Forteca (prolgolimab) / Biocad - LARVOL DELTA

Experience with prolgolimab in the treatment of patients with relapsed and refractory classical Hodgkin lymphoma (ASH 2025) - "Objective: To evaluate the efficacy and safety of prolgolimab both as monotherapy and in combination with DHAP chemotherapy (dexamethasone, cytarabine, cisplatin), as well as to assess the feasibility of peripheral blood stem cell (PBSC) collection followed by auto-HSCT in patients with r/r cHL...Disease progression was noted in 6 patients, who were subsequently switched to bendamustine-based chemotherapy regimens. PBSC collection was successfully performed in 15 patients after chemomobilization with etoposide (375 mg/m²/day on days 1–2)... The combination of prolgolimab with DHAP chemotherapy is highly effective and safe, with no negative impact on PBSC collection. Achieving tumor response prior to auto-HSCT and the use of prolgolimab as consolidation therapy can lead to durable remissions without additional toxicity in patients with r/r cHL."

Clinical • Bone Marrow Transplantation • Cardiovascular • Classical Hodgkin Lymphoma • Endocrine Disorders • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Pulmonary Embolism • Respiratory Diseases • CD34 • PD-L2

Single-center prospective clinical study on the assessment of the safety and efficiency of the use of PD1 inhibitor prolgolymab in combination with chemotherapy as a neoadjuvant treatment for patients with primary locally advanced squamous cell carcinoma of the esophagus (ESMO Asia 2025) - "Сlinical trial was initiated to evaluate the safety and efficacy of neoadjuvant immunochemotherapy with an IgG1 anti-PD-1 monoclonal antibody Prolgolimab in patients with primary resectable esophageal SCC. This study is a single-center, single-sleeve, phase I/II trial of neoadjuvant immunochemotherapy with prolgolimab 200 mg plus paclitaxel (175 mg/m2) plus cisplatin (75 mg/ m2) or carboplatin (AUC 5-6) on day 1 of a 21day cycle for four cycles, followed by surgical treatment. Neoadjuvant chemotherapy combined with an immune checkpoint inhibitor prolgolimab appears safe and effective in patients with resectable esophageal cancer."

Clinical • Combination therapy • IO biomarker • Metastases • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

Neoadjuvant Immunotherapy With Prolgolimab in Patients With Locally Advanced Microsatellite Instability/Defective Mismatch Repair Colorectal Cancer. (PubMed, JCO Precis Oncol) - P2 | "The use of prolgolimab in locally advanced dMMR/MSI CRC is associated with high rates of pCR and cCR, allowing for further exploration of organ-sparing approaches in these patients."

dMMR • Journal • Mismatch repair • Colon Cancer • Colorectal Cancer • Microsatellite Instability • Oncology • Solid Tumor • MSI

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

Neoadjuvant immunotherapy with prolgolimab in locally advanced dMMR/MSI colorectal cancer: Final pathological response analysis and 12-months disease-free survival (ESMO-GI 2025) - P2 | "Prolgolimab showed high efficacy (80.8% MPR, 61.5% pCR) and acceptable toxicity with a 12-month DFS of 93.3% in pts with resectable dMMR/MSI CRC. These findings suggest prolgolimab is one of promising immunotherapy option for dMMR/MSI CRC."

Clinical • dMMR • IO biomarker • Metastases • Colorectal Cancer • Oncology • Solid Tumor • BRAF • MSI

Baseline Radiomics as a Prognostic Tool for Clinical Benefit from Immune Checkpoint Inhibition in Inoperable NSCLC Without Activating Mutations. (PubMed, Cancers (Basel)) - " A comprehensive ensemble radiomics approach was applied to pretreatment CT scans to prognosticate overall survival (OS) and predict progression-free survival (PFS) in a cohort of 220 consecutive patients with inoperable NSCLC treated with first-line ICIs (pembrolizumab or atezolizumab, nivolumab or prolgolimab) as monotherapy or in combination. Predictive performance was lower for 6-month (AUC = 0.719) and 12-month PFS (AUC = 0.739) endpoints. Our radiomics pipeline improved selection of NSCLC patients for immunotherapy and could spare non-responders unnecessary toxicity while enhancing cost-effectiveness."

