October 10, 2017
By Alex Keown, BioSpace.com Breaking News Staff
INDIANAPOLIS – Eli Lilly was stymied in its attempt to expand the indications for recently approved Verzenio (abemaciclib), a cyclin-dependent kinase (CDK)4 and CDK6 inhibitor.
This morning, the drug company announced its Phase III Juniper trial examining Verzenio as a monotherapy for treatment of patients with KRAS-mutated, advanced non-small lung cancer (NSCLC) failed to meet its primary endpoint of overall survival. Share prices were down more than 3 percent in early trading to $84.02 from its closing price of $87.04.
At the end of September, the U.S. Food and Drug Administration approved Verzenio in combination with AstraZeneca’s Faslodex as a treatment for adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer that has progressed after endocrine therapy.
The Juniper failure is the latest setback for the Indiana-based Eli Lilly. In April, the FDA rejected baricitinib, a rheumatoid arthritis drug. Lilly and its development partner Incyte Corporation said there will be a significant delay “beyond 2017” in addressing the FDA’s concerns to seek approval.
In the Juniper trial, Verzenio went head-to-head against Roche’s erlotinib in Stage IV NSCLC. In its announcement, Lilly did not provide additional details on how the two drugs fared head-to-head, only to say the drug did not meet its primary endpoint. Lilly did say that an analysts of the secondary endpoints, progression-free survival and overall response rate, showed “evidence of monotherapy activity in the abemaciclib arm.” The company added that the control arm showed a “higher overall survival rate than expected” based on historical data for that drug setting.
“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,” Levi Garraway, Eli Lilly’s head of global development and medical affairs, said.
Garaway said company researchers will continue to analyze the secondary endpoints from the failed Phase III trial and “explore specific patient subgroups” to find a way forward with the drug as a treatment for NSCLC. Additionally, Garaway said the company will continue to delve into oncology research to find 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. We look forward to seeing the results of these studies,” Garaway added.
During the 453-patient Juniper trial, those who were dosed with Verzenio received 200 mg of the medicine twice per day on a continuous dosing schedule. Patients taking the Roche drug received 150 mg of erlotinib administered at its approved dose and schedule until disease progression, death or unacceptable toxicity.
When Garaway spoke with BioSpace last month about Verzenio’s efficacy as a breast cancer treatment, he pointed to the idea of continuous dosing as a way to “maximize its treatment effect, to shrinking tumors and improving outcomes for patients.” Continuous dosing is something the company hoped would give Verzenio an advantage over rival inhibitors in the same space, including Pfizer’s Ibrance and Novartis’ Kisqali.
Lilly intends to submit the Juniper trial data for presentation at a medical meeting in 2018. The company did not specify which conference.
