CHMP issues positive opinion for Gilead’s Trodelvy plus Keytruda in PD-L1-positive first-line metastatic triple-negative breast cancer

The CHMP of the European Medicines Agency has adopted a positive opinion recommending marketing authorisation for Trodelvy in combination with Keytruda for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer who have not yet received systemic therapy for metastatic disease and whose tumours express PD-L1 with a combined positive score of 10 or above. A European Commission decision on this indication is expected later in 2026.

Metastatic triple-negative breast cancer is an aggressive malignancy characterised by swift disease progression and a poor prognosis. Around 40% of metastatic triple-negative breast cancer tumours carry PD-L1 positivity, a feature associated with a more aggressive disease course and shorter survival, making the early initiation of effective treatment particularly urgent. For a significant proportion of those living with this most aggressive form of breast cancer, first-line therapy may represent their sole opportunity for systemic treatment.

“People with metastatic triple-negative breast cancer need effective treatment options as early as possible in the course of their disease, particularly when their tumors express PD-L1,” said Evandro de Azambuja, MD, PhD, Head of the Medical Support Team, Jules Bordet Institute and Investigator of the ASCENT-04 study. “This positive opinion is welcome news for our patients and the entire clinical community. If authorized, Trodelvy plus Keytruda would build on the recent approval of Trodelvy monotherapy and help establish a Trodelvy-based approach as a first-line treatment option for patients with metastatic triple-negative breast cancer across PD-L1 status.”

The recommendation draws on findings from the Phase 3 ASCENT-04/KEYNOTE-D19 study, which showed a highly statistically significant and clinically meaningful improvement in progression-free survival with Trodelvy plus Keytruda against the combination of standard of care chemotherapy and Keytruda as a first-line treatment in PD-L1 positive patients. Across the study population, Trodelvy plus Keytruda reduced the risk of disease progression or death by 35% in patients with PD-L1 positive metastatic triple-negative breast cancer. The trial incorporated a patient-centred crossover design, permitting those in the chemotherapy arm to access Trodelvy once their disease progressed.

“Building on our established leadership in metastatic TNBC, this positive opinion reinforces our commitment to the breast cancer community,” said Mika Kakefuda Derynck, MD, Senior Vice President, Clinical Development, Oncology, Gilead Sciences. “People with metastatic TNBC desperately need new options as early as possible. This positive opinion, coupled with the recent EMA approval of Trodelvy monotherapy, is an important step in changing outcomes for these patients.”

The European Commission has already granted approval for Trodelvy as a standalone therapy for adults with unresectable or metastatic triple-negative breast cancer who have not received prior systemic therapy for metastatic disease and are not suitable candidates for PD-1 or PD-L1 inhibitor treatment.

In the United States, the FDA has approved Trodelvy for the first-line treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer, covering its use as a single agent for those who are not candidates for PD-L1 inhibitor-based therapy, and in combination with Keytruda or Keytruda Qlex for patients whose tumours express PD-L1 at a combined positive score of 10 or above as confirmed by an FDA-authorised test.

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Related Topics and Keywords

breast cancer, CHMP, gilead, KEYTRUDA, PD-L1-positive first-line metastatic triple-negative breast cancer, positive first-line metastatic triple-negative breast cancer, Trodelvy