Case Studies
Oncology Programs
PD-1 Checkpoint Inhibitor
Challenge
Complex irAE profile spanning dermatologic, hepatic, endocrine, and pulmonary organ systems with variable onset timing
ArcaScience Approach
Deployed multi-organ irAE detection models with temporal pattern analysis across 12,000+ patient records
Results
- ✓73% faster irAE signal detection
- ✓94% accuracy in causality assessment
- ✓PBRER generation time reduced from 14 weeks to 3 weeks
CDK4/6 Inhibitor
Challenge
Quantifying benefit-risk balance of neutropenia management against PFS improvement in combination with endocrine therapy
ArcaScience Approach
Integrated clinical trial and real-world evidence across 8,400 patients to model dose modification impact on efficacy
Results
- ✓Identified optimal dose modification thresholds
- ✓67% reduction in BRA compilation time
- ✓FDA submission accepted without information requests on BRA section
Bispecific T-Cell Engager
Challenge
Cytokine release syndrome and neurological toxicity in a vulnerable patient population with limited treatment alternatives
ArcaScience Approach
Built CRS grading prediction model integrated with benefit assessment using minimal residual disease endpoints
Results
- ✓Real-time CRS risk stratification
- ✓89% sensitivity in neurotoxicity signal detection
- ✓Supported accelerated approval submission
Aggregate Outcomes
Results Across Oncology Programs
70%+
Reduction in BRA Preparation Time
90%+
Accuracy in AE Classification
3x
Faster Regulatory Submissions
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