Checkpoint inhibition • IO biomarker • Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

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

Correlation of clinical benefit from immune checkpoints and baseline radiomic signature in inoperable NSCLC without activating mutations. (ASCO 2025) - " We included patients with inoperable NSCLC treated in 1st or 2nd line with ICI (pembrolizumab and bioanalogues, atezolizumab, nivolumab or prolgolimab) either as monotherapy or a combination. Overall, our study highlights that radiomics can achieve very good performance in the prognostication of clinical benefit, defined as prolonged overall survival in patients with lung cancer treated with ICI. Prognostic models developed in this study may potentially provide a clinical predictor of disease outcome outperforming routinely used clinicopathological parameters."

Clinical • IO biomarker • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Autoimmune endocrinopathies associated with the use of immune checkpoint inhibitors: a clinical case of a combination of primary hypothyroidism due to destructive thyroiditis and diabetes mellitus (ESPE-ESE 2025) - "In December 2022, the patient was prescribed prolgolimab, a human monoclonal antibody that binds specifically to PD-1, inhibiting its interaction with PD-L1 and PD-L2 to prevent tumor cells from evading the immune system...Approximately one year after the diabetes mellitus diagnosis, and following three courses of immune checkpoint therapy (nivolumab + ipilimumab), the patient developed destructive thyroiditis in its hypothyroid phase...Levothyroxine sodium was initiated at 75mcg/day, with gradual titration to 112.5mcg/day to achieve targeted hypothyroidism compensation. Results This case highlights the complex immune response triggered by ICIs, as evidenced by the sequential onset of two significant autoimmune endocrinopathies-diabetes mellitus and thyroiditis. The varied timing of these events underscores the need for diligent monitoring for endocrine disorders throughout different phases of ICI therapy."

Checkpoint inhibition • Clinical • Diabetes • Endocrine Disorders • Hepatology • Immunology • Melanoma • Metabolic Disorders • Oncology • Solid Tumor

CONDITIONING WITH HIGH-DOSE MITOXANTRONE AND MELPHALAN BEFORE AUTOLOGOUS STEM CELL TRANSPLANTATION IN PATIENTS WITH RELAPSED/REFRACTORY CLASSIC HODGKIN LYMPHOMA (EBMT 2025) - "Consolidation therapy with brentuximab vedotin was performed in four patients, with prolgolimab- in one patient. To our knowledge, this is the largest series of r/r cHL cases treated with Mitoxantrone/Melphalan conditioning regimen and ASCT. Mitoxantrone/Melphalan is a feasible and effective conditioning regimen in majority of heavily pretreated r/r cHL patients. Additional studies in order to evaluate long-term extra-hematological toxicity are needed."

Clinical • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Classical Hodgkin Lymphoma • Hematological Disorders • Hematological Malignancies • Hodgkin Lymphoma • Leukemia • Lymphoma • Oncology • Transplantation • CD34

INTERIM ANALYSIS OF SECOND-LINE PROLGOLIMAB THERAPY IN CLASSIC HODGKIN LYMPHOMA: A STEP TOWARD TRANSPLANT-FREE TREATMENT (PROLGO-HL) (EBMT 2025) - P2 | "Non-CR pts are switched to combination therapy (Prolgo 1 mg/kg D1,15; Bendamustine 90 mg/m2 D1,2, 28-day cycle, for up to 3 cycles). This study represents initial evaluation of Prolgo efficacy and safety as a second-line therapy for cHL, focusing on avoiding autoHCT in patients achieving early CR. Preliminary findings indicate a favorable toxicity profile and encouraging efficacy, demonstrating the potential for achieving remission without the need for chemotherapy or autoHCT in the second-line treatment of cHL. Clinical Trial Registry: NCT05757466"

Clinical • Classical Hodgkin Lymphoma • Diabetes • Hematological Malignancies • Hodgkin Lymphoma • Infectious Disease • Lymphoma • Melanoma • Metabolic Disorders • Oncology • Pneumonia • Renal Calculi • Respiratory Diseases • Solid Tumor • Transplantation

INTERIM ANALYSIS OF SECOND-LINE PROLGOLIMAB THERAPY IN CLASSIC HODGKIN LYMPHOMA: A STEP TOWARD TRANSPLANT-FREE TREATMENT (PROLGO-HL) (EBMT 2025) - P2 | "Non-CR pts are switched to combination therapy (Prolgo 1 mg/kg D1,15; Bendamustine 90 mg/m2 D1,2, 28-day cycle, for up to 3 cycles). This study represents initial evaluation of Prolgo efficacy and safety as a second-line therapy for cHL, focusing on avoiding autoHCT in patients achieving early CR. Preliminary findings indicate a favorable toxicity profile and encouraging efficacy, demonstrating the potential for achieving remission without the need for chemotherapy or autoHCT in the second-line treatment of cHL. Clinical Trial Registry: NCT05757466"

