Advanced Gastric Cancer: Triple Combination Second-Line Immunotherapy
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Phase I/II Multicenter Trial
- August 30, 2019
Phase I/II trial (ESMO GI 2019) evaluates nivolumab plus ramucirumab plus paclitaxel for second-line treatment of advanced unresectable/recurrent gastric and gastroesophageal junction cancer.
Treatment Regimen
4-week cycles:
- Nivolumab 3 mg/kg (Days 1, 15)
- Ramucirumab 8 mg/kg (Days 1, 15)
- Paclitaxel 80 mg/m² (Days 1, 8, 15)
Efficacy Results
6-Month Progression-Free Survival: 46.4% (exceeded target >35%)
Median PFS: 5.1 months
By PD-L1 Expression:
- PD-L1 Negative: 6-mo PFS 48.5%
- PD-L1 Positive: 6-mo PFS 66.7%
Objective Response Rate: 37.2%
Safety Profile
Grade 3+ Adverse Events: 93.0%
Immune-Related AEs (Grade 3+): 32.6%
Treatment-Related Mortality: 1 (thrombocytopenia)
Clinical Note
PD-L1 expression appears predictive of improved response, suggesting potential patient enrichment strategy.
Data Source
Phase I/II study of nivolumab combined with paclitaxel plus ramucirumab as second-line treatment in advanced gastric cancer. ESMO Gastrointestinal Cancers 2019, Abstract #SO-001.
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