Novartis to Request Kisqali’s Approval to Treat Premenopausal Women on Basis of Phase 3 Trial

Novartis to Request Kisqali’s Approval to Treat Premenopausal Women on Basis of Phase 3 Trial

Novartis plans to begin work with regulatory authorities to request that Kisqali (ribociclib) be approved as a first-line treatment for premenopausal women with HR-positive, HER2-negative advanced breast cancer.

This decision came after a Phase 3 trial demonstrated that Kisqali, in combination with hormone treatment, delayed disease progression or death in these women, compared to hormone treatment alone — allowing the trial to meet its primary goal.

The company will present data from the trial — which adds to the already extensive Phase 3 data on Kisqali — at the upcoming San Antonio Breast Cancer Symposium (SABCS) in December.

“There remains a significant unmet treatment need in younger women diagnosed with premenopausal advanced breast cancer, as the disease tends to be more aggressive with a poorer prognosis,” Samit Hirawat, executive vice president and head of Global Drug Development at Novartis Oncology, said in a press release.

Kisqali was tested in combination with various oral or injection hormone therapies in the Phase 3 MONALEESA-7 trial (NCT02278120), which included more than 670 women ages 25 to 58. All had advanced or metastatic breast cancer that produced the hormone receptor (HR), but not the human epidermal growth factor receptor-2 (HER2). They were randomly assigned to treatment with either a Kisqali combination or hormonal treatment alone.

While Novartis said the treatment prolonged survival without the cancer progressing, it is withholding details for its San Antonio presentation.

“The MONALEESA-7 trial is the first CDK 4/6 inhibitor Phase 3 trial designed specifically for this patient population, and we are excited that the study met its primary endpoint, which may allow us to expand the population of patients who can benefit from treatment with Kisqali. We look forward to presenting MONALEESA-7 study data at SABCS next month and discussing these results with regulatory agencies worldwide,” said Hirawat.

Kisqali is a medication that blocks two types of an enzyme called cyclin-dependent kinase (CDK). It is currently approved, in combination with so-called aromatase inhibitor drugs, to treat HR-positive, HER2-negative advanced breast cancer in postmenopausal women.

Kisqali has gone through extensive Phase 3 investigations, but most focused on postmenopausal woman. Three ongoing Phase 3 trials, all recruiting patients, include premenopausal women to further demonstrate Kisqali’s effectiveness in this group.

EarLEE-1 (NCT03078751) and EarLEE-2 (NCT03081234) are randomized trials to test Kisqali as an adjuvant treatment, together with hormone therapy, in women not previously treated with a CDK4/6 inhibitor. CompLEEment (NCT02941926) is evaluating Kisqali in combination with Femara (letrozole). The trials have either started recruitment or will do so shortly.

Enrollment and other information is available by clicking on each trial’s identification number.