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Association details:
| Biomarker: | RAS wild-type + HER-2 positive |
|---|---|
| Cancer: | Colorectal Cancer |
| Drug: | Herceptin (trastuzumab) (HER2 inhibitor) + Tukysa (tucatinib) (HER2 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
FDA grants accelerated approval to tucatinib with trastuzumab for colorectal cancer
Published date:
01/19/2023
Excerpt:
...Food and Drug Administration (FDA) granted accelerated approval to tucatinib (Tukysa, Seagen Inc.) in combination with trastuzumab for RAS wild-type HER2-positive unresectable or metastatic colorectal cancer that has progressed following fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
Source:
Excerpt:
TUKYSA is a kinase inhibitor 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.
Source:
Title:
A Study of Tucatinib and Trastuzumab in People With Rectal Cancer
Excerpt:
...The primary objective of this trial is to determine the clinical complete response rate after the completion of initial neoadjuvant tucatinib and trastuzumab followed by standard of care induction chemotherapy (assessed around week 21 ± 4 weeks) in subjects with HER2-positive, RAS wild-type locally advanced rectal adenocarcinoma...
Trial ID:
Source:
Title:
551O - Impact of baseline molecular alterations on the efficacy of tucatinib (TUC) plus trastuzumab (Tras) for HER2+, RAS WT metastatic CRC (mCRC) in MOUNTAINEER
Published date:
10/16/2023
Excerpt:
This exploratory analysis of the MOUNTAINEER trial found generally consistent clinical efficacy of TUC + Tras to the primary analysis across subsets of pts w/ HER2+ RAS-WT mCRC and other clinically relevant genomic alterations.
Trial ID:
Source:
Title:
Tucatinib plus trastuzumab for chemotherapy-refractory, HER2-positive, RAS wild-type unresectable or metastatic colorectal cancer (MOUNTAINEER): a multicentre, open-label, phase 2 study
Published date:
05/01/2023
Excerpt:
We assessed the activity of tucatinib plus trastuzumab in patients with chemotherapy-refractory, HER2-positive, RAS wild-type unresectable or metastatic colorectal cancer....Tucatinib plus trastuzumab had clinically meaningful anti-tumour activity and favourable tolerability.
DOI:
10.1016/S1470-2045(23)00150-X
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:
