Ganetespib: Phase II/III ongoing
Synta said investigators at Cardiff University advanced the ganetespib plus low-dose cytarabine arm into the Phase III portion of the open-label, international Phase II/III AML Less Intensive (LI-1) trial in patients ages >60 years with AML or high-risk MDS. The trial is also comparing other treatments with or without cytarabine. Advancement into the Phase III portion was based on an interim analysis of complete response data from 50 patients who received ganetespib plus cytarabine in the Phase II portion. The Phase III portion will enroll about 200 patients each in the ganetespib plus cytarabine and cytarabine alone arms and will include an interim futility analysis.
AML LI-1 may add other therapies as they become available and is already evaluating quizartinib ( AC220) from Ambit Biosciences Corp. (NASDAQ:AMBI, San Diego, Calif.); tosedostat from CTI Biopharma Corp. (NASDAQ:CTIC; Milan:CTIC, Seattle, Wash.); and selinexor ( KPT-330) from Karyopharm Therapeutics Inc. (NASDAQ:KPTI, Natick, Mass.). The National Cancer Research Institute Hematological Oncology Study Group is conducting the trial. ...