Drug major Merck & Co., Inc. (MRK) Friday announced positive results of Phase 3 trials with its anti-PD-1 therapy KEYTRUDA<\/b> (pembrolizumab) in various cancers.<\/p>\n
In the Phase 3 KEYNOTE-756 trial, KEYTRUDA<\/b> 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.<\/p>\n
Separately, Merck announced results from the Phase 3 KEYNOTE-671 trial, which showed KEYTRUDA<\/b> 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.<\/p>\n
The KEYNOTE-671 trial evaluated KEYTRUDA<\/b> 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.<\/p>\n
Further, in the Phase 3 KEYNOTE-811 trial, KEYTRUDA<\/b> 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.<\/p>\n
KEYNOTE-756 is a randomized, double-blind, Phase 3 trial that is fully accrued, evaluating KEYTRUDA<\/b> in combination with chemotherapy as neoadjuvant treatment, followed by adjuvant treatment with KEYTRUDA<\/b> plus endocrine therapy for the treatment of high-risk, early-stage ER+\/HER2- breast cancer. The dual primary endpoints are pCR rate and EFS, and secondary endpoints include overall survival.<\/p>\n
The company noted that in Phase 3 KEYNOTE-756 trial, KEYTRUDA<\/b> plus chemotherapy before surgery met one of its dual primary endpoints of pCR. It significantly improved pCR rate compared to neoadjuvant placebo plus chemotherapy.<\/p>\n
Merck noted that KEYNOTE-756 is the first positive Phase 3 study with an immunotherapy regimen to demonstrate a statistically significant improvement in pCR rate in the neoadjuvant setting for this patient population.<\/p>\n
The company is presenting these pCR results during a late-breaking proffered paper session at the European Society for Medical Oncology (ESMO) Congress 2023.<\/p>\n
The safety profile of KEYTRUDA<\/b> in this trial was consistent with that observed in previously reported studies.<\/p>\n
Further, at the Phase 3 KEYNOTE-671 trial’s prespecified second interim analysis with a median follow-up of 36.6 months, neoadjuvant KEYTRUDA<\/b> plus chemotherapy followed by KEYTRUDA as a single agent after surgical resection significantly improved overall survival or OS.<\/p>\n
At the first interim analysis of the study, KEYNOTE-671 met the trial’s other dual primary endpoint of event-free survival or EFS.<\/p>\n
The company’s Phase 3 KEYNOTE-811 trial evaluated KEYTRUDA<\/b> 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. <\/p>\n
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