KEYNOTE-522 Trial: Pembrolizumab Boosts Survival in Early TNBC

Peter Schmid, MD, PhD, of Barts Cancer Institute at Queen Mary University in London, United Kingdom, discusses the background, methods, and design of the phase 3 KEYNOTE-522 trial (NCT03036488).

In the randomized, double-blind, phase 3 study, experts explored treatment with neoadjuvant pembrolizumab (Keytruda) plus chemotherapy, followed by adjuvant pembrolizumab, in patients aged 18 years and older with early-stage triple-negative breast cancer.

Updated findings from the study were presented at the 2024 ESMO Congress and showed Results from the phase 3 KEYNOTE-522 trial (NCT03036488) in patients with early-stage triple-negative breast cancer (TNBC) showed that neoadjuvant pembrolizumab with chemotherapy, followed by adjuvant pembrolizumab, led to a statistically significant improvement in overall survival vs neoadjuvant chemotherapy plus placebo, followed by adjuvant placebo.

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0:09 | The KEYNOTE-522 trial was designed to look into the benefit of pembrolizumab on top of chemotherapy in patients with stage II and stage III triple-negative breast cancer. Patients were randomized 2:1 to 6 months of preoperative chemotherapy, either with pembrolizumab or with placebo, followed by surgery followed by 6 months of pembrolizumab or placebo. The chemotherapy regimen chosen in this trial was what I would describe as the most effective chemotherapy regimen we have at the moment. That is really important, because the benefit of pembrolizumab, shown on top of that, is even more relevant.

0:50 | We used 12 weeks of weekly paclitaxel and carboplatin, followed by 12 weeks of AC or EC. In this clinical trial, the trial has 2 primary end points, co primary end points. The short-term end point [is] pathological complete response, which means the complete disappearance of all invasive cancer at the time of surgery, and then the long-term end point inventory survival, which means the reduction in recurrences, which is obviously the long-term benefit of the treatment.

REFERENCE:

Schmid P, Cortes J, Dent R, et al. Neoadjuvant pembrolizumab or placebo plus chemotherapy followed by adjuvant pembrolizumab or placebo for high-risk early-stage TNBC: overall survival results from the phase III KEYNOTE-522 study. Presented at: 2024 ESMO Congress; September 13-17, 2024; Barcelona, Spain. Abstract LBA4.