KEYNOTE-522否极泰来
早前（2021-2-9）ODAC以10:0的结果，建议“FDA应该推迟决定Keytruda在TNBC新辅助治疗的申请，直到M司能够提供更多三期临床的数据”。
IA1分析结果显示，Pembro+化疗组的pCR率达到64.8%，而对照组仅为51.2%，绝对差异达13.6%，P=0.00055。
其他方式定义pCR的结果显示，ypT0ypN0：两组pCR率分别为59.9%和45.3%，绝对差异14.5%；ypT0/Tis：两组pCR率分别为68.6%和53.7%，绝对差异14.8%。
IA2分析结果显示，Pembro+化疗组的pCR率64.0%，对照组为54.7%，绝对差异9.2%，P=0.00221。
IA3分析结果显示，Pembro+化疗组的pCR率63.0%，对照组为55.6%，绝对差异7.5%。
亚组分析显示，根据淋巴结状态、肿瘤大小、卡铂用药方案、年龄等进行分层，均提示帕博利珠单抗+化疗组的pCR率更优。
IA2时EFS分析，结果显示Pembro+化疗组与安慰剂+化疗组18个月的EFS率分别为91.3%和85.3%。
IA3时EFS分析，结果显示Pembro++化疗组与安慰剂+化疗组27个月的EFS率分别为86.6%和76.4%。
这次DMC进行的中期分析显示，相较于单独化疗新辅助，Keytruda+化疗作为新辅助方案后Keytruda单药辅助给EFS带来了具有统计学意义和临床意义的改善，KEYNOTE-522在高位的早期TNBC患者中达到了EFS和pCR的双终点，KEYTRUDA也成为首个为TNBC的新辅助/辅助治疗的EFS带来统计学显著改善的anti-PD-1疗法
In Pivotal Study, KEYTRUDA® (pembrolizumab) In Combination With Chemotherapy Before Surgery and Continuing as a Single Agent After Surgery Showed Statistically Significant Improvement in EFS Versus Pre-Operative Chemotherapy
KEYTRUDA Is the First Anti-PD-1 Therapy to Show a Statistically Significant Improvement in EFS as Neoadjuvant and Adjuvant Therapy for TNBC
KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced positive results from the pivotal neoadjuvant/adjuvant Phase 3 KEYNOTE-522 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy as pre-operative (neoadjuvant) treatment and then continuing as a single agent (adjuvant) treatment after surgery. KEYNOTE-522 met its dual primary endpoint of event-free survival (EFS) for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC). Based on an interim analysis conducted by the independent Data Monitoring Committee (DMC), neoadjuvant KEYTRUDA plus chemotherapy followed by adjuvant KEYTRUDA as monotherapy showed a statistically significant and clinically meaningful improvement in EFS compared with neoadjuvant chemotherapy alone. As previously communicated, KEYNOTE-522 met its other dual primary endpoint of pathological complete response (pCR). The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies; no new safety signals were identified.