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Tucatinib

Tucatinib Improves PFS, OS in HER2-Positive Metastatic Breast Cancer

The small-molecule HER2 inhibitor tucatinib showed improvements in progression-free survival (PFS) and overall survival (OS) for patients with metastatic HER2-positive (HER2+) breast cancer, according to results from phase II of the HER2CLIMB trial.

FDA has approved tucatinib (Tukysa) with trastuzumab (Herceptin) to treat HER2-positive advanced colorectal cancer.

An oral tyrosine kinase inhibitor that targets the HER2 tyrosine kinase.

Is highly selective for the kinase domain of HER2 achieving more than 1000-4

fold selectivity for HER2 relative to epidermal growth factor receptor.

The tucatinib was administered in combination with trastuzumab and capecitabine and compared with trastuzumab and capecitabine alone.

Tucatinib resulted in a 46% reduction in the risk of disease progression or death compared the combination of trastuzumab (Herceptin) and capecitabine (Xeloda) alone.

For patients with brain metastases, tucatinib group resulted in a 52% reduction in the risk of disease progression or death as compared with the non-tucatinib group.

Adverse events: in the include diarrhea, increased aspartate aminotransferase, increased alanine aminotransferase (ALT) and bilirubin.

Approved for use in combination with trastuzumab (Herceptin) and capecitabine (Xeloda) for the treatment of patients with unresectable locally advanced or metastatic HER2-positive breast cancer, including patients with brain metastases, following at least 1 prior anti-HER2-based regimen in the metastatic setting.

Tukysa trade name.

Phase II HER2CLIMB trial, showed that the tucatinib triplet reduced the risk of death by 34% compared with trastuzumab and capecitabine alone in heavily pretreated patients with unresectable locally advanced or metastatic HER2-positive breast cancer.

The median overall survival (OS) was 21.9 months with the tucatinib triplet compared with 17.4 months with trastuzumab and capecitabine alone.

The 1- and 2-year OS rates were 76% versus 62% and 45% versus 27% in the tucatinib and control arms, respectively. 

The median duration of progression free survival was 7.8 months in the tucatinib+combination group and 5.6 months in the placebo-combination group, corresponding 46% lower risk of disease progression or death in the treatment group.

The median duration of overall survival was 21.9 months in the tucatinib-combination group in 17.4 months in the placebo-combination group corresponding to a 34% lower risk of death in the tucatinib combination group.

Among participants with brain metastases, tucatinib combined showed median CNS-progression free survival of 9.9 months versus 4.2 months with all the treatments, and median overall survival of 18.1 months versus 12 months among patients with active brain metastasis.

Tucatinib inclusive triple regimen in patients with metastatic disease that  received  one more HER2 based regimens is very active and compelling for its used for patients with brain metastases.

Tucatinib in combination with the trastusumab and capecitabine improved the overall survival, while reducing the risk of developing new brain metastasis in patients with ERBB2  positive metastatic breast cancer.

FDA has approved tucatinib (Tukysa) with trastuzumab (Herceptin) to treat HER2-positive advanced colorectal cancer.

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