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Tucatinib

(Tukysa®)

Tukysa®

Drug updated on 12/11/2024

Dosage FormTablet (oral; 50 mg, 150 mg)
Drug ClassKinase inhibitors
Ongoing and
Completed Studies		ClinicalTrials.gov

Indication

  • Indicated in combination with trastuzumab and capecitabine for 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
  • 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.

Latest News

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Summary
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  • This summary is based on the review of six systematic review(s)/meta-analysis(es). [1-6]
  • Tucatinib, in combination with trastuzumab and capecitabine (TTC), demonstrated significant improvement in progression-free survival (PFS) across multiple studies, particularly in patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer with brain metastases (hazard ratio (HR) 0.64; 95% confidence interval (CI): 0.35-1.15). Tucatinib-based regimens ranked highest for PFS and overall survival (OS) in second-line treatments.
  • Tucatinib showed an objective response rate (ORR) of 47.3% in patients with asymptomatic and/or active brain metastases. In comparison, trastuzumab deruxtecan (T-DXd) achieved an ORR of 64% in heavily pretreated populations.
  • In terms of OS, tucatinib-based regimens consistently ranked highly, particularly in second-line treatment settings, outperforming other HER2-targeted therapies like ado-trastuzumab emtansine (T-DM1) and neratinib.
  • Tucatinib-based regimens were associated with key adverse events including grade 3-5 diarrhea (22%, 95% CI: 14%-32%), neutropenia (11%, 95% CI: 5%-18%), hepatic toxicity (7%, 95% CI: 1%-16%), and sensory neuropathy (6%, 95% CI: 2%-12%). These events were notable but considered manageable and tolerable within the treatment context.
  • Comparative safety analyses indicated that tucatinib had a tolerable safety profile compared to other treatments such as T-DM1, which also exhibited acceptable safety outcomes.
  • Tucatinib-based regimens have shown particular effectiveness in HER2-positive breast cancer patients with brain metastases, with PFS and ORR significantly improved compared to other treatments. In heavily pretreated populations, tucatinib combined with trastuzumab and capecitabine demonstrated an ORR of 47.3%, and in first-line treatments, the taxanes + trastuzumab + pertuzumab (THP) regimen was optimal for both PFS and OS.