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1. TVB-2640 (FASN Inhibitor) for the Treatment of Nonalcoholic Steatohepatitis: FASCINATE-1, a Randomized, Placebo-Controlled Phase 2a Trial.

Author

Loomba, Rohit, Loomba, Rohit, Mohseni, Rizwana, Lucas, K Jean, Gutierrez, Julio A, Perry, Robert G, Trotter, James F, Rahimi, Robert S, Harrison, Stephen A, Ajmera, Veeral, Wayne, Jeffrey D, O'Farrell, Marie, McCulloch, William, Grimmer, Katharine, Rinella, Mary, Wai-Sun Wong, Vincent, Ratziu, Vlad, Gores, Gregory J, Neuschwander-Tetri, Brent A, Kemble, George, Loomba, Rohit, Loomba, Rohit, Mohseni, Rizwana, Lucas, K Jean, Gutierrez, Julio A, Perry, Robert G, Trotter, James F, Rahimi, Robert S, Harrison, Stephen A, Ajmera, Veeral, Wayne, Jeffrey D, O'Farrell, Marie, McCulloch, William, Grimmer, Katharine, Rinella, Mary, Wai-Sun Wong, Vincent, Ratziu, Vlad, Gores, Gregory J, Neuschwander-Tetri, Brent A, and Kemble, George

Abstract

Background & aimsIncreased de novo lipogenesis creates excess intrahepatic fat and lipotoxins, propagating liver damage in nonalcoholic steatohepatitis. TVB-2640, a fatty acid synthase inhibitor, was designed to reduce excess liver fat and directly inhibit inflammatory and fibrogenic pathways. We assessed the safety and efficacy of TVB-2640 in patients with nonalcoholic steatohepatitis in the United States.Methods3V2640-CLIN-005 (FASCINATE-1) was a randomized, placebo-controlled, single-blind study at 10 US sites. Adults with ≥8% liver fat, assessed by magnetic resonance imaging proton density fat fraction, and evidence of liver fibrosis by magnetic resonance elastography ≥2.5 kPa or liver biopsy were eligible. Ninety-nine patients were randomized to receive placebo or 25 mg or 50 mg of TVB-2640 (orally, once-daily for 12 weeks). The primary end points of this study were safety and relative change in liver fat after treatment.ResultsLiver fat increased in the placebo cohort by 4.5% relative to baseline; in contrast TVB-2640 reduced liver fat by 9.6% in the 25-mg cohort (n = 30; least squares mean: -15.5%; 95% confidence interval, -31.3 to -0.23; P = .053), and 28.1% in the 50-mg cohort (n = 28; least squares mean: -28.0%; 95% confidence interval, -44.5 to -11.6; P = .001). Eleven percent of patients in the placebo group achieved a ≥30% relative reduction of liver fat compared to 23% in the 25-mg group, and 61% in the 50-mg group (P < .001). Secondary analyses showed improvements of metabolic, pro-inflammatory and fibrotic markers. TVB-2640 was well tolerated; adverse events were mostly mild and balanced among the groups.ConclusionsTVB-2640 significantly reduced liver fat and improved biochemical, inflammatory, and fibrotic biomarkers after 12 weeks, in a dose-dependent manner in patients with nonalcoholic steatohepatitis. ClinicalTrials.gov, Number NCT03938246.

Published
2021

2. TVB-2640 (FASN Inhibitor) for the Treatment of Nonalcoholic Steatohepatitis: FASCINATE-1, a Randomized, Placebo-Controlled Phase 2a Trial.

Author

Loomba, Rohit, Loomba, Rohit, Mohseni, Rizwana, Lucas, K Jean, Gutierrez, Julio A, Perry, Robert G, Trotter, James F, Rahimi, Robert S, Harrison, Stephen A, Ajmera, Veeral, Wayne, Jeffrey D, O'Farrell, Marie, McCulloch, William, Grimmer, Katharine, Rinella, Mary, Wai-Sun Wong, Vincent, Ratziu, Vlad, Gores, Gregory J, Neuschwander-Tetri, Brent A, Kemble, George, Loomba, Rohit, Loomba, Rohit, Mohseni, Rizwana, Lucas, K Jean, Gutierrez, Julio A, Perry, Robert G, Trotter, James F, Rahimi, Robert S, Harrison, Stephen A, Ajmera, Veeral, Wayne, Jeffrey D, O'Farrell, Marie, McCulloch, William, Grimmer, Katharine, Rinella, Mary, Wai-Sun Wong, Vincent, Ratziu, Vlad, Gores, Gregory J, Neuschwander-Tetri, Brent A, and Kemble, George

