Fimepinostat (CUDC‐907) in patients with relapsed/refractory diffuse large B cell and high‐grade B‐cell lymphoma: report of a phase 2 trial and exploratory biomarker analyses
Summary Fimepinostat (CUDC‐907), a first‐in‐class oral small‐molecule inhibitor of histone deacetylase and phosphatidylinositol 3‐kinase, demonstrated efficacy in a phase 1 study of patients with relapsed/refractory (R/R) diffuse large and high‐grade B‐cell lymphomas (DLBCL/HGBL), particularly those...
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| Published in | British journal of haematology Vol. 195; no. 2; pp. 201 - 209 |
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| Main Authors | , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
England
Blackwell Publishing Ltd
01.10.2021
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| Subjects | |
| Online Access | Get full text |
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| Abstract | Summary
Fimepinostat (CUDC‐907), a first‐in‐class oral small‐molecule inhibitor of histone deacetylase and phosphatidylinositol 3‐kinase, demonstrated efficacy in a phase 1 study of patients with relapsed/refractory (R/R) diffuse large and high‐grade B‐cell lymphomas (DLBCL/HGBL), particularly those with increased MYC protein expression and/or MYC gene rearrangement/copy number gain (MYC‐altered disease). Therefore, a phase 2 study of fimepinostat was conducted in this patient population with 66 eligible patients treated. The primary end‐point of overall response (OR) rate for patients with MYC‐IHC ≥40% (n = 46) was 15%. Subsequently, exploratory pooled analyses were performed including patients treated on both the phase 1 and 2 studies based upon the presence of MYC‐altered disease as well as a biomarker identified by Virtual Inference of Protein activity by Enriched Regulon analysis (VIPER). For these patients with MYC‐altered disease (n = 63), the overall response (OR) rate was 22% with seven responding patients remaining on treatment for approximately two years or longer, and VIPER yielded a three‐protein biomarker classification with positive and negative predictive values of ≥85%. Prolonged durations of response were achieved by patients with MYC‐altered R/R DLBCL/HGBL treated with single‐agent fimepinostat. Combination therapies and/or biomarker‐based patient selection strategies may lead to higher response rates in future clinical trials. |
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| AbstractList | Summary
Fimepinostat (CUDC‐907), a first‐in‐class oral small‐molecule inhibitor of histone deacetylase and phosphatidylinositol 3‐kinase, demonstrated efficacy in a phase 1 study of patients with relapsed/refractory (R/R) diffuse large and high‐grade B‐cell lymphomas (DLBCL/HGBL), particularly those with increased MYC protein expression and/or MYC gene rearrangement/copy number gain (MYC‐altered disease). Therefore, a phase 2 study of fimepinostat was conducted in this patient population with 66 eligible patients treated. The primary end‐point of overall response (OR) rate for patients with MYC‐IHC ≥40% (n = 46) was 15%. Subsequently, exploratory pooled analyses were performed including patients treated on both the phase 1 and 2 studies based upon the presence of MYC‐altered disease as well as a biomarker identified by Virtual Inference of Protein activity by Enriched Regulon analysis (VIPER). For these patients with MYC‐altered disease (n = 63), the overall response (OR) rate was 22% with seven responding patients remaining on treatment for approximately two years or longer, and VIPER yielded a three‐protein biomarker classification with positive and negative predictive values of ≥85%. Prolonged durations of response were achieved by patients with MYC‐altered R/R DLBCL/HGBL treated with single‐agent fimepinostat. Combination therapies and/or biomarker‐based patient selection strategies may lead to higher response rates in future clinical trials. Fimepinostat (CUDC‐907), a first‐in‐class oral small‐molecule inhibitor