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news.Synta Pharmaceuticals has announced final results from the GALAXY-1 trial, a global, randomized, multi-center study designed to identify the patients with advanced non-small cell lung cancer (NSCLC) with adenocarcinoma histology most likely to benefit from second-line treatment with the company’s lead drug candidate, the Hsp90 inhibitor ganetespib, in combination with docetaxel versus docetaxel alone.
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Ganetespib is a next-generation inhibitor of the chaperone protein Hsp90, which is critical for the activation and stability of numerous proteins that drive cancer growth and proliferation. Ganetespib has been studied in over 1000 patients to date.
GALAXY-1 was designed to identify patient populations that are most responsive to treatment with the combination of ganetespib and docetaxel. Co-primary endpoints of the study were progression free survival (PFS) in patients with elevated LDH (eLDH) and PFS in patients with mutant KRAS (mKRAS).
Key secondary endpoints were overall survival (OS) and PFS in adenocarcinoma patients. Prespecified stratification factor analysis has shown that the chemosensitive patient population (defined as patients diagnosed with advanced NSCLC more than six months prior to study entry) derived the most benefit with combination treatment. This chemosensitive population was selected for the ongoing Phase III GALAXY-2 trial.
The safety profile of adenocarcinoma patients treated with the combination of ganetespib (G) and docetaxel (D) was favorable, consistent with previously reported results. The most common adverse events (AEs), all grades, were neutropenia (46% vs. 45%), diarrhea (50% vs. 17%) and fatigue (35% vs. 24%), for G+D (N=123) vs. D (N=126), respectively.
Diarrhea was effectively prevented or managed with standard supportive care; the incidence of grade 3 or 4 diarrhea was 4% (G+D) vs. 0 (D). Fatigue was predominantly grade 1 and grade 2; grade 3 or 4 fatigue was 6% (G+D) vs. 4% (D). The most common grade 3 or 4 AEs were neutropenia (41% vs. 42%), febrile neutropenia (9% vs. 5%), and leukopenia (10% vs. 6%).
Only one case of visual impairment was reported in this study, which was mild (Grade 1) and transient. The safety profile of patients in the chemosensitive population being evaluated in Phase 3 was comparable to the profile in the adenocarcinoma population.
Synta Chief Medical Officer Dr Vojo Vukovic noted that results from the final analysis of GALAXY-1 support the company’s selection of the chemosensitive patient population for study in the pivotal Phase 3 GALAXY-2 trial.
"This mature data set confirms that the improvements in progression-free survival and overall survival with ganetespib and docetaxel in chemosensitive patients are very encouraging," Dr Vukovic added.
Publication of the final data from GALAXY-1 is expected in the second half of 2014. A slide set summarizing these results can be found on the Synta website.