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6 results on '"Demidov, Lev"'

1. Overall Survival Benefit with Tebentafusp in Metastatic Uveal Melanoma

Author

Nathan, Paul, Hassel, Jessica C, Rutkowski, Piotr, Baurain, Jean-Francois, Butler, Marcus O, Schlaak, Max, Sullivan, Ryan J, Ochsenreither, Sebastian, Dummer, Reinhard, Kirkwood, John M, Joshua, Anthony M, Sacco, Joseph J, Shoushtari, Alexander N, Orloff, Marlana, Piulats, Josep M, Milhem, Mohammed, Salama, April KS, Curti, Brendan, Demidov, Lev, Gastaud, Lauris, Mauch, Cornelia, Yushak, Melinda, Carvajal, Richard D, Hamid, Omid, Abdullah, Shaad E, Holland, Chris, Goodall, Howard, Piperno-Neumann, Sophie, Investigators, IMCgp100-202, UCL - SSS/IREC/MIRO - Pôle d'imagerie moléculaire, radiothérapie et oncologie, UCL - (SLuc) Centre du cancer, and UCL - (SLuc) Unité d'oncologie médicale

Subjects
Adult, Male, Uveal Neoplasms, Oncology, medicine.medical_specialty, Recombinant Fusion Proteins, MEDLINE, Antineoplastic Agents, Disease, Therapeutics, Antibodies, Monoclonal, Humanized, law.invention, Randomized controlled trial, law, Internal medicine, medicine, Humans, Càncer, Melanoma, neoplasms, Survival analysis, Aged, Cancer, Aged, 80 and over, business.industry, General Medicine, Exanthema, Middle Aged, Ophthalmopathies, medicine.disease, Terapèutica, Ipilimumab, Survival Analysis, eye diseases, Dacarbazine, Clinical trial, Cutaneous melanoma, Monoclonal, Female, Cytokine Release Syndrome, business, Oftalmopaties
Abstract

Background: Uveal melanoma is a disease that is distinct from cutaneous melanoma, with a low tumor mutational burden and a 1-year overall survival of approximately 50% in patients with metastatic uveal melanoma. Data showing a proven overall survival benefit with a systemic treatment are lacking. Tebentafusp is a bispecific protein consisting of an affinity-enhanced T-cell receptor fused to an anti-CD3 effector that can redirect T cells to target glycoprotein 100-positive cells. Methods: In this open-label, phase 3 trial, we randomly assigned previously untreated HLA-A*02:01-positive patients with metastatic uveal melanoma in a 2:1 ratio to receive tebentafusp (tebentafusp group) or the investigator's choice of therapy with single-agent pembrolizumab, ipilimumab, or dacarbazine (control group), stratified according to the lactate dehydrogenase level. The primary end point was overall survival. Results: A total of 378 patients were randomly assigned to either the tebentafusp group (252 patients) or the control group (126 patients). Overall survival at 1 year was 73% in the tebentafusp group and 59% in the control group (hazard ratio for death, 0.51; 95% confidence interval [CI], 0.37 to 0.71; P

Published
2021

2. Overall Survival Benefit with Tebentafusp in Metastatic Uveal Melanoma

Author

Nathan, Paul, primary, Hassel, Jessica C., additional, Rutkowski, Piotr, additional, Baurain, Jean-Francois, additional, Butler, Marcus O., additional, Schlaak, Max, additional, Sullivan, Ryan J., additional, Ochsenreither, Sebastian, additional, Dummer, Reinhard, additional, Kirkwood, John M., additional, Joshua, Anthony M., additional, Sacco, Joseph J., additional, Shoushtari, Alexander N., additional, Orloff, Marlana, additional, Piulats, Josep M., additional, Milhem, Mohammed, additional, Salama, April K.S., additional, Curti, Brendan, additional, Demidov, Lev, additional, Gastaud, Lauris, additional, Mauch, Cornelia, additional, Yushak, Melinda, additional, Carvajal, Richard D., additional, Hamid, Omid, additional, Abdullah, Shaad E., additional, Holland, Chris, additional, Goodall, Howard, additional, and Piperno-Neumann, Sophie, additional

Published
2021
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3. Overall Survival Benefit with Tebentafusp in Metastatic Uveal Melanoma

