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BCD-100 is an experimental investigational agent whose form is not stated in the registry from Biocad in phase 3 trials for melanoma, with its target not yet stated publicly.
BCD-100 is an investigational agent whose form is not stated in the registry developed by Biocad. Its molecular target is not stated in the ClinicalTrials.gov intervention record, and OnCo has not confirmed one from the sponsor's pipeline page. ClinicalTrials.gov describes the intervention as: Subject recieves prolgolimab 3 mg/kg as an intravenous infusion once every 3 weeks (Q3W) simultaneously with placebo, a total of 4 intravenous infusions. Beginning with the 5th infusion, subjects are switched to prolgolimab 1 mg/kg monother. It is the investigational product in 1 recruiting or active industry-led phase 2 and phase 3 interventional cancer trial, including the phase 3 study NCT05732805 (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), in melanoma. The largest, NCT05732805, plans to enrol 270 participants with primary completion was scheduled for 2024-06-20 on the registry. Status reflects the highest phase registered on ClinicalTrials.gov; no efficacy results are recorded here.
Mechanism not stated in the ClinicalTrials.gov record or on the sponsor's pipeline page.
1.BCD-100 binds its target.
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A domestically developed checkpoint antibody has now produced a positive phase 3 overall-survival result in lung cancer, which is the strongest evidence yet that Russian oncology can supply its own immunotherapy rather than import it. The trial ran in Russia with sites in China, Hungary and Slovakia and has not been reviewed by the European Medicines Agency or the United States Food and Drug Administration.
This is the evidence on which Russia licensed a PD-1 antibody of its own making, which matters because it is the reason immunotherapy remained available in Russian melanoma clinics on domestic supply. It is a single-country randomised phase 2 with no comparator against an established PD-1 antibody, so it does not establish equivalence with nivolumab or pembrolizumab.
Query for this drug: (TITLE:"BCD-100" OR ABSTRACT:"BCD-100" OR TITLE:"prolgolimab" OR ABSTRACT:"prolgolimab" OR TITLE:"Forteca" OR ABSTRACT:"Forteca") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about BCD-100, not a curated reading list.
Shares 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, Biocad, Melanoma and the tag pipeline.
Shares Biocad and the tag pipeline.
Shares Biocad and the tag pipeline.
Shares Biocad and the tag pipeline.
Shares Biocad and the tag pipeline.
Shares Melanoma and the tag pipeline.
Shares Melanoma and the tag pipeline.
Shares Melanoma and the tag pipeline.