Skip to main content
x

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

TrialSettingRegimenTimingAnalogous Datroway trial
Ascent-031st-line TNBC (PD-L1-ineligible)Monotherapy, vs chemoToplined 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 + chemoToplined positive for PFS in Apr 2025; trend to OS improvement; full data at ASCO 2025Tropion-Breast05, data due 2026
Ascent-05Adjuvant TNBC (following neoadjuvant therapy)+ Keytruda, vs Keytruda +/- chemoCompletes Jun 2027Tropion-Breast03, data due >2026

Source: OncologyPipeline & clinicaltrials.gov.

Tags

Molecular Drug Targets