of histone deacetylase and phosphatidylinositol 3‐kinase, demonstrated efficacy in a phase 1 study of patients with relapsed/refractory (R/R) diffuse large and high‐grade B‐cell lymphomas (DLBCL/HGBL), particularly those with increased MYC protein expression and/or MYC gene rearrangement/copy number gain (MYC‐altered disease). Therefore, a phase 2 study of fimepinostat was conducted in this patient population with 66 eligible patients treated. The primary end‐point of overall response (OR) rate for patients with MYC‐IHC ≥40% (n = 46) was 15%. Subsequently, exploratory pooled analyses were performed including patients treated on both the phase 1 and 2 studies based upon the presence of MYC‐altered disease as well as a biomarker identified by Virtual Inference of Protein activity by Enriched Regulon analysis (VIPER). For these patients with MYC‐altered disease (n = 63), the overall response (OR) rate was 22% with seven responding patients remaining on treatment for approximately two years or longer, and VIPER yielded a three‐protein biomarker classification with positive and negative predictive values of ≥85%. Prolonged durations of response were achieved by patients with MYC‐altered R/R DLBCL/HGBL treated with single‐agent fimepinostat. Combination therapies and/or biomarker‐based patient selection strategies may lead to higher response rates in future clinical trials. Fimepinostat (CUDC-907), a first-in-class oral small-molecule inhibitor of histone deacetylase and phosphatidylinositol 3-kinase, demonstrated efficacy in a phase 1 study of patients with relapsed/refractory (R/R) diffuse large and high-grade B-cell lymphomas (DLBCL/HGBL), particularly those with increased MYC protein expression and/or MYC gene rearrangement/copy number gain (MYC-altered disease). Therefore, a phase 2 study of fimepinostat was conducted in this patient population with 66 eligible patients treated. The primary end-point of overall response (OR) rate for patients with MYC-IHC ≥40% (n = 46) was 15%. Subsequently, exploratory pooled analyses were performed including patients treated on both the phase 1 and 2 studies based upon the presence of MYC-altered disease as well as a biomarker identified by Virtual Inference of Protein activity by Enriched Regulon analysis (VIPER). For these patients with MYC-altered disease (n = 63), the overall response (OR) rate was 22% with seven responding patients remaining on treatment for approximately two years or longer, and VIPER yielded a three-protein biomarker classification with positive and negative predictive values of ≥85%. Prolonged durations of response were achieved by patients with MYC-altered R/R DLBCL/HGBL treated with single-agent fimepinostat. Combination therapies and/or biomarker-based patient selection strategies may lead to higher response rates in future clinical trials.Fimepinostat (CUDC-907), a first-in-class oral small-molecule inhibitor of histone deacetylase and phosphatidylinositol 3-kinase, demonstrated efficacy in a phase 1 study of patients with relapsed/refractory (R/R) diffuse large and high-grade B-cell lymphomas (DLBCL/HGBL), particularly those with increased MYC protein expression and/or MYC gene rearrangement/copy number gain (MYC-altered disease). Therefore, a phase 2 study of fimepinostat was conducted in this patient population with 66 eligible patients treated. The primary end-point of overall response (OR) rate for patients with MYC-IHC ≥40% (n = 46) was 15%. Subsequently, exploratory pooled analyses were performed including patients treated on both the phase 1 and 2 studies based upon the presence of MYC-altered disease as well as a biomarker identified by Virtual Inference of Protein activity by Enriched Regulon analysis (VIPER). For these patients with MYC-altered disease (n = 63), the overall response (OR) rate was 22% with seven responding patients remaining on treatment for approximately two years or longer, and VIPER yielded a three-protein biomarker classification with positive and negative predictive