# DESTINY-CRC02

Source: https://onco.cc/trials/destiny-crc02/  
OnCo record `destiny-crc02` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Enhertu shrank about four in ten heavily pretreated HER2-positive bowel cancers, including ones that had already stopped responding to other HER2 drugs.

## Summary

DESTINY-CRC02, trial NCT04744831 sponsored by Daiichi Sankyo and AstraZeneca and reported in 2023, showed that trastuzumab deruxtecan shrinks about four in ten heavily pretreated HER2-positive metastatic colorectal cancers, including ones that had already stopped responding to other HER2 drugs. It randomised 122 patients to 5.4 or 6.4 mg/kg, with confirmed response rates of 37.8 and 27.5 percent respectively, responses regardless of prior HER2 therapy or RAS status, and the data supported the 2024 tumour-agnostic HER2 IHC 3+ accelerated approval, which covers colorectal cancer at the lower dose. OnCo links it to colorectal cancer, HER2 as a target, trastuzumab deruxtecan and the tumour-agnostic approval term, and the result is consistent with DESTINY-CRC01. Without a randomised comparison, whether the drug improves survival over other HER2 combinations is the open question.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT04744831
- Phase: 2
- Setting: Pretreated HER2-positive metastatic colorectal cancer: T-DXd 5.4 vs 6.4 mg/kg
- Sponsor: Daiichi Sankyo / AstraZeneca
- Enrolled: 122
- Result: ORR 37.8% (5.4 mg/kg).
- Outcomes: Objective response rate: T-DXd 5.4 mg/kg 37.8 percent vs T-DXd 6.4 mg/kg 27.5 percent
- Replication: Consistent with DESTINY-CRC01 (ORR 45% in IHC3+/ISH+).

## Sources

- ClinicalTrials.gov NCT04744831: https://clinicaltrials.gov/study/NCT04744831

## Connected records

- cancers: [Colorectal cancer](https://onco.cc/cancers/colorectal/), [HER2-amplified colorectal cancer](https://onco.cc/cancers/her2-amplified-colorectal/)
- technologies: [Antibody-drug conjugate (ADC)](https://onco.cc/technologies/adc/), [Topoisomerase-I inhibitors (and ADC payloads)](https://onco.cc/technologies/topoisomerase-inhibitors/)
- targets: [HER2](https://onco.cc/targets/her2/)
- drugs: [Trastuzumab deruxtecan](https://onco.cc/drugs/trastuzumab-deruxtecan/)
- companies: [AstraZeneca](https://onco.cc/companies/astrazeneca/), [Daiichi Sankyo](https://onco.cc/companies/daiichi-sankyo/)
- terms: [Tumour-agnostic (tissue-agnostic) approval](https://onco.cc/terms/tumour-agnostic/)
- trials: [DESTINY-CRC01](https://onco.cc/trials/destiny-crc01/), [MOUNTAINEER-03](https://onco.cc/trials/mountaineer-03/)
- key papers: [Assessment of a HER2 scoring system for colorectal cancer: results from a validation study](https://onco.cc/key-papers/paper-valtorta-her2-scoring-colorectal-heracles-mod-pathol-2015/), [Trastuzumab deruxtecan (DS-8201) in patients with HER2-expressing metastatic colorectal cancer (DESTINY-CRC01)](https://onco.cc/key-papers/paper-siena-destiny-crc01-trastuzumab-deruxtecan-lancet-oncol-2021/), [Trastuzumab deruxtecan in patients with HER2-positive advanced colorectal cancer (DESTINY-CRC02): primary results from a multicentre, randomised, phase 2 trial](https://onco.cc/key-papers/paper-destiny-crc02-lancet-oncol-2024/)

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