NOTE

🌱 created from: mgc1l

nivofgfr2

  • Design: Phase 2, single-arm, multi-center trial
  • Number of patients: 23 patients enrolled
  • Patients characteristics: HER2-negative with centrally confirmed expression of PD-L1 and FGFR2
  • Agent: Nivolumab 360 mg with CapeOX (capecitabine and oxaliplatin)
  • Treatment line: First-line
  • Trial Acronym/NCTId Number: NIVOFGFR2, NCT05859477
ParameterResult
1-year PFS rate30.4%
Median PFS6.2 months
ORR21.7%
  • Highlight of toxicity: Grade ≥3 treatment-related adverse events reported in 9 (39.1%) patients
  • One-line summarize: Nivolumab in combination with chemotherapy shows modest efficacy and acceptable safety profile in patients with FGFR2-positive, PD-L1-positive metastatic GC.

References

Efficacy and safety of nivolumab and CapeOX in patients with previously untreated FGFR2-positive, PD-L1-positive advanced gastric cancer: A single-arm, multicenter, phase 2 study NIVOFGFR2. | Journal of Clinical Oncology