KEYTRUDA (pembrolizumab) has demonstrated promising results in the treatment of high-risk early-stage triple-negative breast cancer (TNBC) in the Phase 3 KEYNOTE-522 trial.
KEYTRUDA, in combination with chemotherapy as pre-operative treatment followed by single-agent use after surgery, significantly improved overall survival (OS) compared to pre-operative chemotherapy alone. This landmark achievement marks the first immunotherapy-based regimen to show a statistically significant OS benefit in this patient population.
The positive OS results add to the previously reported pathological complete response and event-free survival data from the KEYNOTE-522 trial. KEYTRUDA’s safety profile remained consistent with previous studies.
This OS benefit adds to a growing body of evidence supporting KEYTRUDA’s effectiveness in earlier stages of cancer. KEYNOTE 522 is the fourth trial to demonstrate an OS benefit with KEYTRUDA-based regimens in early-stage settings, following studies in cervical cancer, non-small cell lung cancer, and renal cell carcinoma.
In the United States, KEYTRUDA is approved for two indications in TNBC: as part of neoadjuvant and adjuvant treatment for high-risk early-stage TNBC and in combination with chemotherapy for locally recurrent unresectable or metastatic TNBC with PD-L1 expression.
Merck’s ongoing clinical development program continues to explore KEYTRUDA’s role in various breast cancer subtypes, with studies evaluating its use in adjuvant treatment, high-risk early-stage estrogen receptor-positive breast cancer, and unresectable locally advanced or metastatic ER+/HER2- breast cancer.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
