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Lunch and Poster Display session

7P - Trastuzumab deruxtecan (T-DXd) for advanced breast cancer (ABC) patients (pts), regardless of HER2 status: A phase II study with biomarkers analysis (DAISY) - update analysis with longer follow-up

Date

16 May 2024

Session

Lunch and Poster Display session

Presenters

Veronique Dieras

Citation

Annals of Oncology (2024) 9 (suppl_4): 1-34. 10.1016/esmoop/esmoop103010

Authors

V.C. Dieras1, F. André2, A. Lusque3, B. Pistilli2, T. Bachelot4, J. Pierga5, F. Viret6, C. Levy7, L. Salabert8, F. Dalenc9, C. Jouannaud10, P. Fournel11, X. Durando12, T. Petit13, C. Mahier Ait Oukhatar14, T. Filleron15, M.F. Mosele2, M. Lacroix-Triki16, A. Ducoulombier17, E. deluche18

Author affiliations

  • 1 Centre Eugene - Marquis, Rennes/FR
  • 2 Gustave Roussy - Cancer Campus, Villejuif/FR
  • 3 Institut Claudius Regaud - IUCT Oncopole, Toulouse, Cedex/FR
  • 4 Centre Léon Bérard, Lyon/FR
  • 5 Institut Curie, Paris/FR
  • 6 IPC - Institut Paoli-Calmettes, Marseille/FR
  • 7 Centre Francois Baclesse, 14076 - Caen/FR
  • 8 Institute Bergonié - Centre Régional de Lutte Contre le Cancer (CLCC), Bordeaux/FR
  • 9 Centre Claudius-Regaud, 31059 - Toulouse/FR
  • 10 Institut Jean Godinot, 51100 - Reims/FR
  • 11 Centre Hospitalier Universitaire de Saint-Etienne, Saint-Étienne/FR
  • 12 Centre Jean PERRIN, Clermont-Ferrand, Cedex/FR
  • 13 Centre Paul Strauss Centre de Lutte contre le Cancer, Strasbourg/FR
  • 14 Unicancer, Paris, Cedex/FR
  • 15 Institut Claudius Regaud - IUCT Oncopole, 31059 - Toulouse, Cedex/FR
  • 16 Institut Gustave Roussy, Villejuif/FR
  • 17 Centre Anticancer Antoine Lacassagne, Nice/FR
  • 18 CHU Limoges - Hopital Dupuytren, Limoges/FR

Resources

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Abstract 7P

Background

The HER2-targeted antibody-drug conjugate (ADC) T-DXd demonstrated efficacy in heavily pretreated HER2-over- and -low expressing ABC. We aimed to assess the activity of T-DXd in HER2-over/low expressing or IHC-0 ABC, to describe the drug mechanisms of action and to identify biomarkers associated to drug response or resistance.

Methods

DAISY is an open-label phase II trial to assess the efficacy of T-DXd in ABC with extensive biomarkers analysis (1) in 3 cohorts: Cohort 1 (HER2 over-expressing: 3+ on IHC or ISH+), Cohort 2 (HER2 low-expressing: 1+ or 2+/ISH-) and cohort 3 (HER2-IHC 0). The primary endpoint was the confirmed objective response rate (ORR). Secondary endpoints were clinical benefit rate, duration of response (DOR), progression-free (PFS), overall survival (OS) and safety. Here we report clinical activity and safety with a longer follow-up of 38.4 months [95%CI: 35.3-40.9].

Results

185 women and 1 man were enrolled between 2019 and 2021. Among the safety population (179 pts), median [range] age was 55 [24-82] years, median number of previous metastatic line was 5 [0-17] and 12 pts harbored triple-negative ABC. Median number of cycles was 10 [1-63]. In December 2023, 6 pts were still on-treatment. The table shows T-Dxd activity in the full analysis set population (177 pts). Important to note, PFS rate at 24 months was 31% [95%CI: 20-43] in cohort 1. A total of 173 pts (96.6%) had at least one treatment-related adverse event (TRAE). Eight pts (4.5%) had drug related ILD or pneumonitis (grade (G) 1 in 6 pts, G2 and G5 in 1 pt each), 18 pts discontinued treatment due to TRAEs. Table: 7P

Total Cohort 1 Cohort 2 Cohort 3
BOR confirmed n/N [95%CI] 86/177 (48.6%) [41.0; 56.2] 48/68 (70.6%) [58.3; 81.0] 27/72 (37.5%) [26.4; 49.7] 11/37 (29.7%) [15.9; 47.0]
Median DOR (months) [95%CI] 8.5 [6.8; 9.7] 9.7 [7.2; 17.9] 7.6 [4.4; 9.4] 6.8 [2.8; 17.5]
Median PFS (months) [95%CI] 7.1 [6.6; 8.7] 11.1 [8.5; 14.4] 6.8 [4.6; 8.5] 4.2 [2.0; 5.7]
Median OS (months) [95%CI] 19.6 [16.1; 22.3] 31.2 [22.4; Not Reached] 19.3 [11.5; 22.1] 12.1 [8.3; 15.0]

Conclusions

Consistent with previously reported data, T-DXd showed clinically meaningful activity in pts with HER2-overexpressing ABC and antitumour activity in those with HER2-low and non-expressing ABC during extended follow-up. Safety profile was consistent with previous reports. (1) Mosele F and alNat Med 2023

Clinical trial identification

NCT04132960.