Author

UCL - SSS/IREC/MIRO - Pôle d'imagerie moléculaire, radiothérapie et oncologie, UCL - (SLuc) Centre du cancer, UCL - (SLuc) Unité d'oncologie médicale, Nathan, Paul, Hassel, Jessica C., Rutkowski, Piotr, Baurain, Jean-Francois, Butler, Marcus O., Schlaak, Max, Sullivan, Ryan J., Ochsenreither, Sebastian, Dummer, Reinhard, Kirkwood, John M., Joshua, Anthony M., Sacco, Joseph J., Shoushtari, Alexander N., Orloff, Marlana, Piulats, Josep M., Milhem, Mohammed, Salama, April K.S., Curti, Brendan, Demidov, Lev, Gastaud, Lauris, Mauch, Cornelia, Yushak, Melinda, Carvajal, Richard D., Hamid, Omid, Abdullah, Shaad E., Holland, Chris, Goodall, Howard, Piperno-Neumann, Sophie, UCL - SSS/IREC/MIRO - Pôle d'imagerie moléculaire, radiothérapie et oncologie, UCL - (SLuc) Centre du cancer, UCL - (SLuc) Unité d'oncologie médicale, Nathan, Paul, Hassel, Jessica C., Rutkowski, Piotr, Baurain, Jean-Francois, Butler, Marcus O., Schlaak, Max, Sullivan, Ryan J., Ochsenreither, Sebastian, Dummer, Reinhard, Kirkwood, John M., Joshua, Anthony M., Sacco, Joseph J., Shoushtari, Alexander N., Orloff, Marlana, Piulats, Josep M., Milhem, Mohammed, Salama, April K.S., Curti, Brendan, Demidov, Lev, Gastaud, Lauris, Mauch, Cornelia, Yushak, Melinda, Carvajal, Richard D., Hamid, Omid, Abdullah, Shaad E., Holland, Chris, Goodall, Howard, and Piperno-Neumann, Sophie

Abstract

BACKGROUND Uveal melanoma is a disease that is distinct from cutaneous melanoma, with a low tumor mutational burden and a 1-year overall survival of approximately 50% in patients with metastatic uveal melanoma. Data showing a proven overall survival benefit with a systemic treatment are lacking. Tebentafusp is a bispecific protein consisting of an affinity-enhanced T-cell receptor fused to an anti-CD3 effector that can redirect T cells to target glycoprotein 100–positive cells. METHODS In this open-label, phase 3 trial, we randomly assigned previously untreated HLAA*02:01–positive patients with metastatic uveal melanoma in a 2:1 ratio to receive tebentafusp (tebentafusp group) or the investigator’s choice of therapy with singleagent pembrolizumab, ipilimumab, or dacarbazine (control group), stratified according to the lactate dehydrogenase level. The primary end point was overall survival. RESULTS A total of 378 patients were randomly assigned to either the tebentafusp group (252 patients) or the control group (126 patients). Overall survival at 1 year was 73% in the tebentafusp group and 59% in the control group (hazard ratio for death, 0.51; 95% confidence interval [CI], 0.37 to 0.71; P<0.001) in the intentionto-treat population. Progression-free survival was also significantly higher in the tebentafusp group than in the control group (31% vs. 19% at 6 months; hazard ratio for disease progression or death, 0.73; 95% CI, 0.58 to 0.94; P=0.01). The most common treatment-related adverse events in the tebentafusp group were cytokine-mediated events (due to T-cell activation) and skin-related events (due to glycoprotein 100–positive melanocytes), including rash (83%), pyrexia (76%), and pruritus (69%). These adverse events decreased in incidence and severity after the first three or four doses and infrequently led to discontinuation of the trial treatment (2%). No treatment-related deaths were reported. CONCLUSIONS Treatment with tebentafusp resulted in longer overall

Published
2021

4. Combined Vemurafenib and Cobimetinib in BRAF-Mutated Melanoma

Author

Larkin, James, primary, Ascierto, Paolo A., additional, Dréno, Brigitte, additional, Atkinson, Victoria, additional, Liszkay, Gabriella, additional, Maio, Michele, additional, Mandalà, Mario, additional, Demidov, Lev, additional, Stroyakovskiy, Daniil, additional, Thomas, Luc, additional, de la Cruz-Merino, Luis, additional, Dutriaux, Caroline, additional, Garbe, Claus, additional, Sovak, Mika A., additional, Chang, Ilsung, additional, Choong, Nicholas, additional, Hack, Stephen P., additional, McArthur, Grant A., additional, and Ribas, Antoni, additional