Abstract

Background & aimsIncreased de novo lipogenesis creates excess intrahepatic fat and lipotoxins, propagating liver damage in nonalcoholic steatohepatitis. TVB-2640, a fatty acid synthase inhibitor, was designed to reduce excess liver fat and directly inhibit inflammatory and fibrogenic pathways. We assessed the safety and efficacy of TVB-2640 in patients with nonalcoholic steatohepatitis in the United States.Methods3V2640-CLIN-005 (FASCINATE-1) was a randomized, placebo-controlled, single-blind study at 10 US sites. Adults with ≥8% liver fat, assessed by magnetic resonance imaging proton density fat fraction, and evidence of liver fibrosis by magnetic resonance elastography ≥2.5 kPa or liver biopsy were eligible. Ninety-nine patients were randomized to receive placebo or 25 mg or 50 mg of TVB-2640 (orally, once-daily for 12 weeks). The primary end points of this study were safety and relative change in liver fat after treatment.ResultsLiver fat increased in the placebo cohort by 4.5% relative to baseline; in contrast TVB-2640 reduced liver fat by 9.6% in the 25-mg cohort (n = 30; least squares mean: -15.5%; 95% confidence interval, -31.3 to -0.23; P = .053), and 28.1% in the 50-mg cohort (n = 28; least squares mean: -28.0%; 95% confidence interval, -44.5 to -11.6; P = .001). Eleven percent of patients in the placebo group achieved a ≥30% relative reduction of liver fat compared to 23% in the 25-mg group, and 61% in the 50-mg group (P < .001). Secondary analyses showed improvements of metabolic, pro-inflammatory and fibrotic markers. TVB-2640 was well tolerated; adverse events were mostly mild and balanced among the groups.ConclusionsTVB-2640 significantly reduced liver fat and improved biochemical, inflammatory, and fibrotic biomarkers after 12 weeks, in a dose-dependent manner in patients with nonalcoholic steatohepatitis. ClinicalTrials.gov, Number NCT03938246.

Published
2021

3. Guidance of sentinel lymph node biopsy decisions in patients with T1-T2 melanoma using gene expression profiling.

Author

Vetto, John T., Hsueh, Eddy C., Gastman, Brian R., Dillon, Larry D., Monzon, Federico A., Cook, Robert W., Keller, Jennifer, Huang, Xin, Fleming, Andrew, Hewgley, Preston, Gerami, Pedram, Leachman, Sancy, Wayne, Jeffrey D., Berger, Adam C., Fleming, Martin D., Vetto, John T., Hsueh, Eddy C., Gastman, Brian R., Dillon, Larry D., Monzon, Federico A., Cook, Robert W., Keller, Jennifer, Huang, Xin, Fleming, Andrew, Hewgley, Preston, Gerami, Pedram, Leachman, Sancy, Wayne, Jeffrey D., Berger, Adam C., and Fleming, Martin D.

Abstract

AIM: Can gene expression profiling be used to identify patients with T1-T2 melanoma at low risk for sentinel lymph node (SLN) positivity? PATIENTS & METHODS: Bioinformatics modeling determined a population in which a 31-gene expression profile test predicted <5% SLN positivity. Multicenter, prospectively-tested (n = 1421) and retrospective (n = 690) cohorts were used for validation and outcomes, respectively. RESULTS: Patients 55-64 years and ≥65 years with a class 1A (low-risk) profile had SLN positivity rates of 4.9% and 1.6%. Class 2B (high-risk) patients had SLN positivity rates of 30.8% and 11.9%. Melanoma-specific survival was 99.3% for patients ≥55 years with class 1A, T1-T2 tumors and 55.0% for class 2B, SLN-positive, T1-T2 tumors. CONCLUSION: The 31-gene expression profile test identifies patients who could potentially avoid SLN biopsy.

