Results of Phase I Monotherapy Trial

1403.1: Results From Phase I Monotherapy Trial

  • In Phase I studies, brigimadlin had a manageable safety profile1,2

  • DLTs were mainly thrombocytopenia and neutropenia2

    – The MTD of brigimadlin was 60 mg Q3W

    – The RDE was selected as 45 mg Q3W

  • Nausea was the most common TRAE; antiemetic prophylaxis or treatment was implemented2

  • Neutropenia and thrombocytopenia were the most common grade ≥3 TRAEs1

Brig - ResultsT

 

1. LoRusso P, et al. ASCO 2023. Poster 11554; 2. Gounder M, et al. CTOS 2022. Oral Presentation #19.

  • In patients with MDM2-amplified DDLPS (69 patients), preliminary median PFS was 7.9 months (95% CI: 4.2–9.9) and ORR was 14.5%1

    – 10/69 (14.5%) patients achieved a PR

    – A further 47 (68.1%) patients had SD

    – DCR was 82.6%1

Phase I monotherapy trial data - tumor response over time in patients with DDLPS

Results of Phase I Combination Trial

1403.2: Results From Phase 1 Combination Trial

As of August 2022, 27 patients have received brigimadlin plus ezabenlimab at 30 mg (n=13) and at 45 mg (n=14)

Phase I safety data

  • Brigimadlin plus ezabenlimab showed a manageable safety profile, including in patients with liposarcoma

  • Most common any-cause grade ≥3 AEs were anemia (n=7), thrombocytopenia (n=7), and lymphocyte count decreased (n=6)

  • The RDE was selected as brigimadlin at 45 mg Q3W + ezabenlimab 240 mg

 
 Safety Data

Early antitumor activity

  • Among response-evaluable patients who received brigimadlin plus ezabenlimab:

    – 8 of 24 patients (33%) achieved PR

    – 14 of 24 patients (58%) had SD

Best change from baseline (%) among response-evaluable patients who received brigimadlin plus ezabenlimab (n=24)

Tolcher A, et al. CTOS 2022. Poster 167.