Novartis breast cancer drug helped delay return of disease

Novartis AG’s breast cancer drug helped prevent the disease coming back a year after treatment had ended, in new data that will be closely compared with a rival product from Eli Lilly.

Novartis’ Kisqali reduced the risk of breast cancer recurrence by 28.5 per cent in a four-year follow-up of patients with certain early types of the illness, according to data presented Monday at the European Society for Medical Oncology in Barcelona. That’s an improvement on previous data published at the end of last year.

The new data looked at what happens in the 12 months following a three-year spell of treatment with Kisqali and endocrine therapy. Regulators are already assessing earlier evidence that showed patients taking Kisqali and endocrine therapy lived for longer without disease, compared with those just receiving endocrine therapy.

The latest findings indicate that across the patient groups tested — with stage two or three early breast cancer that is positive for certain hormone receptors and has low levels of the HER2 protein — there was a significant benefit in receiving Kisqali.

US approval for the drug in these early-stage patients is expected by the end of September, said Jeff Legos, global head of oncology at Novartis. The drug is already approved as a treatment for breast cancer that has spread. It’s a key driver of sales, with revenue for Kisqali increasing by 69 per cent in 2023 compared with the year prior.

“These are really clinically meaningful improvements,” said Legos in an interview. The safety data also remains mostly unchanged from earlier findings, with “no long-term residual side effects,” he said.

Verzenio

The findings are crucial to the battle between Novartis’ Kisqali and Eli Lilly’s Verzenio, said Bloomberg Intelligence’s Max Nisen. The percentage of patients remaining alive and without cancer will need to rival the four-year data seen with Lilly’s drug, Nisen said in a note before the study was published.

Kisqali’s 28.5 per cent drop in the risk of recurrence is less than the 35 per cent seen with Verzenio at four years. However 88.5 per cent of patients on Kisqali and endocrine therapy were alive without cancer at four years — higher than the 85.5 per cent seen with Lilly’s Verzenio.

Key overall survival data wasn’t mature at the time of the analysis, said Legos. However, he hailed a “positive trend in the right direction” indicating an 18 per cent reduction of risk in death.