Prediction of , index 1945
Prospective Prediction
- Prediction Index
- 1945
- Prediction Date
- Commercial Prediction
- partial FAILURE (commercially insufficient additive clinical benefit in OS for gedatolisib + fulvestrant + palbociclib at most numerically superior to SoC alpelisib + fulvestrant for PIK3CA MT population and non-superior to SoC fulvestrant for PIK3CA WT population despite with additional gedatolisib-related toxicity) FAILURE (commercially insufficient additive clinical benefit in OS for gedatolisib + fulvestrant non-inferior to SoC for both PIK3CA MT population PIK3CA WT population with additional gedatolisib-related toxicity)
- Technical Prediction
- partial SUCCESS (statistically significant yet moderate additive clinical benefit in ORR/PFS for gedatolisib + fulvestrant + palbociclib moderately superior to SoC alpelisib + fulvestrant for PIK3CA MT population slightly superior to SoC fulvestrant for PIK3CA WT population despite with additional gedatolisib-related toxicity) partial FAILURE (statistically insignificant additive clinical benefit in ORR/PFS for gedatolisib + fulvestrant non-superior to SoC fulvestrant for both PIK3CA MT population and PIK3CA WT with additional gedatolisib-related toxicity)
Readout of
Prediction Validation
- Readout Date
- Prediction To Readout
- 207 days in advance
- Readout Data Interpretation
- gedatolisib + palbociclib + fulvestrant (“gedatolisib triplet”) achieved 9.3 months mPFS strongly superior to 2.0 months achieved by fulvestrant monotherapy (HR= 0.24; P<0.0001) yet achieved 23.7 months mOS only numerically superior to 18.5 months achieved by fulvestrant monotherapy (HR=0.69 P=0.1328); wait for MT population data
- Press Release
- Press Release (ir.celcuity.com)
Prediction Result
- Prediction Accuracy
- Correct Prediction
- Clinical Benefit Conclusion
- statistically significant (superior mPFS) and commercially insufficient (non-superior mOS)
- Prediction Classification
- True Negative (TN)