KEY TAKEAWAYS
- The phase 3 study analyzed the association of T-cell-inflamed gene expression profile with clinical outcomes from KEYNOTE-119.
- The pts were randomly assigned to receive either pembro for up to 35 cycles or TPC (capecitabine, eribulin, gemcitabine, or vinorelbine).
- The study’s findings revealed a positive association between GEP and clinical outcomes in pts with mTNBC who are treated with pembro.
The study involved an exploratory analysis to investigate the correlation between T-cell inflamed gene expression profile (GEP) and clinical outcomes from KEYNOTE-119.
It involved patients (pts) with centrally confirmed metastatic triple-negative breast cancer (mTNBC), ECOG PS ≤1, and 1-2 prior systemic treatments for metastatic breast cancer. The pts were randomized 1:1 to receive either pembro 200 mg Q3W for up to 35 cycles or TPC (capecitabine, eribulin, gemcitabine, or vinorelbine). Tumor RNA profiling was conducted on the RNA-seq platform (Illumina, San Diego, CA). The relationship between GEP and clinical outcomes was assessed using logistic regression (best objective response [BOR] per RECIST v1.1) and Cox proportional hazards models (PFS and OS) with baseline adjustment for ECOG PS. The Clopper and Pearson method was used to estimate 95% CIs for BOR.
The GEP analysis conducted on 333 pts(pembro, n=177; TPC, n=156) as of April 11, 2019, revealed a significant correlation between GEP and improved BOR, PFS, and OS in pts treated with pembro, but not TPC. HR for OS in pts with GEP non-low (≥1st tertile) was 0.77 (95% CI, 0.58–1.04), while in pts with GEP low (<1st tertile), it was 1.72 (1.15–2.55). It’s crucial to mention that no relationship was observed between BRCA/HRD status and treatment response.
The study suggested a direct correlation between GEP and clinical outcomes in pts with mTNBC who were administered pembro treatment, particularly in the GEP-enriched group. These results are of immense significance in steering future investigations of biomarker status and its influence on patient outcomes in this population.
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT02555657
Cortes, J., Lipatov, O., Im, S., Gonçalves, A., Lee, K.S., Schmid, P., Tamura, K., Testa, L., Ohtani, S., Harbeck, N., Loi, S., Salgado, R.F., Lunceford, J., Karantza, V., Mejia, J.A., Cristescu, R., Nebozhyn, M., Jelinic, P., Huang, L., Winer, E.P. Annals of Oncology (2023) 8 (1suppl_4): 101223-101223. 10.1016/esmoop/esmoop101223.
