Dr. Burris on Investigational Approaches in TNBC

Howard A. "Skip" Burris, III, MD, FASCO, FACP, chief medical officer and president, Clinical Operations, Sarah Cannon Research Institute, 2019-2020 ASCO president-elect, and a 2014 Giant of Cancer Care^® in Drug Development, discusses investigational immunotherapy approaches in triple-negative breast cancer (TNBC).

Data from the phase III KEYNOTE-522 trial, which were presented at the 2019 ESMO Congress and 2019 San Antonio Breast Cancer Symposium (SABCS), showed that the addition of the PD-1 inhibitor pembrolizumab (Keytruda) to neoadjuvant chemotherapy increased the pathologic complete response (pCR) rate in patients with TNBC, irrespective of lymph node involvement.

Specifically, data from the 2019 ESMO Congress showed that the pCR rate was 64.8% with pembrolizumab plus chemotherapy versus 51.2% with chemotherapy alone. Although the benefit was observed irrespective of PD-L1 expression, investigators saw greater activity with pembrolizumab in patients with higher PD-L1 expression, says Burris. At the 2019 SABCS, the pCR rate among patients whose disease had spread to the lymph nodes was 64.8% and 44.1% with pembrolizumab and chemotherapy, respectively.

Furthermore, data from the phase I/II TOPACIO/KEYNOTE-162 trial, which combined niraparib (Zejula) with pembrolizumab appear encouraging, adds Burris. Among 60 evaluable patients, the objective response rate was 25%; this rate increased to 45% among the 11 evaluable patients with BRCA mutations.