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Association details:
| Biomarker: | HER-2 positive |
|---|---|
| Cancer: | Colorectal Cancer |
| Drug: | Herceptin (trastuzumab) (HER2 inhibitor) + Tukysa (tucatinib) (HER2 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Seagen Announces TUKYSA® (tucatinib) in Combination with Trastuzumab Granted Priority Review by FDA for Previously Treated HER2-Positive Metastatic Colorectal Cancer
Published date:
09/19/2022
Excerpt:
Seagen Inc...announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) seeking accelerated approval for TUKYSA® (tucatinib) in combination with trastuzumab for adult patients with HER2-positive colorectal cancer who have received at least one prior treatment regimen for unresectable or metastatic disease....The sNDA submission is based on the results of the pivotal phase 2 MOUNTAINEER trial.
Title:
Medicines and Healthcare Products Regulatory Agency (MHRA) Authorises Seagen’s TUKYSA (tucatinib) as Part of Combination Regimen for the Treatment of Adult Patients with Locally Advanced or Metastatic HER2-Positive Breast Cancer
Excerpt:
Seagen UK Ltd. today announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation in Great Britain for TUKYSA (tucatinib) in combination with trastuzumab and capecitabine for the treatment of adult patients with HER2-positive locally advanced or metastatic breast cancer who have received at least two prior anti-HER2 treatment regimens.
Source:
Title:
A Study of Tucatinib and Trastuzumab in People With Rectal Cancer
Excerpt:
...- Have confirmed HER2-positive rectal adenocarcinoma, as defined by having tumor tissue tested at a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory, meeting at least one of the following criteria: 1....
Trial ID:
Source:
Title:
LBA27 - Additional analyses of MOUNTAINEER: A phase II study of tucatinib and trastuzumab for HER2-positive mCRC
Published date:
09/05/2022
Excerpt:
As of 28 Mar 2022, 86 pts received ≥1 dose of study treatment in cohorts A+B and 30 pts in cohort C. The ORR by week 12 in cohort C was 3.3% (95% CI, 0.1, 17.2) with DCR of 80.0%. Twenty-eight of 30 pts (93.0%) crossed over to received TUC + Tras, with cORR of 17.9% (95% CI, 6.1, 36.9).TUC monotherapy and TUC + Tras after crossover were well tolerated, consistent with the primary analysis. Disease stabilization was observed in most pts on TUC monotherapy; radiographic responses increased slightly after Tras addition. Monotherapy, crossover, and response data from the primary analysis show that concurrent initiation of dual HER2 blockade with TUC + Tras achieves optimal clinical benefit.
Trial ID:
