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June 1, 2014
16:17 EDTNKTRNektar announces new data from Phase 2 study of NKTR-102
Nektar Therapeutics announced new data from an investigator-sponsored Phase 2 study of NKTR-102, etirinotecan pegol, in patients with Avastin-refractory high-grade glioma conducted at Stanford Cancer Institute under the direction of Lawrence Recht, M.D., Professor of Neurology and Neurosurgery, with co-investigator Seema Nagpal, M.D., Clinical Assistant Professor of Neurology and Neurological Sciences, Stanford School of Medicine. The primary endpoint was met and exceeded with fifty-five percent 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, median survival from time of first NKTR-102 infusion and median overall survival from date of pathologic diagnosis or confirmation of high-grade glioma. 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 had Grade 3 toxicity attributable to NKTR-102 as a result of not taking anti-diarrheal medication. Hematologic toxicity was mild. As of May 31, there is one patient in the study who is continuing on NKTR-102 monotherapy.
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December 11, 2014
18:03 EDTNKTRNektar reports data from Phase 3 BEACON study of NKTR-102
Nektar Therapeutics 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 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 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 inhibition as well as to measure chemo-sensitivity in metastatic cancer patients
08:05 EDTNKTRFDA Pediatric Oncologic Subcommittee to hold a meeting
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December 9, 2014
08:02 EDTNKTRMoventig approved in EU for opioid-induced constipation
Nektar (NKTR) reported partner AstraZeneca (AZN) announced that MOVENTIG has been granted Marketing Authorisation by the European Commission for the treatment of opioid-induced constipation in adult patients who have had an inadequate response to laxative. MOVENTIG is the first once-daily oral peripherally-acting mu-opioid receptor antagonist to be approved in the European Union.
07:44 EDTNKTRAmerican Association for Cancer Research to hold a symposium
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