Merck Reveals Positive Results From Phase 3 KEYTRUDA Trials In Various Cancers

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. 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 to neoadjuvant placebo plus chemotherapy.

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.

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.

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