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18 results on '"DeMarco, Dena"'

1. Dose escalation of subcutaneous epcoritamab in patients with relapsed or refractory B-cell non-Hodgkin lymphoma: an open-label, phase 1/2 study

Author

Hutchings, Martin, Mous, Rogier, Clausen, Michael Roost, Johnson, Peter, Linton, Kim M, Chamuleau, Martine E D, Lewis, David John, Sureda Balari, Anna, Cunningham, David, Oliveri, Roberto S, Elliott, Brian, DeMarco, Dena, Azaryan, Ada, Chiu, Christopher, Li, Tommy, Chen, Kuo-mei, Ahmadi, Tahamtan, and Lugtenburg, Pieternella J

Published
2021
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2. Semimechanistic Physiologically‐Based Pharmacokinetic/Pharmacodynamic Model Informing Epcoritamab Dose Selection for Patients With B‐Cell Lymphomas

Author

Li, Tommy, primary, Hiemstra, Ida H., additional, Chiu, Christopher, additional, Oliveri, Roberto S., additional, Elliott, Brian, additional, DeMarco, Dena, additional, Salcedo, Theodora, additional, Egerod, Frederikke Lihme, additional, Sasser, Kate, additional, Ahmadi, Tahamtan, additional, and Gupta, Manish, additional

Published
2022
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5. O17-1 Subcutaneous (SC) epcoritamab induces complete responses across R/R B-cell NHL subtypes: Updated dose-escalation data

Author

Hutchings, Martin, primary, Mous, Rogier, additional, Clausen, Michael Roost, additional, Johnson, Peter, additional, Linton, Kim M., additional, Chamuleau, Martine E.D., additional, Lewis, David J., additional, Balari, Anna Sureda, additional, Cunningham, David, additional, Oliveri, Roberto S., additional, DeMarco, Dena, additional, Elliott, Brian, additional, Chen, Kuo-mei, additional, and Lugtenburg, Pieternella J., additional

Published
2021
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6. Subcutaneous epcoritamab in patients with relapsed/refractory B-cell non-Hodgkin lymphoma: Safety profile and antitumor activity.

Author

Clausen, Michael Roost, primary, Lugtenburg, Pieternella, additional, Hutchings, Martin, additional, Johnson, Peter W. M., additional, Linton, Kim M., additional, Lewis, David John, additional, Chamuleau, Martine, additional, Sureda Balari, Anna, additional, Cunningham, David, additional, Elliott, Brian, additional, DeMarco, Dena, additional, Chen, Kuo-mei, additional, and Mous, Rogier, additional

Published
2021
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7. Subcutaneous epcoritamab in patients with relapsed/refractory B-cell non-Hodgkin lymphoma: Safety profile and antitumor activity:Journal of Clinical Oncology

Author

Clausen, Michael Roost, Lugtenburg, Pieternella, Hutchings, Martin, Johnson, Peter W. M., Linton, Kim M., Lewis, David John, Chamuleau, Martine, Sureda Balari, Anna, Cunningham, David, Elliott, Brian, DeMarco, Dena, Chen, Kuo-mei, and Mous, Rogier

