nurulimab (BCD-145) / Biocad - LARVOL DELTA

Neoadjuvant anti–PD-1 prolgolimab monotherapy in resectable high-risk melanoma: Pathologic response and early event-free survival in a prospective single-arm phase II CRISTINA study. (ASCO 2026) - P | "Recently reported data for prolgolimab+nurulimab (N = 205) showed pCR 38.5%, near-CR 4.4%, motivating evaluation of prolgolimab mono as a simpler potentially non-inferior approach. NST prolgolimab monotherapy achieved MPR rates above the historical benchmark with encouraging early EFS. MPR—especially pCR—was strongly associated with improved EFS, with no progressions observed among pCR pts. In exploratory analyses, neither time from neoadj start to surgery nor receipt of adjuvant therapy appeared to materially affect EFS."

Clinical • Monotherapy • P2 data • Melanoma • Solid Tumor • BRAF

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