Eli Lilly announced Tuesday that a Phase III study of Verzenio (abemaciclib) in KRAS-mutated, advanced non-small-cell lung cancer (NSCLC) failed to meet its primary endpoint of overall survival. The company noted that "the control arm showed a higher overall survival rate than expected based on historical data in this setting."
The JUNIPER trial randomised 453 patients with stage IV NSCLC with a detectable KRAS mutation, who had progressed after platinum-based chemotherapy and who may have received one additional systemic therapy, to be administered either Verzenio or Roche and Astellas' Tarceva (erlotinib). Along with the study's main goal, secondary endpoints of the trial included overall response rate and progression-free survival.
According to Eli Lilly, an analysis of top-line data from the study for both progression-free survival and overall response rate showed evidence of monotherapy activity in patients given Verzenio. The drugmaker indicated that adverse events were generally consistent with previous studies of the CDK4/6 inhibitor, with the most common being diarrhoea, fatigue, decreased appetite and nausea. The company said it will submit the results for presentation at a medical meeting next year.
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Levi Garraway, senior vice president of global development and medical affairs, said "as we analyse secondary endpoints and explore specific patient subgroups in order to better evaluate the prospects for [Verzenio] in NSCLC, we will continue to work with the oncology community to inform potential future treatment avenues for patients with KRAS-mutated advanced lung cancer." Garraway added "we have several studies ongoing of rational combinations that include [Verzenio] in non-small-cell lung cancer and other malignancies."
Last month, the FDA approved Verzenio for use in combination with AstraZeneca's Faslodex (fulvestrant) to treat adults with HR-positive, HER2-negative breast cancer whose disease has advanced on endocrine therapy, and for use on its own if patients were previously treated with endocrine therapy and chemotherapy after the cancer had metastasised. For related analysis, see Physician Views Poll Results: Like Kisqali, there is some room for Verzenio in an Ibrance-dominated market.
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