A TROP2 ADC helped in non-squamous lung cancer but not squamous, and the overall survival result fell short.
TROPION-Lung01, trial NCT04656652 sponsored by AstraZeneca and Daiichi Sankyo and reported in 2023, found that the TROP2 antibody-drug conjugate datopotamab deruxtecan helped in previously treated non-squamous non-small-cell lung cancer but not in squamous disease, and that the overall survival result fell short. It randomised 604 patients to datopotamab deruxtecan or docetaxel, met its primary progression-free survival endpoint with a modest effect driven by the non-squamous subgroup, while overall survival, also a primary endpoint, was not significantly different. It led to a narrowed EGFR-mutant approval based on TROPION-Lung05 rather than an all-comers indication, and whether TROP2 ADCs have a place in lung cancer without a driver mutation 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.
605 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survival (BICR)primary | Datopotamab deruxtecan | 299 | 4.4 months | 0.75 (0.62 to 0.91) | 0.004 | link |
| Docetaxel | 305 | 3.7 months | ||||
| Overall survivalprimary | Datopotamab deruxtecan | - | 12.9 months | 0.94 (0.78 to 1.14) | - | link |
| Docetaxel | - | 11.8 months | ||||
| Progression-free survival, non-squamous | Datopotamab deruxtecan | - | 5.5 months | 0.63 (0.51 to 0.79) | - | link |
| Docetaxel | - | 3.6 months |
Shares Datopotamab deruxtecan, Daiichi Sankyo, Topoisomerase-I inhibitors (and ADC payloads), AstraZeneca.
Shares Benjamin Besse, Daiichi Sankyo, Antibody-drug conjugate (ADC), Lung cancer (all types).
Shares Datopotamab deruxtecan, PD-L1-high non-small-cell lung cancer without a driver mutation, Topoisomerase-I inhibitors (and ADC payloads), AstraZeneca.
Shares TROP2 PET to choose and sequence TROP2 ADCs, TROP2 ADC roadmap: sacituzumab govitecan → Dato-DXd → sac-TMT → bispecifics and PET, Datopotamab deruxtecan, Antibody-drug conjugate (ADC).
Shares TROP2 PET to choose and sequence TROP2 ADCs, TROP2 ADC roadmap: sacituzumab govitecan → Dato-DXd → sac-TMT → bispecifics and PET, Datopotamab deruxtecan, Daiichi Sankyo.
Shares Datopotamab deruxtecan, Topoisomerase-I inhibitors (and ADC payloads), AstraZeneca, Antibody-drug conjugate (ADC).
Shares Datopotamab deruxtecan, Topoisomerase-I inhibitors (and ADC payloads), AstraZeneca, Antibody-drug conjugate (ADC).
Shares Datopotamab deruxtecan, PD-L1-high non-small-cell lung cancer without a driver mutation, Daiichi Sankyo, Non-small-cell lung cancer.