Eli Lilly (LLY) said Friday a combination using its blockbuster drug, Verzenio, reduced the risk of death by nearly 16% over two years for some breast cancer patients.
Dr. Stephen Johnston, a lead investigator in the study, called the results “an important step forward” in treating breast cancer patients. This is the first contemporary medicine in over two decades to demonstrate a clear improvement in overall survival as an adjuvant treatment for breast cancer, he said in a statement. Adjuvant drugs are given after the primary treatment to help prevent a relapse.
The results could help bolster use of Verzenio among patients with this form of breast cancer. Though the combination has been approved for four years, some physicians won’t be persuaded without overall survival data, says Jacob Van Naarden, executive vice president and president of Lilly Oncology.
“There’s a cohort of physicians out there who say, ‘You want me to add two years of this new medicine on top of what else I give my patients in this setting?’ ” he told Investor’s Business Daily. “Every new medicine you add, adds adverse events and tolerability issues.”
These data remove that argument, he said.
“I don’t think that’s really up for debate anymore once these data get out there,” he said.
Verzenio Cuts Risk Of Death
Verzenio works by blocking the CDK4 and CDK6 enzymes. These enzymes are involved in cell division, a key process for how cancer grows and spreads. Last year, Verzenio brought in a whopping $5.31 billion in sales, making it the company’s second-biggest drug behind type 2 diabetes treatment Mounjaro.
Verzenio rivals Pfizer‘s (PFE) Ibrance and Novartis‘ (NVS) Kisqali. Last year, Ibrance generated $4.37 billion in sales while Kisqali brought in $3.03 billion. But Ibrance sales are declining amid competition from Verzenio and Kisqali. By 2030, analysts call for just $1 billion in Ibrance sales, but a whopping $8 billion and $11.06 billion from Verzenio and Kisqali, respectively.
And there’s still plenty of growing room for Verzenio, Van Naarden said.
Lilly’s study, dubbed MonarchE, focused on patients whose cancer cell have receptors for estrogen and progesterone, but don’t overproduce the HER2 protein. The company studied the impact of Verzenio plus endocrine therapy following surgery.
The key measure in Eli Lilly’s study was overall survival. This determines how long patients live before dying of any cause. Patients who received the Verzenio and endocrine therapy combination for two years were 15.8% less likely to die.
Earlier-Than-Usual Benefit
At the median, Eli Lilly followed patients for 6.3 years. More than three-quarters of patients had been followed for at least four years after the two-year treatment period.
Paradigm-shifting test results like these usually take place after running tests for 10 years or longer, David Hyman, Lilly’s chief medical officer, told IBD.
“Actually to see any survival advantage this early on — six-and-a-half, seven years — is pretty unprecedented in the last 30 years of treating this disease,” Hyman said.
Van Naarden, of Lilly Oncology, said patients only get an added two years of Verzenio treatment. Oftentimes, adjuvant treatments are taken until the cancer returns or the patient dies.
“It’s an unusual thing for a finite duration treatment in cancer to then deliver such long-term outcomes that matter,” he said.
Survival ‘Matters Most’
Patients on the regimen also showed long-term improvements in invasive disease-free survival and distant relapse-free survival. The former measures the length of time from the study’s start to the first relapse, new cancer or death. The latter measures how long patients live without any cancer relapse.
“For patients, survival is what matters most,” said Johnston, the lead investigator.
In addition to the strong overall survival results, Verzenio plus endocrine therapy reduced the risk of recurrence at seven years. Notably, 32% fewer patients who received the combination were living with metastatic cancer compared to those given endocrine therapy alone.
Importantly, the combination proved as safe as Verzenio alone. There were no new safety problems, and side effects were generally managed with dosing changes.
Lilly Oncology’s Van Naarden says the results reinforce the adjuvant treatment as the new standard of care for patients with this form of breast cancer.
Can Lilly Stock Rise Again?
Lilly stock is trading above its key moving averages, though has pulled back slightly from a run-up tied to the Trump administration’s new drug-pricing efforts.
Shares have a middle-of-the-road Relative Strength Rating of 49 out of a best-possible 99. This puts shares in the bottom half of all stocks when it comes to 12-month performance, according to IBD Digital.
Follow Allison Gatlin on X/Twitter at @AGatlin_IBD.
YOU MAY ALSO LIKE:
Novo Nordisk Bulks Up Its Obesity-Tied Portfolio With $5.2 Billion Buyout
S&P Drug Titan J&J Slides On Its Surprise Spinoff Plans
IBD Stock Of The Day: See How To Find, Track And Buy The Best Stocks
Best Growth Stocks To Buy And Watch: See Updates To IBD Stock Lists
Find Winning Stocks With MarketSurge Pattern Recognition & Custom Screens
