# HERTHENA-Lung02

Source: https://onco.cc/trials/herthena-lung02/  
OnCo record `herthena-lung02` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A HER3 ADC delayed progression by only a few days more than chemotherapy and did not extend survival, so its US application was withdrawn.

## Summary

HERTHENA-Lung02, trial NCT05338970 sponsored by Daiichi Sankyo and Merck and reported in 2025, tested the HER3 antibody-drug conjugate patritumab deruxtecan against platinum chemotherapy in EGFR-mutant non-small-cell lung cancer after a third-generation EGFR inhibitor. It randomised 586 patients and met its primary progression-free survival endpoint, but the median gain over chemotherapy amounted to days and overall survival was no different, so the companies withdrew the accelerated approval application on 29 May 2025. OnCo links it to HER3 as a target and to Benjamin Besse, and records the trial as a lesson that antibody-drug conjugate activity after targeted therapy does not guarantee benefit over a platinum doublet, since the single-arm HERTHENA-Lung01 signal did not translate. Whether HER3 remains a viable target in this setting is the open question.

## Fields

- Kind: Trial
- Status: mixed
- Last checked: 2026-09-06
- Registry id: NCT05338970
- Phase: 3
- Setting: EGFR-mutant NSCLC after third-generation TKI: patritumab deruxtecan vs platinum chemotherapy
- Sponsor: Daiichi Sankyo / Merck
- Enrolled: 586
- Result: PFS HR 0.77 (5.8 vs 5.4 months); OS not significant; BLA withdrawn.
- Outcomes: Progression-free survival (BICR): Patritumab deruxtecan 5.8 months vs Platinum + pemetrexed 5.4 months, HR 0.77; Overall survival: Patritumab deruxtecan 16.8 months vs Platinum + pemetrexed 16.8 months, HR 0.98
- Replication: Did not replicate the single-arm HERTHENA-Lung01 response signal into an OS benefit; the US filing was withdrawn.

## Sources

- ClinicalTrials.gov NCT05338970: https://clinicaltrials.gov/study/NCT05338970
- Merck: BLA withdrawn: https://www.merck.com/news/patritumab-deruxtecan-biologics-license-application-for-patients-with-previously-treated-locally-advanced-or-metastatic-egfr-mutated-non-small-cell-lung-cancer-voluntarily-withdrawn/

## Connected records

- cancers: [EGFR-mutated non-small-cell lung cancer](https://onco.cc/cancers/egfr-mutant-nsclc/), [Lung cancer (all types)](https://onco.cc/cancers/lung-cancer/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/)
- technologies: [Antibody-drug conjugate (ADC)](https://onco.cc/technologies/adc/)
- targets: [HER3](https://onco.cc/targets/her3/)
- drugs: [Patritumab deruxtecan](https://onco.cc/drugs/patritumab-deruxtecan/)
- companies: [Daiichi Sankyo](https://onco.cc/companies/daiichi-sankyo/)
- people: [Benjamin Besse](https://onco.cc/people/benjamin-besse/)

---
JSON: https://onco.cc/api/v1/entities/herthena-lung02.json