Summary

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• Tukysa (tucatinib) is indicated 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. It is also indicated in combination with trastuzumab for the treatment of adult patients with RAS wild-type HER2-positive unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
• This summary is based on the review of five systematic review(s)/meta-analysis(es). ^[1-5]
• TKI-containing regimens demonstrated a non-statistically significant trend towards improved PFS in HER2-positive BCBM and BM patients compared to non-TKI regimens, with a HR of 0.64 (95% CI: 0.35-1.15; p=0.132) and 0.67 (95% CI: 0.41-1.12; p=0.13), respectively.
• Tucatinib combined with trastuzumab and capecitabine showed a high ORR of 47.3% in asymptomatic/active BM patients and significantly improved survival outcomes, ranking highest in both PFS and OS in network meta-analyses.
• T-DM1 and XHTuC regimens were effective in second-line treatments, with T-DM1 ranking first in PFS and OS, and XHTuC ranking first in ORR for advanced/metastatic HER2+ breast cancer.
• In Meta-Analysis 1, reported Grade 3-5 adverse events included diarrhea (22%), neutropenia (11%), hepatic toxicity (7%), and sensory neuropathy (6%).
• Safety in Meta-Analyses 2, 3, and Network Meta-Analysis 1 is not explicitly detailed, while Network Meta-Analysis 2 deemed T-DM1 and XHTuC regimens acceptable in safety, though not detailed in studies.
• There is no population type or subgroup information available in the reviewed studies.