Eli Lilly and Company's enzastaurin, an investigational, multi-targeted therapy that is currently the focus of two global Phase III clinical trials, one for the treatment of glioblastoma and one in non-Hodgkin's lymphoma, is the subject of several abstracts presented at the annual meeting of the American Society of Clinical Oncology (ASCO).
New pre-clinical data provided support for the oral agent's activity in a number of difficult to treat and chemo resistant tumor types. Clinical results also highlighted enzastaurin's potential to enhance the benefit of standard-of-care chemotherapies such as Gemzar) (gemcitabine HCl), Alimta) (pemetrexed) and Xeloda) (capecitabine) with manageable side effects.
"Pre-clinical data showing enzastaurin's synergistic activity with standard-of-care chemotherapies like Gemzar and Alimta, suggest this oral agent is a book containing many chapters, and we look forward to understanding all of enzastaurin's promising applications," said Richard Gaynor, M.D., vice president, cancer research and global oncology platform leader for Eli Lilly and Company.
Three presentations were made highlighting enzastaurin's potential for additive or synergistic anticancer effects without excessive toxicity in advanced solid tumors including lung, breast, pancreas, and head/neck cancers. The data were gathered from three Phase I studies that combined enzastaurin with Gemzar/cisplatin (abstract #2046), Alimta (abstract #2047) and capecitabine (abstract #2048). Each study showed similar results, concluding in each case the enzastaurin combination was generally well tolerated across all dose levels; and there were no observations of significant alterations in pharmacokinetics (the process by which a medication is absorbed, distributed, metabolized, and eliminated by the body). Further data on enzastaurin's safety (abstract #13077) were published from a review of data gathered from three Phase I and II studies, suggesting that enzastaurin is generally well tolerated across all doses and for extended durations. According to this analysis and given the severity of the disease and absence of controlled studies for comparisons, no event other than chromaturia or fecal discoloration (due to reddish-orange color of the active ingredient) appears to be definitively attributable to enzastaurin.