Efficacy

Efficacy of Kisqali (Ribociclib) in Breast Cancer

Ribociclib, marketed as Kisqali, is a targeted therapy drug that has been approved for the treatment of certain types of breast cancer. Specifically, it is used in combination with an aromatase inhibitor for the treatment of premenopausal and postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer. Clinical trials have demonstrated that Kisqali, in combination with letrozole, significantly increases progression-free survival compared to letrozole alone. The MONALEESA-2 trial, for instance, showed a median progression-free survival of over 25 months for patients treated with the combination of Kisqali and letrozole, compared to 16 months for those who received letrozole alone.

In addition to its use with an aromatase inhibitor, Kisqali is also approved for use with fulvestrant in women who have received prior endocrine therapy. In the MONALEESA-3 trial, patients treated with Kisqali plus fulvestrant experienced a median progression-free survival of 20.5 months, versus 12.8 months for those receiving fulvestrant alone. These results indicate that Kisqali is effective in prolonging the time before the disease progresses in women with HR+/HER2- advanced or metastatic breast cancer.

Efficacy of Margenza (Margetuximab-cmkb) in Breast Cancer

Margenza (margetuximab-cmkb) is a monoclonal antibody that has been approved for use in combination with chemotherapy for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. The approval of Margenza was based on the results of the SOPHIA study, which demonstrated an improvement in progression-free survival. Patients who received Margenza in combination with chemotherapy had a median progression-free survival of 5.8 months compared to 4.9 months for those who received trastuzumab plus chemotherapy.

While the improvement in progression-free survival with Margenza is modest, it provides an additional treatment option for patients with HER2-positive metastatic breast cancer who have progressed on previous therapies. The SOPHIA study also showed a trend toward improved overall survival with Margenza, although these results were not statistically significant at the time of the analysis. Further studies are ongoing to fully understand the potential survival benefits of Margenza in this patient population.