The European Commission has approved the antibody-drug conjugate Trodelvy as a first-line treatment for adults with unresectable or metastatic triple-negative breast cancer (TNBC) who are not eligible for PD-(L)1 inhibitor therapy.
The approval is based on results from the Phase 3 ASCENT-03 trial, which showed that Trodelvy reduced the risk of disease progression or death by 38% compared with standard chemotherapy. Patients treated with Trodelvy had a median progression-free survival of 9.7 months, compared with 6.9 months for those receiving chemotherapy. The benefit was observed across all biomarker groups studied, including patients with different BRCA and TROP2 statuses.
While overall response rates were similar between the two groups, Trodelvy nearly doubled the median duration of response, extending it from 7.2 months with chemotherapy to 12.2 months. Patients receiving Trodelvy also maintained their physical functioning longer, whereas those on chemotherapy experienced a decline over time.
Although side effects were common in both treatment groups, the approval provides a new first-line option for patients with this aggressive form of breast cancer and marks an important advance in TNBC care across Europe.