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.


Survey: The Critical Role of Innovation in Launching Successful OTC Products

This research aims to understand the importance of product innovation and dose forms in driving new product design and development, consumer engagement and purchase interest for Over-the-Counter medicines. The first 50 qualified respondents will receive a $5 Amazon gift card. Take the survey now.

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.

Suggested Articles

With drug-resistant bacteria on the rise, antibiotics have struggled to keep up. But with an FDA nod for Nabriva's Xenleta, some of that may change.

JAK drugs have run into safety issues, and if the label for AbbVie's Rinvoq is any indication, the FDA now believes those the issues are class-wide.

Rather than "we did the best we could," Vas Narasimhan, during an internal call with managers, said Novartis could have handled the Zolgensma crisis…