Nektar reports etirinotecan pegol Phase 2 study results in patients with Avastin-refractory high-grade glioma
Published on June 2, 2014 at 7:26 AM
Nektar Therapeutics (NASDAQ: NKTR) announced today 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.
"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 August 2012 to May 2013. Patients had a median KPS of 70 and had received a median of three lines of prior therapy, including recurrence following treatment with Avastin. Avastin-refractory was defined as progression by RANO criteria within 60 days of prior Avastin (bevacizumab) treatment. Ninety percent of patients in the trial had glioblastoma. Patients received a median of three cycles (1-22) of NKTR-102 once every three weeks as monotherapy. Six-week progression-free survival in at least 25% of the patients was needed to reject the null hypothesis for the primary endpoint.