According to a new study published online in the journal The Lancet Oncology, researchers have found that linsitinib, an IGF-1R and insulin receptor inhibitor, did not improve overall survival in patients with locally advanced or metastatic adrenocortical carcinoma.
Previous studies have shown that linsitinib has anti-tumor activity and acceptable tolerability in patients with adrenocortical adenocarcinoma, so researchers sought to compare its efficacy versus placebo in patients with advanced adrenocortical carcinoma.
For the international, double-blind, placebo-controlled phase 3 study, researchers enrolled 139 patients with advanced adrenocortical carcinoma, a rare, aggressive cancer that lacks many treatment options, and assigned 90 of whom to linsitinib and 49 to placebo. Patients in the linsitinib group received linsitinib 150mg orally twice daily.
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Results showed that there was no difference in overall survival between linsitinib and placebo (median 323 days; 95% CI: 256 – 507 vs 365 days; 95% CI: 249 – 556; HR = 0.94; P = 0.77). There were 92 deaths in total during the study.
In regard to safety, the most common severe adverse events associated with linsitinib were fatigue, nausea, and hyperglycemia.
Because linsitinib did not increase overall survival compared with placebo, the researchers cannot recommend linsitinib as treatment for patients with advanced adrenocortical carcinoma.