The Phase 3 trial will enroll approximately 500 adenocarcinoma patients and overall survival will be the primary endpoint. Based on results from the Phase 2b trial, the Phase 3 trial will exclude patients who experienced rapidly progressing disease, an estimated 30 to 40% of the total eligible population. The resulting population, which excludes rapidly progressing patients, showed a substantially enhanced survival difference between the ganetespib arm and the control arm in the Phase 2b trial as compared to the survival difference observed in the total population.Two event-driven interim analyses for the Phase 3 trial have been specified. Based on current projections and statistical assumptions, the Company expects these analyses, together with the final analysis, to occur in 2014. Additional elements of the Phase 3 trial design will be announced following the start of enrollment.
- A pre-specified interim analysis of the first 20 patients in the CHIARA trial, which evaluates ganetespib monotherapy in ALK+ NSCLC patients previously untreated with a direct ALK inhibitor, is expected to occur in the first half of 2013.
- An investigator-sponsored trial evaluating the combination of ganetespib plus crizotinib in patients with ALK+ NSCLC that have not been previously treated with an ALK inhibitor continues enrolling and treating patients at Memorial Sloan-Kettering Cancer Center.
- The first patient was treated in the ENCHANT trial, evaluating ganetespib monotherapy for the treatment of HER2 positive and triple negative metastatic breast cancer. The Company expects to report preliminary data from this trial in the first half of 2013.
- The first patient was treated with ganetespib in a randomized Phase 2/3 cooperative group study evaluating ganetespib plus low dose ara-C (LDAC) vs. LDAC alone for the treatment of elderly patients with acute myeloid leukemia (AML) who are unable to tolerate intensive chemotherapy. This “Less Intensive 1” (LI-1) study evaluates a number of treatments in this randomized setting. Additional information is available at http://www.controlled-trials.com/ISRCTN40571019.
- A European cooperative group plans to initiate a randomized trial comparing paclitaxel with and without ganetespib in patients with advanced ovarian cancer in 2013