- Novartis’ breast cancer drug Kisqali along with standard therapy helped prevent recurrence in significantly more patients than the standard treatments alone, the company said Monday, heating up a rivalry with Eli Lilly in treating people with early stage disease.
- Without disclosing specifics, the Swiss drugmaker said that, upon an interim look at a large study called NATALEE, Kisqali led to a statistically significant reduction in the risk of cancer relapse. The company will present fuller data at an upcoming medical meeting and present it to the Food and Drug Administration and other regulatory authorities.
- Lilly’s similar drug Verzenio in 2021 won approval in this setting, known as the “adjuvant” setting and following surgical removal of tumors. Novartis believes Kisqali could be cleared for wider use than Verzenio because the NATALEE trial included less severely ill patients than Lilly’s studies did.
Kisqali and Verzenio are both blockbuster medicines. They emerged as part of a new class of cancer drugs called CDK4/6 inhibitors in the middle of the last decade and have since worked their way into earlier lines of care. Pfizer’s Ibrance is also a CDK4/6 inhibitor, but missed in a clinical trial in the adjuvant setting.
Ibrance nonetheless remains the biggest seller of the group, with more than $5 billion in revenue in 2022. But Verzenio has been making inroads since its approval as an adjuvant treatment. Fueled by that clearance, the drug saw its sales grow by 84%, to $2.5 billion, in 2022, making it one of the Indiana-based company’s best-selling medicines. Its dominance in the adjuvant setting could be challenged by Kisqali, however.
The patients Verzenio won its adjuvant approval for were those at high risk of recurrence if they had stage III tumors — meaning their disease had spread to tissues and lymph nodes near the affected breast — or those with stage II tumors found in lymph nodes. In NATALEE, Novartis enrolled stage II patients regardless of lymph node involvement, which includes patients whose disease is only in the breast.
That difference means that two to three times more patients could be eligible to receive Kisqali if the FDA approves Novartis’ drug based on the NATALEE trial, wrote Evercore ISI analyst Umer Raffat, in a research note.
Another factor in physicians’ choice could be safety and duration of treatment, Raffat wrote. Verzenio led to higher rates of diarrhea in clinical testing, while Kisqali recipients more depletion of disease-fighting white blood cells. Patients were on treatment with Verzenio for two years in the study underlying Lilly’s approval, while they were on drug for three years in Novartis’ study.