Ganetespib fails Phase III trial for treatment of NSCLC- Synta Pharma

Synta Pharmaceuticals has announced that it has decided to terminate the Phase III GALAXY-2 trial of ganetespib and docetaxel in the second-line treatment of patients with advanced non-small cell lung adenocarcinoma. Based on the review of a pre-planned interim analysis, the study’s independent data monitoring committee concluded that the addition of ganetespib to docetaxel is unlikely to demonstrate a statistically significant improvement in the primary endpoint of overall survival compared to docetaxel alone.

The committee noted that the combination of ganetespib and docetaxel was generally well tolerated in the study, with an adverse event profile consistent with previous studies combining these agents. GALAXY-2 is a Phase III global, randomised, multi-centre trial. Synta continues to support enrolment in four additional large, randomised, multi-centre investigator-sponsored studies:

• the GANNET 53 trial of ganetespib and paclitaxel in ovarian cancer
• the AML LI-1 trial of ganetespib with low dose cytarabine (Ara-C) in acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS)
• the AML 18 trial of ganetespib with standard DA (daunorubicin and Ara-C) in AML and high-risk MDS
• the I-SPY 2 TRIAL of ganetespib and standard chemotherapy in women with newly diagnosed, locally advanced breast cancer