Published
2019

4. Completion Dissection or Observation for Sentinel-Node Metastasis in Melanoma.

Author

Faries, Mark B., Thompson, John F., Cochran, Alistair J., Andtbacka, Robert H., Mozzillo, Nicola, Zager, Jonathan S., Jahkola, Tiina, Bowles, Tawnya L., Testori, Alessandro, Beitsch, Peter D., Hoekstra, Harald J., Moncrieff, Marc, Ingvar, Christian, Wouters, Michel W.J.M., Sabel, Michael S., Levine, Edward A., Agnese, Doreen, Henderson, Michael, Dummer, Reinhard, Rossi, Carlo R., Neves, Rogerio I., Trocha, Steven D., Wright, Frances, Byrd, David R., Matter, Maurice, Hsueh, Eddy, MacKenzie-Ross, Alastair, Johnson, Douglas B., Terheyden, Patrick, Berger, Adam C., Huston, Tara L., Wayne, Jeffrey D., Smithers, B. Mark, Neuman, Heather B., Schneebaum, Schlomo, Gershenwald, Jeffrey E., Ariyan, Charlotte E., Desai, Darius C., Jacobs, Lisa, McMasters, Kelly M., Gesierich, Anja, Hersey, Peter, Bines, Steven D., Kane, John M., Barth, Richard J., McKinnon, Gregory, Farma, Jeffrey M., Schultz, Erwin, Vidal-Sicart, Sergi, Hoefer, Richard A., Lewis, James M, Scheri, Randall, Kelley, Mark C., Nieweg, Omgo E., Noyes, R. Dirk, Hoon, Dave S.B., Wang, He-Jing, Elashoff, David A., Elashoff, Robert M., Faries, Mark B., Thompson, John F., Cochran, Alistair J., Andtbacka, Robert H., Mozzillo, Nicola, Zager, Jonathan S., Jahkola, Tiina, Bowles, Tawnya L., Testori, Alessandro, Beitsch, Peter D., Hoekstra, Harald J., Moncrieff, Marc, Ingvar, Christian, Wouters, Michel W.J.M., Sabel, Michael S., Levine, Edward A., Agnese, Doreen, Henderson, Michael, Dummer, Reinhard, Rossi, Carlo R., Neves, Rogerio I., Trocha, Steven D., Wright, Frances, Byrd, David R., Matter, Maurice, Hsueh, Eddy, MacKenzie-Ross, Alastair, Johnson, Douglas B., Terheyden, Patrick, Berger, Adam C., Huston, Tara L., Wayne, Jeffrey D., Smithers, B. Mark, Neuman, Heather B., Schneebaum, Schlomo, Gershenwald, Jeffrey E., Ariyan, Charlotte E., Desai, Darius C., Jacobs, Lisa, McMasters, Kelly M., Gesierich, Anja, Hersey, Peter, Bines, Steven D., Kane, John M., Barth, Richard J., McKinnon, Gregory, Farma, Jeffrey M., Schultz, Erwin, Vidal-Sicart, Sergi, Hoefer, Richard A., Lewis, James M, Scheri, Randall, Kelley, Mark C., Nieweg, Omgo E., Noyes, R. Dirk, Hoon, Dave S.B., Wang, He-Jing, Elashoff, David A., and Elashoff, Robert M.

Abstract

BACKGROUND: Sentinel-lymph-node biopsy is associated with increased melanoma-specific survival (i.e., survival until death from melanoma) among patients with node-positive intermediate-thickness melanomas (1.2 to 3.5 mm). The value of completion lymph-node dissection for patients with sentinel-node metastases is not clear. METHODS: In an international trial, we randomly assigned patients with sentinel-node metastases detected by means of standard pathological assessment or a multimarker molecular assay to immediate completion lymph-node dissection (dissection group) or nodal observation with ultrasonography (observation group). The primary end point was melanoma-specific survival. Secondary end points included disease-free survival and the cumulative rate of nonsentinel-node metastasis. RESULTS: Immediate completion lymph-node dissection was not associated with increased melanoma-specific survival among 1934 patients with data that could be evaluated in an intention-to-treat analysis or among 1755 patients in the per-protocol analysis. In the per-protocol analysis, the mean (±SE) 3-year rate of melanoma-specific survival was similar in the dissection group and the observation group (86±1.3% and 86±1.2%, respectively; P=0.42 by the log-rank test) at a median follow-up of 43 months. The rate of disease-free survival was slightly higher in the dissection group than in the observation group (68±1.7% and 63±1.7%, respectively; P=0.05 by the log-rank test) at 3 years, based on an increased rate of disease control in the regional nodes at 3 years (92±1.0% vs. 77±1.5%; P CONCLUSIONS: Immediate completion lymph-node dissection increased the rate of regional disease control and provided prognostic information but did not increase melanoma-specific survival among patients with melanoma and sentinel-node metastases. (Funded by the National Cancer Institute and others; MSLT-II ClinicalTrials.gov number, NCT00297895 .).

