Lilly Drug Fails to Meet Endpoint in Advanced Lung Cancer Trial

Eli Lilly and Company reported this week that abemaciclib (Verzenio) failed to meet the primary endpoint of overall survival (OS) in a phase 3 clinical trial, according to a press release. The CDK4/6 inhibitor was being explored as a monotherapy for advanced non-small cell lung cancer (NSCLC).

While abemaciclib did not meet its primary endpoint, Lilly found that the drug may improve progression-free survival and overall response rate as a monotherapy.

Additionally, Lilly reported that control patients had higher OS rates than expected, which may have affected the study outcome.

"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, global development and medical affairs, Lilly Oncology.

The phase 3 JUNIPER clinical trial evaluated the safety and efficacy of abemaciclib versus erlotinib (Tarceva) in 453 patients with stage 4 NSCLC with a KRAS mutation whose disease progressed after treatment with platinum-based chemotherapy. Patients were randomized to receive twice daily treatment with abemaciclib 200-mg or erlotinib 150-mg.

Common adverse events included diarrhea, fatigue, decreased appetite, and nausea, according to the release.

Currently, abemaciclib plus fulvestrant is indicated to treat women with HR+, HER2- advanced or metastatic breast cancer whose disease progressed following endocrine therapy. The drug is also indicated as a monotherapy for patients with HR+, HER2- advanced or metastatic breast cancer whose disease progressed after endocrine therapy and had received previous chemotherapy for metastatic disease, according to Lilly.

"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,” Dr Garraway concluded. “Moreover, we have several studies ongoing of rational combinations that include abemaciclib in non-small cell lung cancer and other malignancies. We look forward to seeing the results of these studies."