Molecular determinants of clinical outcomes with pembrolizumab versus paclitaxel in a randomized, open-label, phase III trial in patients with gastroesophageal adenocarcinoma

Shitara K., ÖZGÜROĞLU M., Bang Y., Di Bartolomeo M., Mandala M., Ryu M., ...More

ANNALS OF ONCOLOGY, vol.32, no.9, pp.1127-1136, 2021 (Journal Indexed in SCI) identifier identifier identifier

  • Publication Type: Article / Article
  • Volume: 32 Issue: 9
  • Publication Date: 2021
  • Doi Number: 10.1016/j.annonc.2021.05.803
  • Title of Journal : ANNALS OF ONCOLOGY
  • Page Numbers: pp.1127-1136
  • Keywords: pembrolizumab, chemotherapy, tumor mutational burden, gastroesophageal adenocarcinoma, gastric cancer, TUMOR MUTATIONAL BURDEN, CTLA-4 BLOCKADE, PD-1 BLOCKADE, BENEFIT, CHEMO


Background: In the phase III KEYNOTE-061 trial (NCT02370498), pembrolizumab did not significantly improve overall survival versus paclitaxel as second-line therapy for gastric/gastroesophageal junction (GEJ) adenocarcinoma with programmed death-ligand 1 (PD-L1) combined positive score (CPS) >= 1 tumors. The association of tissue tumor mutational burden (tTMB) status and clinical outcomes was determined, including the relationship with CPS and microsatellite instability-high (MSI-H) status.