Subjects
hemic and lymphatic diseases
Abstract

7518Background: Epcoritamab is a CD20xCD3 bispecific antibody that induces T-cell?mediated killing of CD20?positive malignant B-cells. We present updated data, including progression-free survival (PFS) from the dose escalation part of the first-in-human phase 1/2 study of epcoritamab in pts with relapsed or refractory (R/R) B-cell non-Hodgkin lymphoma (B-NHL; NCT03625037). Methods: Adults with R/R CD20+ B-NHL received flat-dose 1 mL SC epcoritamab (step-up dosing approach) in 28-day cycles (q1w: cycles 1?2; q2w: cycles 3?6; q4w thereafter) until disease progression or unacceptable toxicity. Step-up dosing and standard prophylaxis were used to mitigate severity of cytokine release syndrome (CRS). Results: At data cut off (1/31/2021), 68 pts with B-NHL were enrolled across histologies including diffuse large B-cell lymphoma (DLBCL; n = 46 [67.6%]; de novo and transformed), follicular lymphoma (FL; 12 [17.6%]), mantle cell lymphoma (MCL; 4 [5.9%]), and others (6 [8.8%]). Majority were heavily pretreated (median [range] prior lines: DLBCL, 3 [1?6]; FL, 4.5 [1?18]); including prior CAR-T (n = 6) and prior ASCT (n = 10). At median follow-up of 14.1 mo (DLBCL, 10.2 mo; FL, 15.2 mo), treatment was ongoing in 15 (22%) pts. Most common treatment-emergent adverse events (AEs) were pyrexia (69%), CRS (59%), and injection site reaction (47%). CRS events were all grade 1 or 2 and most occurred in cycle 1; neurotoxicity was limited (6%; grade 1: 3%; grade 3: 3%; all transient). One case of tumor lysis syndrome was observed (1.5%; grade 3); there were no cases of febrile neutropenia or treatment-related death. Overall response is shown for DLBCL ≥12 mg and ≥48 mg and FL ≥12 mg, corresponding to the minimal efficacy threshold (Table). Responses deepened over time (PR converted to CR: DLBCL, 6 pts; FL, 3 pts). Median time to response was 1.4 mo (DLBCL) and 1.9 mo (FL). Among DLBCL pts achieving CR with ≥6 mg (n = 11), none relapsed while on treatment. The median PFS for pts with DLBCL ≥12 mg (n = 22) was 9.1 mo (95% CI: 1.6, NE; median follow-up 9.3 mo) and for pts with DLBCL ≥48 mg (n = 11) median PFS was not reached (median follow-up 8.8 mo). Updated analyses will be presented. Conclusions: With longer follow-up, SC epcoritamab demonstrated substantial single-agent activity, inducing deep and durable clinically meaningful responses, with a consistent safety profile. Notably no severe (grade ≥3) CRS events, no febrile neutropenia, and limited neurotoxicity was observed. Clinical trial information: NCT03625037.DLBCLFLMCL≥12 mg48?60 mg12?48 mg0.76?48 mgEvaluable pts221154ORR, n (%)15 (68.2)10 (91)4 (80)2 (50)CR, n (%)10 (45.5)6 (55)3 (60)1 (25)PR, n (%)5 (22.7)4 (36)1 (20)1 (25)SD, n (%)1 (4.5)001 (25)PD, n (%)5 (22.7)01 (20)0

Published
2021

8. Dose escalation of subcutaneous epcoritamab in patients with relapsed or refractory B-cell non-Hodgkin lymphoma: an open-label, phase 1/2 study

Author

MS Hematologie, Infection & Immunity, Cancer, Hutchings, Martin, Mous, Rogier, Clausen, Michael Roost, Johnson, Peter, Linton, Kim M, Chamuleau, Martine E D, Lewis, David John, Sureda Balari, Anna, Cunningham, David, Oliveri, Roberto S, Elliott, Brian, DeMarco, Dena, Azaryan, Ada, Chiu, Christopher, Li, Tommy, Chen, Kuo-Mei, Ahmadi, Tahamtan, Lugtenburg, Pieternella J, MS Hematologie, Infection & Immunity, Cancer, Hutchings, Martin, Mous, Rogier, Clausen, Michael Roost, Johnson, Peter, Linton, Kim M, Chamuleau, Martine E D, Lewis, David John, Sureda Balari, Anna, Cunningham, David, Oliveri, Roberto S, Elliott, Brian, DeMarco, Dena, Azaryan, Ada, Chiu, Christopher, Li, Tommy, Chen, Kuo-Mei, Ahmadi, Tahamtan, and Lugtenburg, Pieternella J

Published
2021

9. Subcutaneous Epcoritamab Induces Complete Responses with an Encouraging Safety Profile across Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma Subtypes, Including Patients with Prior CAR-T Therapy: Updated Dose Escalation Data

