Synta Pharmaceuticals Corp., a biopharmaceutical company focused on research, development and commercialization of novel oncology medicines, recently announced that the company has decided to cease its Phase 3 GALAXY-2 trial of docetaxel and ganetespib as a second-line therapy for patients with a diagnosis of advanced non-small cell lung adenocarcinoma.
Based on the assessment of a previous planned interim analysis, the trial’s Independent Data Monitoring Committee (IDMC) determined that adding ganetespib to docetaxel is unlikely to prove a statistically significant increase in the study’s primary outcome of overall survival in comparison with docetaxel alone. The IDMC noted that the ganetespib plus docetaxel combination was generally well accepted by patients, and the experience of adverse events in GALAXY-2, a Phase 3 multi-center, global, randomized trial, was similar to that seen in previous trials where these drug agents were examined together.
Upon official acceptance of the IDMC’s advice, the company will communicate with regulatory authorities and notify researchers that treatment with the drug ganetespib should be ceased in the GALAXY-2 study.
“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 Chief Executive Officer of Synta, in a press release. “We thank the patients, caregivers and investigators who participated in GALAXY-2.”
The company will continue enrollment in four supplementary multi-center, randomized, large, investigator-sponsored trials, including: the GANNET53 study of paclitaxel and ganetespib in patients with a diagnosis of an ovarian cancer; the AML LI-1 study of ganetespib plus low dose cytarabine (Ara-C) in patients with a diagnosis of acute myeloid leukemia (AML) as well as patients with high-risk myelodysplastic syndrome (MDS); the AML18 study of ganetespib combined with standard DA (daunorubicin and Ara-C) in patients with AML and in patients with high-risk MDS; and the I-SPY 2 study of ganetespib combined with typical chemotherapy in women with a recent diagnosis of locally advanced breast cancer.
“Pending discussions with the relevant investigators, we will continue to support ongoing investigator-sponsored studies while we determine the appropriate path forward for ganetespib,” Mr. Schor added. “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.”
Non-small-cell lung carcinoma (NSCLC) is any type of epithelial lung cancer other than small cell lung carcinoma (SCLC). As a class, NSCLCs are relatively insensitive to chemotherapy, compared to small cell carcinoma. When possible, they are primarily treated by surgical resection with curative intent, although chemotherapy is increasingly being used both pre-operatively (neoadjuvant chemotherapy) and post-operatively (adjuvant chemotherapy).
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