Excerpt:KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated...in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Evidence Level:Sensitive: B - Late Trials
Title:
Pembrolizumab plus chemotherapy versus placebo plus chemotherapy for HER2-negative advanced gastric cancer (KEYNOTE-859): a multicentre, randomised, double-blind, phase 3 trial
Excerpt:Participants in the pembrolizumab plus chemotherapy group had a significant and clinically meaningful improvement in overall survival with manageable toxicity compared with participants in the placebo plus chemotherapy group. Therefore, pembrolizumab with chemotherapy might be a first-line treatment option for patients with locally advanced or metastatic HER2-negative gastric or gastro-esophageal junction adenocarcinoma.
DOI:10.1016/S1470-2045(23)00515-6
Evidence Level:Sensitive: B - Late Trials
Title:
Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy Significantly Improved Overall Survival Versus Chemotherapy Alone in Patients With HER2-Negative Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma Regardless of PD-L1 Expression
Excerpt:Merck...announced results from the pivotal Phase 3 KEYNOTE-859 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with human epidermal growth factor receptor 2 (HER2)-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. After a median follow-up of 31.0 months (range, 15.3-46.3 months), KEYTRUDA in combination with chemotherapy significantly improved overall survival (OS), reducing the risk of death by 22% (HR=0.78 [95% CI, 0.70-0.87]; p<0.0001) compared to chemotherapy alone for these patients, regardless of PD-L1 expression. Median OS was 12.9 months (95% CI, 11.9-14.0) for KEYTRUDA plus chemotherapy versus 11.5 months (95% CI, 10.6-12.1) for chemotherapy alone.
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
Study to Explore the Safety, Tolerability and Efficacy of MK-3475 in Combination With INCB024360 in Participants With Selected Cancers
Excerpt:...- Human epidermal growth factor receptor 2 (HER2) negative as per American Society of Clinical Oncology/College of American Pathologists guidelines....
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859/KEYNOTE-859)-China Extension
Excerpt:...- Has human epidermal growth factor receptor 2 (HER2) negative cancer...
More C2 evidence
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-012/KEYNOTE-012)
Excerpt:...- triple negative breast cancer (estrogen, progesterone, and human epidermal growth factor receptor 2 [HER2] negative)...
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859/KEYNOTE-859)
Excerpt:...- Has human epidermal growth factor receptor 2 (HER2) negative cancer...
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
Phase II Trial of Neoadjuvant Pembrolizumab for Patients With Early Stage Gastroesophageal Adenocarcinoma
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
A Study of Pembrolizumab (MK-3475) in Participants With Recurrent or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (MK-3475-059/KEYNOTE-059)
Excerpt:...- HER2/neu negative...
Less C2 evidence
Evidence Level:Sensitive: C3 – Early Trials
Title:
KEYNOTE-859 study of pembrolizumab plus chemotherapy for advanced HER2-negative gastric or gastroesophageal junction (G/GEJ) cancer: Outcomes in the protocol-specified PD-L1–selected populations.
Excerpt:Together with the efficacy and safety results from the ITT population, these data support pembro + chemo as a new first-line treatment option for pts with locally advanced or metastatic HER2-negative G/GEJ adenocarcinoma, regardless of PD-L1 expression.
DOI:10.1200/JCO.2023.41.16_suppl.4014