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Lilly Reports Topline Results from Phase 3 JUNIPER Trial Evaluating Verzenio™ (abemaciclib) in KRAS-Mutated, Advanced Non-Small Cell Lung Cancer

(Eli Lilly) Oct 10, 2017 - Eli Lilly and Company today announced that its Phase 3 JUNIPER study evaluating Verzenio™ (abemaciclib), a cyclin-dependent kinase (CDK)4 and CDK6 inhibitor, as monotherapy in KRAS-mutated, advanced non-small lung cancer (NSCLC) did not meet its primary endpoint of overall survival (OS).

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H. Jack West, MD (Posted: October 10, 2017)

quotesThis is an unfortunate result, in a hard setting to treat. About 20% of patients with advanced NSCLC have a KRAS mutation, making it the most common molecular aberration we see, but also one for which we have no effective targeted therapy. Abemaciclib demonstrated promising activity in earlier phase clinical studies, so this was certainly an important study. However, the fact that patients with a KRAS mutation are well recognized as been especially unlikely to benefit much from EGFR TKI therapy like erlotinib have led some critics to charge that the control arm in this study was receiving what we might interpret as little more than a placebo with side effects. Nevertheless, there was no difference in overall survival. Despite the improvements in some secondary endpoints and the charge that the control arm did better than expected (which I believe was due to the requirement that patients have failed docetaxel-based chemo, along with most having received an immune checkpoint inhibitor as well, making this a highly selected population for less aggressively paced disease), these results will likely not be enough to make this a viable treatment approach. Effective treatment for KRAS mutated NSCLC remains a significant unmet need, with insufficient progress marked by this agent and trial.quotes

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