Here’s a breakdown of the efficacy and safety data shared in the publication, based on the provided text:
Efficacy Data:
* ORR (Central Assessment): 42.4% (95% CI, 25.5%-60.8%)
* Time to Response (median): 1.4 months (95% CI, 1.3-1.8)
* Duration of Response (Median): 5.9 months (95% CI, 4.4-9.0)
* 12-Month OS Rate (Estimated): 41.4% (95% CI, 24.4%-57.6%)
* 24-Month OS Rate (Estimated): 19.4% (95% CI, 7.5%-35.5%)
Safety/Tolerability Data:
* Any-Grade AEs: 97.3% (Grade ≥3, 83.8%)
* Serious AEs: 70.3% (Any grade); 67.6% (Grade ≥3)
* Treatment-Related AEs: 91.9% (Grade ≥3, 51.4%)
* Common AEs (≥10% of patients):
* Anemia
* Nausea
* Hypercalcemia
* Lymphopenia
* Thrombocytopenia
* Leukopenia
* Neutropenia
