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ePoster Display

264P - AMEERA-1: Subgroup analyses of phase I/II study of amcenestrant (SAR439859), an oral selective estrogen receptor (ER) degrader (SERD), with palbociclib in postmenopausal women with ER+/ human epidermal growth factor receptor 2-negative (HER2–) advanced breast cancer (aBC)

Date

16 Sep 2021

Session

ePoster Display

Topics

Tumour Site

Breast Cancer

Presenters

Sarat Chandarlapaty

Citation

Annals of Oncology (2021) 32 (suppl_5): S457-S515. 10.1016/annonc/annonc689

Authors

S. Chandarlapaty1, H.M. Linden2, P. Neven3, K. Petrakova4, A. Bardia5, P. Kabos6, S. Braga7, V. Boni8, V. Pelekanou9, N. Ternès10, A. Gosselin10, M. Celanovic9, P. Cohen10, G. Paux9, M. Campone11

Author affiliations

  • 1 N/a, Memorial Sloan Kettering Cancer Center, 10065 - New York/US
  • 2 N/a, University of Washington Medical Center, Seattle Cancer Care Alliance, Seattle/US
  • 3 N/a, Universitair Ziekenhuis Leuven, Leuven/BE
  • 4 N/a, Masarykův Onkologický Ustav, Brno/CZ
  • 5 N/a, Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston/US
  • 6 N/a, University of Colorado, Aurora/US
  • 7 N/a, Instituto CUF de Oncologia, Lisbon/PT
  • 8 N/a, START Madrid-CIOCC, Centro Oncológico Clara Campal, HM Hospitales Sanchinarro, Madrid/ES
  • 9 N/a, Sanofi, Cambridge/US
  • 10 N/a, Sanofi, Paris/FR
  • 11 N/a, Institut de Cancérologie de l'Ouest, René Gauducheau, St Herblain/FR

Resources

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Abstract 264P

Background

Amcenestrant is an optimized, oral SERD that has shown favorable safety and encouraging antitumor activity in combination with palbociclib (palbo) in ER+/HER2– aBC. Here, we report updated data, including antitumor activity by subgroups.

Methods

This open-label, phase 1/2 study assessed palbo 125 mg (21 days on, 7 off) + amcenestrant in dose escalation (Part C; n = 15; 200 and 400 mg QD in 28-day cycles) and dose expansion (Part D; n = 30; 200 mg recommended phase 2 dose) in ER+/HER2– aBC patients (pts) with ≥ 6 months of prior endocrine therapy. Antitumor activity was assessed by objective response (OR) rate (ORR; confirmed complete response [CR] and partial response [PR]) and clinical benefit (CB) rate (CBR; CR, PR, or stable disease [SD] ≥ 24 weeks) per RECIST v1.1 in response-evaluable pts without prior CDK4/6 or mTOR inhibitors (n = 35; Part C, n = 6; Part D, n = 29). Subgroup analyses by prior treatment and baseline ESR1 mutation status (wild-type [wt] or mutated [m]) were conducted. ESR1 mutations and genomic profiling were assessed in cfDNA by ddPCR and NGS, respectively.

Results

Subgroup analyses are shown in the table (March, 2021 cut off). CB was observed for 7/8 pts with Y537S, D538G, E380Q, or Y537N baseline ESR1 mutations; OR was observed for 3/8 pts with D538G or E380Q. In 33 response-evaluable pts with baseline NGS data: 23 pts had wtESR1 + other genomic aberrations, with OR in 6/23 (26.1%) and CB in 16/23 (69.6%); of 11/33 pts with OR, 8 pts had wtESR1 (including 1 pt with prior fulvestrant, PIK3CA and PTEN) and 2 pts had no aberration; of 5/33 pts with mESR1 and concurrent aberrations, 2/5 had OR and 4/5 had CB; of 9/33 pts with no CB, genomic aberrations included PIK3CA and TP53. Table: 264P

