Extimia (empegfilgrastim) / Biocad - LARVOL DELTA

Prolgolimab With Chemo as 1st Line Therapy for Patients With Advanced Nsnsclc: Extended 36 Months Follow-Up of Phase III Trial DOMAJOR (IASLC-WCLC 2026) - "The phase III DOMAJOR trial has previously demonstrated superior efficacy of prolgolimab plus pemetrexed and platinum-based chemotherapy (cisplatin or carboplatin) over placebo plus chemotherapy (chemo)...Conclusions : After 36 months, prolgolimab plus chemo maintained significant survival benefits over chemo alone in first-line advanced nsNSCLC, with a consistent effect regardless of PD-L1 expression and a manageable safety profile. Significant differences in PFS and OS benefit shown in the study will be explored in further studies."

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

MATCHING-ADJUSTED INDIRECT COMPARISON (MAIC) OF PRIMARY EMPEGFILGRASTIM AND FILGRASTIM FN PROPHYLAXIS: FINAL RESULTS FROM EMPEREAL STUDY (MASCC-ISOO 2026) - "Results MONITOR-GCSF included 1117 patients...MAIC showed statistically significant superiority of empegfilgrastim over filgrastim in % of patients with FN (-5.0 (-6.3, -3.7) p<0.001), CIN4 (-9.8 (-14.4, -5.2) p<0.001), CIN3-4 (-16.9 (-22.1, -11.6) p<0.001), DLN (-8.7 (-10.8, -6.6) p<0.001). Conclusions Study have showed that empegfilgrastim is associated with a lower risk of FN and CIN in comparison with filgrastim in patients with solid tumors."

Clinical • Bladder Cancer • Breast Cancer • Chemotherapy-Induced Neutropenia • Febrile Neutropenia • Genito-urinary Cancer • Lung Cancer • Neutropenia • Ovarian Cancer • Prostate Cancer • Solid Tumor

Efficacy and safety of the pertuzumab biosimilar BCD‑178 versus the originator pertuzumab in patients with HER2-positive locally advanced breast cancer: Results from the international, double-blind, randomized, phase III PREFER trial. (ASCO 2026) - P3 | "Patients were randomized 1:1 to receive neoadjuvant therapy with either BCD‑178 or OP, combined with trastuzumab and chemotherapy (TCHP regimen)... In patients with HER2+, hormone receptor-negative locally advanced breast cancer, the biosimilar BCD‑178 demonstrated equivalent efficacy, safety, immunogenicity, and pharmacokinetics to the originator pertuzumab within a neoadjuvant TCHP regimen."

Clinical • Metastases • P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • HER-2

Efficacy of neoadjuvant TCHP with primary empegfilgrastim (E) prophylaxis in HER2-positive early breast cancer (HER2+ eBC): Final results of the DEFENDOR SPECIAL study. (ASCO 2026) - P=N/A | " From April 2020 to September 2023, 105 patients (pts) with HER2+ eBC received NAТ: 6 docetaxel/carboplatin/trastuzumab + pertuzumab + empegfilrastim (TCHP+E)... The use of empegfilgrastim allows to provide 96% RDI. TCHP with empegfilgrastim shows high efficacy in HER2+ breast cancer across HR status and tumor stage. HER2 expression level is a significant predictor of pCR."

Clinical • Breast Cancer • Febrile Neutropenia • HER2 Breast Cancer • HER2 Positive Breast Cancer • Neutropenia • Oncology • Solid Tumor • Thrombocytopenia • HER-2

Empegfilgrastim for primary febrile neutropenia prophylaxis during induction chemotherapy with docetaxel, cisplatin, and 5-fluorouracil in head and neck squamous cell carcinoma. (ASCO 2026) - "Primary prophylaxis with empegfilgrastim during DCF induction CT was associated with a relatively low incidence of grade 3–4 neutropenia and FN in pts with advanced HNSCC, while allowing the majority to complete planned treatment. Further analyses are planned to compare the efficacy and safety of empegfilgrastim administration on day 2 versus day 3 of the DCF regimen."

