When stratified by PD-L1 status, the pCR rate was 68.9% with pembrolizumab vs 54.9% with placebo in patients with PD-L1–positive disease (∆ 14.2% 95% CI, 5.3%-23.1%). The pCR rate in the overall population was 64.8% with pembrolizumab/chemotherapy vs 51.2% with placebo/chemotherapy (∆ 13.6% 95% CI, 5.4%-21.8% P =. The median follow-up was 15.3 months in the pembrolizumab arm and 15.8 months in the placebo arm.Įvent-free survival (EFS) and pCR were dual primary end points for the study pCR was defined as ypT0/Tis ypN0 disease. Following surgery, adjuvant pembrolizumab was continued for 9 cycles or until disease recurrence or unacceptable toxicity. The phase 3 KEYNOTE-522 trial randomized patients with newly diagnosed TNBC (n = 1174) 2:1 to receive 200 mg of neoadjuvant pembrolizumab (Keytruda) every 3 weeks (n = 784) or placebo (n = 390).2All patients received 4 cycles of carboplatin plus paclitaxel followed by 4 cycles of doxorubicin or epirubicin plus cyclophosphamide. We have to be careful, in anything we do, of chasing the bright, shiny object,” said Brufsky, medical director of the Magee-Women’s Cancer Program, co-director of the Comprehensive Breast Cancer Center, and associate director for clinical investigations at the University of Pittsburgh Medical Center Hillman Cancer Center. “We have to wait for before we can make a decision. Brufsky, MD, PhD, in a virtual presentation during the 38th Annual Miami Breast Cancer Conference®, an event hosted by Physician’s Education Resource®, LCC. Although phase 3 data suggest that the addition of checkpoint inhibitors to neoadjuvant chemotherapy could improve pathologic complete response (pCR) rates for patients with early-stage triple-negative breast cancer (TNBC), immature data and the risk of long-term toxicity indicate that the therapy is not ready for primetime, said Adam M.

Keynote 522 study design