- Eli Lilly & Co.'s newly approved Verzenio failed to improve overall survival in a late-stage study testing the CDK 4/6 inhibitor in lung cancer patients with a mutation known as KRAS, the Indianapolis drugmaker said on Tuesday.
- While the setback doesn't take away from what Lilly sees as a potentially best-in-class profile for Verzenio in breast cancer, the Phase 3 miss could hamper the company's plans to develop the drug outside of that market.
- Lilly recently revamped its approach to cancer R&D, signalling its intent to become more competitive in the hot therapeutic space. Verzenio is a key foundational asset for that push and has been a bright spot amid setbacks and delays for Lilly's pipeline in other areas.
Targeting tumor dependencies like RAS mutations is a core part of Lilly's updated R&D strategy.
With Verzenio — still more commonly known by its nonproprietary name abemaciclib — Lilly has focused on investigating the drug in cancer types where the CDK4 biology plays a role in cancer growth. KRAS mutant lung cancers, for example, can tap CDK4 protein as an engine for cell division, making a CDK 4/6 inhibitor like Verzenio a logical drug to investigate.
JUNIPER, the study that Lilly read out Tuesday, pitted Verzenio monotherapy against Roche AG's Tarceva (erlotinib) in previously treated patients with KRAS-mutated advanced non-small lung cancer.
Unfortunately for Lilly, treatment with Verzenio failed to improve overall survival. The drugmaker did note its medicine showed evidence of activity when measured by progression-free survival and response rates (both secondary endpoints). A higher-than-expected survival rate in the control arm also checked the study's ability to show a statistically significant benefit to Verzenio, Lilly said.
Still, the setback will likely lead to questions about Verzenio's potential beyond breast cancer. Lilly currently lists mid-stage studies of Verzenio in squamous non-small cell lung cancer and pacreatic cancer on its pipeline.
For now, Verzenio's failure in lung cancer will keep the focus on the breast cancer market where Lilly hopes to steal market share away from Pfizer Inc's Ibrance (palbociclib) and Novartis AG's Kisqali (ribociclib).
(It is perhaps worth noting that neither Pfizer or Novartis list studies in lung cancer for their respective drugs on their pipeline — although Pfizer is partnered with the Dana-Farber Cancer Institute on two lung trials, including one involving KRAS.)
Verzenio's recent approval was for use in second-line treatment of HR+/HER2- metastatic breast cancer. Its true test, though, will come if the Food and Drug Administration OK's it for use in the first-line setting. Lilly expects to file for approval in that indication sometime in the first quarter of next year based on strong results from its MONARCH 3 study.
Shares in the drugmaker initially fell by nearly 2% early Tuesday before reversing some later that morning.