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Pertuzumab plus Trastuzumab for HER2-Amplified Colorectal Cancer
Dual-targeted HER2 therapy with pertuzumab and trastuzumab has shown activity in patients with HER2-amplified metastatic colorectal cancer (mCRC; NEJM JW Oncol Hematol May 2019 and Lancet Oncol 2019; 20:518).
To evaluate this approach further, investigators conducted an industry-funded, prospective, phase 2 basket trial (TAPUR) that assessed the use of pertuzumab and trastuzumab in previously treated mCRC patients who had HER2 amplification and/or HER2/3 mutation, the presence of which is seen in only 5% to 10% of mCRC patients. Of the 38 patients in the trial, 74% were HER2-amplified with or without HER2/3 mutation, 26% had only HER2/3 mutation, 68% had left-sided colon or rectal primaries, 84% had received ≥3 prior lines of therapy, and 29% had KRAS mutation.
In the HER2-amplified group, the disease-control rate (the primary end point) was 54%, rejecting the null hypothesis of a 15% disease-control rate, and the objective response rate was 25%. Median progression-free survival was 17.2 weeks, and overall survival was 60.0 weeks. Patients with HER2/3 mutation did not respond to treatment, nor did patients with KRAS or BRAF mutation. No new safety signals were observed.
These results further identify HER2 amplification in mCRC as targetable with HER2 combination therapy. Of note, no responses were seen in patients with HER2/3 mutations, and the presence of RAS or BRAF mutation conveyed therapy resistance. The TAPUR trial supports prior reports of activity for HER2-directed combination therapies, and potential use of these therapies is endorsed by U.S. National Comprehensive Cancer Network guidelines.
Gupta R et al.
Title: Pertuzumab plus trastuzumab in patients with colorectal cancer with ERBB2 amplification or ERBB2/3 mutations: Results from the TAPUR study.
Source: JCO Precis Oncol 2022 Oct ; [e-pub]. (Abstract/FREE Full Text)