Clinical • Classical Hodgkin Lymphoma • Diabetes • Hematological Malignancies • Hodgkin Lymphoma • Infectious Disease • Lymphoma • Melanoma • Metabolic Disorders • Oncology • Pneumonia • Renal Calculi • Respiratory Diseases • Solid Tumor • Transplantation

Gut microbiota in patients with locally advanced cutaneous melanoma as a predictor of response to immunotherapy aPD1 (EADO-WCM 2025) - "Whole-genome sequencing was performed on a NextSeq 1000 analyzer (Illumina) Results The study group included 23 patients with stage IIIB-D melanoma or its equivalent, who received 3 doses of aPD1 blocker (prolgolimab or pembrolizumab) in the neoadjuvant setting, followed by evaluation of the therapy effect and surgical intervention in the amount of regional lymphadenectomy or removal of the metastatic lesion (with M1a equivalent). pCR - 8, non-pCR/disease progression - 15.Faecalebacterium prausnitzii (88%) and Eubacterium rectale (50%) were found in the majority of responders as part of the gut microbiota. It was also noted that Prevotella copri clade A (47%) and Prevotella copri clade B (34%) were found in the non-responder group Conclusions In a Russian population of skin melanoma patients, the composition of the gut microbiota shows similar trends in microbial signatures in responders and non-responders to checkpoint inhibitors. Additional patient characteristics..."

Clinical • Gut Microbiota • Metastases • Cutaneous Melanoma • Infectious Disease • Melanoma • Oncology • Solid Tumor

Network meta-analysis (NMA) of the first-line therapy for advanced non-squamous non-small cell lung cancer (nsNSCLC): Does PD-L1 expression modify effect of the immunotherapy on the overall survival (OS)? (ELCC 2025) - "PD-L1 expression does not modify the effect of immunotherapy over CT ± Bevacizumab on the OS. Prologlimab+CT and Nivolumab+Bevacizumab+CT have benefit in the OS over all other treatment options irrespective to the proportion of pts with positive PD-1 expression."

IO biomarker • Metastases • Retrospective data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Prolgolimab with chemotherapy as first-line treatment for advanced non-squamous non-small-cell lung cancer. (PubMed, Eur J Cancer) - P3 | "Among patients with advanced NSCLC the addition of prolgolimab to pemetrexed and a platinum-based drug increased OS and PFS, with no new safety concerns. This benefit was retained in patients with PD-L1 negative tumors. (ClinicalTrials.gov, NCT03912389)."

IO biomarker • Journal • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Pulmonary Disease • Solid Tumor • PD-L1

Prolgolimab with Chemotherapy as First-Line Treatment for Advanced Non-Squamous Non-Small-Cell Lung Cancer (Eur J Cancer) - P3 | N=292 | DOMAJOR (NCT03912389) | Sponsor: Biocad | "After a median follow-up of 18 months, the median OS was not reached (95% CI, 22.28 – NA) in the prolgolimab-combination group vs 14.6 months (95% CI, 11.73 – 19.15) in the placebo-combination group (HR, 0.51; 95% CI, 0.35 – 0.73, p = 0.0001). The OS improvement was independent of PD-L1 status. Median progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) was 7.7 months in the prolgolimab-combination group and 5.5 months in the placebo-combination group (HR, 0.65; 95% CI, 0.49 – 0.85, p = 0.0004)."

P3 data • Non Small Cell Lung Cancer

EFFICACY AND SAFETY OF PROLGOLIMAB MONOTHERAPY OR IN COMBINATION WITH BENDAMUSTINE IN SECOND-LINE THERAPY FOR R/R CLASSIC HODGKIN LYMPHOMA: TRIAL IN PROGRESS (PROLGO-HL) (ISHL 2024) - P2 | "This study is the first to assess Prolgo efficacy and safety as second-line therapy for cHL, aiming to avoid auto-HSCT in early CR patients. Preliminary data demonstrate an anticipated toxicity profile and promising efficacy with the potential for chemotherapy and auto-HSCT avoidance."

Clinical • Combination therapy • Monotherapy • Bone Marrow Transplantation • Diabetes • Hematological Malignancies • Hodgkin Lymphoma • Infectious Disease • Lymphoma • Melanoma • Metabolic Disorders • Oncology • Pneumonia • Renal Calculi • Respiratory Diseases • Solid Tumor

Preclinical comparison of prolgolimab, pembrolizumab and nivolumab. (PubMed, Sci Rep) - "An in vivo study in mice inoculated with CT26.wt cancer cells showed that tumor growth inhibition was 16% for pembrolizumab and 56% for prolgolimab. This study warrants clinical comparison of IgG1- and IgG4-based anti-PD-1 antibodies."

