Dr. Schmid on Additional Results From the KEYNOTE-522 Trial in Early-Stage TNBC

Peter Schmid, MD, PhD, FRCP, professor of cancer medicine, Royal College of Physicians, clinical director, Breast Cancer Centre, honorary consultant medical oncologist, St. Bartholomew’s Hospital, chair, Cancer Medicine, lead, Centre of Experimental Cancer Medicine, Barts Cancer Institute, discusses additional results from the phase 3 KEYNOTE-522 trial (NCT03036488) in early-stage triple-negative breast cancer (TNBC).

The KEYNOTE-522 trial randomized patients with early-stage TNBC to receive neoadjuvant pembrolizumab (Keytruda) plus chemotherapy vs placebo plus chemotherapy, followed by adjuvant pembrolizumab vs placebo. Initial findings from the study revealed that pembrolizumab/chemotherapy followed by pembrolizumab led to a statistically significant and clinically meaningful improvement in event-free survival (EFS) vs placebo/chemotherapy followed by placebo.

During the 2021 San Antonio Breast Cancer Symposium, updated findings from the study were presented, demonstrating robust treatment benefit with the experimental regimen in an EFS sensitivity analysis. Moreover, the benefit was observed irrespective of nodal status, overall disease stage, menopausal status, HER2 status, and lactate dehydrogenase.

Ultimately, these findings confirm the utility of neoadjuvant and adjuvant pembrolizumab across a wide spectrum of patients with early-stage TNBC and underscore the importance of conducting sensitivity and subgroup analyses in clinical trials, concludes Schmid.