The European Commission (EC) has granted marketing authorization to sacituzumab govitecan-hziy (Trodelvy) in combination with pembrolizumab (Keytruda) for the treatment of adult patients with unresectable, locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic disease and whose tumors express PD-L1 with a combined positive score (CPS) of 10 or higher.¹
This approval was based on findings from the phase 3 ASCENT-04/KEYNOTE-D19 trial (NCT05382286). Findings showed that the median progression-free survival (PFS) by blinded independent central review (BICR) was 11.2 months (95% CI, 9.3-16.7) with sacituzumab govitecan plus pembrolizumab vs 7.8 months (95% CI, 7.3-9.3) with chemotherapy plus pembrolizumab (HR, 0.65; 95% CI, 0.51-0.84; P = .0009).² The respective objective response rates (ORRs) were 61% (95% CI, 55%-68%) and 55% (95% CI, 48%-62%). The overall survival (OS) data were immature at the time of the analysis.
The decision follows the June 23, 2026, EC approval of sacituzumab govitecan monotherapy for the treatment of adult patients with unresectable, locally advanced or metastatic TNBC who have not received prior systemic therapy for metastatic disease and who are not candidates for PD-1/PD-L1 inhibitor therapy.3 This regulatory decision was based on data from the phase 3 ASCENT-03 trial (NCT05382299).
“The approval of [sacituzumab govitecan] plus [pembrolizumab] represents a meaningful advance in the treatment of patients with PD-L1–positive metastatic TNBC [mTNBC],” Evandro de Azambuja, MD, PhD, head of the Medical Support Team at the Jules Bordet Institute in Brussels, Belgium, and an investigator of the ASCENT-04 study, stated in a news release.¹ “This regimen helps redefine a standard of care by offering a novel first-line treatment option for a metastatic patient population with a particularly aggressive form of breast cancer.”
What was the design of ASCENT-04?
This trial enrolled patients with previously untreated, locally advanced or metastatic TNBC who had at least a 6-month interval since their last treatment in the curative setting.4 Patients were randomly assigned 1:1 to be treated with intravenous sacituzumab govitecan at 10 mg/kg on days 1 and 8 of each 21-day cycle, in combination with pembrolizumab at 200 mg on day 1 of each cycle; or chemotherapy in combination with investigator’s choice of paclitaxel, nab-paclitaxel (Abraxane), or gemcitabine plus carboplatin, plus pembrolizumab at the same dose and schedule.
