• 1

    LBA8: KEYNOTE-522: Phase 3 Study of Pembrolizumab + Chemotherapy versus Placebo + Chemotherapy as Neoadjuvant Treatment, Followed by Pembrolizumab versus Placebo as Adjuvant Treatment for Early Triple-Negative Breast Cancer (TNBC) Schmid et al.

  • 2

    LBA9: Phase 3 study of veliparib with carboplatin and paclitaxel in HER2-negative advanced/metastatic gBRCA-associated breast cancer: BROCADE3 Dieras et al.


Discussion of KEYNOTE-522 and BROCADE3

Phase 3 Studies and take home messages

Summary of BROCADE3

  • Veliparib+Carbo+Paclitaxel followed by veliparib continuation monotherapy significantly improved PFS in germline BRCA associated BCs.
  • Main AE was ≥3 Thrombocytopenia (40% vs 28%)
  • Veliparib monotherapy was well tolerated
  • No significant OS benefit (analysis immature)
  • Hard to know if the effect observed is due to upfront V-chemo combination and/or continuation phase of monotherapy

Summary of KEYNOTE-522

  • KN522 shows statistically significant improvement when pembrolizumab is added to a solid neoadjuvant control arm
  • Carbo control arm pCR is about right
  • Promising but very early EFS: unclear what a pCR increase with IO will translate to EFS improvement.

  • High rates of PD-L1 positivity in early stage >80% (unlike late stage >40% SP142)
    • PD-L1 pos vs neg effects
    • ? Role of assay, role of chemotherapy, pCR rates in higher CPS scores?

Many other questions are raised such as:

  • Do all early stage TNBC need AC-TC-pembro?
  • Working out Dose and scheduling
  • Chemo: what is additive or synergistic or even detrimental?
  • IO agents: what is the best scheduling and duration of PD-(L)1 agents ?
  • Further biomarker analysis – TIL composition, WES, germline BRCA status, TNBC subtypes

This event is sponsored by: :



Sherene Loi MBBS (Hons), PhD, FRACP, FAHMS

Medical Oncologist and & Head, Breast Cancer ...

Melbourne, VICTORIA, Australia

Professor Sherene Loi's research interest is to translate interesting scientific findings into innovative treatment approaches.

Comments (0)