Drug major Merck & Co., Inc. (MRK) Friday announced positive results of Phase 3 trials with its anti-PD-1 therapy KEYTRUDA (pembrolizumab) in various cancers.In the Phase 3 KEYNOTE-756 trial, KEYTRUDA in combination with chemotherapy showed statistically significant improvement in pathological complete response or pCR rate as neoadjuvant therapy versus chemotherapy in high-risk, early-stage ER+/HER2- breast cancer.Separately, Merck announced results from the Phase 3 KEYNOTE-671 trial, which showed KEYTRUDA plus chemotherapy before surgery and continued as single agent after surgery reduced risk of death by 28% versus pre-operative chemotherapy in resectable stage II, IIIA or IIIB non-small cell lung cancer or NSCLC.The KEYNOTE-671 trial evaluated KEYTRUDA as a perioperative treatment regimen, which includes treatment before surgery (neoadjuvant) and after surgery (adjuvant), for patients with resectable stage II, IIIA or IIIB NSCLC.Further, in the Phase 3 KEYNOTE-811 trial, KEYTRUDA plus Trastuzumab and chemotherapy significantly improved progression-free survival or PFS versus Trastuzumab and chemotherapy in first-line HER2-positive Advanced Gastric or Gastroesophageal Junction or GEJ Adenocarcinoma.KEYNOTE-756 is a randomized, double-blind, Phase 3 trial that is fully accrued, evaluating KEYTRUDA in combination with chemotherapy as neoadjuvant treatment, followed by adjuvant treatment with KEYTRUDA plus endocrine therapy for the treatment of high-risk, early-stage ER+/HER2- breast cancer.

Drug major Merck＆Co.，Inc。（MRK）周五宣布其抗PD-1疗法KEYTRUDA（pembrolizumab）在各种癌症中的3期临床试验取得积极成果。在第3阶段KEYNOTE-756试验中，KEYTRUDA联合化疗显示，在高危早期ER+/HER2-乳腺癌中，新辅助治疗与化疗相比，病理完全缓解或pCR率有统计学意义上的显着改善。另外，默克公布了第3阶段KEYNOTE-671试验的结果，该试验显示KEYTRUDA加化疗在手术前继续作为单药治疗，与可切除的II期，IIIA或IIIB期的术前化疗相比，死亡风险降低了28%。非小细胞肺癌或NSCLC。KEYNOTE-671试验评估了KEYTRUDA作为围手术期治疗方案，包括可切除II期，IIIA或IIIB期NSCLC患者的手术前（新辅助）和手术后（辅助）治疗。此外，在第3阶段KEYNOTE-811试验中，KEYTRUDA加曲妥珠单抗和化疗显着改善了一线HER2阳性进展期胃或胃食管交界处或GEJ腺癌的无进展生存期或PFS与曲妥珠单抗和化疗的关系。KEYNOTE-756是一项随机，双盲，3期临床试验，完全累计，评估KEYTRUDA联合化疗作为新辅助治疗，然后用KEYTRUDA加内分泌治疗辅助治疗高风险，早期ER+/HER2-乳腺癌。

The dual primary endpoints are pCR rate and EFS, and secondary endpoints include overall survival.The company noted that in Phase 3 KEYNOTE-756 trial, KEYTRUDA plus chemotherapy before surgery met one of its dual primary endpoints of pCR. It significantly improved pCR rate compared .

双重主要终点是pCR率和EFS，次要终点包括总生存期。该公司指出，在第3阶段KEYNOTE-756试验中，KEYTRUDA加手术前的化疗符合其pCR的双重主要终点之一。它显着提高了pCR率。

The company is presenting these pCR results during a late-breaking proffered paper session at the European Society for Medical Oncology (ESMO) Congress 2023.The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies.Further, at the Phase 3 KEYNOTE-671 trial's prespecified second interim analysis with a median follow-up of 36.6 months, neoadjuvant KEYTRUDA plus chemotherapy followed by KEYTRUDA as a single agent after surgical resection significantly improved overall survival or OS.At the first interim analysis of the study, KEYNOTE-671 met the trial's other dual primary endpoint of event-free survival or EFS.The company's Phase 3 KEYNOTE-811 trial evaluated KEYTRUDA in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with human epidermal growth factor receptor 2 or HER2-positive locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma.

该公司正在2023年欧洲肿瘤内科学会（ESMO）大会上的一次最新的论文会议上介绍这些pCR结果。该试验中KEYTRUDA的安全性与先前报道的研究中观察到的一致。此外，在第3阶段KEYNOTE-671试验的预先指定的第二次中期分析中，中位随访时间为36.6个月，新辅助KEYTRUDA加化疗后KEYTRUDA作为单一药物在手术切除后显着改善总体生存或OS。在第一次中期研究分析，KEYNOTE-671符合该试验的另一个无事件生存或EFS的双重主要终点。该公司的3期KEYNOTE-811试验评估了KEYTRUDA联合曲妥珠单抗，氟嘧啶和含铂化疗，用于人表皮生长因子受体2或HER2阳性局部晚期不可切除或转移性胃或GEJ腺癌患者的一线治疗。

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