Author

Hutchings, Martin, primary, Mous, Rogier, additional, Clausen, Michael Roost, additional, Johnson, Peter, additional, Linton, Kim M, additional, Chamuleau, Martine E.D., additional, Lewis, David John, additional, Sureda Balari, Anna, additional, Cunningham, David, additional, Oliveri, Roberto S, additional, DeMarco, Dena, additional, Elliott, Brian, additional, Chen, Kuo-mei, additional, and Lugtenburg, Pieternella J., additional

Published
2020
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11. ABCL-346: Subcutaneous (SC) Epcoritamab (GEN3013; DuoBody-CD3×CD20) in Patients with Relapsed/Refractory (R/R) B-Cell Non-Hodgkin Lymphoma (B-NHL): Dose-Escalation Data from a Phase I/II Trial

Author

Hutchings, Martin, primary, Lugtenburg, Pieternella, additional, Mous, Rogier, additional, Clausen, Michael Roost, additional, Chamuleau, Martine, additional, Linton, Kim, additional, Rule, Simon, additional, Lopez, Juanita, additional, Oliveri, Roberto S, additional, DeMarco, Dena, additional, Elliott, Brian, additional, and Johnson, Peter, additional

Published
2020
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12. Epcoritamab (GEN3013; DuoBody-CD3×CD20) to induce complete response in patients with relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL): Complete dose escalation data and efficacy results from a phase I/II trial.

Author

Hutchings, Martin, primary, Lugtenburg, Pieternella, additional, Mous, Rogier, additional, Clausen, Michael Roost, additional, Chamuleau, Martine, additional, Linton, Kim, additional, Rule, Simon, additional, Lopez, Juanita Suzanne, additional, Oliveri, Roberto S, additional, DeMarco, Dena, additional, Elliott, Brian, additional, and Johnson, Peter, additional

Published
2020
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13. First-in-Human, Phase 1/2 Trial to Assess the Safety and Clinical Activity of Subcutaneous GEN3013 (DuoBody®-CD3×CD20) in B-Cell Non-Hodgkin Lymphomas

Author

Lugtenburg, Pieternella, primary, Mous, Rogier, primary, Clausen, Michael Roost, primary, Chamuleau, Martine E.D., primary, Johnson, Peter, primary, Linton, Kim, primary, Rule, Simon, primary, Oliveri, Roberto S, primary, DeMarco, Dena, primary, Hiemstra, Ida H, primary, Chen, Guang, primary, Azaryan, Ada, primary, Gupta, Manish, primary, Ahmadi, Tahamtan, primary, and Hutchings, Martin, primary

Published
2019
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14. A noninterventional observational registry of patients with multiple myeloma treated with lenalidomide in Taiwan

Author

Huang, Shang-Yi, primary, Yu, Yuan-Bin, additional, Yeh, Su-Peng, additional, Chen, Tsai-Yun, additional, Kao, Woei-Yau, additional, Chen, Chih-Cheng, additional, Wang, Ming-Chung, additional, Lin, Hsuan-Yu, additional, Lin, Sheng-Fung, additional, Lin, Tseng-Hsi, additional, Hua, Ye, additional, Puccio-Pick, Marie, additional, DeMarco, Dena, additional, Jacques, Christian, additional, and Dunn, Po, additional

Published
2017
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15. Long-term use of lenalidomide and low-dose dexamethasone in Chinese patients with relapsed/refractory multiple myeloma: MM-024 Extended Access Program

Author

Du, Xin, primary, Jin, Jie, additional, Cai, Zhen, additional, Chen, Fangping, additional, Zhou, Dao-bin, additional, Yu, Li, additional, Ke, Xiaoyan, additional, Li, Xiao, additional, Wu, Depei, additional, Meng, Fanyi, additional, DeMarco, Dena, additional, Zhang, Jingshan, additional, Mei, Jay, additional, and Hou, Jian, additional