Last prior therapy Baseline ESR1 status by ddPCR
Response-evaluable pts (n=35) Overall Neo(adjuvant) Advanced wtESR1 mESR1
Best Overall Response, n (%)
•Number 35 15 20 27 8
•Complete Response (CR) 0 0 0 0 0
•Partial Response (PR) 12 (34.3%) 4 (26.7%) 8 (40.0%) 9 (33.3%) 3 (37.5%)
•Stable Disease (SD) 22 (62.9%) 10 (66.7%) 12 (60.0%) 17 (63.0%) 5 (62.5%)
•Progressive Disease (PD) 1 (2.9%) 1 (6.7%) 0 1 (3.7%) 0
Objective Response Rate, n (%) 12 (34.3%) 4 (26.7%) 8 (40.0%) 9 (33.3%) 3 (37.5%)
Clinical Benefit Rate, n (%) 26 (74.3%) 8 (53.3%) 18 (90.0%) 19 (70.4%) 7 (87.5%)

Conclusions

Amcenestrant combined with palbociclib showed encouraging OR and CB in pts with ER+/HER2- aBC, irrespective of ESR1 mutation status.

Clinical trial identification

NCT03284957.

Editorial acknowledgement

Editorial support was provided by Rohan Keshwara, PhD, and Julian Martins, MBBS, MA, of inScience Communications (Philadelphia, PA, USA), funded by Sanofi.

Legal entity responsible for the study

Sanofi.

Funding

Sanofi.

