A HER3 ADC delayed progression by only a few days more than chemotherapy and did not extend survival, so its US application was withdrawn.
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.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
586 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survival (BICR)primary | Patritumab deruxtecan | 293 | 5.8 months | 0.77 (0.63 to 0.94) | 0.011 | link |
| Platinum + pemetrexed | 293 | 5.4 months | ||||
| Overall survival | Patritumab deruxtecan | - | 16.8 months | 0.98 (0.79 to 1.22) | - | link |
| Platinum + pemetrexed | - | 16.8 months |
Shares Patritumab deruxtecan, Daiichi Sankyo, EGFR-mutated non-small-cell lung cancer, Antibody-drug conjugate (ADC).
Shares Patritumab deruxtecan, Daiichi Sankyo, Antibody-drug conjugate (ADC), Non-small-cell lung cancer.
Shares Patritumab deruxtecan, Daiichi Sankyo, Antibody-drug conjugate (ADC).
Shares Patritumab deruxtecan, Daiichi Sankyo, Antibody-drug conjugate (ADC).
Shares Patritumab deruxtecan, HER3, Non-small-cell lung cancer.
Shares Benjamin Besse, Daiichi Sankyo, Antibody-drug conjugate (ADC), Lung cancer (all types).
Shares Patritumab deruxtecan, HER3, Non-small-cell lung cancer.
Shares Patritumab deruxtecan, Daiichi Sankyo, Antibody-drug conjugate (ADC).