Nektar Reports etirinotecan pegol Phase 2 study results in patients with high grade glioma Avastin refractory -
Nektar Therapeutics (NASDAQ: NKTR) announced today new data from a phase 2 investigator-sponsored by NKTR-102 (etirinotecan pegol) in high quality glioma patients refractory Avastin conducted at Stanford cancer Institute under the direction of Lawrence Recht, MD, professor of neurology and neurosurgery, with co-investigator Seema Nagpal, MD, clinical assistant professor of neurology and neurological sciences, Stanford School of Medicine.
"Patients with high quality refractory Avastin glioma currently have little or no treatment options to help them manage their disease," said Dr. Recht.. "Patients progressing rapidly once resistance develops, objective answers are rarely seen in this study, we have seen three patients - 15%, all with glioblastoma - with partial responses confirmed on one NKTR-102 agent according to Rano criteria and eight additional patients - 40% -. who had stable disease as best response "
The trial enrolled 20 patients with high-grade glioma from August 2012 to May 2013. The patients had a median KPS of 70 and had received a median three lines of prior therapy including recurrence after treatment with Avastin. Avastin refractory was defined as progression by Rano criteria within 60 days of Avastin (bevacizumab) prior treatment. Ninety percent of patients in the test had glioblastoma. patients received a median of three cycles (1-22) for NKTR-102 once every three weeks as monotherapy. Six weeks of progression-free survival in at least 25% of patients was needed to reject the null hypothesis for the primary endpoint.
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