Eli Lilly’s breast cancer drug Verzenio has failed to improve overall survival in a late-stage study assessing the drug’s potential in patients with KRAS-mutated, advanced non-small lung cancer (NSCLC).
In the Phase III Juniper trial 453 patients with stage IV NSCLC and a detectable KRAS mutation, whose disease progressed after platinum-based chemotherapy and who may have received one additional systemic therapy, were randomised to receive either Verzenio (abemaciclib) or erlotinib until disease progression, death or unacceptable toxicity.
While the study failed to hit its primary endpoint of improving overall survival, an analysis of the secondary study endpoints of both progression-free survival and overall response rate showed evidence of monotherapy activity in the Verzenio arm, the firm noted.
"While the outcome is unfortunate for patients with KRAS-mutated, advanced lung cancer, we remain encouraged by the antitumour activity observed with abemaciclib in this form of lung cancer where few clinical advances have been achieved," said Levi Garraway, senior vice president, global development and medical affairs, at Lilly Oncology.
“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,” he added.
Lilly said it would submit full data for presentation at a medical meeting next year.
Verzenio, an inhibitor of CDK4 and CDK6, was approved last September in the US to treat certain advanced breast cancers.