In the heat of the CDK4/6 market showdown, Eli Lilly has notched an overall survival win to back Verzenio’s case against Novartis’ rival offering.
Lilly’s Verzenio has proven its ability to prolong the lives of patients with HR-positive, HER2-negative, node-positive high-risk early breast cancer, the company said Wednesday.
Verzenio, used on top of endocrine therapy after surgery, showed a “statistically significant and clinically meaningful” improvement in overall survival (OS) compared with endocrine therapy alone in the phase 3 monarchE trial, according to Lilly.
“Preventing disease relapse and helping patients live longer is the ultimate goal and a high bar in the adjuvant setting,” Jacob Van Naarden, president of Lilly Oncology, said in a statement. “Achieving a statistically significant OS benefit with just two years of Verzenio therapy reinforces its differentiated profile in high-risk HR+, HER2- early breast cancer.”
Van Naarden’s “two years” comment can be viewed as a direct shot at Novartis’ Kisqali, which is dosed up to three years in the same adjuvant setting.
The rivalry between the two CDK4/6 inhibitors entered a new phase in September of 2024, when Kisqali notched a broader FDA approval in HR-positive, HER2-negative high-risk early breast cancer. Importantly, Kisqali's label also covers some node-negative patients. That seemingly small distinction effectively gives Kisqali twice as many eligible patients as its rival in the adjuvant treatment setting.
Before Lilly’s announcement on Wednesday, both drugs had delivered phase 3 data showing they can lower the risk of disease recurrence or death. Now, Lilly may soon be able to promote Verzenio’s overall survival benefit, pending FDA approval.
Lilly plans to share detailed results at a future medical meeting and will discuss the findings with regulatory bodies, the company said.
Achieving a statistically significant showing on overall survival is not a small feat for Verzenio. Previously, Verzenio’s phase 3 Monarch 3 trial in first-line advanced breast cancer narrowly missed the overall survival mark in its final analysis. That readout handed Novartis a win, as Kisqali remains the only CDK4/6 agent to have demonstrated a life extension benefit in that treatment setting.
Alongside all this, Kisqali’s launch in early breast cancer continues to add pressure to Verzenio’s growth outlook.
As of June, the Novartis drug was claiming 61% new-to-brand U.S. patient share in the adjuvant setting, while surpassing Pfizer’s first-to-market Ibrance to achieve total market share leadership in the metastatic setting.
By the numbers, Kisqali’s growth momentum is unmatched by others in the field. In the second quarter, sales of the Novartis drug grew 64% year over year to $1.18 billion. During the same period, Lilly recorded $1.49 billion in Verzenio revenue, good for a 12% increase from the same period last year.