Summary of key GALAXY-1 one-year follow-up findings being presented at the WCLC Meeting
A detailed presentation of the one-year follow-up analysis results may be found on the home page of the Company’s website, www.syntapharma.com. Key findings include:
- 65% of overall survival (OS) events in the primary adenocarcinoma population have occurred.
- Targeting at least 70% of OS events for final analysis, expected by early 2014.
- Consistent with previously reported results, encouraging OS improvements were observed in the prespecified chemosensitive patient population (diagnosis of advanced disease greater than 6 months; N=178), together with a lack of activity in the refractory population. These results continue to confirm the selection of the chemosensitive patient population for the GALAXY-2 Phase 3 trial.
- Overall survival Hazard Ratio in the chemosensitive population was 0.75 (90% CI 0.56, 1.03; 1-sided p=0.065) and 0.72 (90% C.I. 0.52, 0.98; 1-sided p=0.040) in the Cox proportional hazards univariate (unadjusted) and multivariate (adjusted) models, respectively. Median overall survival was 10.7 months for ganetespib and docetaxel versus 7.4 months for docetaxel alone.
- The trial evaluates two other potential biomarkers for use in selecting patients for the Phase 3 trial, elevated LDH (eLDH) and mutant KRAS (mKRAS). The eLDH population continued to show promising PFS and OS improvements, consistent with the hypothesis of HIF-1alpha inhibition by ganetespib, and LDH as a marker for upregulated HIF-1alpha. No evidence for enhanced activity in the mKRAS population was observed.
- Certain differences in enrollment and treatment patterns across centers, which can confound large, global studies, were observed in GALAXY-1. These observations have allowed for further optimization of the GALAXY-2 Phase 3 trial.
“We are encouraged by these results and the implications for Phase 3,” said Dr. Vojo Vukovic, Chief Medical Officer, Synta. “In addition to confirmation of the choice of patient selection, the results give us useful information for optimizing the GALAXY-2 operational plan and statistical assumptions.”