LEXINGTON, Mass. ( TheStreet) --On May 3, Synta Pharmaceuticals (SNTA) announced that an interim analysis of its ganetespib phase II trial in lung cancer was underway. Two months later, Synta still hasn't announced results. What is taking so damn long?
The painfully slow number crunching from the OPEN LABEL ganetespib study is even more mystifying given Synta already primed investors with good news. On May 3, the company also announced plans to push ganetespib into phase III studies based on the drug's "strong activity" in two subgroups of lung cancer patients enrolled in the phase II study. Synta didn't say which patient subgroups (prospectively defined, apparently) are benefiting from treatment but it's widely believed to be patients with mutation to the KRAS protein (mKRAS) and well as patients with high levels of the enzyme LDH. Both mKRAS and elevated LDH are negative markers of disease severity that makes treating lung cancer more difficult.
Not so coincidentally, Synta shares have doubled in value to more than $8 since May 3, as investors anticipate positive results from the ganetespib lung cancer study.Any time now, Synta… The Synta phase II study enrolls 240 patients with non-small cell lung cancer that no longer responds to initial therapy. The patients in the study are randomized to receive treatment with a combination of ganetespib plus the chemo drug docetaxel or docetaxel alone. The primary endpoint of the study is to determine whether adding ganetespib to docetaxel can significantly prolong the time before tumors start growing again or patients die -- so-called progression-free survival (PFS). Synta has indicated that this interim analysis will encompass data from about half the patients in the study. The company has also hinted that the overall results are likely to be negative.
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