OnCo
trialsTrialMixed

TROPION-Lung01

A TROP2 ADC helped in non-squamous lung cancer but not squamous, and the overall survival result fell short.

PFS HR 0.75 overall, driven by non-squamous (HR 0.63); OS HR 0.94 not significant. Led to a narrowed EGFR-mutant approval (TROPION-Lung05) rather than all-comers.

Setting
Previously treated advanced NSCLC: Dato-DXd vs docetaxel
Phase
Phase 3
Sponsor
AstraZeneca / Daiichi Sankyo
Registry
Headline result
PFS HR 0.75; OS HR 0.94.
Reported
2023
Enrolled
604
Replication
Mixed result; the approval that followed was narrowed to EGFR-mutant NSCLC on the basis of TROPION-Lung05 (single-arm), not this trial.

Outcomes

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In plain words
What these results mean for people, not percentages
604 people took part
Progression-free survival (BICR)primarysurrogate endpoint
  • Median 4.4 vs 3.7 months with Datopotamab deruxtecan compared with Docetaxel; about 0.7 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 25 percent lower chance of the event at any given time (hazard ratio 0.75, likely range 0.62 to 0.91).
  • 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 survivalprimarysurvival endpoint
  • Median 12.9 vs 11.8 months with Datopotamab deruxtecan compared with Docetaxel; about 1.1 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 6 percent lower chance of the event at any given time (hazard ratio 0.94, likely range 0.78 to 1.14).
  • 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.
Progression-free survival, non-squamoussurrogate endpoint
  • Median 5.5 vs 3.6 months with Datopotamab deruxtecan compared with Docetaxel; about 1.9 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 37 percent lower chance of the event at any given time (hazard ratio 0.63, likely range 0.51 to 0.79).
  • 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.
Be careful
  • These results apply to the people the trial enrolled: Previously treated advanced NSCLC: Dato-DXd vs docetaxel. People in a different situation may not see the same effect.

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.

604 participants enrolled.

Progression-free survival (BICR)primary
HR 0.75 (0.62–0.91) · p = 0.004
Datopotamab deruxtecan
4.4 mo
Docetaxel
3.7 mo
Source
Overall survivalprimary
HR 0.94 (0.78–1.14)
Datopotamab deruxtecan
12.9 mo
Docetaxel
11.8 mo

Not significant

Source
Progression-free survival, non-squamous
HR 0.63 (0.51–0.79)
Datopotamab deruxtecan
5.5 mo
Docetaxel
3.6 mo
Source
EndpointArmnValueHR (95% CI)pSource
Progression-free survival (BICR)primaryDatopotamab deruxtecan2994.4 months0.75 (0.62–0.91)0.004link
Docetaxel3053.7 months
Overall survivalprimaryDatopotamab deruxtecan12.9 months0.94 (0.78–1.14)link
Docetaxel11.8 months
Progression-free survival, non-squamousDatopotamab deruxtecan5.5 months0.63 (0.51–0.79)link
Docetaxel3.6 months
Replication
Mixed result; the approval that followed was narrowed to EGFR-mutant NSCLC on the basis of TROPION-Lung05 (single-arm), not this trial.

Connected

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