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Synta presents ganetespib Phase 2 trial results in advanced non-small cell lung cancer at ASCO 2011

April 09, 2017

Of the 76 evaluable patients, 14 were in cohort A (EGFR mutation), 13 were in cohort B (KRAS mutation), and 48 were in cohorts C and D (neither EGFR nor KRAS mutation). 23 of 48 evaluable patients in cohorts C and D were subsequently tested for ALK translocation or rearrangement, in up to three separate assays.

Of the 23 patients tested for ALK translocation or rearrangement (ALK+), 8 patients were ALK+ in at least one assay. Six of these eight patients (75%) showed tumor shrinkage in target lesions, one patient showed no change in tumor size, and one patient achieved stable disease (tumor growth <20%). The disease control rate in this population was 7/8 (88%), and the objective response rate (CR+PR) was 4/8 (50%).

In cohorts C and D, wild type for EGFR and KRAS, tumor shrinkage in target lesions was seen in 15/48 (31%). The stable disease rate per RECIST was 24/48 (50%), the objective response rate was 4/48 (8%), and the disease control rate was 28/48 (58%).

Of the 13 evaluable patients in cohort B, with KRAS mutation, eight patients experienced tumor shrinkage in target lesions (62%). The stable disease rate per RECIST was 5/13 (38%). The overall disease control rate was 38%.

Of the 14 evaluable patients in Cohort A, with EGFR mutation, five patients experienced tumor shrinkage (36%). The stable disease rate per RECIST was 7/14 (50%). The overall disease control rate was 50%.

In total, of the 76 evaluable patients, the overall disease control rate at 8 weeks was 54% and the overall objective response rate was 5.3%.

The most common adverse events were diarrhea, fatigue and nausea. In a total of 96 patients treated, the most common adverse events grade 3 or higher occurring in more than 5% of patients were dyspnoea in 12 patients (12.5%), fatigue in 12 patients (12.5%) , diarrhea in 9 patients (9.4%) and hyponatraemia in 5 patients (5.2%). The most common adverse events were diarrhea in 75 patients (78.1%), fatigue in 48 patients (50%), nausea in 37 patients (38.5%) and decreased appetite in 32 patients (33.3%).

Source: Synta Pharmaceuticals Corp.