Legal entity responsible for the study

Unicancer.

Funding

Daiichi Sankyo.

Disclosure

V.C. Dieras: Financial Interests, Personal, Advisory Board, National advisory board: Pierre Fabre Oncologie; Financial Interests, Personal, Advisory Board, Steering Committee, consultant, Symposium, travel expenses: Roche Genentech; Financial Interests, Personal, Advisory Board, + Symposia and travel expenses: Novartis; Financial Interests, Personal, Advisory Board, Advisory boards, symposia, travel expenses: Pfizer; Financial Interests, Personal, Advisory Board, Symposia, travel expenses: Lilly, AstraZeneca, MSD; Financial Interests, Personal, Advisory Board, Symposia,travel expenses: Daiichi Sankyo; Financial Interests, Personal, Advisory Board, symposia,travel expenses: Seagen, Gilead; Financial Interests, Personal, Advisory Board, Steering Committee: AbbVie; Financial Interests, Personal, Advisory Board: Eisai, Medac GmbH; Financial Interests, Personal, Other, IDMC: Sanofi; Financial Interests, Personal, Advisory Board, national board: Menarini; Financial Interests, Personal and Institutional, Other, IDMC: Sanofi; Financial Interests, Institutional, Invited Speaker: Roche Genentech, AstraZeneca; Financial Interests, Institutional, Invited Speaker, Steering Committee: Lilly; Financial Interests, Institutional, Invited Speaker, + IDMC: Daiichi Sankyo; Financial Interests, Institutional, Invited Speaker, PI: Seagen. F. André: Financial Interests, Personal, Advisory Board: Lilly France; Financial Interests, Institutional, Advisory Board: AstraZeneca, Daiichi Sankyo, Roche, Lilly, Pfizer, Owkin, Novartis, Guardant Health, N-Power Medicine, Servier, Gilead, Boston Pharmaceutics; Financial Interests, Institutional, Research Grant: AstraZeneca, Lilly, Novartis, Pfizer, Roche, Daiichi, Guardant Health, Owkin. B. Pistilli: Financial Interests, Institutional, Advisory Board: AstraZeneca, Seagen, Lilly, Daiichi Sankyo, MSD; Financial Interests, Institutional, Invited Speaker: Gilead, Novartis, AstraZeneca, AstraZeneca, Gilead, Seagen, MSD, Novartis, Novartis; Financial Interests, Personal, Advisory Board: Pierre Fabre, Daiichi Sankyo; Financial Interests, Personal, Other, travel support: AstraZeneca, Pierre Fabre, MSD, Daiichi Sankyo; Financial Interests, Personal, Other, Travel support: Pfizer; Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Institutional, Funding: Daiichi Sankyo; Non-Financial Interests, Project Lead: Unicancer. T. Bachelot: Financial Interests, Personal, Advisory Board: Novartis, AstraZeneca, Pfizer, Seagen, Daiichi Sankyo; Financial Interests, Institutional, Advisory Board: Lilly; Financial Interests, Institutional, Research Grant: Novartis, Roche, AstraZeneca, Seagen, Pfizer; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Institutional, Invited Speaker: AstraZeneca; Non-Financial Interests, Principal Investigator: Roche, AstraZeneca. J. Pierga: Financial Interests, Personal, Advisory Board: Pfizer, Lilly, Seagen, MSD, Novartis, Exact Sciences, Gilead, AstraZeneca, Eisai; Financial Interests, Personal, Invited Speaker: Roche, Daiichi Sankyo, Menarini, Veracyte, Pfizer, Lilly, Seagen, MSD, Novartis, Daiichi Sankyo; Financial Interests, Institutional, Invited Speaker: AstraZeneca, Novartis, Daiichi Sankyo; Financial Interests, Institutional, Other, IDMC: Sanofi; Financial Interests, Institutional, Funding: Servier. C. Levy: Non-Financial Interests, Personal, Other, Medical Symposium: Gilead, Pfizer; Financial Interests, Institutional, Sponsor/Funding: Lilly; Non-Financial Interests, Institutional, Principal Investigator: Daiichi Sankyo, Novartis, Roche. C. Jouannaud: Financial Interests, Personal, Advisory Board: Daiichi Sankyo AstraZeneca. P. Fournel: Financial Interests, Personal, Advisory Board: BMS, Sanofi, Janssen; Financial Interests, Personal, Invited Speaker: AstraZeneca, MSD, Amgen; Financial Interests, Personal, Other, Congress invitation: Takeda; Financial Interests, Institutional, Invited Speaker: BMS, Ipsen. C. Mahier Ait Oukhatar: Financial Interests, Institutional, Funding: Daiichi Sankyo. T. Filleron: Financial Interests, Personal, Other, working group: Janssen-Cilag,; Financial Interests, Institutional, Invited Speaker: Lilly; Financial Interests, Institutional, Other, working group: Roche; Other, Consulting (compensated to my institution): Cellectis. M.F. Mosele: Financial Interests, Institutional, Invited Speaker: Novartis; Financial Interests, Personal, Full or part-time Employment: PEGASCY. M. Lacroix-Triki: Financial Interests, Personal, Advisory Board, invited speaker: AstraZeneca; Financial Interests, Personal and Institutional, Advisory Board, invited speaker: Daiichi Sankyo; Financial Interests, Personal, Invited Speaker: Roche diagnostics. All other authors have declared no conflicts of interest.

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