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"These updated Phase 2 data are consistent with earlier studies ofpicoplatin in this difficult-to-treat patient population and compare favorablywith the median survival for the entire population of relapsed patients whoreceive other second-line chemotherapy," said Jerry McMahon, Ph.D., chairmanand CEO of Poniard. "These results are promising because patients withplatinum-resistant and -refractory small cell lung cancer have very limitedtreatment options. They typically experience rapid disease progression andlow overall survival following treatment with existing chemotherapies, whichhave significant toxicities."
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The updated picoplatin Phase 2 data were presented during a posterdiscussion session at the International Association for the Study of LungCancer's (IASLC) 12th World Conference on Lung Cancer in Seoul, Korea.
Additional Phase 2 Study Findings
In addition to the overall and one-year survival findings, the updatedanalysis of results from the open-label, multi-center Phase 2 trial showedthat the disease control rate was 48.1 percent in the 77 evaluable patients.This is similar to that observed with currently available treatments, but witha more manageable side effect profile and less frequent administration. Atthe time of the updated analysis, 63 patients had died from diseaseprogression. The most common side effects were hematologic and includedthrombocytopenia, anemia and neutropenia. No grade 3 or 4 neurotoxicity ornephrotoxicity and no treatment-related deaths occurred.
Pivotal Phase 3 SPEAR Trial Design
Poniard's ongoing international, multi-center, randomized, controlledSPEAR trial is comparing picoplatin plus best supportive care to bestsupportive care alone to evaluate the efficacy of picoplatin after relapse.Best supportive care includes care and treatment to optimize the comfort ofpatients and their ability to function, as well as to minimize the sideeffects of palliative cancer treatments. The primary efficacy endpoint isoverall survival, with overall response rates, progression-free survival anddisease control also being evaluated. The trial, which is enrolling patientswho are refractory to, or who have progressed within six months of completing,treatment with first-line platinum chemotherapy (cisplatin or carboplatin), isbeing conducted at clinical sites in Europe and India.
"Since the initiation of the SPEAR trial in the second quarter of 2007, wehave made significant progress in open
