Table 3.
Clinical benefit and confirmed best overall response rates in the safety-evaluable population and selected subgroup responders (objective response rate).
| Giredestrant 10 mg | Giredestrant 30 mg | Giredestrant 90/100 mg ± LHRH | Giredestrant 250 mg ± LHRH | All giredestrant doses | Giredestrant 100 mg + palbociclib 125 mg ± LHRH | All patients | |
|---|---|---|---|---|---|---|---|
| (n = 6) | (n = 41) | (n = 55) | (n = 9) | (n = 111) | (n = 64) | (N = 175) | |
| Clinical benefit by investigator in clinical benefit–evaluablea patients | 1 (16.7%) | 22 (53.7%) | 28 (50.9%) | 3 (33.3%) | 54 (48.6%) | 52 (81.3%) | 106 (60.6%) |
| ORR | 1 (16.7%) | 9 (22.0%) | 6 (10.9%) | 0 | 16 (14.4%) | 27 (42.2%) | 43 (24.6%) |
| (95% CI) | (0.42–64.12) | (10.56–37.61) | (4.11–22.25) | (0–33.63) | (8.47–22.35) | (29.94–55.18) | (18.39–31.64) |
| ORR in patients with measurable disease at baseline | 1 (25.0%) | 9 (30.0%) | 6 (14.6%) | 0 | 16 (19.8%) | 27 (48.2%) | 43 (31.4%) |
| Total n (95% CI) | 4 (0.63–80.59) | 30 (14.73–49.40) | 41 (5.57–29.17) | 6 (0–45.93) | 81 (11.73–30.09) | 56 (34.66–61.97) | 137 (23.73–39.87) |
| CR | 0 | 0 | 0 | 0 | 0 | 6 (9.4%) | 6 (3.4%) |
| PR | 1 (16.7%) | 9 (22.0%) | 6 (10.9%) | 0 | 16 (14.4%) | 21 (32.8%) | 37 (21.1%) |
| SD | 2 (33.3%) | 12 (29.3%) | 27 (49.1%) | 5 (55.6%) | 46 (41.4%) | 28 (43.8%) | 74 (42.3%) |
| Non-CR/non-PD | 0 | 6 (14.6%) | 5 (9.1%) | 0 | 11 (9.9%) | 2 (3.1%) | 13 (7.4%) |
| PD | 2 (33.3%) | 14 (34.1%) | 13 (23.6%) | 3 (33.3%) | 32 (28.8%) | 6 (9.4%) | 38 (21.7%) |
| NE | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Missing | 1 (16.7%) | 0 | 4 (7.3%) | 1 (11.1%) | 6 (5.4%) | 1 (1.6%) | 7 (4.0%) |
| Duration of response (months) | |||||||
| Median | 12.0 | NE | 17.5 | NE | 17.5 | NE | 22.8 |
| 95% CI | NE | (7.5–NE) | (3.7–NE) | NE | (7.5–NE) | (17.4–NE) | (14.9–NE) |
| Range | 12–12 | 3b–14b | 3–34b | NE | 3–34b | 4b–32b | 3–34b |
Note: Data are number of patients (%) unless specified. Responders are patients with best confirmed response of CR or PR by RECIST v1.1. 95% CI for rates were constructed using the Clopper–Pearson method. Patients were classified as “SD” if assessment was at least 6 weeks from baseline/study entry. Patients were classified as “NE” if all post-baseline response assessments were reported as NE, or SD assessment occurred within 6 weeks from baseline/study entry. Patients were classified as “missing” if no post-baseline response assessments were available. Clinical benefit includes patients with confirmed CR, PR, or the first occurrence of disease progression observed on or after 24 weeks. Note that one patient from the giredestrant 100 mg ± LHRH agonist cohort is currently counted as one of the patients who had SD as the best overall response as well as having clinical benefit; however, this patient had the target lesion removed, and therefore became response non-evaluable per RECIST v1.1.
aClinical benefit–evaluable population is defined as patients with confirmed CR, PR, or patients who discontinued from study, or patients staying on the treatment for at least 24 weeks since cycle 1, day 1 of giredestrant.
bCensored observation.