Table 5 Post hoc subgroup analyses by <3 prior lines of therapy in the metastatic setting, by no prior CDK4/6 or mTOR inhibitors or fulvestrant, and by no prior CK4/6 inhibitors in the Part B response-evaluable population by independent central review.

From: AMEERA-1 phase 1/2 study of amcenestrant, SAR439859, in postmenopausal women with ER-positive/HER2-negative advanced breast cancer

 

≤3 prior lines in the metastatic settingd

No prior CDK4/6i, mTORi, or fulvestrante

No prior CDK4/6if

Best overall response, n (%)

Number

27

11

19

Complete response (CR)a

1 (3.7)

0

1 (5.3)

Partial response (PR)a

4 (14.8)

4 (36.4)

4 (21.1)

Stable disease (SD)

12 (44.4)

4 (36.4)

9 (47.4)

Progressive disease (PD)

10 (37.0)

3 (27.3)

5 (26.3)

Not evaluable

0

0

0

Objective response rate, n (%) [90% CI]a,b

5 (18.5) [7.6–35.1]

4 (36.4) [13.5–65.0]

5 (26.3) [11.0–47.6]

Clinical benefit rate, n (%) [90% CI]c

12 (44.4) [28.0–61.8]

6 (54.5) [27.1–80.0]

10 (52.6) [32.0–72.6]

  1. CDK4/6 cyclin-dependent kinase 4 and 6, CI confidence interval, i inhibitor, mTOR mammalian target of rapamycin.
  2. aConfirmation of complete and partial responses are required (i.e., a second examination done ≥28 days apart, in order to confirm the antitumor response).
  3. b90% CI estimated by the Clopper-Pearson interval.
  4. cClinical benefit rate: complete or partial responses or prolonged stable disease (i.e., for ≥24 weeks).
  5. dSubset of Part B response-evaluable population with ≤3 prior lines in the metastatic setting, including ≤1 of either prior chemotherapy or CDK4/6 inhibitor, and no prior mTOR inhibitor.
  6. eSubset of Part B response-evaluable population with no prior fulvestrant, CDK4/6 inhibitor, or mTOR inhibitor.
  7. fSubset of Part B response-evaluable population with no prior CDK4/6 inhibitor.
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