Chemotherapy-Induced Neutropenia • Febrile Neutropenia • Head and Neck Cancer • Hematological Disorders • Neutropenia • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Febrile neutropenia prophylaxis with prolonged G-CSF in elderly cancer patients: Analysis from the EMPREREAL study. (ASCO 2026) - "These results support the effectiveness of primary prophylaxis with empegfilgrastim in routine practice for elderly patients. Clinical outcomes at the patient level."

Clinical • Breast Cancer • Chemotherapy-Induced Neutropenia • Febrile Neutropenia • Heart Failure • Hepatology • Liver Failure • Lung Cancer • Neutropenia • Oncology • Solid Tumor

Final results of the phase III OCTAVA trial: Clinical benefit of low-dose anti–CTLA-4 plus anti–PD-1 combination vs anti–PD-1 monotherapy in unresectable or metastatic melanoma. (ASCO 2026) - P3 | "Funded by JSC BIOCAD Clinical Trial Registration Number: NCT05732805 Background: BCD-217-2/OCTAVA is an international, multi-center, randomized, double-blind, placebo-controlled phase III study conducted to assess the efficacy and safety of nurulimab +prolgolimab (nuru + prolgo ) combination therapy with continued prolgolimab therapy compared to prolgolimab monotherapy at the 1st line treatment of patients (pts) with unresectable or metastatic melanoma (un/mM)... The OCTAVA trial results demonstrated a statistically significant and clinically meaningful improvement in PFS for the 1st line low-dose nuru + prolgo combination followed by prolgo maintenance, compared to prolgo monotherapy, in patients with unresectable or metastatic melanoma. This efficacy benefit was accompanied by manageable rate of immune-related AE, consistent with the known profile of CTLA-4/PD-1 combinations. These results support the use of the nuru + prolgo regimen as a valuable 1st line..."

Clinical • Metastases • Monotherapy • P3 data • Melanoma • Solid Tumor • CTLA4 • IL17RA • PD-1

THE EFFICACY AND SAFETY OF DIVOZILIMAB, ANTI-CD20 MONOCLONAL ANTIBODY IN PATIENTS WITH SYSTEMIC SCLEROSIS (SSWC 2026) - P3 | "Subanalysis included the changes in mRSS from baseline at W48 in subgroups of male and female, with and without concomitant mycophenolate mofetil (MMF), and with initial forced vital capacity (FVC) >80% or <80%... Divozilimab treatment leads to signifi- cant decrease of skin fibrosis comparing to standard treatment with favorable safety profile, which allows to consider DIV as an actual therapeutic option for SSc."

Clinical • Fibrosis • Immunology • Scleroderma • Systemic Sclerosis

Arvenacogene sanparvovec: A novel gene therapy for hemophilia B – results from A phase I–II first-in-human trial (ASH 2025) - P1/2 | "A single administration of ANB-002 (arvenacogene sanparvovec) gene therapy to 13 patients withmoderately severe or severe hemophilia B resulted in durable factor IX expression, sustained clinicalbenefit that made it possible completely discontinue the FIX prophylaxis for 10 from 13 participants.Therapy was well tolerated."

First-in-human • Gene therapy • P1/2 data • Gene Therapies • Hematological Disorders • Hemophilia • Hemophilia B • Rare Diseases

Network Meta-Analysis of Survival Outcomes in the First-Line Treatment of Unresectable or Metastatic Melanoma: Scoping Review of Methodology (ISPOR-EU 2025) - "NMA is widely used to compare treatments for unresectable or metastatic melanoma, but most studies lack modern methodological approaches, including unclear model selection, absence of proportional hazards testing, and reliance on aggregated data, which limits the accurate modelling of time-dependent effects and interpretability of results. Future research should adopt IPD NMA with flexible survival models for more reliable results."

Metastases • Retrospective data • Review • Melanoma • Solid Tumor

The Disease Burden of Systemic Sclerosis in the Russian Federation (ISPOR-EU 2025) - "Lack of pathogenetic therapies for SSc has forced patients to rely on largely ineffective treatments (nearly all drugs for the primary disease are used off-label). This contributes to the development of numerous life-threatening complications, that consume most direct medical costs and ultimately result in early death. Simultaneously, patients experience significant declines in work productivity, leading to unemployment and substantial economic losses."

