Study shows efficacy of dual-HER2 targeted therapy for patients with HER2-positive colorectal cancerInvestigator-initiated trial based on GI-SCREEN-Japan/GOZILA study may lead to the world's first effective treatment for HER2-positive colorectal cancer

November 12, 2021
National Cancer Center Japan
Japan Agency for Medical Research and Development
in Japanese

Highlights

• National Cancer Center Hospital East (Director: Atsushi Ohtsu), the National Cancer Center (President: Hitoshi Nakagama) conducted an investigator-initiated clinical trial (TRIUMPH study, EPOC1602) to evaluate the efficacy and safety of the combination of pertuzumab and trastuzumab, an anti-HER2 antibody therapy, in patients with HER2-positive colorectal cancer confirmed by tumor tissue analysis or liquid biopsy.
• This trial showed that a tumor response was achieved in approximately 30% of patients, confirming that the results exceeded the predetermined efficacy criteria.
• The results of the TRIUMPH study were also compared with those of patients with HER2-positive colorectal cancer who met the same criteria in the SCRUM-Japan Registry and suggested that the combination therapy may have superior efficacy compared with conventionally used anti-cancer treatment. The TRIUMPH study was the first clinical trial in the world to show the efficacy of the combination therapy in patients with HER2-positive colorectal cancer prospectively confirmed by liquid biopsy.
• Longitudinal liquid biopsies revealed several characteristics that indicate a high likelihood of efficacy, suggesting that repeated liquid biopsies may be useful in predicting treatment efficacy.

The results have been published online in "Nature Medicine" on 12 November 2021, Japan time.

Prospects

The results of this trial are expected to lead to the world's first effective treatment for patients with HER2-positive colorectal cancer patients. In addition, liquid biopsy may be utilized for the selection of therapeutic drugs for colorectal cancer patients, prediction of efficacy, and discovery of resistance factors.

Publication

Journal name

Nature Medicine

Title

Circulating tumor DNA-guided treatment with pertuzumab plus trastuzumab for metastatic colorectal cancer with HER2 (ERBB2) amplification: the TRIUMPH phase 2 Trial (EPOC1602)

Authors

Yoshiaki Nakamura, Wataru Okamoto, Takeshi Kato, Taito Esaki, Ken Kato, Yoshito Komatsu, Satoshi Yuki, Toshiki Masuishi, Tomohiro Nishina, Hiromichi Ebi, Kentaro Sawada, Hiroya Taniguchi, Nozomu Fuse, Shogo Nomura, Makoto Fukui, Seiko Matsuda, Yasutoshi Sakamoto, Hiroshi Uchigata, Kana Kitajima, Naomi Kuramoto, Takashi Asakawa, Steve Olsen, Justin I. Odegaard, Akihiro Sato, Satoshi Fujii, Atsushi Ohtsu, Takayuki Yoshino

DOI

10.1038/s41591-021-01553-w

URL

https://www.nature.com/articles/s41591-021-01553-w

Publication date

12 November,2021

Support

Japan Agency for Medical Research and Development (AMED)

• Project Promoting Clinical Trials for Development of New Drugs
  "Investigator initiated trial in HER2-positive unresectable and recurrent colorectal cancer utilizing the Nation-wide genome screening consortium (SCRUM-Japan) patient registry" (Principal Investigator: Takayuki Yoshino)（JP20lk0201054）
• Practical Research for Innovative Cancer Control
  "Creation of Comprehensive Catalog on Clonal Evolution of Cancer Genome Alteration in Metastatic Colorectal Cancer Utilizing Circulating Tumor DNA Analysis" (Principal Investigator: Yoshiaki Nakamura)（JP20ck0106445）
• Project Promoting Clinical Trials for Development of New Drugs
  "Constructing a cancer registry based on the nation-wide genome screening project (SCRUM-Japan) for new oncology agent development" (Principal Investigator: Atsushi Ohtsu)（JP18lk0201056）

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