nurulimab (BCD-145) / Biocad - LARVOL DELTA

Adjusting to Nonoverlapping Variables in the Unanchored Matching-Adjusted Indirect Comparisons of Survival Outcomes: Application of Monte Carlo Simulations (ISPOR-EU 2025) - P3, P3b/4 | "OBJECTIVES: This research aims to compare overall (OS) and progression-free (PFS) survival between two anti-PD1+anti-CTLA4 combinations (prologolimab+nurulimab and nivolumab+ipilimumab) in the first line therapy of patients with advanced melanoma. Systematic literature review revealed three randomized clinical trials: OCTAVA (NCT05732805, 135 patients on prolgolimab+nurulimab (PROLGO+NURU)), CheckMate-067 (NCT01844505, 314 patients on nivolumab 1 mg/kg + ipilimumab 3 mg/kg (NIVO1+IPI3)), CheckMate-511 (NCT02714218, 178 patients on NIVO1+IPI3, 180 patients on nivolumab 3 mg/kg + ipilimumab 1 mg/kg (NIVO3+IPI1))... Monte-Carlo simulations are applicable for adjustment to non-overlapping variables in MAICs, although they require additional assumptions about survival distribution on the study treatment in unstudied populations, which are subject to further validation."

Melanoma • Mucosal Melanoma • Solid Tumor

Improved clinical outcomes with low-dose anti-CTLA-4 (Nurulimab) plus anti-PD-1 (Prolgolimab) vs. anti-PD-1 monotherapy in advanced cutaneous melanoma: Results from the phase III OCTAVA trial. (PubMed, Eur J Cancer) - P3 | "The Nuru+Prolgo fixed-dose combination demonstrated significantly superior efficacy versus aPD-1 monotherapy in first-line un/mM, with a manageable safety profile."

Clinical • Clinical data • Journal • Monotherapy • P3 data • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor • IL17RA

Efficacy and safety of first-line prolgolimab and nurulimab versus nivolumab and ipilimumab in advanced or metastatic melanoma: Indirect treatment comparison. (ASCO 2025) - P3 | "Pairwise unanchored MAICs showed statistically significantly higher OS and better safety profile in patients who received PROLGO+NURU combination compared to NIVO+IPI in the first-line treatment of advanced or metastatic melanoma."

Clinical • Metastases • Melanoma • Oncology • Solid Tumor

A phase I dose escalation trial of BCD-145 in patients with unresectable or metastatic melanoma. (ASCO 2024) - P1 | "BCD-145 demonstrated a tolerable safety profile and preliminary anti-tumor activity in pts with unr/mM. Anti-tumor effects of BCD-145 were observed in pts who had progressed on prior treatment. Further co-targeting PD-1 and CTLA-4 simultaneously will achieve a better anti-tumor activity due to cooperative binding to exhausted T-cell subsets."

Clinical • Metastases • P1 data • Anemia • Cardiovascular • Endocrine Disorders • Hematological Disorders • Hypertension • Infectious Disease • Melanoma • Metabolic Disorders • Neutropenia • Oncology • Respiratory Diseases • Solid Tumor • CD4 • CD8 • ICOS • PD-1