# Overall Survival with Pembrolizumab in Early-Stage Triple-Negative Breast Cancer

Source: https://onco.cc/key-papers/paper-keynote-522-n-engl-j-med-2024-update/  
OnCo record `paper-keynote-522-n-engl-j-med-2024-update` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Later report from the KEYNOTE-522 trial registered as NCT03036488, in New England Journal of Medicine (2024); its title describes an updated or longer-term analysis.

## Summary

Background: In patients with early-stage triple-negative breast cancer, the phase 3 KEYNOTE-522 trial showed significant improvements in pathological complete response and event-free survival with the addition of pembrolizumab to platinum-containing chemotherapy. Here we report the final results for overall survival.

Methods: We randomly assigned, in a 2:1 ratio, patients with previously untreated stage II or III triple-negative breast cancer to receive neoadjuvant therapy with four cycles of pembrolizumab (at a dose of 200 mg) or placebo every 3 weeks plus paclitaxel and carboplatin, followed by four cycles of pembrolizumab or placebo plus doxorubicin-cyclophosphamide or epirubicin-cyclophosphamide. After definitive surgery, patients received adjuvant pembrolizumab (pembrolizumab-chemotherapy group) or placebo (placebo-chemotherapy group) every 3 weeks for up to nine cycles. The primary end points were pathological complete response and event-free survival. Overall survival was a secondary end point.

Results: Of the 1174 patients who underwent randomization, 784 were assigned to the pembrolizumab-chemotherapy group and 390 to the placebo-chemotherapy group. At the data-cutoff date (March 22, 2024), the median follow-up was 75.1 months (range, 65.9 to 84.0). The estimated overall survival at 60 months was 86.6% (95% confidence interval [CI], 84.0 to 88.8) in the pembrolizumab-chemotherapy group, as compared with 81.7% (95% CI, 77.5 to 85.2) in the placebo-chemotherapy group (P = 0.002). Adverse events were consistent with the established safety profiles of pembrolizumab and chemotherapy.

Conclusions: Neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab resulted in a significant improvement, as compared with neoadjuvant chemotherapy alone, in overall survival among patients with early-stage triple-negative breast cancer. (Funded by Merck Sharp and Dohme, a subsidiary of Merck [Rahway, NJ]; KEYNOTE-522 ClinicalTrials.gov number, NCT03036488.).

Indexed on Europe PMC as PubMed record 39282906 (DOI 10.1056/nejmoa2409932). Its abstract cites the registry id NCT03036488, which is how it was matched to this trial; no figure has been checked by an editor.

## Fields

- Kind: Key paper
- Last checked: 2026-09-22
- Tags: europepmc-ingest
- Journal: New England Journal of Medicine
- Year: 2024
- DOI: 10.1056/nejmoa2409932
- Authors: Schmid P, Cortes J, Dent R, et al.
- What it means: A second publication from the KEYNOTE-522 trial, later than the first and described in its title as an update or longer-term analysis. Read it with the primary publication linked from the trial page; the record was linked automatically and its figures have not been checked by hand.
- Caveats: Matched to the trial by the registry id cited in the Europe PMC record; the summary reproduces the record's abstract and no figure has been verified against the full paper.; Chosen as a later report by words in its title (updated, long-term, final, overall survival or a year count), not by reading the paper.

## Sources

- N Engl J Med 2024: https://doi.org/10.1056/nejmoa2409932
- PubMed: https://pubmed.ncbi.nlm.nih.gov/39282906/
- Europe PMC: https://europepmc.org/article/MED/39282906
- ClinicalTrials.gov NCT03036488: https://clinicaltrials.gov/study/NCT03036488

## Connected records

- trials: [KEYNOTE-522](https://onco.cc/trials/keynote-522/)
- journals: [New England Journal of Medicine](https://onco.cc/journals/nejm/)

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