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Linsitinib comparable to placebo for adrenal cancer treatment
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The investigational drug linsitinib did not increase overall survival in patients with adrenal cancer, according to phase 3 study results.
However, a small group of patients showed a significant response to the drug.
“While it was only a small subset of patients who responded to linsitinib, this remains very promising in the era of precision medicine,” Gary D. Hammer, MD, PhD, of the University of Michigan Comprehensive Cancer said in a press release.
Linsitinib, developed by OSI Pharmaceuticals, is an oral inhibitor of insulin-like growth factor-1 receptor and insulin receptor.
Hammer and colleagues conducted a randomized trial between December 2009 and July 2011 of 139 patients assigned to twice-daily 150-mg oral linsitinib (n = 90) or placebo (n = 49) to determine the effectiveness of the drug on advanced andrenocortical carcinoma. Researchers unblinded the study in March 2012 because no difference was found for survival between the groups.
Overall survival was 323 days among the linsitinib group compared with 356 days in the placebo group; which did not yield a difference (HR = 0.94; 95% CI, 0.61-1.44). Similarly, no difference was found between the groups for progression-free survival (HR = 0.83; 95% CI, 0.56-1.21). However, compared with zero participants in the placebo group, progression-free survival for at least 150 days was found among eight participants taking linsitinib.
At the time the study was unblinded, four participants remained on placebo and cancer was controlled for 2 years to 4 years.
“This was a real response for a small group of patients,” Hammer said. “If we can find a way to identify who is likely to be among the exceptional responders, we can potentially make a real difference for this group of patients. This paved the way toward individualized and improved therapeutic options in adrenal cancer.” – by Amber Cox
Disclosure: Hammer reports various financial ties with Atterocor, ISIS Pharmaceuticals and Orphagen. The study was funded in part by Astellas. See the full study for a complete list of all other researchers’ relevant financial disclosures.
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