Efficacy

Efficacy of Kisqali (Ribociclib) in Breast Cancer

Kisqali (ribociclib) is a targeted therapy known as a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, which is used in the treatment of certain types of breast cancer. Specifically, it is indicated for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer. The efficacy of Kisqali has been demonstrated in multiple clinical trials. In these studies, ribociclib, in combination with an aromatase inhibitor or fulvestrant, has been shown to significantly improve progression-free survival (PFS) compared to the aromatase inhibitor or fulvestrant alone. This improvement in PFS indicates that ribociclib effectively delays the progression of the disease in the studied population.

One of the pivotal trials that supported the approval of Kisqali was the MONALEESA-2 trial. In this study, postmenopausal women with HR+/HER2- advanced breast cancer who had received no prior therapy for advanced disease were treated with ribociclib in combination with letrozole. The combination treatment resulted in a significant improvement in median PFS compared to letrozole alone. Subsequent trials, such as MONALEESA-7 and MONALEESA-3, have also supported the efficacy of ribociclib in premenopausal women and in combination with fulvestrant, respectively.

Efficacy of Tukysa (Tucatinib) in Breast Cancer

Tukysa (tucatinib) is an oral tyrosine kinase inhibitor that is specifically designed to target HER2, a protein that can promote the growth of cancer cells. For patients with HER2-positive breast cancer, tucatinib has been shown to be an effective treatment option. The approval of Tukysa was based on the results of the HER2CLIMB trial, which included patients with HER2-positive advanced or metastatic breast cancer, including those with brain metastases. In this trial, tucatinib, in combination with trastuzumab and capecitabine, demonstrated a significant improvement in PFS and overall survival (OS) compared to trastuzumab and capecitabine alone.

The HER2CLIMB trial was particularly noteworthy for including patients with brain metastases, a group often excluded from clinical trials. The addition of tucatinib to the standard treatment regimen was found to reduce the risk of disease progression or death in the overall population and also showed a reduction in the risk of disease progression or death in patients with brain metastases. These results indicate that tucatinib is an effective option for patients with HER2-positive breast cancer, addressing an unmet need for patients with brain metastases from this disease.