publication date: Aug. 4, 2016
- Aug. 4, 2016
July 2016PDF



Ovarian Cancer

Niraparib Demonstrates Prolonged PFS in Phase III Trial,
Achieving Primary Endpoint

Niraparib achieved its primary endpoint in a phase III ovarian cancer trial, demonstrating prolonged progression-free survival compared to placebo among patients who are germline BRCA mutation carriers; among patients who are not germline BRCA mutation carriers, but who have homologous recombination deficient tumors as determined by the Myriad myChoice HRD test; and overall in patients who are not germline BRCA mutation carriers.

The trial, NOVA, is a double-blind, international trial that enrolled more than 500 patients with recurrent ovarian cancer who were in a response to their most recent platinum-based chemotherapy. There is currently no therapy approved by FDA for maintenance treatment of patients with recurrent ovarian cancer following response to platinum, according to Tesaro Inc., niraparib’s sponsor. Niraparib is an oral, once-daily PARP inhibitor.


Breast Cancer

Phase III Trial Rules Out Inferiority of
Trastuzumab Biosimilar ABP 980

Amgen and Allergan plc announced results from a phase III study evaluating efficacy and safety of biosimilar ABP 980 compared with trastuzumab in patients with human epidermal growth factor receptor 2-positive early breast cancer.

ABP 980 is being developed as a biosimilar to trastuzumab, a recombinant DNA-derived humanized monoclonal immunoglobulin G1 kappa antibody which targets HER2. The active ingredient of ABP 980 is a humanized monoclonal antibody that has the same amino acid sequence as trastuzumab. ABP 980 has the same pharmaceutical dosage form and strength as trastuzumab in the U.S. and the European Union.


Drugs and Targets


Colorectal Cancer




NCI CTEP-Approved Trials For the Month of July

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