Nurdati (prolgolimab/nurulimab) / Biocad - LARVOL DELTA

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

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 (Eur J Cancer) - P3 | N=270 | OCTAVA (NCT05732805) | Sponsor: Biocad | "With a median follow-up of 15.8 months, median PFS was significantly longer with nurulimab+prolgolimab [15.4 months (95% CI, 10.3-ND)] compared to prolgolimab monotherapy [10.8 months (4.7-ND)] (HR 0.68; 95% CI, 0.482-0.957; iRECIST). RECIST 1.1 analysis confirmed this benefit (mPFS 9.9 vs 2.8 months). ORR and DCR were also higher in the combination arm. Grade 3–4 treatment-related AE: 16.3% (combination) vs 14.0% (monotherapy). Immune-related AEs (irAE): 52.6% vs 32.4% (p=0.0007); Gr. ≥3 irAE: 13.3% vs 5.9% (p=0.04). Discontinuations due to AE: 9.6% vs 4.4%."

P3 data • Melanoma

NEO-MIMAJOR: A Study of Neoadjuvant Therapy With BCD-217 (Nurulimab + Prolgolimab) in Patients With Resectable Stage III Skin Melanoma (clinicaltrials.gov) - P3 | N=411 | Active, not recruiting | Sponsor: Biocad | Recruiting ➔ Active, not recruiting

Enrollment closed • Melanoma • Oncology • Solid Tumor • BRAF • PD-L1

Proved clinical benefit of low-dose anti-CTLA4 + anti-PD-1 immunotherapy versus mono anti-PD-1 therapy in patients unresectable or metastatic melanoma: Phase III OCTAVA trial (AACR 2025) - P3 | "OCTAVA trial resuts demonstrated that the fixed-dose combination of nurulimab + prolgolimab is significantly more effective than aPD-1 monotherapy without a serious deterioration of the safety profile in patients with metastatic or unresectable cutaneous melanoma as 1st line therapy."

Clinical • Metastases • P3 data • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor • IL17RA

OCTAVA: A Clinical Study of BCD-217 (Nurulimab + Prolgolimab) Followed by Anti-PD-1 Compared to Anti-PD-1 Monotherapy as First-Line Treatment in Subjects With Unresectable/Metastatic Melanoma (clinicaltrials.gov) - P3 | N=270 | Active, not recruiting | Sponsor: Biocad | Recruiting ➔ Active, not recruiting | Trial completion date: Apr 2025 ➔ Jul 2025

Enrollment closed • Monotherapy • Trial completion date • Melanoma • Oncology • Solid Tumor • BRAF • PD-L1

Anti-PD1 + low-dose anti-CTLA4 immunotherapy pathological response rate in patients with stage III resectable melanoma: Phase III NEOMIMAJOR trial interim analysis (ESMO 2024) - P3 | "Here we present the primary interim analysis of the pathological response rate and safety of BCD-217 in neoadjuvant systemic therapy (NAST) arm. Pts with respectable stage III melanoma were randomized in 2 treatment arms: BCD-217 arm and CLND + adjuvant pembrolizumab arm. The presented data shows that 2 cycles of BCD-217 are enough to achieve pCR and potentially avoid CLND in ∼40% pts. pCR/pnCR can be recognized as a hallmark of OS/DFS improvement according to INMC. There were no severe irAEs or treatment-related AEs."

Clinical • P3 data • P3 data: top line • Melanoma • Oncology • Solid Tumor • IL17RA

NEO-MIMAJOR: A Study of Neoadjuvant Therapy With BCD-217 (Nurulimab + Prolgolimab) in Patients With Resectable Stage III Skin Melanoma (clinicaltrials.gov) - P3 | N=410 | Recruiting | Sponsor: Biocad

New P3 trial • Melanoma • Oncology • Solid Tumor • BRAF • PD-L1

OBERTON: Study of Efficacy and Safety of BCD-217 (Anti-CTLA-4 and Anti-PD-1) Followed By BCD-100 (Anti-PD-1) Versus BCD-100 Monotherapy as First-Line Treatment in Patients With Unresectable or Metastatic Melanoma (clinicaltrials.gov) - P2 | N=117 | Active, not recruiting | Sponsor: Biocad | Unknown status ➔ Active, not recruiting | Trial completion date: Nov 2021 ➔ Dec 2023 | Trial primary completion date: Aug 2021 ➔ Jul 2023

Enrollment closed • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Melanoma • Oncology • Solid Tumor • BRAF • PD-L1

OCTAVA: A Clinical Study of BCD-217 (Nurulimab + Prolgolimab) Followed by Anti-PD-1 Compared to Anti-PD-1 Monotherapy as First-Line Treatment in Subjects With Unresectable/Metastatic Melanoma (clinicaltrials.gov) - P3 | N=270 | Recruiting | Sponsor: Biocad

Metastases • Monotherapy • New P3 trial • Melanoma • Oncology • Solid Tumor • BRAF • PD-L1

Study of Efficacy and Safety of BCD-217 (Anti-CTLA-4 and Anti-PD-1) Followed By BCD-100 (Anti-PD-1) Versus BCD-100 Monotherapy as First-Line Treatment in Patients With Unresectable or Metastatic Melanoma (clinicaltrials.gov) - P2; N=112; Recruiting; Sponsor: Biocad; Not yet recruiting ➔ Recruiting; Trial completion date: Sep 2022 ➔ Nov 2021

Clinical • Enrollment open • Monotherapy • Trial completion date • Melanoma • Oncology • Solid Tumor • BRAF • PD-L1