Disclosure

S. Chandarlapaty: Financial Interests, Personal, Advisory Role: Lilly; Financial Interests, Personal, Advisory Role: Novartis; Financial Interests, Personal, Advisory Role: Sanofi; Financial Interests, Personal, Advisory Role: Paige.ai; Financial Interests, Institutional, Research Grant: Daiichi Sankyo; Financial Interests, Institutional, Research Grant: Paige.ai. H.M. Linden: Other, Personal, Stocks/Shares, An Immediate Family Member: Evolent; Financial Interests, Personal, Advisory Board: Sanofi; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Advisory Board: Tolmar; Financial Interests, Institutional, Research Grant: Zionexa; Financial Interests, Institutional, Research Grant: Eisai; Financial Interests, Institutional, Research Grant: Zenatalis; Financial Interests, Institutional, Research Grant: Zymeworks. P. Neven: Financial Interests, Institutional, Advisory Role: Lilly; Financial Interests, Institutional, Advisory Role: Pfizer; Financial Interests, Institutional, Advisory Role: Novartis; Financial Interests, Institutional, Advisory Role: Roche; Financial Interests, Institutional, Advisory Role: Radius Health; Financial Interests, Institutional, Other, Travel, Accommodations, Expenses: Lilly; Financial Interests, Institutional, Other, Travel, Accommodations, Expenses: Pfizer; Financial Interests, Institutional, Other, Travel, Accommodations, Expenses: Roche. K. Petrakova: Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Speaker’s Bureau: Roche; Financial Interests, Personal, Speaker’s Bureau: Novartis; Financial Interests, Personal, Speaker’s Bureau: Pfizer; Financial Interests, Personal, Speaker’s Bureau: AstraZeneca. A. Bardia: Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: Genentech; Financial Interests, Personal, Advisory Board: Merck; Financial Interests, Personal, Advisory Board: Radius Health; Financial Interests, Personal, Advisory Board: Immunomedics; Financial Interests, Personal, Advisory Board: Sanofi; Financial Interests, Personal, Advisory Board: Daiichi Pharma/AstraZeneca; Financial Interests, Personal, Advisory Board: Puma; Financial Interests, Personal, Advisory Board: Biothernostics Inc.; Financial Interests, Personal, Advisory Board: Phillips; Financial Interests, Personal, Advisory Board: Eli Lilly; Financial Interests, Personal, Advisory Board: Foundation Medicine; Financial Interests, Institutional, Research Grant: Genentech; Financial Interests, Institutional, Research Grant: Novartis; Financial Interests, Institutional, Research Grant: Pfizer; Financial Interests, Institutional, Research Grant: Merck; Financial Interests, Institutional, Research Grant: Sanofi; Financial Interests, Institutional, Research Grant: Radius Health; Financial Interests, Institutional, Research Grant: Immunomedics; Financial Interests, Institutional, Research Grant: Daiichi Pharma/AstraZeneca. P. Kabos: Financial Interests, Personal, Advisory Board: Eli Lilly; Financial Interests, Personal, Research Grant: Genentech; Financial Interests, Personal, Research Grant: Eli Lilly; Financial Interests, Personal, Research Grant: Pfizer; Financial Interests, Personal, Research Grant: AstraZeneca; Financial Interests, Personal, Research Grant: Sanofi; Financial Interests, Personal, Research Grant: Radius Health. V. Boni: Financial Interests, Personal, Other, Honoraria: Loxo; Financial Interests, Personal, Other, Honoraria: IDEAYA Biosciences; Financial Interests, Personal, Advisory Role: OncoArt; Financial Interests, Personal, Advisory Role: Guidepoint Global; Financial Interests, Personal, Speaker’s Bureau: Solti; Financial Interests, Institutional, Research Grant: Sanofi; Financial Interests, Institutional, Research Grant: Seattle Genetics; Financial Interests, Institutional, Research Grant: Loxo; Financial Interests, Institutional, Research Grant: Novartis; Financial Interests, Institutional, Research Grant: CytomX Therapeutics; Financial Interests, Institutional, Research Grant: Kura Oncology; Financial Interests, Institutional, Research Grant: Tesaro; Financial Interests, Institutional, Research Grant: Roche/Genentech; Financial Interests, Institutional, Research Grant: Bristol Myers Squibb; Financial Interests, Institutional, Research Grant: Menarini; Financial Interests, Institutional, Research Grant: Synthon; Financial Interests, Institutional, Research Grant: Janssen; Financial Interests, Institutional, Research Grant: Merck; Financial Interests, Institutional, Research Grant: Lilly; Financial Interests, Institutional, Research Grant: Merus; Financial Interests, Institutional, Research Grant: Pfizer; Financial Interests, Institutional, Research Grant: Incyte; Financial Interests, Institutional, Research Grant: AbbVie; Financial Interests, Institutional, Research Grant: Zenith Epigenetics; Financial Interests, Institutional, Research Grant: Genmab; Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Institutional, Research Grant: Seattle Genetics; Financial Interests, Institutional, Research Grant: Adaptimmune; Financial Interests, Institutional, Research Grant: Alkermes; Financial Interests, Institutional, Research Grant: Array BioPharma; Financial Interests, Institutional, Research Grant: BioNTech AG; Financial Interests, Institutional, Research Grant: Boston Biomedical; Financial Interests, Institutional, Research Grant: Boehringer Ingelheim Pharmaceuticals Inc; Financial Interests, Institutional, Research Grant: Amgen; Financial Interests, Institutional, Research Grant: Bayer HealthCare Pharmaceuticals, Inc.; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: START. V. Pelekanou, N. Ternès, A. Gosselin, M. Celanovic, P. Cohen, G. Paux: Financial Interests, Personal, Full or part-time Employment: Sanofi. M. Campone: Financial Interests, Personal and Institutional, Research Grant: Pfizer; Financial Interests, Personal and Institutional, Research Grant: AstraZeneca; Financial Interests, Personal and Institutional, Research Grant: Sanofi; Financial Interests, Personal and Institutional, Research Grant: Pierre Fabre; Financial Interests, Personal and Institutional, Research Grant: Takeda; Financial Interests, Personal and Institutional, Research Grant: AbbVie; Financial Interests, Personal and Institutional, Research Grant: Servier; Financial Interests, Personal and Institutional, Research Grant: Sandoz; Financial Interests, Personal and Institutional, Research Grant: Accord; Financial Interests, Personal and Institutional, Speaker’s Bureau: Novartis; Financial Interests, Personal and Institutional, Speaker’s Bureau: Lilly. All other authors have declared no conflicts of interest.

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