![]() About 790 patients were included in the two chemotherapy-containing arms presented. The nivolumab plus ipilimumab arm was stopped early for undisclosed reasons. 9 Patients were randomly assigned to receive nivolumab plus chemotherapy (either FOLFOX or CAPOX), chemotherapy alone, or nivolumab plus ipilimumab. View largerĬheckMate-649 was a global, randomized phase III trial that included patients with untreated advanced adenocarcinoma of the esophagus, gastroesophageal junction (GEJ), or stomach, regardless of PD-L1 expression. The Figure below illustrates the evolution of immunotherapy in gastro-esophageal cancer in terms of lines of therapy and regulatory approvals. This year, however, the field has taken a giant step forward with the presentation of three randomized trials-CheckMate-649, ATTRACTION-4, and KEYNOTE-590-during the European Society for Medical Oncology Virtual Congress 2020 on September 21. ![]() 6,7 The KEYNOTE-062 trial failed to demonstrate superior overall survival (OS) with pembrolizumab compared with chemotherapy, and failed to show an additional benefit of pembrolizumab combined with chemotherapy compared with chemotherapy alone in first-line metastatic gastric cancer. 4,5 Nivolumab and pembrolizumab subsequently received FDA approval in the second-line setting (ATTRACTION-3 and KEYNOTE-181 trials, respectively), but only for esophageal squamous cell carcinoma (ESCC) and-for pembrolizumab-only for patients with tumor PD-L1 combined positive score (CPS) ≥ 10%. ![]() 3 The JAVELIN Gastric 100 and JAVELIN Gastric 300 studies compared avelumab to chemotherapy as first-line maintenance and second-line therapy, respectively, and also failed to demonstrate clinical benefit. The KEYNOTE-061 trial showed that pembrolizumab was not superior to chemotherapy in the second-line setting. 1,2 However, subsequent trial results were discouraging. Food and Drug Administration (FDA) approval and nivolumab was approved in Japan in the third-line metastatic setting (KEYNOTE-059 and ATTRACTION-2 trials, respectively), it appeared that immunotherapy would race forward into the first-line and adjuvant therapy settings. Three years ago, when pembrolizumab received U.S.
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