What question did this study set out to answer?

This research aimed to evaluate the efficacy of pembrolizumab combined with paclitaxel in patients with HR+/HER2- metastatic breast cancer enriched based on tumor mutational burden.

February 19, 2026Clinical Cancer Research

Abstract PS1-11-05: Phase II trial of pembrolizumab in combination with paclitaxel in the hormone receptor-positive metastatic breast cancer enriched with tumor mutational burden determined by whole exome sequencing: Korean Cancer Study Group trial (KCSG BR20-16)

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This research aimed to evaluate the efficacy of pembrolizumab combined with paclitaxel in patients with HR+/HER2- metastatic breast cancer enriched based on tumor mutational burden.
Multicenter, single-arm, phase II trial design.
Patients with HR+/HER2- metastatic breast cancer resistant to endocrine therapy were prescreened for tumor mutational burden.
Whole-exome sequencing of tumor biopsies was performed to calculate tumor mutational burden.
Patients treated with pembrolizumab and paclitaxel until disease progression or toxicity warranted discontinuation.
The investigator-assessed objective response rate was 65.2%.
Median progression-free survival was 7.5 months with a follow-up of 13.5 months.
Patients with immune-related adverse events experienced longer progression-free survival compared to those without (9.1 vs. 5.8 months).
Tumor mutational burden was positively correlated with tumor reduction, indicating higher TMB linked to greater efficacy of treatment.

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Implication

Phase II trial evaluates pembrolizumab plus paclitaxel in hormone receptor-positive metastatic breast cancer, suggesting feasible treatment strategies.

Cite This Study

Sohn et al. (2026) studied this question.

synapsesocial.com/papers/6996a83eecb39a600b3eeca0 https://doi.org/10.1158/1557-3265.sabcs25-ps1-11-05

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Implication

Phase II trial evaluates pembrolizumab plus paclitaxel in hormone receptor-positive metastatic breast cancer, suggesting feasible treatment strategies.

Abstract PS1-11-05: Phase II trial of pembrolizumab in combination with paclitaxel in the hormone receptor-positive metastatic breast cancer enriched with tumor mutational burden determined by whole exome sequencing: Korean Cancer Study Group trial (KCSG BR20-16)

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Discussion

Implication

Cite This Study

Abstract PS1-11-05: Phase II trial of pembrolizumab in combination with paclitaxel in the hormone receptor-positive metastatic breast cancer enriched with tumor mutational burden determined by whole exome sequencing: Korean Cancer Study Group trial (KCSG BR20-16)

Key Points

Discussion

Implication

Cite This Study

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