Gene Therapies • Immunology • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases • Scleroderma • Systemic Sclerosis

Predicting Outcomes and Estimating Minimum Sample Sizes for Divozilimab Efficacy in NMOSD: A Clinical Trial Simulation and Unanchored Matching-Adjusted Indirect Comparison (ISPOR-EU 2025) - "Simulation modelling predicts the 6-month ARR of 0.116 (90% CI: 0.030; 0.212) for Divozilimab, corresponding to ARR of 0.117 (90% CI: 0.050; 0.315) versus placebo. A minimum sample size of 35 patients receiving Divozilimab is predicted to provide ≥90% power to demonstrate superiority based on the primary objective."

Biomarker • Clinical • CNS Disorders • Immunology • Neuromyelitis Optica Spectrum Disorder • Rare Diseases • IL2RG

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

Efficacy and Safety of Biologics to Treat Adults With Active Radiographic Axial Spondyloarthritis: Systematic Review and Bayesian Network Meta-Analysis (ISPOR-EU 2025) - "OBJECTIVES: To compare efficacy and safety of IL-17 inhibitors in the treatment of adults with active radiographic axial spondyloarthritis (r-AxSpA) over a 16-week period using network meta-analysis (NMA). We conducted systematic literature search in PubMed and Embase in November 2024 to retrieve publications with results of randomized controlled trials (RCTs) evaluating efficacy and safety of IL-17 inhibitors (netakimab, secukinumab, ixekizumab, bimekizumab, brodalumab, xeligekimab, vunakizumab) in adults with active r-AxSpA... Netakimab showed the highest relative efficacy among available IL-17 inhibitors used to treat adults with active r-AxSpA over 16-week horizon and demonstrated a favorable safety profile."

Retrospective data • Review • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Seronegative Spondyloarthropathies • Spondylarthritis • IL17A

HEMATOPOIETIC STEM CELL MOBILIZATION USING PEG-G-CSF EMPEGFILGRASTIM (EXTIMIA®) IN PATIENTS WITH LYMPHOPROLIFERATIVE DISEASES: EXPERIENCE OF SEVERAL CENTERS IN THE RUSSIAN FEDERATION (EBMT 2025) - "The results of the first multicenter experience with the use of Extimia® BIOCAD (INN: empegfilgrastim) for the mobilization of autologous blood stem cells in patients with lymphoproliferative diseases demonstrate its high efficacy with a favorable safety and tolerability profile: 74% (66/89) of successful mobilizations after a single administration of a fixed dose of the drug."

Clinical • B Cell Lymphoma • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Multiple Myeloma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Plasmacytoma • Solid Tumor • T Cell Non-Hodgkin Lymphoma

DEFENDOR: Real-world evidence of primary prolonged G-CSF prophylaxis by empegfilgrastim for relative dose intensity compliance in patients with solid tumors—The final analysis. (ASCO 2024) - "Here we present the final results of a multicenter prospective observational post-marketing study of safety and efficacy of pegylated G-CSF Extimia (INN: empegfilgrastim, JSC BIOCAD) in pts with ST who receive cytotoxic therapy... Primary prolonged G-CSF prophylaxis by empegfilgrastim allows effectively maintaining RDI across various tumor types (TT) and treatment groups in pts with ST in routine clinical practice. Clinical trial information: NCT0481144."

Clinical • Compliance • HEOR • Real-world • Real-world evidence • Anemia • Chemotherapy-Induced Neutropenia • Hematological Disorders • Neutropenia • Oncology • Solid Tumor

Defendor: Real-world evidence of primary prolonged G-CSF prophylaxis by empegfilgrastim for relative dose intensity compliance in patients with solid tumors—The primary analysis. (ASCO 2022) - P | "This multicenter prospective observational post-registration study of prolonged G-CSF empegfilgrastim (Extimia) was designed to evaluate the RDI of the cytotoxic therapy course under PP by empegfilgrastim in patients (pts) with ST receiving myelosuppressive therapy in the routine clinical practice... Thus, PP with prolonged G-CSF empefilgrastim allows effectively maintain RDI in different nosology and treatment groups in pts with ST in the routine clinical practice."

