# DESTINY-PanTumor02

Source: https://onco.cc/trials/destiny-pantumor02/  
OnCo record `destiny-pantumor02` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

DESTINY-PanTumor02 gave the HER2-directed antibody-drug conjugate Enhertu to 267 patients in seven cohorts of HER2-expressing solid tumours, endometrial and cervical cancer among them. Endometrial cancer responded best, and in April 2024 the FDA granted the first tumour-agnostic HER2 approval, for tumours with the strongest HER2 staining and no satisfactory alternative.

## Summary

DESTINY-PanTumor02, trial NCT04482309 sponsored by AstraZeneca and Daiichi Sankyo and published in JCO in 2024, showed that trastuzumab deruxtecan shrinks tumours across seven cohorts of HER2-expressing cancers, with endometrial cancer among the best responders, leading to the first tumour-agnostic HER2 approval. It was a phase 2 of 267 patients with HER2 IHC 2+ or 3+ solid tumours in seven cohorts; the endometrial cohort responded in 57.5 percent overall and 84.6 percent of IHC 3+ cases, the cervical cohort in half, and FDA accelerated approval followed in April 2024 for HER2 IHC 3+ solid tumours with no satisfactory alternative. HER2 testing is now recommended in serous endometrial carcinoma, and how far the tumour-agnostic label should reach is the open question.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT04482309
- Phase: 2
- Setting: HER2-expressing (IHC 2+/3+) solid tumours after ≥1 line, seven cohorts including endometrial and cervical: trastuzumab deruxtecan
- Sponsor: AstraZeneca / Daiichi Sankyo
- Enrolled: 267
- Result: Endometrial ORR 57.5% (84.6% in IHC 3+); cervical ORR 50%.
- Outcomes: Objective response rate, endometrial cohort: T-DXd (all HER2 IHC 2+/3+) 57.5% vs T-DXd (IHC 3+ only) 84.6%; Objective response rate, cervical cohort: T-DXd (all) 50%; Confirmed objective response by independent central review, biliary tract cancer cohort with HER2 IHC 3+ (Enhertu label): Trastuzumab deruxtecan (biliary tract, IHC 3+) 45.5%

## Notes

- Biliary tract cancer cohort: the tumour-agnostic FDA approval of April 2024 (HER2 IHC 3+ solid tumours with no satisfactory alternative) rests on this trial, and the Enhertu label table gives the biliary tract cohort with IHC 3+ as 22 patients with a confirmed response rate of 45.5 percent (95 percent confidence interval 24.4 to 67.8). Across the whole trial the IHC 3+ response rate was 51.4 percent (111 patients) with median duration of response 19.4 months. UK sites: London, Manchester and Sutton (registry). No NICE appraisal of trastuzumab deruxtecan for HER2-positive solid tumours or biliary tract cancer was found in September 2026.

## Sources

- ClinicalTrials.gov NCT04482309: https://clinicaltrials.gov/study/NCT04482309
- JCO 2024: https://ascopubs.org/doi/10.1200/JCO.23.02005
- Enhertu label (openFDA): DESTINY-PanTumor02 efficacy by tumour type: https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ENHERTU%22

## Connected records

- cancers: [Advanced or recurrent endometrial cancer](https://onco.cc/cancers/advanced-recurrent-endometrial-cancer/), [Biliary tract cancer (all types)](https://onco.cc/cancers/biliary-tract-cancer/), [Biliary tract cancer (cholangiocarcinoma)](https://onco.cc/cancers/cholangiocarcinoma/), [Cervical cancer](https://onco.cc/cancers/cervical/), [Endometrial cancer](https://onco.cc/cancers/endometrial/), [Gallbladder cancer](https://onco.cc/cancers/gallbladder/), [p53-abnormal endometrial cancer, including uterine serous carcinoma](https://onco.cc/cancers/endometrial-p53-abnormal/), [Recurrent or metastatic cervical cancer](https://onco.cc/cancers/recurrent-metastatic-cervical-cancer/), [Uterine carcinosarcoma](https://onco.cc/cancers/uterine-carcinosarcoma/)
- 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: [Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups)](https://onco.cc/terms/gallbladder-cancer-in-biliary-trials/), [Tumour-agnostic (tissue-agnostic) approval](https://onco.cc/terms/tumour-agnostic/)
- people: [Funda Meric-Bernstam](https://onco.cc/people/funda-meric-bernstam/)
- key papers: [DESTINY-PanTumor02: trastuzumab deruxtecan in HER2-expressing solid tumours](https://onco.cc/key-papers/paper-destiny-pantumor02-jco-2024/), [Efficacy and safety of trastuzumab deruxtecan in patients with HER2-expressing biliary tract or pancreatic tumors: a subgroup analysis of DESTINY-PanTumor02](https://onco.cc/key-papers/paper-oh-destiny-pantumor02-biliary-pancreatic-esmo-open-2026/)
- ideas: [HER2 ADCs as standard for HER2-positive serous endometrial cancer](https://onco.cc/ideas/idea-her2-adc-serous-endometrial/), [Reflex HER2 testing of every advanced gallbladder and extrahepatic biliary cancer](https://onco.cc/ideas/idea-gbc-reflex-her2-testing-advanced-biliary/)
- roadmaps: [Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials](https://onco.cc/roadmaps/gallbladder-cancer-roadmap/)

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