ESMO 2022 | Phase I dose-escalation and expansion study evaluating BI 907828 in patients with solid tumours

Patrick Schöffski, MD, MPH, KU Leuven, Leuven, Belgium, talks on a Phase I dose-escalation and expansion study (NCT03449381) evaluating the safety and efficacy of the MDM2–p53 antagonist BI 907828 in patients with solid tumours. 94 patients were enrolled. The primary endpoint was progression-free survival (PFS) and secondary endpoints included objective response rate (ORR) and the number of patients with grade ≥3 treatment-related adverse events (AEs). Disease control rate was 93% in dedifferentiated liposarcoma (LPS) and 88% in well-differentiated LPS. A confirmed partial response (PR) was achieved in 5 pts and 3 patients had unconfirmed PR. For patients with other solid tumours, 2/4 with MDM2-amplified biliary tract cancer and 1 with MDM2-amplified pancreatic adenocarcinoma had a confirmed PR. Conclusively, BI 907828 demonstrated antitumour activity and a manageable safety profile in patients with advanced solid tumours, including LPS. This interview took place at the European Society for Medical Oncology (ESMO) 2022 Congress in Paris, France.