Table 4 Prespecified analyses of antitumor activity in the response-evaluable populations of Parts A and B.

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

Population

Part A

Part B

Part B

Part B

Review method

Local

ICR

ICR

ICR

Endpoint

Secondary

Interim

Primary

Secondary by baseline ESR1 statusd

Subgroup

   

Wild-type

Mutated

Best overall response, n (%)

     

 Number

16

45

46

26

19

 Complete response (CR)a

0

1 (2.2)

1 (2.2)

1 (3.8)

0

 Partial response (PR)a

1 (6.3)

4 (8.9)

4 (8.7)

3 (11.5)

1 (5.3)

 Stable disease (SD)

8 (50.0)

19 (42.2)

19 (41.3)

10 (38.5)

9 (47.4)

 Progressive disease (PD)

7 (43.8)

19 (42.2)

20 (43.5)

11 (42.3)

8 (42.1)

 Not evaluable (NE)

0

2 (4.4)

2 (4.3)

1 (3.8)

1 (5.3)

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

1 (6.3) [0.3–26.4]

5 (11.1) [4.5–22.0]

5 (10.9) [4.4–21.5]

4 (15.4) [5.4–31.8]

1 (5.3) [0.3–22.6]

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

8 (50.0) [27.9–72.1]

13 (28.9) [18.0–42.0]

13 (28.3) [17.6–41.1]

9 (34.6) [19.4–52.6]

4 (21.1) [7.5–41.9]

  1. CI confidence interval, ESR1 estrogen receptor 1, ICR independent central review, Local investigator/local radiologist review.
  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. dOne patient had missing baseline ESR1 status.
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