![]() ![]() In a prespecified exploratory analysis among patients who achieved pathologic complete response, event-free survival events occurred in 27 (5.5%) of 494 (5.5%) vs 16 (7.4%) of 217 patients (HR = 0.73, 95% CI = 0.39–1.36) estimated 36-month event-free survival rates were 94.4% vs 92.5%. In subgroup analyses, hazard ratios were: 0.65 (95% CI = 0.46–0.91) among 408 vs 196 patients with positive nodal status and 0.58 (95% CI = 0.37–0.91) among 376 vs 194 with negative nodal status, and 0.67 (95% CI = 0.49–0.92) among 656 vs 317 with PD-L1–positive disease (combined positive score ≥ 1) and 0.48 (95% CI = 0.28–0.85) among 128 vs 69 with PD-L1–negative status. The hazard ratio for distant progression and distant recurrence–free survival was 0.61 (95% CI = 0.46–0.82), with estimated 36-month rates of 87.0% vs 80.7%. First events consisted of progression of disease that precluded definitive surgery in 1.8% vs 3.8% of patients, local recurrence in 3.6% vs 4.4%, distant recurrence in 7.7% vs 13.1%, second primary cancer in 0.8% vs 1.0%, and death from any cause in 1.9% vs 1.5%. An event-free survival event occurred in 123 patients (15.7%) in the pembrolizumab group and 93 (23.8%) in the control group (hazard ratio = 0.63, 95% confidence interval = 0.48–0.82, P <. Median follow-up at the fourth planned interim analysis (data cutoff in March 2021) was 39.1 months (range = 30.0–48.0 months). A prior report from the study showed that the addition of pembrolizumab to neoadjuvant chemotherapy resulted in a significantly higher rate of pathologic complete response. The primary endpoints were pathologic complete response and event-free survival, defined as time to disease progression that precluded definitive surgery, local or distant recurrence, occurrence of a second primary cancer, or death from any cause. After definitive surgery, patients in the pembrolizumab group received pembrolizumab, and those in the placebo group received placebo every 3 weeks for up to nine cycles. Neoadjuvant treatment consisted of four cycles of pembrolizumab at 200 mg or placebo every 3 weeks plus paclitaxel at 80 mg/m 2 once weekly and carboplatin at area under the curve = 5 every 3 weeks, followed by four cycles of pembrolizumab or placebo plus doxorubicin at 60 mg/m 2 or epirubicin at 90 mg/m 2 plus cyclophosphamide at 600 mg/m 2 every 3 weeks for the next 12 weeks. ![]() “These highly anticipated event-free survival results in this TNBC population build upon earlier findings from the KEYNOTE-522 trial and further support the potential use of Keytruda in these patients,” Vicki Goodman, M.D., vice president, clinical research, Merck Research Laboratories, said in a statement.In the double-blind trial, 1,174 patients with previously untreated stage II or III triple-negative breast cancer (T1c, N1-2 or T2-4, N0-2) from sites in 21 countries were randomly assigned 2:1 between March 2017 and September 2018 to receive neoadjuvant pembrolizumab plus chemotherapy (n = 784) or placebo plus chemotherapy (n = 390), followed by adjuvant pembrolizumab vs placebo. Keytruda is currently approved under accelerated approval in the United States in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1. The trial is continuing to allow for additional follow-up of overall survival, a key secondary endpoint. In May, Merck had announced that KEYNOTE-522 met the dual primary endpoint of pathological complete response at the first interim analysis. No new safety concerns were seen in this fourth interim analysis. This is the first time an anti-PD-1/L1 therapy has demonstrated a statistically significant event-free survival result. ![]() After a median follow up of 39 months, the Keytruda regimen reduced the risk of event-free survival events by 37%. This study compared Keytruda and chemotherapy given before surgery followed by Keytruda (the Keytruda regimen) compared with adjuvant chemotherapy followed by placebo after surgery (the chemotherapy-placebo regimen). Merck’s Keytruda (pembrolizumab) demonstrated positive event-free survival (EFS) in patients with high-risk, early stage triple-negative breast cancer in the pivotal neoadjuvant/adjuvant phase 3 study KEYNOTE-522, according to results presented at European Society for Medical Oncology (ESMO) Virtual Plenary. ![]()
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