Onco-Summaries: Daily Oncology Updates at a Glance
- Oncofocus Team
- Jun 26
- 1 min read
23/06/2026
EC approves Trodelvy (sacituzumab govitecan) monotherapy as first-line Tx for metastatic triple-negative breast cancer patients ineligible for PD-(L)1 therapy (Ref)
Gilead Sciences announced that the European Commission granted marketing authorization for sacituzumab govitecan-hziy (Trodelvy; Trop-2-directed ADC) as monotherapy for adults with unresectable or metastatic triple-negative breast cancer (mTNBC) who have not received prior systemic therapy for metastatic disease and are not candidates for PD-1 or PD-L1 inhibitor therapy
Approval is based on results from the pivotal Phase 3 ASCENT-03/NCT05382299 trial of sacituzumab govitecan vs investigator's-choice chemotherapy (paclitaxel, nab-paclitaxel, or gemcitabine plus carboplatin) in previously untreated advanced TNBC who were not PD-(L)1 inhibitor candidates
The primary endpoint, PFS by blinded independent central review, was met: median PFS was 9.7 mos (95% CI 8.1-11.1) vs 6.9 mos (95% CI 5.6-8.2) - HR: 0.62; P<0.001
ORR: 48.0% (95% CI, 42 to 54) vs 46.0% (95% CI, 40 to 52)
mOS: 21.5 mos (95% CI, 17.7-NR) vs 20.2 (95% CI, 18.2-NR) - HR 0.98
Gr ≥3 TRAEs: 61.0% vs 53.0%
Gilead also disclosed a supplemental EMA filing for Trodelvy + Keytruda (pembrolizumab; MSD) in PD-L1-positive 1L mTNBC, based on ASCENT-04, now under review. In the US, supplemental FDA filings covering both ASCENT-03 and ASCENT-04 have been submitted
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