Guardant Health presents data from Phase II TRIUMPH trial
Guardant Health and the National Cancer Center Hospital East present data at the European Society of Medical Oncology conference from a prospective, multi-center phase II clinical trial, TRIUMPH. The study showed that patients with metastatic colorectal cancer with a HER2 amplification detected by the Guardant360 assay experienced clinical benefit from National Comprehensive Cancer Network guideline-recommended HER2-directed combination therapy. The study included patients with RAS-wild-type mCRC refractory to standard EGFR-directed therapies, and HER2 amplification detected using standard tissue-based testing or Guardant360. An interim analysis, led by principal investigators from the National Cancer Center Hospital East in Japan, demonstrated that mCRC patients with HER2 amplification detected by Guardant360 and treated with HER2-directed combination therapy achieved an objective response rate of 33.3%. Excluding patients with known markers of resistance detected by Guardant360, the ORR was 45.5%. The overall median progression-free survival was 4.0 months, and the median duration of response was 4.2 months. Importantly, patients with HER2-amplified tumors who also had Guardant360-detected mutations in KRAS, NRAS, PIK3CA or HER2 had much poorer responses and shorter PFS. In contrast, median PFS was 5.6 months when mutations in these genes were not detected by Guardant360.