
Trodelvy trumps Datroway again

Gilead’s TROP2-targeting ADC Trodelvy has already prevailed in one first-line triple-negative breast cancer setting, and now it’s apparently succeeded in another. On Friday Gilead toplined as positive the pivotal Ascent-03 study, in patients ineligible for PD-(L)1 inhibition – meaning they’re PD-L1 negative, have already received a checkpoint inhibitor in the (neo)adjuvant setting, or have comorbidities preventing checkpoint inhibitor use. This is another win for Trodelvy in its battle against AstraZeneca and Daiichi’s Datroway; the latter has yet to see data from its analogous trial, Tropion-Breast02, although these are imminent. However, Gilead only noted a “highly statistically significant and clinically meaningful improvement” on the primary endpoint of PFS; on overall survival the company said “no OS detriment was observed”, but added that the data were immature. More will become clear when full results are presented at a future medical meeting. Last month Gilead scored in another first-line TNBC study, Ascent-04, evaluating Trodelvy plus Keytruda in PD-L1-positive patients; data from that trial will feature as a late-breaker at ASCO. Again, a pivotal study of Datroway in a similar setting, Tropion-Breast05, has yet to read out.
Pivotal Trodelvy trials in TNBC
Trial | Setting | Regimen | Timing | Analogous Datroway trial |
---|---|---|---|---|
Ascent-03 | 1st-line TNBC (PD-L1-ineligible) | Monotherapy, vs chemo | Toplined positive for PFS in May 2025; "no OS detriment" | Tropion-Breast02, data due H1 2025 (from H2 2024) |
Ascent-04 (Keynote-D19) | 1st-line TNBC (PD-L1+ve) | + Keytruda, vs Keytruda + chemo | Toplined positive for PFS in Apr 2025; trend to OS improvement; full data at ASCO 2025 | Tropion-Breast05, data due 2026 |
Ascent-05 | Adjuvant TNBC (following neoadjuvant therapy) | + Keytruda, vs Keytruda +/- chemo | Completes Jun 2027 | Tropion-Breast03, data due >2026 |
Source: OncologyPipeline & clinicaltrials.gov.
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