Neoadjuvant Pembrolizumab/Chemotherapy Approved by European Commission for Locally Advanced, Early-Stage TNBC

European patients with locally advanced or early-stage triple-negative breast cancer at high risk of recurrence can now receive treatment with neoadjuvant pembrolizumab and chemotherapy, as well as pembrolizumab monotherapy post surgery following its approval by the European Commission.

Neoadjuvant pembrolizumab (Keytruda) and chemotherapy followed by adjuvant pembrolizumab monotherapy was approved by the European Commission for the treatment of locally advanced or early-stage triple-negative breast cancer (TNBC) at high risk of relapse, according to a press release published by Merck.1

The regulatory decision was based on findings from the phase 3 KEYNOTE-522 trial (NCT03036488), which compared the combination regimen vs placebo and chemotherapy in patients with TNBC. The experimental combination yielded a prolonged reduction in event-free survival or death of 37% (HR, 0.63; 95% CI, 0.48-0.82; P = .00031).

“[TNBC] has a high risk of recurrence within the first five years, so it’s meaningful for patients to have access to new therapies that can reduce the risk of disease progression,” Peter Schmid, FRCP, MD, PhD, lead of the Centre for Experimental Cancer Medicine, Barts Cancer Institute in London, England, said in a press release. “The approval of this [pembrolizumab] regimen marks a turning point for patients with high-risk early-stage TNBC, as they now have an immunotherapy option in early stages of the disease that has demonstrated significant improvements in pathological complete response and event-free survival compared to neoadjuvant chemotherapy.”

Neoadjuvant pembrolizumab plus chemotherapy followed by single agent pembrolizumab post surgery was approved by the FDA in July 2021 for patients with high-risk early-stage TNBC.2

References

  1. European Commission approves KEYTRUDA® (pembrolizumab) plus chemotherapy as neoadjuvant treatment, then continued as adjuvant monotherapy after surgery for locally advanced or early-stage triple-negative breast cancer at high risk of recurrence. News release. Merck. May 24, 2022. Accessed May 26, 2022. https://bit.ly/3GlOx7A
  2. FDA approves KEYTRUDA (pembrolizumab) for treatment of patients with high-risk early-stage triple-negative breast cancer in combination with chemotherapy as neoadjuvant treatment, then continued as single agent as adjuvant treatment after surgery. News release. Merck. July 27, 2021. Accessed May 26, 2022. https://bit.ly/2Vc0rgX