Assessing the Long-Term Safety and Efficacy of Nivolumab Plus Chemotherapy for Broader Clinical Adoption in Advanced GI Cancers
Panelists discuss how the adoption of immunotherapy-chemotherapy combinations in clinical practice requires careful consideration of both long-term safety profiles and sustained efficacy data. A 5-year follow-up period generally provides valuable insights into delayed adverse events and durability of response, which helps inform risk-benefit assessments. The balance between safety and efficacy should be evaluated on a patient-specific basis, considering factors such as performance status, comorbidities, and tumor characteristics.
- Does the long-term safety profile of nivolumab plus chemotherapy at 5 years provide sufficient reassurance for broader adoption in clinical practice?
- How does this balance with efficacy?
FDA Approves Pembrolizumab/Chemo in First-Line Gastric/GEJ Adenocarcinoma
March 19th 2025Data from the phase 3 KEYNOTE-811 trial supported the FDA approval of this pembrolizumab combination in locally advanced unresectable or metastatic, PD-L1–positive, HER2-positive gastric or GEJ adenocarcinoma.
