Nektar
Therapeutics NKTR today presented biomarker data from a sub-study of
the Phase 3 BEACON study of etirinotecan pegol (NKTR-102) which collected and
analyzed circulating tumor cell (CTC) samples from patients in the study. A
total of 80% of the 852 patients enrolled in the BEACON trial participated in
the CTC sub-study. Among the 627 patients who participated and had evaluable
baseline samples, CTCs were detected in 97% of these samples.
For the 611 evaluable baseline patient samples which yielded CTCs, potential
NKTR-102 target-specific pharmacodynamic biomarkers (Top1, Top2, and Ki67)
were detected in the majority of samples. The pharmacodynamic biomarkers
assessed in the CTC sub-study were chosen because of their potential ability
to predict response to topoisomerase 1 inhibition as well as to measure
chemo-sensitivity in metastatic cancer patients.^1,2,3,4
"We were encouraged to find that the CTC sub-study confirmed the presence of
several potential target-specific pharmacodynamic biomarkers, such as
topoisomerase 1, in the patients enrolled in our study," said Ivan Gergel, MD,
senior vice president drug development and chief medical officer of Nektar
Therapeutics. "The analysis from the BEACON CTC sub-study could help us better
understand which additional patient populations would benefit from NKTR-102.
We expect topline results from the BEACON study to be available in the first
quarter of 2015."
The data were presented during the 2014 San Antonio Breast Cancer Symposium
(SABCS) in San Antonio.
NKTR-102 is the first long-acting topoisomerase 1 inhibitor with an extended
half-life and a unique molecular structure that is designed to concentrate the
drug in tumors. It is currently being evaluated in the Phase 3 BEACON (BrEAst
Cancer Outcomes with NKTR-102) study in patients with locally recurrent or
metastatic breast cancer who previously have been treated with anthracycline,
taxane or capecitabine (ATC). CTCs are cancer cells shed from either the
primary tumor or its metastases that circulate in the peripheral blood. CTCs
are emerging tumor biomarkers, collected through a minimally invasive blood
draw, providing a "liquid" biopsy sample and allowing for post-treatment
monitoring of patients.
Study Design and Results
In this CTC sub-study of the BEACON study, 7.5 mL whole blood samples from
patients were drawn and analyzed for the number of CTCs, the percent of cells
staining positive for a given biomarker, and the mean fluorescence intensity,
reflecting the normalized intensity of the specific biomarker in the biomarker
positive CTCs. Results showed that CTCs were detected in 97 percent of 627
evaluable baseline samples. The median number of CTCs per 7.5 mL blood draw
was 472, which permitted evaluation of biomarkers at baseline and over the
course of treatment.
Poster Presentation Details
Details of the NKTR-102 poster presentation follow.
o Poster Title: Etirinotecan Pegol (NKTR-102) Target-specific
Pharmacodynamic Biomarkers in Circulating Tumor Cells from Patients with
Metastatic Breast Cancer, Dr. Edith Perez, et al.
o Poster Number: P3-10-03
o Session Title/Track: Treatment: Advanced Chemotherapy
o Date and Time: Thursday, December 11, 2014, 5:00-7:00 p.m. Central Time,
o Location: Henry B. Gonzalez Convention Center, Exhibit Halls A-B
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