New research revealed tumor mutational burden was linked to improved event-free survival with pembrolizumab in early TNBC, whereas multiple biomarkers showed prognostic value.
New biomarker analyses from the phase 3 KEYNOTE-522 trial provide insights into the biological factors that may influence response to pembrolizumab plus chemotherapy in early-stage triple-negative breast cancer .San Antonio Breast Cancer Symposium 2024
The KEYNOTE-522 trial previously demonstrated that the addition of pembrolizumab to neoadjuvant chemotherapy, followed by adjuvant pembrolizumab, significantly improved pCR, EFS, and overall survival compared with chemotherapy alone in patients with high-risk, early-stage TNBC. In an interview, Sharma cautioned about overinterpreting the association between TMB and improved EFS in the pembrolizumab plus chemotherapy group. “Very few patients had high TMB, and although this exploratory analysis is intriguing, it does not inform patient practice due to such small numbers,” she said. “The criterion for high TMB used in this analysis is not something we have available in commercial assays, which report TMB on a different scale.
“High HRD is more than 16% , and low HRD is less than 16%. That has been validated with the Myriad myRisk test,” she said. Although this analysis provides valuable insights into the biological factors influencing treatment outcomes in early-stage TNBC, Sharma emphasized that “none of these biomarkers are clinically available and did not identify patients who would not benefit from addition of pembrolizumab to neoadjuvant chemotherapy” and that “these findings do not impact current patient decisions.”
Malignant Breast Neoplasm Breast Carcinoma Biomarker Biological Marker Multi-Biomarker Disease Activity MBDA Multibiomarker Disease Activity Chemotherapy PCR Polymerase Chain Reaction Polymerase Chain Reaction (PCR) Biologic Therapy Biologics Genomics Genomic Medicine Immunotherapy Triple Negative Breast Cancer Triple-Negative Breast Cancer Tumor Cancer
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