Novartis' Kisqali sharpens survival edge with second phase 3 win

Novartis will unveil details from Kisqali's latest phase 3 win at an upcoming medical meeting. (Novartis)

In June, Novartis’ Kisqali showed it could prolong the lives of breast cancer patients, making it the first in its class to do so. And now, it’s done it again.

In a phase 3 study, Kisqali significantly extended the lives of post-menopausal women with HR-positive, HER2-negative breast cancer, the Swiss drugmaker said Wednesday. The group included both previously untreated women and women who had already failed on one prior therapy.

Details on the trial win are under wraps for now, with Novartis set to debut them at an upcoming medical meeting. In the meantime, though, it’ll be submitting full results to global health authorities so they can consider a label update, it said.


Using AI and RWD to Uncover Rare Disease Insights, Accelerate Commercialization and Improve Patient Outcomes

Wednesday, March 24 | 2pm ET / 11am PT

Learn how transformed real world data into real world insights to assist Audentes in their development of AT132 for the treatment of XLMTM. The session reviews how IPM.ia and Audentes collaborated to uncover the XLMTM patient population.

RELATED: ASCO: Novartis' Kisqali posts first-in-class survival win in younger women

The study, dubbed Monaleesa-3, marks the second in which Kisqali has shown it can lengthen lives. At June’s American Society of Clinical Oncology annual meeting, Novartis trotted out results from the Monaleesa-7 trial in which a combination of Kisqali, the hormone suppressant gosrelin and either tamoxifen or an aromatase inhibitor cut the risk of death by 29% compared with endocrine therapy alone in premenopausal patients with no prior endocrine therapy.

Meanwhile, though Kisqali now has two survival victories to its name, its competitors—Pfizer’s Ibrance and Eli Lilly’s Verzenio—have just one between them, thanks to a positive showing this week from Verzenio. And after a slow start, Novartis is hoping this distinction will help turn prescribers in its favor.

RELATED: Novartis nabs much-needed new nod for slow-growing breast cancer drug Kisqali

Kisqali pulled in just $111 million in second-quarter sales, Novartis reported earlier this week—just barely more than the $109.4 million generated by Verzenio, which hit the market more than six months after Kisqali did. Ibrance, for its part, is way ahead of the pack thanks to a yearslong head start; it put up $1.26 billion in second-quarter sales, and it continues to benefit from expansion of the class, Pfizer said.