NEJM: Addition of pembrolizumab before and after surgery significantly improves survival in early-stage triple-negative breast cancer

KEYNOTE-522 is a Phase 3 clinical trial designed to evaluate the prognostic impact of the addition of the immune checkpoint inhibitor pembrolizumab to neoadjuvant chemotherapy compared with neoadjuvant chemotherapy alone in patients with early-stage triple-negative breast cancer
.

Preliminary analysis showed that the addition of pembrolizumab to a neoadjuvant chemotherapy regimen significantly improved the rate of pathological complete response (defined as the absence of invasive cancer in both breast and lymph nodes) in

To evaluate the effect of the addition of the immune checkpoint inhibitor pembrolizumab to neoadjuvant chemotherapy compared with neoadjuvant chemotherapy alone on prognosis in patients with early-stage triple-negative breast cancer immune breast cancer (definition: absence of invasive cancer in both breast and lymph nodes)

The other primary endpoint of the trial, event-free survival, is reported here
.

The trial randomized patients with previously untreated stage II or III triple-negative breast cancer in a 2:1 ratio to receive neoadjuvant chemotherapy + 4 cycles of pembrolizumab (200 mg) or placebo + paclitaxel and carboplatin, followed by 4 cycles of pembrolizumab or placebo + doxorubicin-cyclophosphamide or epirubicin-cyclophosphamide
.

After radical surgery, patients continued to receive adjuvant chemotherapy plus pembrolizumab or placebo for 9 cycles (1 cycle/3 weeks)

Event-free survival in the two groups

Event-free survival in the two groups

A total of 1174 patients were enrolled, of which 784 were assigned to the pembrolizumab-chemotherapy group and 390 to the placebo-chemotherapy group
.

As of March 23, 2021 (at the fourth scheduled interim analysis), the median follow-up was 39.

At month 36, the estimated event-free survival rates for the pembrolizumab-chemotherapy and placebo-chemotherapy groups were 84.

Overall survival of the two groups of patients

Overall survival of the two groups of patients

In conclusion, for patients with early-stage triple-negative breast cancer, neoadjuvant pembrolizumab combined with chemotherapy, plus postoperative pembrolizumab adjuvant therapy, can significantly improve event-free productivity compared with neoadjuvant chemotherapy alone
.

For patients with early-stage triple-negative breast cancer, neoadjuvant pembrolizumab combined with chemotherapy, plus postoperative adjuvant pembrolizumab, significantly improved event-free productivity compared with neoadjuvant chemotherapy alone
.

For patients with early-stage triple-negative breast cancer, neoadjuvant pembrolizumab combined with chemotherapy, plus postoperative adjuvant pembrolizumab, significantly improved event-free productivity compared with neoadjuvant chemotherapy alone

Original source:

Peter Schmid, et al.

Event-free Survival with Pembrolizumab in Early Triple-Negative Breast Cancer.
Leave a Comment here