Eli Lilly concedes a PhIII flop for abemaciclib as breakout strategy flounders

Levi Garraway

Just days after a laggard Eli Lilly won its first approval for its CDK4/6 cancer drug abemaciclib, the pharma giant has been forced to concede a key failure for its bid to leapfrog some major league competition at Pfizer and Novartis.

Their drug, marketed as Verzenio, flopped on the primary overall survival endpoint in a Phase III trial for KRAS-mutated non-small cell lung cancer. Investigators had hoped to achieve a breakthrough after gaining an OK in metastatic breast cancer, looking to break out after falling far behind Pfizer’s leading Ibrance and Novartis’ rival Kisqali.

The researchers involved were sticking to the toppling results, touting evidence of an advantage on progression-free survival, but adding that a higher-than-expected response rate in the control arm could have scuttled the primary goal.

Investors didn’t like the sound of it, though, sending Lilly’s shares down 1.2% on the miss.

The pharma giant recruited 453 patients for the JUNIPER study, dividing them between abemaciclib and erlotinib.

Lilly, though, is nothing if not persistent. Levi Garraway, senior vice president, global development and medical affairs, Lilly Oncology, noted:

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. We look forward to seeing the results of these studies.

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