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.
>To contact the writer of this article, click here: Adam Feuerstein. >To follow the writer on Twitter, go to http://twitter.com/adamfeuerstein. >To submit a news tip, send an email to: email@example.com. Follow TheStreet on Twitter and become a fan on Facebook.
Select the service that is right for you!COMPARE ALL SERVICES
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
- Real Money + Doug Kass Plus 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV