OnCo
trialsTrialMixed

HERTHENA-Lung02

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delayed progression by only a few days more than chemotherapy and did not extend survival, so its US application was withdrawn.

586 patients. PFS 5.8 vs 5.4 months (HR 0.77, statistically significant but clinically marginal); OS not significant. Daiichi Sankyo and Merck withdrew the accelerated-approval BLA on 29 May 2025. A lesson that ADC activity after TKI does not guarantee benefit over platinum doublets.

Setting
EGFR-mutant NSCLC after third-generation TKI: patritumab deruxtecan vs platinum chemotherapy
Phase
Phase 3
Sponsor
Daiichi Sankyo / Merck
Registry
Headline result
PFS HR 0.77 (5.8 vs 5.4 months); OS not significant; BLA withdrawn.
Reported
2025
Enrolled
586
Replication
Did not replicate the single-arm HERTHENA-Lung01 response signal into an OS benefit; the US filing was withdrawn.

Outcomes

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In plain words
What these results mean for people, not percentages
586 people took part
Progression-free survival (BICR)primarysurrogate endpoint
  • Median 5.8 vs 5.4 months with Patritumab deruxtecan compared with Platinum + pemetrexed; about 0.4 months longer for half the group.
  • A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
  • Put another way, the treated group had about 23 percent lower chance of the event at any given time (hazard ratio 0.77, likely range 0.63 to 0.94).
  • This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
Overall survivalsurvival endpoint
  • Median 16.8 vs 16.8 months with Patritumab deruxtecan compared with Platinum + pemetrexed; about 0 months longer for half the group.
  • A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
  • Put another way, the treated group had about 2 percent lower chance of the event at any given time (hazard ratio 0.98, likely range 0.79 to 1.22).
  • The likely range for the hazard ratio crosses 1, so the difference could be due to chance.
  • Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
  • Not significant.
Be careful
  • These results apply to the people the trial enrolled: EGFR-mutant NSCLC after third-generation TKI: patritumab deruxtecan vs platinum chemotherapy. People in a different situation may not see the same effect.
  • The trial selected people by a biomarker (EGFR); the result should not be assumed for people whose cancer does not have it.

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 participants enrolled.

Progression-free survival (BICR)primary
HR 0.77 (0.63–0.94) · p = 0.011
Patritumab deruxtecan
5.8 mo
Platinum + pemetrexed
5.4 mo
Source
Overall survival
HR 0.98 (0.79–1.22)
Patritumab deruxtecan
16.8 mo
Platinum + pemetrexed
16.8 mo

Not significant

Source
EndpointArmnValueHR (95% CI)pSource
Progression-free survival (BICR)primaryPatritumab deruxtecan2935.8 months0.77 (0.63–0.94)0.011link
Platinum + pemetrexed2935.4 months
Overall survivalPatritumab deruxtecan16.8 months0.98 (0.79–1.22)link
Platinum + pemetrexed16.8 months
Replication
Did not replicate the single-arm HERTHENA-Lung01 response signal into an OS benefit; the US filing was withdrawn.

Connected

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