ASCO 2011

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The results of the Phase 3, placebo-controlled SUCCEED trial, which evaluated the oral mTOR inhibitor ridaforolimus as maintenance therapy in advanced sarcoma patients following clinical benefit from prior standard cytotoxic chemotherapy, have shown that the primary endpoint of progression-free survival has been met to maintain the benefit of prior chemotherapy, as reported at the American Society of Clinical Oncology’s 2011 Annual Meeting.

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In the RADIANT-3 trial, the largest randomized, double-blind, placebo-controlled, Phase 3 trial in patients with advanced pancreatic neuroendocrine tumors, everolimus demonstrated a statistically and clinically significant median improvement in progression-free survival and significant reductions in tumor and secretory biomarkers, according to data presented at the American Society of Clinical Oncology’s 2011 Annual Meeting.

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Regorafenib, a novel oral kinase inhibitor that has demonstrated a broad spectrum of antitumor activity in preclinical and early phase trials, showed clinical benefit in patients with advanced gastrointestinal stromal tumors (GIST) after prior therapy with imatinib or sunitinib failed, as reported at the American Society of Clinical Oncology’s 2011 Annual Meeting.

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Although the response rate was significantly improved, second-line treatment with amrubicin, a third-generation anthracycline and topoisomerase II inhibitor, missed the primary endpoint of significantly improving overall survival over topotecan in the Phase 3 open-label ACT-1 trial to treat small cell lung cancer, according to results presented at the American Society of Clinical Oncology’s 2011 Annual Meeting.

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The addition of iniparib to gemcitabine/carboplatin did not meet prespecified criteria for significance for co-primary endpoints of overall survival and progression-free survival in patients with metastatic triple-negative breast cancer, according to results of a study presented at the American Society of Clinical Oncology’s 2011 Annual Meeting.