Synta Pharmaceuticals Corp. (NASDAQ: SNTA) today announced results from
an interim analysis of the Phase 2b portion of the GALAXY trial, a
global, randomized, multi-center Phase 2b/3 study designed to evaluate
the efficacy and safety of the Company's lead Hsp90 inhibitor,
ganetespib, as second-line treatment for advanced non-small cell lung
cancer (NSCLC). The results showed good tolerability for the combination
of ganetespib (G) and docetaxel (D), as well as meaningful improvements
in overall survival (OS) in adenocarcinoma patients receiving docetaxel
plus ganetespib compared to those receiving docetaxel alone. The results
were presented by Suresh Ramalingam, MD, Professor, Hematology & Medical
Oncology, and Director, Translational Thoracic Malignancies Program, of
the Winship Cancer Institute of Emory University, in a poster session at
the European Society for Medical Oncology 2012 Congress in Vienna,
Austria. A copy of the poster is available at http://www.syntapharma.com/documents/Ganetespib_GALAXY_ESMO_2012_Poster.pdf.
The GALAXY trial is based on a two-stage, operationally adaptive design.
The first-stage, randomized, open-label, 240-patient Phase 2b portion of
the trial is enrolling Stage IIIB/IV NSCLC patients who have progressed
following one prior line of therapy, and is designed to identify the
patient population, defined by biomarker or other disease
characteristic, for advancement into the Phase 3 portion of the trial.
An interim analysis was planned for when approximately 80% of the target
240 adenocarcinoma patients had been enrolled. A total of 187 patients
were enrolled at the time of analysis, of which 172 patients had been
entered into the clinical database at the time of data cutoff.
"The preliminary results from GALAXY indicate that the addition of
ganetespib to docetaxel is well tolerated and may improve outcomes in
patients compared to docetaxel alone," said Dr. Ramalingam, a Principal
Investigator of the study. "This includes promising improvements in
survival seen across the broad adenocarcinoma population as well as in
key predefined patient populations. A well-tolerated combination regimen
that extends survival associated with salvage therapy in NSCLC will meet
a much awaited need to improve the current standard of care."
Targeting the dependence of cancer cell growth and proliferation
pathways on the Hsp90 chaperone represents a new way to interrupt cancer
cell signaling and reduce tumor aggressiveness. Hsp90 inhibition by
ganetespib simultaneously inhibits multiple critical cancer-promoting
pathways, including pathways responsible for tumor metastasis,
angiogenesis, and resistance to conventional therapies.
"Chaperone inhibition offers a third approach to targeting cancer growth
pathways, distinct from kinase inhibitors or antibodies, which target a
single oncogenic driver. Ganetespib may be the first compound to unlock
the true potential of chaperone inhibition, effectively changing the
biology of tumors," said Dean Fennell, PhD, FRCP, FRCPI, Professor of
Thoracic Medical Oncology at the University Hospitals of Leicester, also
a Principal Investigator of the GALAXY trial. "The magnitude and
consistency of improvement that has been observed in this analysis
exceeded our expectations for trials of this stage. We are all looking
forward to the final clinical and molecular profiling results from this
portion of the GALAXY trial, and to bringing this exciting compound to
"The objective of the interim analysis presented today was to identify
the best choice of patient population and trial design for transitioning
to the Phase 3 stage of the study," said Safi R. Bahcall, PhD, President
and CEO of Synta. "The broad-based activity seen in the results
presented today support advancing into the Phase 3 stage in all
adenocarcinoma patients. The results have yielded a rich data set which
we are using to optimize and de-risk the Phase 3 stage of the program.
We are hopeful that this next stage of development will lead to a new
treatment option for patients fighting this devastating disease."
Enrollment completion of the Phase 2b stage of the GALAXY trial and the
transition to the Phase 3 stage are expected later this year. Based on
current assumptions, the Company anticipates that Phase 3 will enroll
approximately 500 adenocarcinoma patients, with overall survival as a
primary endpoint. Biomarker findings and other patient selection and
treatment experience from the Phase 2b stage will be incorporated into
the design of the Phase 3 stage. An announcement with additional Phase 3
details is anticipated later this year, following discussion with
Synta Pharmaceuticals Corp.