PD-L1 in triple-negative breast cancer

3 EU-approved indications in triple-negative breast cancer need a PD-L1 result: pembrolizumab (1st line, advanced), sacituzumab govitecan (1st line, advanced) and atezolizumab (1st line, advanced).
Approved indications, Triple-negative breast cancer
DrugBiomarker requirementRegimenSettingConditions
PD-L13
Atezolizumab
Tecentriq
IC ≥ 1%
+ nab-paclitaxel
1L
advanced
No prior chemotherapy for metastatic disease
CPS ≥ 10
+ chemotherapy
1L
advanced
No prior chemotherapy for metastatic disease
CPS ≥ 10
+ pembrolizumab
1L
advanced
No prior systemic therapy for metastatic disease

4 approvals for TNBC need no biomarker and apply whatever the result. All approvals for TNBC

See also

Label wording3

The sentence from section 4.1 of the SmPC that each indication above comes from.

  1. Pembrolizumab (Keytruda)
    KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic triple-negative breast cancer in adults whose tumours express PD-L1 with a CPS ≥ 10 and who have not received prior chemotherapy for metastatic disease (see section 5.1).
  2. Sacituzumab govitecan (Trodelvy)
    in combination with pembrolizumab, 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 tumours express PD-L1 with a combined positive score (CPS) ≥ 10 (see sections 4.2 and 5.1).
  3. Atezolizumab (Tecentriq)
    Tecentriq in combination with nab-paclitaxel is indicated for the treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumours have PD-L1 expression ≥ 1% and who have not received prior chemotherapy for metastatic disease.