values of ≥85%. Prolonged durations of response were achieved by patients with MYC-altered R/R DLBCL/HGBL treated with single-agent fimepinostat. Combination therapies and/or biomarker-based patient selection strategies may lead to higher response rates in future clinical trials. Fimepinostat (CUDC‐907), a first‐in‐class oral small‐molecule inhibitor of histone deacetylase and phosphatidylinositol 3‐kinase, demonstrated efficacy in a phase 1 study of patients with relapsed/refractory (R/R) diffuse large and high‐grade B‐cell lymphomas (DLBCL/HGBL), particularly those with increased MYC protein expression and/or MYC gene rearrangement/copy number gain (MYC‐altered disease). Therefore, a phase 2 study of fimepinostat was conducted in this patient population with 66 eligible patients treated. The primary end‐point of overall response (OR) rate for patients with MYC‐IHC ≥40% ( n = 46) was 15%. Subsequently, exploratory pooled analyses were performed including patients treated on both the phase 1 and 2 studies based upon the presence of MYC‐altered disease as well as a biomarker identified by Virtual Inference of Protein activity by Enriched Regulon analysis (VIPER). For these patients with MYC‐altered disease ( n = 63), the overall response (OR) rate was 22% with seven responding patients remaining on treatment for approximately two years or longer, and VIPER yielded a three‐protein biomarker classification with positive and negative predictive values of ≥85%. Prolonged durations of response were achieved by patients with MYC‐altered R/R DLBCL/HGBL treated with single‐agent fimepinostat. Combination therapies and/or biomarker‐based patient selection strategies may lead to higher response rates in future clinical trials. Fimepinostat (CUDC-907), a first-in-class oral small-molecule inhibitor of histone deacetylase and phosphatidylinositol 3-kinase, demonstrated efficacy in a phase 1 study of patients with relapsed/refractory (R/R) diffuse large and high-grade B-cell lymphomas (DLBCL/HGBL), particularly those with increased MYC protein expression and/or MYC gene rearrangement/copy number gain (MYC-altered disease). Therefore, a phase 2 study of fimepinostat was conducted in this patient population with 66 eligible patients treated. The primary end-point of overall response (OR) rate for patients with MYC-IHC ≥40% (n = 46) was 15%. Subsequently, exploratory pooled analyses were performed including patients treated on both the phase 1 and 2 studies based upon the presence of MYC-altered disease as well as a biomarker identified by Virtual Inference of Protein activity by Enriched Regulon analysis (VIPER). For these patients with MYC-altered disease (n = 63), the overall response (OR) rate was 22% with seven responding patients remaining on treatment for approximately two years or longer, and VIPER yielded a three-protein biomarker classification with positive and negative predictive values of ≥85%. Prolonged durations of response were achieved by patients with MYC-altered R/R DLBCL/HGBL treated with single-agent fimepinostat. Combination therapies and/or biomarker-based patient selection strategies may lead to higher response rates in future clinical trials. |
| Author | Smith, Sonali M. Micallef, Ivana N. Kelly, Kevin Ramchandren, Radhakrishnan Iyer, Swaminathan Alvarez, Mariano Oki, Yasuhiro Shen, Yao Parker, Jefferson Martinez, Elizabeth Stevens, Don A. Bosker, Gideon Batlevi, Connie Califano, Andrea Landsburg, Daniel J. Barta, Stefan K. Roemeling, Reinhard Soikes, Raul Martell, Robert E. |
