Nektar Therapeutics (NKTR)

[surf1944]

1:38AM Nektar Therapeutics presents target-specific biomarkers being assessed in ongoing Phase 3 BEACON study of etirinotecan pegol for the treatment of metastatic breast cancer (NKTR) 9.47 : Co announces a series of target-specific biomarkers that are being evaluated in the development of etirinotecan pegol for the treatment of breast cancer. A series of assays for target-specific pharmacodynamic biomarkers for etirinotecan pegol, including the molecular target topoisomerase I, have been established and are being measured in the Phase 3 BEACON study. The biomarkers were identified from Circulating Tumor Cell samples which were collected prior to patient treatment. Additional CTC patient samples are being collected at regular intervals during treatment and at the end of treatment.

Preliminary results from the initial pre-dose samples found CTCs in over 90% of patient samples, with a median of 200 CTCs per 7.5 mL blood draw. Patient participation in the CTC sub-set of the BEACON study is projected to be over 75%. Measurements of each biomarker expression over time will be analyzed in order to identify potential predictive biomarkers for clinical response to etirinotecan pegol.