among patients where the use of post-study chemotherapy between treatment arms was balanced," stated Dr. Ciuleanu. "These data include a number of significant outcomes, including improved overall survival among those individuals who did not receive post-study chemotherapy, the study's principal confounding factor, and among early relapsing or platinum refractory patients, a clinically meaningful population. Further, picoplatin exhibits a manageable safety profile consistent with prior clinical experience. These results warrant further investigation in this indication."
"The SPEAR trial provides valuable insight into picoplatin's potential as an effective new treatment option for the vastly underserved early relapsing or platinum refractory SCLC patient population," said Ronald A. Martell, chief executive officer of Poniard Pharmaceuticals. "These results are encouraging, both for Poniard and the oncologists addressing this difficult to treat disease. We continue to work toward establishing a path forward for picoplatin in this indication, as well as in other solid tumors where picoplatin has produced meaningful safety and efficacy data."
SPEAR Trial DesignThe international, multi-center, randomized, controlled Phase 3 SPEAR trial, one of the largest SCLC studies ever conducted, evaluated the efficacy and safety of picoplatin in 401 patients with SCLC who were refractory to or who progressed within six months of first-line platinum-based therapy. Picoplatin administered as an intravenous infusion once every three weeks plus best supportive care (BSC) was compared to BSC alone. BSC was designed in accordance with the National Comprehensive Cancer Network's guidelines. The primary endpoint of the trial was overall survival. Other endpoints included disease control rate, time to progression and progression-free survival (PFS). The trial was powered at 90 percent to show a 33 percent reduction in risk of death for picoplatin treatment plus BSC compared with BSC alone (hazard ratio of 0.67; p value of 0.05).
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