| Author_xml | – sequence: 1 givenname: Daniel J. orcidid: 0000-0002-5077-4181 surname: Landsburg fullname: Landsburg, Daniel J. email: daniel.landsburg@pennmedicine.upenn.edu organization: University of Pennsylvania – sequence: 2 givenname: Stefan K. surname: Barta fullname: Barta, Stefan K. organization: Fox Chase Cancer Center – sequence: 3 givenname: Radhakrishnan surname: Ramchandren fullname: Ramchandren, Radhakrishnan organization: Karmanos Cancer Institute – sequence: 4 givenname: Connie surname: Batlevi fullname: Batlevi, Connie organization: Memorial Sloan Kettering Cancer Center – sequence: 5 givenname: Swaminathan surname: Iyer fullname: Iyer, Swaminathan organization: Houston Methodist Hospital – sequence: 6 givenname: Kevin surname: Kelly fullname: Kelly, Kevin organization: University of Southern California – sequence: 7 givenname: Ivana N. surname: Micallef fullname: Micallef, Ivana N. organization: Mayo Clinic – sequence: 8 givenname: Sonali M. surname: Smith fullname: Smith, Sonali M. organization: University of Chicago – sequence: 9 givenname: Don A. surname: Stevens fullname: Stevens, Don A. organization: Norton Cancer Institute – sequence: 10 givenname: Mariano surname: Alvarez fullname: Alvarez, Mariano organization: DarwinHealth, Inc – sequence: 11 givenname: Andrea surname: Califano fullname: Califano, Andrea organization: DarwinHealth, Inc – sequence: 12 givenname: Yao surname: Shen fullname: Shen, Yao organization: DarwinHealth, Inc – sequence: 13 givenname: Gideon surname: Bosker fullname: Bosker, Gideon organization: DarwinHealth, Inc – sequence: 14 givenname: Jefferson surname: Parker fullname: Parker, Jefferson organization: Curis, Inc – sequence: 15 givenname: Raul surname: Soikes fullname: Soikes, Raul organization: Curis, Inc – sequence: 16 givenname: Elizabeth surname: Martinez fullname: Martinez, Elizabeth organization: Curis, Inc – sequence: 17 givenname: Reinhard surname: Roemeling fullname: Roemeling, Reinhard organization: Curis, Inc – sequence: 18 givenname: Robert E. surname: Martell fullname: Martell, Robert E. organization: Curis, Inc – sequence: 19 givenname: Yasuhiro surname: Oki fullname: Oki, Yasuhiro organization: Genentech |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/34341990$$D View this record in MEDLINE/PubMed |
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| Copyright | 2021 British Society for Haematology and John Wiley & Sons Ltd 2021 British Society for Haematology and John Wiley & Sons Ltd. Copyright © 2021 John Wiley & Sons Ltd |
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| Keywords | phosphatidylinositol 3-kinase inhibitor diffuse large B-cell lymphoma biomarker MYC histone deacetylase inhibitor |
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Fimepinostat (CUDC‐907), a first‐in‐class oral small‐molecule inhibitor of histone deacetylase and phosphatidylinositol 3‐kinase, demonstrated efficacy... Fimepinostat (CUDC‐907), a first‐in‐class oral small‐molecule inhibitor of histone deacetylase and phosphatidylinositol 3‐kinase, demonstrated efficacy in a... Fimepinostat (CUDC-907), a first-in-class oral small-molecule inhibitor of histone deacetylase and phosphatidylinositol 3-kinase, demonstrated efficacy in a... |
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| SubjectTerms | B-cell lymphoma biomarker Biomarkers Biomarkers, Tumor - analysis Clinical trials Copy number diffuse large B‐cell lymphoma Female Gene rearrangement Hematology Histone deacetylase histone deacetylase inhibitor Histone Deacetylase Inhibitors - administration & dosage Histone Deacetylase Inhibitors - therapeutic use Humans Kinases Lymphoma, Large B-Cell, Diffuse - drug therapy Lymphoma, Large B-Cell, Diffuse - genetics Lymphoma, Non-Hodgkin - drug therapy Lymphoma, Non-Hodgkin - genetics Male Middle Aged Morpholines - administration & dosage Morpholines - therapeutic use MYC Myc protein Patients phosphatidylinositol 3‐kinase inhibitor Phosphoinositide-3 Kinase Inhibitors - administration & dosage Phosphoinositide-3 Kinase Inhibitors - therapeutic use Predictive Value of Tests Proteins Proto-Oncogene Proteins c-myc - genetics Pyrimidines - administration & dosage Pyrimidines - therapeutic use Recurrence Safety Treatment Outcome |
| Title | Fimepinostat (CUDC‐907) in patients with relapsed/refractory diffuse large B cell and high‐grade B‐cell lymphoma: report of a phase 2 trial and exploratory biomarker analyses |
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