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Lilly Dealt a Setback by Phase 3 Lung Cancer Results

“Unfortunate” outcome in phase 3 JUNIPER trial of abemaciclib

Eli Lilly and Company has announced that its phase 3 JUNIPER study evaluating abemaciclib (Verzenio), 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). However, an analysis of the secondary study endpoints of both progression-free survival (PFS) and overall response rate (ORR) showed evidence of monotherapy activity in the abemaciclib arm. In addition, the control arm showed a higher OS rate than expected based on historical data in this setting. Lilly will submit the data for presentation at a medical meeting in 2018.

“While the outcome is unfortunate for patients with KRAS-mutated, advanced lung cancer, we remain encouraged by the antitumor activity observed with abemaciclib in this form of lung cancer where few clinical advances have been achieved,” said Levi Garraway, MD, PhD, Senior Vice President of Global Development and Medical Affairs for Lilly Oncology.

Garraway added, “As we analyze secondary endpoints and explore specific patient subgroups in order to better evaluate the prospects for abemaciclib 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. Moreover, we have several studies ongoing of rational combinations that include abemaciclib in non–small-cell lung cancer and other malignancies.”

JUNIPER, a global phase 3, interventional, open-label study, was designed to evaluate the efficacy and safety of abemaciclib versus erlotinib (Tarceva, OSI Pharmaceuticals) in patients with stage IV NSCLC with a detectable KRAS mutation who have progressed after platinum-based chemotherapy and who may have received one additional systemic therapy. A total of 453 patients were randomized to receive 200 mg of abemaciclib orally twice a day on a continuous dosing schedule, every 12 hours, or 150 mg of erlotinib administered at its approved dose and schedule until disease progression, death, or unacceptable toxicity. The primary endpoint of the study was OS, with key secondary endpoints of safety, ORR, and PFS. The adverse events were generally consistent with previous studies of abemaciclib, with the most common adverse events being diarrhea, fatigue, decreased appetite, and nausea.

Abemaciclib is currently approved in combination with fulvestrant for women with hormone-receptor-positive (HR+), human epidermal growth factor receptor-2 negative (HER2–) advanced or metastatic breast cancer with disease progression following endocrine therapy. It is also indicated as monotherapy for the treatment of adults with HR+, HER2– advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting

Source: BioSpace; October 10, 2017.

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