Novartis breast cancer drug delayed return of disease

Novartis AG's breast cancer drug helped prevent the disease from returning one year after treatment ended, according to new data comparing closely with a rival product from Eli Lilly.

Novartis' Kisqali reduced the risk of breast cancer recurring in patients with certain early forms of the disease by 28.5 percent over a four-year follow-up, according to data presented Monday at the European Society of Medical Oncology in Barcelona. That's an improvement on earlier data published late last year.

The new data looked at what happens in the 12 months after three years of treatment with Kisqali and endocrine therapy. Regulators are already reviewing previous evidence that showed patients taking Kisqali and endocrine therapy lived longer without disease compared with those taking endocrine therapy alone.

The latest evidence suggests that treatment with Kisqali provided significant benefits in all patient groups tested – those with early stage two or three breast cancer that responds positively to certain hormone receptors and has low levels of the HER2 protein.

U.S. approval of the drug for 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 to treat breast cancer that has spread. It is a key revenue driver, with sales for Kisqali expected to increase 69 percent in 2023 compared to last year.

“These are truly clinically meaningful improvements,” Legos said in an interview. The safety data also remained largely unchanged from previous results, and there were “no long-term side effects,” he said.

Verzenio

The results are crucial in the battle between Novartis' Kisqali and Eli Lilly's Verzenio, said Max Nisen of Bloomberg Intelligence. The percentage of patients who remain alive and free of cancer should match the four-year data with Lilly's drug, Nisen said in a note ahead of the study's release.

Kisqali reduces the risk of relapse by 28.5 percent, which is less than the 35 percent seen with Verzenio after four years. However, 88.5 percent of patients who received Kisqali and endocrine therapy were alive and free of cancer after four years – more than the 85.5 percent seen with Lilly's Verzenio.

The most important data on overall survival were not yet available at the time of the analysis, Legos said. However, he welcomed a “positive trend in the right direction” that indicated an 18 percent reduction in the risk of death.