Table 1.
Key Clinical Data
| Parameter | Values | Range | Distribution | |
|---|---|---|---|---|
| All patients: Projected PFS curve based on Weibull distribution in the chemotherapy arm | Shape=1.124 Scale=11.089 | – | – | |
| All patients: Projected OS curve based on Weibull distribution in the chemotherapy arm | Shape=1.458 Scale=31.481 | – | – | |
| HR-positive subgroup: Projected PFS curve based on Weibull distribution in the chemotherapy arm | Shape=1.144 Scale=11.776 | – | – | |
| HR-positive subgroup: Projected OS curve based on Weibull distribution in the chemotherapy arm | Shape=1.455 Scale=33.953 | – | – | |
| All patients: Hazard ratio of T-DXd vs chemotherapy arm for PFS | 0.5 | 0.4–0.63 | Lognormal | |
| All patients: Hazard ratio of T-DXd vs chemotherapy arm for OS | 0.64 | 0.49–0.84 | Lognormal | |
| HR-positive subgroup: Hazard ratio of T-DXd vs chemotherapy arm for PFS | 0.51 | 0.4–0.64 | Lognormal | |
| HR-positive subgroup: Hazard ratio of T-DXd vs chemotherapy arm for OS | 0.64 | 0.48–0.86 | Lognormal | |
| Grade 3 and more AEs in the chemotherapy arm | Incidence | Range | Distribution | |
| Neutropenia | 40.7% | 30.53% to 50.88% | Beta | |
| Anemia | 4.7% | 3.53% to 5.88% | Beta | |
| Thrombocytopenia | 0.6% | 0.45% to 0.75% | Beta | |
| Leukopenia | 19.2% | 14.4% to 24% | Beta | |
| Nausea | 0% | NA | Beta | |
| Fatigue | 4.7% | 3.53% to 5.88% | Beta | |
| Grade 3 and more AEs in the T-DXd arm | ||||
| Neutropenia | 13.7% | 10.28% to 17.13% | Beta | |
| Anemia | 8.1% | 6.08% to 10.13% | Beta | |
| Thrombocytopenia | 5.1% | 3.83% to 6.38% | Beta | |
| Leukopenia | 6.5% | 4.88% to 8.13% | Beta | |
| Nausea | 4.6% | 3.45% to 5.75% | Beta | |
| Fatigue | 7.5% | 5.63% to 9.38% | Beta | |
Abbreviations: PFS, progression-free survival; HR, hormone-receptor; OS, overall survival; AEs, adverse events; T-DXd, trastuzumab deruxtecan.