Phase II trial (BCD-100-2/MIRACULUM) of the novel PD-1 inhibitor (BCD-100) in patients with advanced melanoma.

• DOI: 10.1200/jco.2019.37.15_suppl.9549
• Publication Date: 2019-05-27T16:13:30Z
• Authors: Sergey Fogt; Mariia Shustova; Lev V. Demidov; Vladimir Moiseyenko; Sergei Tjulandin; Tatiana Semiglazova; Svetlana Protsenko; Svetlana Odintsova; Ruslan Zukov; Sergey Lazarev; Yuliya Makarova; Marina Nechaeva; Dina Sakaeva; Aleksey Andreev; Anna Tarasova; Natalia Fadeeva; Olesya Gavrilova; Roman Ivanov
• Keywords: Clinical endpoint; Interim analysis; Concomitant

9549 Background: MIRACULUM (NCT03269565) is a multicenter open-label parallel-arm phase II study investigating the antitumor activity of BCD-100, an IgG1 anti-PD-1 monoclonal antibody with Fc silencing “LALA” mutation, in patients advanced melanoma. Interim analysis at 6-months presented. Methods: Patients (pts) unresectable or metastatic melanoma, without autoimmune disease, and no prior anti-CTLA-4 therapy were eligible. Pts received BCD-100 1 mg/kg Q2W (arm 1) 3 Q3W 2) until disease progression intolerable toxicity. Primary endpoint was ORR assessed per irRECIST by independent central radiology review. A statistical hypothesis that has significant anti-tumor effect (ORR more than 28% protocol population) tested for each arm alpha 0.05 80% power. Results: 126 pts treated 114 evaluable primary (9 dropped out before their first efficacy assessment had major deviations). In 2, 17 (27%) 16 (25%) treatment respectively. The met its both arms. 1, 34% achieved among 59 response-evaluable patients, including 4 CR PR, control rate (DCR) 68%. 29% 55 pts, 2 14 DCR 55%. All responses durable; only one patient presented progression, median PFS OS not reached either arms 6 months follow-up. Treatment-related AEs (TRAEs) occurred 48% arm, 6% 5% grade 3/4 TRAEs Immune-related (irAEs) 30% 3% irAEs arm. Conclusions: Both dosing regimens (1 Q3W) have durable manageable safety profile Clinical trial information: NCT03269565.