Published
2017

5. A Multi-Institutional Phase II Trial of Preoperative Full-Dose Gemcitabine and Concurrent Radiation for Patients With Potentially Resectable Pancreatic Carcinoma

Author

Division of Gastrointestinal Surgery, University of Michigan Health System, 2922 G Taubman-0331, 1500 E. Medical Center Drive, Ann Arbor, Michigan, 48109, Hematology Oncology, University of Michigan Health System, 1500 E. Medical Center Drive, Ann Arbor, Michigan, 48109, Department of Radiation Oncology, University of South Maine, 22 Bramhall Street, Portland, Maine, 04102, Division of Surgical Oncology, Feinberg School of Medicine, Northwestern University, 201 E. Huron, Galter 10-105, Chicago, Illinois, 60611, Division of Radiation Oncology, Feinberg School of Medicine, Northwestern University, 251 E. Huron, LC-178, Chicago, Illinois, 60611, Department of Radiation Oncology, Fox Chase Cancer Center, 7701 Burholme Avenue, Philadelphia, Pennsylvania, 19111, Division of Hematology Oncology, Wayne State University, 3990 John R. Street, Detroit, Michigan, 48201-2018, Department of Radiation Oncology, University Hospitals of Cleveland, 11100 Euclid Avenue, Cleveland, Ohio, 44106-6068, Division of Hematology/Oncology, Feinberg School of Medicine, Northwestern University, 675 N. St. Clair, Galter 21-100, Chicago, Illinois, 60611, Ann Arbor, Freedman, Gary M., Zalupski, Mark M., Small, William, Mulcahy, Mary F., Hoffman, John P., McGinn, Cornelius J., Colletti, Lisa M., Wayne, Jeffrey D., Attaluri, Vikram, Kinsella, Timothy J., Philip, Philip A., Talamonti, Mark S., Division of Gastrointestinal Surgery, University of Michigan Health System, 2922 G Taubman-0331, 1500 E. Medical Center Drive, Ann Arbor, Michigan, 48109, Hematology Oncology, University of Michigan Health System, 1500 E. Medical Center Drive, Ann Arbor, Michigan, 48109, Department of Radiation Oncology, University of South Maine, 22 Bramhall Street, Portland, Maine, 04102, Division of Surgical Oncology, Feinberg School of Medicine, Northwestern University, 201 E. Huron, Galter 10-105, Chicago, Illinois, 60611, Division of Radiation Oncology, Feinberg School of Medicine, Northwestern University, 251 E. Huron, LC-178, Chicago, Illinois, 60611, Department of Radiation Oncology, Fox Chase Cancer Center, 7701 Burholme Avenue, Philadelphia, Pennsylvania, 19111, Division of Hematology Oncology, Wayne State University, 3990 John R. Street, Detroit, Michigan, 48201-2018, Department of Radiation Oncology, University Hospitals of Cleveland, 11100 Euclid Avenue, Cleveland, Ohio, 44106-6068, Division of Hematology/Oncology, Feinberg School of Medicine, Northwestern University, 675 N. St. Clair, Galter 21-100, Chicago, Illinois, 60611, Ann Arbor, Freedman, Gary M., Zalupski, Mark M., Small, William, Mulcahy, Mary F., Hoffman, John P., McGinn, Cornelius J., Colletti, Lisa M., Wayne, Jeffrey D., Attaluri, Vikram, Kinsella, Timothy J., Philip, Philip A., and Talamonti, Mark S.

Abstract

We report the results of a multi-institutional phase II trial that used preoperative full-dose gemcitabine and radiotherapy for patients with potentially resectable pancreatic carcinoma.

Published
2006

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