| September 2015 |
| Lung CancerAvastin Biosimilar Meets Phase III Endpoints, Demonstrating Clinical EquivalenceAmgen and Allergan plc. announced positive top-line results from Avastin biosimilar candidate ABP 215, which met its primary and secondary endpoints in a phase III trial in advanced non-squamous non-small cell lung cancer.ABP 215 is being developed as a biosimilar to Avastin, a recombinant immunoglobulin G1 monoclonal antibody that binds to vascular endothelial growth factor and inhibits the interaction of VEGF with its receptors, VEGF receptor-1 and VEGF receptor-2.The primary endpoint, objective response rate, was within the prespecified margin for ABP 215 compared to Avastin (bevacizumab), showing clinical equivalence. | |
| Neuroendocrine TumorsAfinitor Extends PFS by 7.1 Months in Gastrointestinal and Lung NETsNovartis announced results of a phase III study showing Afinitor (everolimus) tablets reduced the risk of progression by 52 percent (HR=0.48; 95% CI, 0.35-0.67; p<0.00001) compared to placebo in patients with advanced, progressive, nonfunctional neuroendocrine tumors of gastrointestinal or lung origin.The study, RADIANT-4, was presented at the European Cancer Congress in Vienna, Austria.Additionally, the data show Afinitor, a mammalian target of rapamycin (mTOR) inhibitor, extended median progression free survival by 7.1 months: median PFS by central review was 11.0 months (95% CI, 9.23-13.3) in the Afinitor arm and 3.9 months (95% CI, 3.58-7.43) in the placebo arm.Also: | |
| Prostate CancerAdditional Analyses Show Custirsen Lowered Serum Clusterin Levels in CRPC PatientsOncoGenex Pharmaceuticals Inc. presented results from additional exploratory analyses of the phase III SYNERGY trial, demonstrating that custirsen treatment significantly lowered serum clusterin levels from baseline in men with metastatic castrate-resistant prostate cancer.The data, presented at the 2015 European Cancer Congress in Vienna, Austria, showed that sCLU reductions after custirsen treatment resulted in higher two-year survival rates in patients who were at increased risk for poor outcomes. | |
| Myeloid MalignanciesTwo NEJM Papers Evaluate Imetelstat in Myelofibrosis and Essential Thrombocythemia | |
| Bladder CancerCyramza Increases PFS In Phase II Study of Patients Who Failed Platinum Therapy | |
| NCI CTEP-Approved Trials For the Month of September | |
Drugs and Targets
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