Kisqali Combo Improves Progression-Free Survival in HER+/HER2- Breast Cancer

Novartis recently announced positive results from a phase 3 clinical trial of ribociclib (Kisqali) in patients with advanced or metastatic breast cancer, according to a press release.

The MONALEESA-7 study was the first in more than 20 years to assess the superiority of a CDK4/6 inhibitor plus hormone therapy and goserelin versus endocrine therapy among patients with hormone-receptor positive, human epidermal growth factor-2 negative (HR+/HER2-) advanced or metastatic breast cancer, according to Novartis.

Included in the study were more than 670 premenopausal women aged 25 to 58 years with HR+/HER2- advanced or metastatic breast cancer that was not previously treated with endocrine therapy.

Patients were randomized to receive ribociclib in combination with hormone therapies versus endocrine monotherapy. The researchers found that the trial met the primary endpoint of progression-free survival among patients treated with the ribociclib combination, according to a press release.

The authors said these findings add to mounting evidence that support ribociclib plus hormone therapy as a first-line treatment, according to the release. Additionally, the safety of the treatment was consistent with its known profile. The most commonly seen adverse event was low neutrophil levels, according to Novartis.

Ribociclib is approved as a first-line therapy for postmenopausal women with HR+/HER2- advanced or metastatic breast cancer. Currently, it is not approved to treat premenopausal patients.

"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," said Samit Hirawat, executive vice president and head, Global Drug Development at Novartis Oncology. "The MONALEESA-7 trial is the first CDK 4/6 inhibitor Phase III 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."