Novartis says Kisqali reduces risk of cancer recurrence by 25%

Novartis breast cancer drug Kisqali reduces the risk of recurrence by a little more than 25 percent in a pivotal trial on women Diagnosed at an early stage, setting the Swiss drugmaker to win new patients and challenge strong rival Eli Lilly.

The firm said the relative risk reduction of cancer recurrence was 25.2% and that the results were widely consistent regardless of patients' menopausal status or cancer progression status. The results were presented at the annual meeting of the American Society of Clinical Oncology in Chicago. Kisqali was also used in the trial alongside standard endocrine therapy to treat a type of cancer that grows in response to hormones, and it was compared to endocrine therapy alone.

In March, Novartis released a brief preview of Kisqali data, increasing its shares and growth prospects.

Kisqali has been approved to treat hormone-driven breast cancer that has spread to other parts of the body, where Novartis has taken market share from Pfizer's Ibrance.

A previously diagnosed diagnosis, when tumours can still be surgically removed, is much more common, representing about 90% of patients.

The cancer later returns in between a third and one-half of cases, according to the National Cancer Institute.

In the early stages, Eli Lilly is ahead with the approval of rival drug Verzenio. But that is a subset of women who are at high risk of recurrence after surgery, usually diagnosed based on signs of cancer in the lymph nodes.

Novartis faces tough competition, as the U.S. drugmaker has said Verzenio reduces the risk of recurrence by 35% in that group.

But Kisqali is set to become a pioneer in abroader market because it was tested successfully in both high-risk and medium-risk patients, a population that is twice as large.

Investors may be disappointed that the Kisqali read-out fell well short of Verzenio's efficacy.

Novartis stress very low rates of symptomatic side effects in its trial, important to patients facing years-long treatment, with severe diarrhea affecting only 0.6% of participants on Kisqali.

That compares with 8% - 20% of the women in trials with Eli Lilly's Verzenio being affected by severe diarrhea.

We know diarrhea can be a very troublesome, burdensome adverse event for patients taking anti-cancer medicines, said Jeff Legos, head of Oncology Hematology Development at Novartis.

The March trial updateboosted market confidence in targets issued by CEO Vas Narasimhan, for annual sales growth of 4% through 2027 and a core operating income margin of 40% from 2027, analysts have said.

Novartis will request approval for wider use in the U.S. and Europe before the end of the year, the company said.