Kinenza (enzastaurin) is an oral serine/threonine kinase inhibitor that suppresses signaling of protein kinase C (PKC)-beta to induce cell apoptosis, reduce cell proliferation, and suppress tumor-induced angiogenesis. Inhibition of PKC-beta also suppresses the phosphoinositide 3-kinase (PI3K)/protein kinase B (AKT) pathway by preventing activation and phosphorylation of AKT, glycogen synthase kinase (GSK)-3, and ribosomal protein S6.
Denovo Biopharma is developing Kinenza in combination with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) in high-risk diffuse large B-cell lymphoma (DLBCL) patients who express their proprietary, novel genetic biomarker Denovo Genomic Marker 1 (DGM1). Eli Lilly previously halted clinical development of Kinenza in DLBCL and sold the asset to Denovo after the drug failed to meet its primary endpoint in the Phase III PRELUDE trial (ClinicalTrials.gov identifier: NCT00332202). This clinical failure, in addition to limited information on the prevalence and treatment response of DGM1-positive patients, casts doubt on the renewed market potential for Kinenza in DLBCL. Data from the Phase III ENGINE study are needed to better determine the outlook for this drug.
4 Drug Overview
5 Product Profiles
5 Kinenza : NHL: Diffuse large B-cell lymphoma (DLBCL)
LIST OF FIGURES
10 Figure 1: Kinenza for diffuse large B-cell lymphoma – SWOT analysis
11 Figure 2: Datamonitor Healthcare’s drug assessment summary for Kinenza in diffuse large B-cell lymphoma
12 Figure 3: Datamonitor Healthcare’s drug assessment summary for Kinenza in diffuse large B-cell lymphoma
14 Figure 4: Kinenza sales for diffuse large B-cell lymphoma in the US, 2017–26
LIST OF TABLES
5 Table 1: Kinenza drug profile
7 Table 2: Kinenza pivotal trial data in diffuse large B-cell lymphoma
9 Table 3: Kinenza ongoing pivotal trial in diffuse large B-cell lymphoma
15 Table 4: Kinenza sales for diffuse large B-cell lymphoma in the US ($m), 2017–26
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