Efficacy

Nerlynx (neratinib) Efficacy in Breast Cancer

Nerlynx (neratinib) is an oral tyrosine kinase inhibitor that is specifically designed to block the function of the human epidermal growth factor receptor 2 (HER2) protein, which can promote the growth of cancer cells. In the treatment of breast cancer, neratinib is particularly effective in patients with HER2-positive breast cancer, which is a subtype where cancer cells have higher levels of HER2. The efficacy of neratinib was demonstrated in the ExteNET trial, a large international, double-blind, placebo-controlled Phase III trial. In this study, neratinib significantly improved invasive disease-free survival (iDFS) compared to placebo when given to early-stage HER2-positive breast cancer patients who had completed adjuvant trastuzumab-based therapy.

According to the results, the use of neratinib led to a 2-year iDFS rate of 94.2% compared to 91.9% for the placebo group. This benefit was maintained at the 5-year follow-up, with the neratinib group showing a continued improvement in iDFS. The benefit of neratinib was most pronounced in patients who were also hormone receptor-positive, which suggests that this subgroup may derive the most significant benefit from neratinib therapy.

Trodelvy (sacituzumab govitecan-hziy) Efficacy in Breast Cancer

Trodelvy (sacituzumab govitecan-hziy) is an antibody-drug conjugate that targets the Trop-2 receptor, which is expressed in the majority of breast cancers, and delivers the chemotherapy agent SN-38 directly to the cancer cells. It is approved 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 patients with metastatic TNBC who had relapsed or were refractory to previous treatments.

The results of the study showed a significant clinical benefit, with an objective response rate (ORR) of 33%, including complete responses and partial responses. The median duration of response (DOR) was 7.7 months, indicating that the responses were not only notable but also durable. Furthermore, the median progression-free survival (PFS) was 5.5 months, and the median overall survival (OS) was 13 months, which are substantial improvements over historical controls for this patient population. These findings highlight the potential of Trodelvy as a meaningful treatment option for patients with metastatic TNBC, a particularly aggressive and difficult-to-treat form of breast cancer.