Gilead Reports Topline P-III (ASCENT-04/KEYNOTE-D19) Trial Data of Trodelvy Regimen for Previously Untreated Triple-Negative Breast Cancer (TNBC)
Shots:
- The P-III (ASCENT-04/KEYNOTE-D19) trial assessed Trodelvy (10mg/kg, IV, Day 1 & 8 of 21-day cycle) + Keytruda (200mg, IV, Day 1 of 21-day cycle) vs Keytruda + CT in pts (n=443) with inoperable, locally advanced or metastatic TNBC expressing PD-L1 (CPS ≥ 10)
- Trial showed improved PFS (1EP); OS (2EP) was immature but showed early positive trend & will be assessed with continued follow-up. Data to be presented in future meetings & discussed with regulatory authorities
- Trodelvy is being investigated in 3 ongoing P-III trials: ASCENT-03 for 1L mTNBC pts ineligible for PD-L1 based therapy, ASCENT-05 for early-stage TNBC & ASCENT-07 for HR+/HER2- mBC pts post endocrine therapy
Ref: Gilead | Image: Gilead
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