Table 6 ESR1 mutation status at baseline in patients from the biomarker population (Parts A and B excluding the pharmacodynamically inactive amcenestrant QD 20-mg dose) with available data for baseline ESR1 mutational analysis in cfDNA detected by ddPCR (n = 58), and analyzed by those who subsequently achieved clinical benefit versus no benefit during amcenestrant therapy.

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

ESR1 mutations

CB (N = 20)

No CB (N = 38)

Patients with ESR1 wild-type

11

19

Patients with ESR1 mutated

9

19

D538G

5/9 (55.6%)

11/19 (57.9%)

Y537S

4/9 (44.4%)

3/19 (15.8%)

Y537N

3/9 (33.3%)

4/19 (21.1%)

L536H

1/9 (11.1%)

0/19 (0.0%)

S463P

1/9 (11.1%)

5/19 (26.3%)

Y537C

1/9 (11.1%)

4/19 (21.1%)

E380Q

0/9 (0.0%)

5/19 (26.3%)

L536P

0/9 (0.0%)

1/19 (5.3%)

L536R

0/9 (0.0%)

1/19 (5.3%)

  1. CB clinical benefit (complete response + partial response + stable disease ≥24 weeks), cfDNA circulating free DNA, ddPCR droplet digital polymerase chain reaction, ESR1 estrogen receptor 1, QD once daily.
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