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DRUG:

crolibulin (EPC2407)

i
Other names: EPC2407, MX-2407, EPC 2407, EPC-2407, MX116407
Associations
Company:
Immune Pharma
Drug class:
Tubulin polymerization inhibitor, Vascular disrupting agent, Apoptosis inducer
Associations
11ms
Efficacy and safety of nivolumab and CapeOX in patients with previously untreated FGFR2-positive, PD-L1-positive advanced gastric cancer: A single-arm, multicenter, phase 2 study NIVOFGFR2. (ASCO-GI 2024)
In this single-arm, multi-center, phase 2 study, eligible patients had metastatic untreated HER2-negative gastric adenocarcinoma with centrally confirmed expression of PD-L1 (CPS≥5; DAKO 28-8) and FGFR2 (moderate (2+) and strong (3+) membranous staining in more than 1% of tumor cells; Abсam EPR24075-418). Patients received nivolumab 360 mg with CapeOX (capecitabine and oxaliplatin) every 3 weeks... An interim analysis demonstrates modest efficacy and an acceptable safety profile of nivolumab in combination with chemotherapy in patients with FGFR2-positive, PD-L1-positive metastatic GC. Further follow-up is ongoing. 1.
Clinical • P2 data • PD(L)-1 Biomarker • IO biomarker • Metastases
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HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • FGFR2 (Fibroblast growth factor receptor 2)
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PD-L1 expression • HER-2 negative • FGFR2 overexpression • FGFR2 expression
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Opdivo (nivolumab) • capecitabine • oxaliplatin • crolibulin (EPC2407)
over1year
Study of FGFR2 status in gastric cancer by immunohistochemistry and fluorescent in situ hybridization (PubMed, Arkh Patol)
Clone EPR24075-418 showed the best result in assessing the expression of FGFR2: the correlation with FISH results in reaction 3+ was 100%. Due to the high heterogeneity of FGFR2 expression, it is recommended to either examine the material of the primary tumor and metastasis, or evaluate a large volume of the primary tumor.
Journal
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FGFR2 (Fibroblast growth factor receptor 2)
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FGFR2 amplification • FGFR2 expression • FGFR2b expression
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crolibulin (EPC2407)
almost2years
Agreement between FGFR2 immunohistochemistry assays and fluorescence in situ hybridization (FISH) in metastatic gastric cancer: A comparison study. (ASCO-GI 2023)
Pairwise comparison of 4 tests based on the same patient population was performed: 3 IHC assays [Abcam clone EPR24075-418, R&D clone 98706, Santa Cruz clone C-8] and one FISH test... Among patients who were negative by FISH, 86%-93% of the patients were negative by IHC assay (Abcam). Among patients who were positive by FISH, 75-80% of them were positive by IHC. FISH should not be recommended as a substitute for a FGFR2 IHC assay due to high probability of false negative prediction as a result of intratumoral heterogeneity and low PCC.
Metastases
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FGFR2 (Fibroblast growth factor receptor 2)
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FGFR2 amplification • FGFR2 expression • FGFR2b expression
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crolibulin (EPC2407)