KEYNOTE-522 Findings Continue to Shape the Future of TNBC Care

Peter Schmid, MD, PhD, of Barts Cancer Institute at Queen Mary University in London, United Kingdom, discusses his key takeaways from the phase 3 KEYNOTE-522 trial (NCT03036488) and the updated findings presented at the 2024 ESMO Congress.

This study evaluated neoadjuvant pembrolizumab (Keytruda) plus chemotherapy, followed by adjuvant pembrolizumab, in patients with early-stage triple-negative breast cancer. According to findings presented by Schmid at the meeting, this treatment regimen generated a statistically significant improvement in overall survival (OS) vs neoadjuvant chemotherapy plus placebo, followed by adjuvant placebo.

Specifically, the perioperative pembrolizumab regimen led to a reduction in the risk of death by 34% vs the placebo regimen (HR, 0.66; 95% CI, 0.50-0.87; P = .00150), and at a median follow-up of 75.1 months, those in the pembrolizumab arm (n = 784) had a 5-year OS of rate of 86.6% (95% CI, 84.0%-88.8%) compared with 81.7% (95% CI, 77.5%-85.2%) in the placebo arm (n = 390). For the 2 arms, the OS event rates were 14.7% and 21.8%, respectively.

Transcription:

0:09 | My key takeaway from the KEYNOTE-522 trial is that this has already changed practice, but also, [and] actually, more importantly, this is changing patients' lives. We already see every day, fewer recurrences, and this is incredibly humbling to observe. The rate of metastatic triple-negative breast cancer has gone down now, not just by the incorporation initially of platinum, but by the incorporation of pembrolizumab.

0:37 | We have been able to demonstrate that patients respond better, that the recurrences are reduced, and now finally at ESMO 2024, we could also demonstrate that this reduces the risk of death associated with triple-negative breast cancer by 34%. This is, for me, practice-changing, and therefore, really important for all [of the] clinicians out there.

REFERENCE:

Schmid P, Cortes J, Dent R, et al. Neoadjuvant pembrolizumab or placebo plus chemotherapy followed by adjuvant pembrolizumab or placebo for high-risk early-stage TNBC: overall survival results from the phase III KEYNOTE-522 study. Presented at: 2024 ESMO Congress; September 13-17, 2024; Barcelona, Spain. Abstract LBA4.