TABLE 2.
End Point | Giredestrant (n = 151) | PCET (n = 152) |
---|---|---|
Confirmed ORR, No. (%) | 19 (12.6) | 11 (7.2) |
95% CI | 7.75 to 18.95 | 3.67 to 12.58 |
OR (95% CI) | 1.87 (0.86 to 4.07) | |
DoR | n = 19 | n = 11 |
Median, months (95% CI) | NR (5.55 to NE) | 7.39 (7.39 to NE) |
Range, months | 2.0a to 8.9a | 2.8a to 9.3a |
CBR, No. (%) | 48 (31.8) | 32 (21.1) |
95% CI | 24.46 to 39.85 | 14.87 to 28.40 |
OR (95% CI) | 1.79 (1.06 to 3.04) | |
OS: deaths, No. (%) | 18 (11.9) | 11 (7.2) |
PD, No. | 12 | 9 |
Grade 5 AE, No. | 1b | 1c |
Other (post-treatment) | 5d | 1e |
Abbreviations: AE, adverse event; CBR, clinical benefit rate; DoR, duration of response; NE, nonestimable; NR, not reached; OR, odds ratio; ORR, objective response rate; OS, overall survival; PCET, physician's choice of endocrine therapy; PD, progressive disease.
Censored value.
Ischemic stroke.
Pulmonary embolism.
Unrelated–outside of AE reporting period (>30 days post-treatment discontinuation): three COVID-19–related, two septic shocks.
Unrelated–outside of AE reporting period (>30 days post-treatment discontinuation): septicemia.