Poniard’s Phase 3 SPEAR Trial Reaches 320 Event Target

Poniard Pharmaceuticals (Poniard) has announced that 320 evaluable events (patient deaths) have occurred in its pivotal phase 3 SPEAR trial. The trial is being conducted in accordance with a Special Protocol Assessment (SPA) with the FDA, evaluating picoplatin in the treatment of small cell lung cancer (SCLC).

The multi-center, randomised, controlled phase 3 SPEAR trial is evaluating the efficacy and safety of picoplatin as second-line therapy in 401 cancer patients with SCLC who have not responded to or who relapsed following first-line platinum-based therapy.

The SPEAR trial randomised patients with SCLC who were refractory to prior platinum-containing, first-line chemotherapy regimens or who had progressed within six months of first-line therapy. Picoplatin administered as an intravenous infusion once every three weeks plus BSC was compared to BSC alone.

Jerry McMahon, chairman and CEO of Poniard, said: “The 320th event in our pivotal registration SPEAR trial was defined in our SPA with the FDA to enable the company to begin final analysis of data. Our goal is to complete and report the results of our preliminary analysis in the fourth quarter of 2009 and, if positive, initiate the rolling New Drug Application filing process for picoplatin by year-end under the Fast Track designation previously granted by the FDA.

“The SPA helps ensure that the design and clinical endpoints of our randomised trial and our planned analysis of the study are aligned with the FDA to support submission of an NDA.”