Published
2016
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16. Long-Term Use of Lenalidomide Plus Low-Dose Dexamethasone (Rd) in Chinese Patients (pts) with Relapsed/Refractory Multiple Myeloma (RRMM): MM-024 Expanded Access Program (EAP)

Author

Du, Xin, primary, Jin, Jie, additional, Cai, Zhen, additional, Chen, Fangping, additional, Zhou, Dao-bin, additional, Yu, Li, additional, Ke, Xiaoyan, additional, Li, Xiao, additional, Wu, Depei, additional, Meng, Fanyi, additional, DeMarco, Dena, additional, Zhang, Jingshan, additional, Mei, Jay, additional, and Hou, Jian, additional

Published
2014
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17. Long-term use of lenalidomide and low-dose dexamethasone in Chinese patients with relapsed/refractory multiple myeloma: MM-024 Extended Access Program.

Author

Xin Du, Jie Jin, Zhen Cai, Fangping Chen, Dao-bin Zhou, Li Yu, Xiaoyan Ke, Xiao Li, Depei Wu, Fanyi Meng, DeMarco, Dena, Jingshan Zhang, Jay Mei, Jian Hou, Du, Xin, Jin, Jie, Cai, Zhen, Chen, Fangping, Zhou, Dao-Bin, and Yu, Li

Subjects
MULTIPLE myeloma, DEXAMETHASONE, CHINESE people, CANCER relapse, DRUG efficacy, MEDICATION safety, PATIENTS, DISEASES, ANTINEOPLASTIC agents, CLINICAL trials, COMPARATIVE studies, DRUG resistance in cancer cells, DOSE-effect relationship in pharmacology, DRUG side effects, RESEARCH methodology, MEDICAL cooperation, PROGNOSIS, RESEARCH, THALIDOMIDE, EVALUATION research, TREATMENT effectiveness, CLASSIFICATION
Abstract

Background: The efficacy and safety of lenalidomide plus low-dose dexamethasone (Rd) in Chinese patients with relapsed/refractory multiple myeloma (RRMM) was demonstrated in a phase 2, multicenter trial (MM-021). MM-024 was an Extended Access Program (EAP) that allowed responding patients in the MM-021 trial to continue to receive Rd, and to provide additional safety and efficacy data with longer follow-up.Methods: Chinese patients with RRMM who completed ≥ 1 year of Rd therapy in MM-021 and who remained progression-free under Rd entered the Treatment Phase of the MM-024 EAP, continuing Rd at the same dose and schedule. Patients in MM-021 who discontinued Rd treatment or progressed were allowed to enroll in the Safety Follow-Up Phase of the MM-024 EAP. Safety data, including the incidence of second primary malignancies (SPMs), were collected for ≥ 5 years from the time the last on-study patient enrolled in the MM-021 trial (primary end point). Efficacy outcomes (time to progression [TTP], progression-free survival [PFS], and overall survival [OS]) were secondary end points.Results: Median follow-up was 38.4 months for the safety population (n = 80) and 43.3 months for the treatment cohort (n = 41). In the safety population, Grade 3-4 adverse events (AEs) occurred in 60.0 % of patients; the most common grade 3-4 AEs were neutropenia (20.0%), decreased neutrophil count (13.8%), and anemia (11.3%). There was no evidence of cumulative toxicity, and no patients discontinued Rd due to AEs; 2 patients had SPMs. In the treatment cohort, median duration of response was 35.1 months, median TTP was 36.9 months, and median PFS was 36.0 months; median OS was not reached due to the low number of deaths (n = 5).Conclusion: Long-term treatment with Rd has a predictable and manageable safety profile and provides sustained efficacy in Chinese patients with RRMM.Trial Registration: China State Food and Drug Administration (SFDA) registration (CTA reference numbers: 209L10808; 209L10809; 209L10810; and 209L10811) and ClinicalTrials.gov Identifier: NCT02348528. First received January 23, 2015; last updated November 12, 2015; last verified November 2015; study start date September 2012. [ABSTRACT FROM AUTHOR]

Published
2016
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