Clinical • IO biomarker • Journal • Preclinical • Melanoma • Oncology • Solid Tumor

BIOCAD has expanded the indications for the use of the original Russian drug prolgolimab for cancer patients (BIOCAD Press Release) - "The Russian Ministry of Health has approved the use of prolgolimab for the treatment of lung cancer, expanding the current list of indications. The registration of the new indication is based, among other things, on the results of the phase III clinical trial BCD-100-3/DOMAJOR."

Approval • Lung Non-Squamous Non-Small Cell Cancer

A phase III study to access the safety and efficacy of prolgolimab 250 mg fixed dose administered every 3 weeks versus prolgolimab 1 mg/kg every 2 weeks in patients with metastatic melanoma (FLAT). (PubMed, Front Oncol) - P2, P3 | "The immunogenicity study did not detect binding antibodies to prolgolimab in any of the subjects. The obtained results showed that the selected fixed dosing regimen of prolgolimab 250 mg Q3W is characterized by efficacy and safety parameters comparable to that observed for the 1 mg/kg Q2W regimen."

Journal • Metastases • P3 data • Melanoma • Oncology • Solid Tumor

Original Russian drug for melanoma treatment registered in Belarus (BIOCAD Press Release) - "The Ministry of Health of the Republic of Belarus has approved the first Russian original PD-1 inhibitor prolgolimab (trade name Forteka®) for the treatment of one of the most aggressive types of cancer — metastatic or inoperable melanoma. Prolgolimab is aimed at restoring the ability of the human body's immune system to fight the tumor."

Approval • Melanoma

Blood MSI dynamics as a predictive biomarker of immune checkpoint inhibitor therapy efficacy in colorectal cancer (CRC): preliminary results from an observational trial (ECP 2024) - "Patients with localized disease (n=7) received neoadjuvant treatment with prolgolimab (anti-PD-1) (2 CR, 4 PR, 1 death); 2 patients with advanced/metastatic CRC received nivolumab (1 SD, 1 PD). MSI can be evaluated quantitatively via LB to trace patients’ dynamics through the course of treatment. Dynamics of bMSI correlated with the mutational dynamics and treatment outcomes. bMSI was undetectable at follow-up in patients with OR/SD."

Biomarker • Checkpoint inhibition • Clinical • IO biomarker • Observational data • Colorectal Cancer • Gastrointestinal Cancer • Microsatellite Instability • Oncology • Solid Tumor • MSI

Results of a Phase III Trial of Prolgolimab with Chemotherapy as First-Line Therapy for Patients with Advanced Non-Squamous NSCLC: DOMAJOR (IASLC-WCLC 2024) - P3 | "Methods : 292 pts with a/ns NSCLC were randomized 1:1 to receive 4 cycles of prolgolimab (3 mg/kg Q3W) together with pemetrexed, platinum drug (cis- or carboplatin) (group A) or placebo together with pemetrexed, platinum drug (cis- or carboplatin) (group B) followed by prolgolimab/placebo with pemetrexed as 1st line therapy for a/ns NSCLC until disease progression or toxicity (≤36 mos). Prolgolimab in combination with chemotherapy had favorable safety profile without any signs of unexpected toxicity. Most AEs related to study therapy were mild or moderate and did not require treatment discontinuation."

Clinical • IO biomarker • Metastases • P3 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • PD-L1

A phase III study to access the safety and efficacy of prolgolimab 250 mg fixed dose administered every 3 weeks versus prolgolimab 1 mg/kg every 2 weeks in patients with metastatic melanoma (FLAT) (Front Oncol) - P3 | N=114 | FLAT (NCT05783882) | Sponsor: Biocad | "One hundred fourteen patients received prolgolimab 250 mg Q3W, and 61 patients received prolgolimab (Prolgo) 1 mg/kg Q2W (historical control). Objective response was achieved by 33.3% [95% confidence interval (CI): 24.8, 42.8] of patients in the Prolgo 250 mg group compared with 32.8% (95% CI: 21.3, 46.0) of patients in the Prolgo 1 mg/kg group. Risk difference was 0.00, 95% CI (−0.12; NA), p = 0.0082. Both regimens were well tolerated, and safety profiles were comparable."

P3 data • Melanoma