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Novartis’ Kisqali sharpens survival edge with second ph3 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, HER-2 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.

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 yet to come up with one between them. And after a slow start, Novartis is hoping this distinction will help turn prescribers in its favor.

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 years-long head start; it put up $1.26 billion in second-quarter sales, and it continues to benefit from expansion of the class, Pfizer said.