Clinical • HEOR • Real-world evidence • Back Pain • Chemotherapy-Induced Neutropenia • Hematological Disorders • Infectious Disease • Musculoskeletal Pain • Neutropenia • Novel Coronavirus Disease • Oncology • Pain • Solid Tumor • CSF3

Incidence of severe and febrile neutropenia in cancer patients treated with myelosuppressive chemotherapy in real clinical oncology practice: Preliminary results from the FLAME study. (ASCO 2022) - "Primary prophylaxis was given only to 44.1% pts with a high risk of FN [empegfilgrastim (Extimia®) 19,1%, filgrastim 25%]... Preliminary results from this study suggest that the risk of FN is higher from the start of CT. Delaying and reducing the dose of CT is still typical for oncologists. This practice is associated with low adherence to guidelines."

Clinical • Febrile Neutropenia • Gastrointestinal Cancer • Gastrointestinal Disorder • Gynecologic Cancers • Hematological Disorders • Infectious Disease • Lung Cancer • Neutropenia • Oncology • Sarcoma • Solid Tumor

Def_Special: Defendor Special: A Multicenter Prospective Observational Post-registration Study of Combined Chemotherapy With Empegfilrastim Support to Evaluate Safety and Efficacy in Patients With High and "Gray Zone" Risk Reccurrence Breast Cancer, Gastointestinal Cancers and Gynecological Malignancies (clinicaltrials.gov) - P; N=285; Recruiting; Sponsor: Moscow Clinical Scientific Center

Clinical • New trial • Breast Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Neutropenia • Oncology • Solid Tumor • HER-2

DEFENDOR: A Multicenter Prospective Observational Post-registration stuDy of Extimia® (INN: empEgfilrastim) to Evaluate Efficacy and saFEty in patieNts With soliD tumORs (clinicaltrials.gov) - P; N=500; Recruiting; Sponsor: Biocad

Clinical • New trial • Neutropenia • Oncology • Solid Tumor

Efficacy and tolerability of granulocyte colony-stimulating factors in cancer patients after chemotherapy: A systematic review and Bayesian network meta-analysis. (PubMed, Sci Rep) - "S-G-CSF biosimilar, empegfilgrastim, and long-acting G-CSF (L-G-CSF) biosimilar were best G-CSF drugs in reducing severe neutropenia (SN) (cumulative probabilities: 21%, 20%, 15%, respectively). Mecapegfilgrastim, balugrastim, lipegfilgrastim and L-G-CSF biosimilar were best G-CSF drugs in reducing BP (cumulative probabilities: 20%, 14%, 8%, 8%, respectively). Mecapegfilgrastim, lipegfilgrastim and balugrastim might be the most appreciate G-CSF drugs with both good efficacy and tolerability when treating cancer patients after cytotoxic chemotherapy."

Journal • Retrospective data • Review • Hematological Disorders • Musculoskeletal Pain • Neutropenia • Oncology • Pain

CLINICAL AND ECONOMIC ASSESSMENT OF THE IMPORTANCE OF SUPPORTIVE THERAPY IN ONCOLOGY (ISPOR-EU 2019) - "...Corresponding CERs were € 10,312.1 (for Empegfilgrastim), € 10,506.7 (Lipegfilgrastim), € 11,025.4 (Filgrastim), € 11,556.8 (Pegfilgrastim), € 13,310.5 (Lenograstim), and € 17,378.6 (CT without FN prophylaxis with G-CSF). The use of G-CSF as a preventive measure for the development of chemotherapy complications is economically viable from CEA and COI perspectives. Although the expansion of FN prophylaxis in cancer patients increases drug costs for the FN prevention, it also reduces the total costs of cancer patient treatment."

Clinical