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The Cancer Letter Inc.
PO Box 9905
Washington
DC 20016
Tel: 202-362-1809
Fax: 202-379-1787
publication date: Oct 1, 2015
September 2015 PDF



 

Lung Cancer

Avastin Biosimilar Meets Phase III Endpoints, Demonstrating Clinical Equivalence

Amgen 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 Tumors

Afinitor Extends PFS by 7.1 Months in Gastrointestinal and Lung NETs

Novartis 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 Cancer

Additional Analyses Show Custirsen Lowered Serum Clusterin Levels in CRPC Patients

OncoGenex 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 Malignancies

    Two NEJM Papers Evaluate Imetelstat in Myelofibrosis and Essential Thrombocythemia

     

    Bladder Cancer

    Cyramza Increases PFS In Phase II Study of Patients Who Failed Platinum Therapy

     

    NCI CTEP-Approved Trials For the Month of September

     

    Drugs and Targets

    • FDA Approves Varubi for CINV
    • FDA Grants Priority Review for MCNA in invasive bladder cancer
    • FDA Grants Priority Review to Kyprolis in relapsed multiple myeloma

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