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 that included 108 patients with metastatic TNBC. In this study, Trodelvy demonstrated a significant clinical benefit, with an objective response rate (ORR) of 33%, including a 4% complete response rate. The median duration of response was 7.7 months, indicating a substantial period of disease control for patients with this aggressive form of breast cancer.

Further confirming its efficacy, Trodelvy was also assessed in the ASCENT study, a phase 3 trial that compared Trodelvy to chemotherapy chosen by the patient's healthcare provider in patients with relapsed or refractory metastatic TNBC. The results showed a significant improvement in progression-free survival (PFS) and overall survival (OS) for patients treated with Trodelvy. The median PFS was 5.6 months with Trodelvy compared to 1.7 months with chemotherapy, and the median OS was 12.1 months versus 6.7 months, respectively.

Tukysa (tucatinib) Efficacy in Breast Cancer

Tukysa (tucatinib) is a kinase inhibitor used in combination with trastuzumab and capecitabine for the treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting. The efficacy of Tukysa was demonstrated in the HER2CLIMB trial, a randomized, double-blind, placebo-controlled study. Patients receiving Tukysa in combination with trastuzumab and capecitabine had a significant improvement in progression-free survival compared to those receiving placebo with trastuzumab and capecitabine. The median PFS was 7.8 months in the Tukysa arm versus 5.6 months in the placebo arm.

Additionally, Tukysa showed efficacy in patients with brain metastases, a group that is often excluded from clinical trials and has limited treatment options. In the subgroup of patients with brain metastases, the median PFS was 7.6 months for those treated with Tukysa compared to 5.4 months for those on placebo. Overall survival was also improved, with a median OS of 21.9 months in the Tukysa group compared to 17.4 months in the placebo group, highlighting the potential of Tukysa to address a significant unmet need in this patient population.