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. 2024 Mar 27;42(18):2149–2160. doi: 10.1200/JCO.23.01500

TABLE 2.

Secondary Efficacy End Points

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.

a

Censored value.

b

Ischemic stroke.

c

Pulmonary embolism.

d

Unrelated–outside of AE reporting period (>30 days post-treatment discontinuation): three COVID-19–related, two septic shocks.

e

Unrelated–outside of AE reporting period (>30 days post-treatment discontinuation): septicemia.