Novartis’ Kisqali plus endocrine therapy shows significant PFS benefits in advanced breast cancer trials

Swiss pharmaceutical giant Novartis has announced that its breast cancer drug, Kisqali (ribociclib), when used in combination with endocrine therapy, has demonstrated substantial efficacy in extending progression-free survival (PFS) for women with hormone receptor-positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced breast cancer. This conclusion comes from a release of subgroup analyses from the three phase 3 MONALEESA trials, which involved pre-, peri-, and postmenopausal women, regardless of the presence of visceral metastases.

In the MONALEESA-2 trial, Kisqali combined with endocrine therapy extended the median PFS by 11.5 months in patients with visceral metastases compared to those receiving endocrine therapy alone. The MONALEESA-7 trial showed an extension of 13.4 months in similar patient groups. Meanwhile, the MONALEESA-3 trial indicated that median PFS for patients with visceral metastases was not yet reached, compared to 16.5 months for those on endocrine therapy alone.

Denise Yardley, Principal Investigator of the trials at the Sarah Cannon Research Institute, noted the significance of these findings: “Nearly 60% of patients enrolled in the MONALEESA clinical trials had visceral metastases, and all benefited from treatment with ribociclib in combination with endocrine therapy. These results, coupled with the NCCN and ABC4 recommended treatment guidelines for HR+ advanced breast cancer patients with visceral metastases, support the use of ribociclib combination therapy as a standard of care in this patient population.”

Efficacy Metrics:

• The overall response rate (ORR) for Kisqali plus endocrine therapy compared to endocrine therapy alone was 53% vs. 40% in MONALEESA-2, 50% vs. 38% in MONALEESA-7, and 48% vs. 31% in MONALEESA-3 for patients with visceral metastases.
• For patients without visceral disease, the ORR was 59% vs. 35%, 52% vs. 32%, and 49% vs. 39% in the same respective trials.

Samit Hirawat, Head of Novartis Oncology Global Drug Development, emphasized the critical nature of these findings: “Patients living with HR+/HER2- advanced breast cancer who have visceral metastases often face a poorer prognosis and are at a higher risk for treatment resistance and disease progression than those without. These sub analyses reaffirm that it is critical to treat HR+ advanced breast cancer with a CDK4/6 combination therapy, such as Kisqali plus fulvestrant or an aromatase inhibitor, to provide all patients, especially those with visceral metastases, the strongest option for delaying disease progression.”

Novartis also reported that adverse events in patients with visceral metastases were consistent with those observed in the overall study populations and were generally manageable with dose interruptions or reductions.