Synta announces termination for futility of ganetespib Phase III GALAXY-2 trial in lung cancer

IDMC concludes 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.

GALAXY-2 is a Phase III global, randomized, multi-center trial. Synta continues to support enrollment in four additional large, randomized, multi-center investigator-sponsored studies, including: the GANNET53 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 AML18 trial of ganetespib with standard DA (daunorubicin and Ara-C) in AML and high-risk MDS; and the I-SPY 2 TRIAL of ganetespib and standard chemotherapy in women with newly diagnosed, locally advanced breast cancer.

“This disappointing outcome underscores the challenges of treating lung cancer in the second-line setting and determining the precise population for whom ganetespib may be most effective,” said Chen Schor, President and CEO of Synta. “We thank the patients, caregivers and investigators who participated in GALAXY-2.”

Mr Schor continued: “Despite the outcome of this trial, and pending discussions with the relevant investigators, we will continue to support ongoing investigator-sponsored studies while we determine the appropriate path forward for ganetespib. We also look forward to advancing candidates from our HDC platform into the clinic. With the significant cash reserves we have in hand, our pipeline, our scientific internal leadership and network of advisors, we expect to undertake a comprehensive review of our strategy going forward.”

Upon formal acceptance of the IDMC’s recommendation, Synta will communicate with regulatory authorities, and will notify study investigators that treatment with ganetespib should be discontinued in the GALAXY-2 trial.