"Patients with Avastin-refractory high-grade glioma currently have little to no treatment options to help them manage their disease," said Dr. Recht. "Patients progress rapidly once resistance develops, objective responses are rarely seen. In this study we saw three patients - 15%, all with glioblastoma - with confirmed partial responses on single-agent NKTR-102 according to RANO criteria and an additional eight patients - 40% -- who had stable disease as a best response."
The trial enrolled 20 patients with high-grade glioma from
Study Results
The primary endpoint was met and exceeded with fifty-five percent (95% CI: 31%-75%) of patients in the study achieving six-week progression-free survival. Response and disease progression were assessed by RANO criteria in the trial. Three patients, or 15%, achieved partial responses with NKTR-102 monotherapy with maximum percent reductions in tumor area of 86%, 72%, and 59%. An additional eight patients, or 40%, achieved stable disease as best response. Two of the three patients with RANO responses experienced a long duration of response of 14 and 20 months. Secondary endpoints include median progression-free survival (2.2 months), median survival from time of first NKTR-102 infusion (4.5 months) and median overall survival from date of pathologic diagnosis or confirmation of high-grade glioma (17.1 months). NKTR-102 monotherapy was well-tolerated in patients
with Avastin-refractory high-grade glioma with low toxicity in spite of being heavily pre-treated and neurologically symptomatic. Only one patient (5%) had Grade 3 toxicity (diarrhea with dehydration) attributable to NKTR-102 as a result of not taking anti-diarrheal medication. Hematologic toxicity was mild. As of
"Though participants in this trial were heavily pre-treated and more neurologically symptomatic than many clinical trial patients, we observed low toxicity with three partial responses," said Dr. Nagpal. "In addition, two of the three patients with responses experienced a long duration of response of 14 and 20 months, respectively. These results warrant further investigation of NKTR-102 in high-grade glioma, including glioblastoma as single-agent and in combination with bevacizumab, which could theoretically enhance retention of NKTR-102 in the tumor."
The ASCO 2014 data presentation can be accessed at the link below:
http://www.nektar.com/pdf/pipeline/NKTR-102/NKTR-102_ASCO_Poster_2014.pdf
About High-Grade Gliomas
High-grade gliomas, including anaplastic astrocytomas, anaplastic oligodendrogliomas, and glioblastomas, are the most common and most aggressive primary brain tumors. Recurrence after initial therapy with temozolomide and radiation is nearly universal. Since
About NKTR-102 (etirinotecan pegol)
NKTR-102, a novel topoisomerase I inhibitor, is believed to penetrate the vasculature of the tumor environment more readily than normal vasculature, increasing the concentration of active drug within tumor tissue to enhance anti-tumor activity. The unique pharmacokinetic profile of NKTR-102 provides continuous exposure of active drug throughout the entire chemotherapy cycle, with reduced peak exposures that can be associated with toxicities. NKTR-102 is currently being evaluated in a pivotal Phase 3 clinical study in patients with advanced breast cancer (the BEACON study). In
About Nektar
Nektar's technology has enabled eight approved products in the U.S. or
Nektar is headquartered in
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Nektar Media Inquiries:
1. Chamberlain MC. Bevacizumab for recurrent malignant gliomas: efficacy, toxicity, and patterns of recurrence. Neurology. 2009; 72(8): 772-3; author reply 3-4.
DEFINITIONS:
RANO: Revised Assessment in Neuro-Oncology (RANO) criteria is used for assessing disease progression and treatment response in glioblastoma multiforme (GBM)
KPS: Karnofsky Performance Status Scale: A standard way of measuring the ability of cancer patients to perform ordinary tasks. The Karnofsky Performance scores range from 0 to 100. A higher score means the patient is better able to carry out daily activities. KPS may be used to determine a patient's prognosis, to measure changes in a patient's ability to function, or to decide if a patient could be included in a clinical trial.
Avastin is a registered trademark of
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