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Tucatinib

(Tukysa®)

Tucatinib

Drug updated on 10/28/2024

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 HER2-positive breast cancer with brain metastases (HR (hazard ratio) 0.64; 95% CI (confidence interval): 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 overall survival (OS), tucatinib-based regimens consistently ranked highly, particularly in second-line treatment settings, outperforming other HER2-targeted therapies like 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 progression-free survival (PFS) and objective response rates (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 overall survival (OS).