The phase III KEYNOTE-522 trial investigating Keytruda in combination with chemotherapy as neoadjuvant treatment and then continuing as an adjuvant treatment after surgery met its dual primary endpoint of event-free survival for the treatment of patients with high-risk early-stage triple-negative breast cancer.
Early endpoints have the potential to get effective drugs to patients faster, but granting approval to drugs—even accelerated approval—comes with the risk that ineffective or even harmful drugs will be given to patients.
