Efficacy

Verzenio (Abemaciclib) Efficacy in Breast Cancer

Verzenio, known generically as abemaciclib, is a CDK4/6 inhibitor used in the treatment of certain types of breast cancer. Specifically, it is indicated for hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer. Clinical trials have demonstrated that Verzenio, when used in combination with an aromatase inhibitor or fulvestrant, significantly improves progression-free survival (PFS) compared to the use of an aromatase inhibitor or fulvestrant alone. The MONARCH 2 and MONARCH 3 trials have shown that Verzenio, in combination with endocrine therapy, delays disease progression and may also increase overall survival in certain populations.

In the MONARCH 2 trial, patients with HR+, HER2- advanced breast cancer who had progressed after endocrine therapy saw an improvement in median PFS when treated with abemaciclib plus fulvestrant compared to placebo plus fulvestrant. Additionally, a preplanned interim analysis suggested a trend toward improved overall survival, although this outcome requires further investigation. In the MONARCH 3 trial, abemaciclib in combination with an aromatase inhibitor as initial therapy also demonstrated a significant improvement in PFS for postmenopausal women with HR+, HER2- advanced breast cancer.

Trodelvy (Sacituzumab Govitecan-hziy) Efficacy in Breast Cancer

Trodelvy, also known as sacituzumab govitecan-hziy, is an antibody-drug conjugate indicated for the treatment of adult patients with metastatic triple-negative breast cancer (TNBC) who have received at least two prior therapies for metastatic disease. Trodelvy has shown a significant improvement in overall survival and progression-free survival in this patient population. The approval of Trodelvy was based on the results of a phase 3 trial (ASCENT) which demonstrated a statistically significant and clinically meaningful improvement in PFS and overall survival compared to standard chemotherapy.

In the ASCENT study, patients treated with Trodelvy had a median PFS of 5.6 months compared to 1.7 months with chemotherapy. Moreover, the median overall survival was 12.1 months for patients receiving Trodelvy, compared to 6.7 months for those on chemotherapy. These results indicate that Trodelvy provides a new treatment option for patients with metastatic TNBC, a particularly aggressive form of breast cancer with limited therapeutic options and historically poor outcomes.