European Commission approves Keytruda 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.
Merck Inc., announced that the European Commission has approved Keytruda Merck’s anti-PD-1 therapy, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery for adults with locally advanced or early-stage triple-negative breast cancer (TNBC) at high risk of recurrence.
The approval is based on results from the pivotal Phase III KEYNOTE-522 trial, in which Keytruda in combination with chemotherapy before surgery and continued as a single agent after surgery prolonged event-free survival (EFS), reducing the risk of EFS events or death by 37% (HR=0.63 [95% CI, 0.48-0.82]; p=0.00031) compared to neoadjuvant chemotherapy alone in this patient population. Median follow-up time for all patients was 37.8 months (range, 2.7-48).
KEYNOTE-522 was the first large, randomized Phase III study to report a statistically significant and clinically meaningful EFS result among patients with stage II and III TNBC. With this decision, this Keytruda combination becomes the first immunotherapy option approved for patients in the European Union (EU) in this setting.
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