Efficacy

Trodelvy (sacituzumab govitecan-hziy) Efficacy in Breast Cancer

Trodelvy (sacituzumab govitecan-hziy) is an antibody-drug conjugate specifically 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. The efficacy of Trodelvy was evaluated in a study known as IMMU-132-01, a multicenter, single-arm trial. Patients treated with Trodelvy showed a significant improvement in overall response rate (ORR), with a percentage of patients experiencing partial or complete shrinkage of their tumors. Additionally, the median duration of response (DoR) was notable, suggesting that the responses to Trodelvy can be durable.

Further supporting its efficacy, Trodelvy has demonstrated a clinically meaningful improvement in overall survival (OS) in patients with metastatic TNBC. In a phase III trial, ASCENT, patients treated with Trodelvy had a statistically significant and clinically meaningful improvement in OS compared to those receiving standard chemotherapy. These results underscore Trodelvy's potential as a valuable treatment option for patients with this aggressive form of breast cancer.

Margenza (margetuximab-cmkb) Efficacy in Breast Cancer

Margenza (margetuximab-cmkb), in combination with chemotherapy, is approved for the treatment of patients with metastatic HER2-positive breast cancer who have previously received two or more 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, a phase III clinical trial. In this study, patients receiving Margenza in combination with chemotherapy showed an improvement in progression-free survival (PFS) compared to those receiving trastuzumab and chemotherapy. The ORR also favored the Margenza combination, indicating that a higher proportion of patients experienced tumor shrinkage.

While the SOPHIA study demonstrated a trend toward improved OS with Margenza, this result did not reach statistical significance at the time of the primary analysis. However, the improvement in PFS and ORR suggests that Margenza, when used in combination with chemotherapy, can be an effective treatment option for patients with previously treated HER2-positive metastatic breast cancer. Ongoing studies and additional follow-up may provide further insights into the long-term benefits of Margenza in this patient population.