Published
2014
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5. Improved Survival with MEK Inhibition in BRAF-Mutated Melanoma

Author

Flaherty, Keith T., primary, Robert, Caroline, additional, Hersey, Peter, additional, Nathan, Paul, additional, Garbe, Claus, additional, Milhem, Mohammed, additional, Demidov, Lev V., additional, Hassel, Jessica C., additional, Rutkowski, Piotr, additional, Mohr, Peter, additional, Dummer, Reinhard, additional, Trefzer, Uwe, additional, Larkin, James M.G., additional, Utikal, Jochen, additional, Dreno, Brigitte, additional, Nyakas, Marta, additional, Middleton, Mark R., additional, Becker, Jürgen C., additional, Casey, Michelle, additional, Sherman, Laurie J., additional, Wu, Frank S., additional, Ouellet, Daniele, additional, Martin, Anne-Marie, additional, Patel, Kiran, additional, and Schadendorf, Dirk, additional

Published
2012
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6. Three-Year Overall Survival with Tebentafusp in Metastatic Uveal Melanoma.

Author

Hassel JC, Piperno-Neumann S, Rutkowski P, Baurain JF, Schlaak M, Butler MO, Sullivan RJ, Dummer R, Kirkwood JM, Orloff M, Sacco JJ, Ochsenreither S, Joshua AM, Gastaud L, Curti B, Piulats JM, Salama AKS, Shoushtari AN, Demidov L, Milhem M, Chmielowski B, Kim KB, Carvajal RD, Hamid O, Collins L, Ranade K, Holland C, Pfeiffer C, and Nathan P

Subjects
Adult, Humans, HLA-A Antigens, Antineoplastic Combined Chemotherapy Protocols administration & dosage, Antineoplastic Combined Chemotherapy Protocols adverse effects, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Melanoma drug therapy, Melanoma mortality, Melanoma secondary, Uveal Neoplasms drug therapy, Uveal Neoplasms mortality, Uveal Neoplasms secondary, Recombinant Fusion Proteins administration & dosage, Recombinant Fusion Proteins adverse effects, Recombinant Fusion Proteins therapeutic use
Abstract

Background: Tebentafusp, a T-cell receptor-bispecific molecule that targets glycoprotein 100 and CD3, is approved for adult patients who are positive for HLA-A*02:01 and have unresectable or metastatic uveal melanoma. The primary analysis in the present phase 3 trial supported a long-term survival benefit associated with the drug., Methods: We report the 3-year efficacy and safety results from our open-label, phase 3 trial in which HLA-A*02:01-positive patients with previously untreated metastatic uveal melanoma were randomly assigned in a 2:1 ratio to receive tebentafusp (tebentafusp group) or the investigator's choice of therapy with pembrolizumab, ipilimumab, or dacarbazine (control group), with randomization stratified according to the lactate dehydrogenase level. The primary end point was overall survival., Results: At a minimum follow-up of 36 months, median overall survival was 21.6 months in the tebentafusp group and 16.9 months in the control group (hazard ratio for death, 0.68; 95% confidence interval, 0.54 to 0.87). The estimated percentage of patients surviving at 3 years was 27% in the tebentafusp group and 18% in the control group. The most common treatment-related adverse events of any grade in the tebentafusp group were rash (83%), pyrexia (76%), pruritus (70%), and hypotension (38%). Most tebentafusp-related adverse events occurred early during treatment, and no new adverse events were observed with long-term administration. The percentage of patients who discontinued treatment because of adverse events continued to be low in both treatment groups (2% in the tebentafusp group and 5% in the control group). No treatment-related deaths occurred., Conclusions: This 3-year analysis supported a continued long-term benefit of tebentafusp for overall survival among adult HLA-A*02:01-positive patients with previously untreated metastatic uveal melanoma. (Funded by Immunocore; IMCgp100-202 ClinicalTrials.gov number, NCT03070392; EudraCT number, 2015-003153-18.)., (Copyright © 2023 Massachusetts Medical Society.)

Published
2023
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