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Collaborations & Alliances, Trials & Filings

Three New Trials Planned for Synta’s Gentespib

Will test against AML, MDS

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Synta Pharmaceuticals has planned or already begun three new multicenter, randomized trials, supported by the Leukemia & Lymphoma Research Fund and Cancer Research UK, to evaluate ganetespib in combination with chemotherapy in first-line treatment of patients with Acute Myeloid Leukemia (AML) and High Risk Myelodysplastic Syndrome (MDS). The trials are being conducted under the UK National Cancer Institute (NCRI) Haematological Oncology Study Group with investigators in Denmark, France, New Zealand, and the UK, under the sponsorship of Cardiff University.
 
Ganetespib, Synta’s lead anti-cancer drug candidate, inhibits the heat shock protein 90 (Hsp90) chaperone protein and is being studied in more than 25 clinical trials, including an ongoing Phase III trial in advanced non-small cell lung cancer. Preclinical results showed that ganetespib inhibits a number of cancer-promoting factors believed to contribute to the proliferation of leukemic cells and renders them more vulnerable to treatment with chemotherapy. 
 
The three new trials are: 
 
  • AML-LI (less intensive)-1: ongoing, to evaluate the combination of ganetespib with low-dose cytarabine (Ara-C) vs. low-dose Ara-C alone in patients who are not eligible for intensive chemotherapy and are traditionally not included in most trials. As many as 50 patients will be enrolled in the ganetespib arm, after which an interim analysis will be conducted to evaluate the potential of proceeding into a potentially registration-enabling extension. This interim analysis is expected to be conducted later in 2014.
  • AML-18: expected to begin enrolling patients 1H14, will evaluate ganetespib with standard DA (daunorubin and Ara-C) in patients 60 years old and older who can tolerate intensive chemotherapy vs. treatment with standard DA alone. As many as 200 patients are expected to be enrolled in the ganetespib arm. Results from a pilot study conducted in the UK under the auspices of the Cardiff Experimental Cancer Medicine Centre in 2012 confirmed the feasibility and safety of combining ganetespib with intensive chemotherapy in older patients with AML.
  • AML-19: expected to begin enrolling patients in 2H14, will evaluate ganetespib in combination with conventional chemotherapy vs chemotherapy alone in younger patients with AML. The trial is expected to enroll as many as 200 patients in the ganetespib arm and will be conducted by the UK NCRI Group, a network of more than 100 institutions. Patients will receive ganetespib sequentially to standard intensive therapy, followed by ganetespib maintenance treatment. The objective is to identify if ganetespib reduces the risk of relapse in the overall population or in key subgroups, and as a result, improves overall survival, the primary endpoint.
 

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