Lancet oncol: Phase 3 | Pembrolizumab as a second and third-line therapy for metastatic triple-negative breast cancer

In the single-group KEYNOTE-012 and KEYNOTE-086 trials, pembrolizumab showed long-lasting anti-tumor activity and controllable safety in metastatic triple-negative breast cancer .

The KEYNOTE-119 trial is a randomized, open phase 3 trial that recruits patients with diagnosed metastatic triple-negative breast cancer who are at least 18 years old and have an ECOG performance status of 0 or 1 and have previously received first-line treatment for metastatic lesions.

From November 25, 2015 to April 11, 2017, a total of 1098 patients were evaluated, of which 622 (57%) were randomly assigned to the pembrolizumab group (312) or the chemotherapy group (310).

Overall survival

The median follow-up time of pembrolizumab group and chemotherapy group was 31.

The overall survival of patients with different scores of PD-L1 CPS

For patients with CPS ≥ 1, the median overall survival with pembrolizumab or chemotherapy was 10.

Adverse reactions

The most common grade 3-4 treatment-related adverse reactions are anemia (pembrolizumab group vs chemotherapy group: 1% vs 3%), leukopenia (<1% vs 5%), and decreased neutrophil count (< 1% vs 10%) and neutropenia (0 vs 13%).

In summary, the use of pembrolizumab in previously treated metastatic triple-negative breast cancer failed to significantly prolong the overall survival of patients compared with chemotherapy .

Original source:

Eric P Winer, et al.