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Showing papers by "Torben Plesner published in 2018"

Journal Article•DOI•
Daratumumab for the Treatment of Multiple Myeloma.

[...]

Torben Plesner1, Jakub Krejcik•
University of Southern Denmark1
04 Jun 2018-Frontiers in Immunology
TL;DR: This mini-review will summarize the present state of development of the CD38 antibody daratumumab for the treatment of multiple myeloma.
Abstract: This mini-review will summarize the present state of development of the CD38 antibody daratumumab for the treatment of multiple myeloma.

53 citations

Journal Article•DOI•
Phase 3 Randomized Study of Daratumumab Plus Lenalidomide and Dexamethasone (D-Rd) Versus Lenalidomide and Dexamethasone (Rd) in Patients with Newly Diagnosed Multiple Myeloma (NDMM) Ineligible for Transplant (MAIA)

[...]

Thierry Facon, Shaji Kumar1, Torben Plesner2, Robert Z. Orlowski3, Philippe Moreau, Nizar J. Bahlis4, Supratik Basu5, Hareth Nahi6, Cyrille Hulin, Hang Quach7, Hartmut Goldschmidt8, Michael O'Dwyer9, Aurore Perrot, Christopher P. Venner10, Katja Weisel, Joseph R. Mace, Tahamtan Ahmadi11, Christopher Chiu12, Jianping Wang12, Rian Van Rampelbergh12, Clarissa M. Uhlar12, Rachel Kobos12, Ming Qi12, Saad Z. Usmani •
Mayo Clinic1, University of Southern Denmark2, University of Texas MD Anderson Cancer Center3, University of Calgary4, University of Wolverhampton5, Karolinska University Hospital6, St. Vincent's Health System7, University Hospital Heidelberg8, National University of Ireland, Galway9, University of Alberta10, Princeton University11, Janssen Pharmaceutica12
29 Nov 2018-Blood
TL;DR: The prespecified interim analysis of the MAIA study found that D-Rd vs Rd in transplant-ineligible NDMM showed the greatest benefit with a 63% reduction in risk of disease progression or death in patients with MM who had at least one prior line of therapy.

52 citations

Journal Article•DOI•
Influence of Disease and Patient Characteristics on Daratumumab Exposure and Clinical Outcomes in Relapsed or Refractory Multiple Myeloma.

[...]

Xiaoyu Yan1, Pamela L. Clemens1, Thomas A. Puchalski1, Sagar Lonial2, Henk M. Lokhorst3, Peter M. Voorhees4, Saad Z. Usmani4, Paul G. Richardson5, Torben Plesner6, Kevin Liu1, Robert Z. Orlowski7, Nedjad Losic8, Richard Jansson1, Tahamtan Ahmadi1, Kristen Lantz1, Juan Jose Perez Ruixo1, Honghui Zhou1, Xu Steven Xu1 •
Janssen Pharmaceutica1, Emory University2, VU University Medical Center3, Carolinas Healthcare System4, Harvard University5, University of Southern Denmark6, University of Texas MD Anderson Cancer Center7, Genmab8
01 Apr 2018-Clinical Pharmacokinectics
TL;DR: Due to competition with the MM-produced IgG M-protein for neonatal Fc receptor protection from clearance, IgG-based monoclonal antibodies in general may have significantly higher clearance and lower concentrations in IgGMM patients compared with non-IgG MM patients.
Abstract: Objective The aim of this study was to understand the influence of disease and patient characteristics on exposure to daratumumab, an immunoglobulin Gκ (IgGκ) monoclonal antibody, and clinical outcomes in relapsed or refractory multiple myeloma (MM).

23 citations

Journal Article•DOI•
Evaluation of Sustained Minimal Residual Disease (MRD) Negativity in Relapsed/Refractory Multiple Myeloma (RRMM) Patients (Pts) Treated with Daratumumab in Combination with Lenalidomide Plus Dexamethasone (D-Rd) or Bortezomib Plus Dexamethasone (D-Vd): Analysis of Pollux and Castor

[...]

Hervé Avet-Loiseau, Jesús F. San-Miguel1, Tineke Casneuf2, Shinsuke Iida3, Sagar Lonial4, Saad Z. Usmani, Andrew Spencer5, Philippe Moreau, Torben Plesner6, Katja Weisel, Jon Ukropec2, Linda Okonkwo2, Sonali Trivedi2, Christopher Joseph Velas2, Xiang Qin2, Ming Qi2, Christopher Chiu2, Nizar J. Bahlis7 •
University of Navarra1, Janssen Pharmaceutica2, Nagoya City University3, Emory University4, Monash University5, University of Southern Denmark6, University of Calgary7
29 Nov 2018-Blood
TL;DR: Sustained MRD negativity with DARA plus SOC regimens and its association with PFS/OS outcomes in RRMM is evaluated in the intent-to-treat (ITT) population.

17 citations

Journal Article•DOI•
Subcutaneous daratumumab (DARA) in patients (Pts) with relapsed or refractory multiple myeloma (RRMM): Part 2 update of the open-label, multicenter, dose escalation phase 1b study (PAVO).

[...]

Ajai Chari1, Saad Z. Usmani2, Maria-Victoria Mateos, Niels W.C.J. van de Donk3, Jonathan L. Kaufman4, Philippe Moreau, Albert Oriol Rocafiguera, Torben Plesner5, Lotfi Benboubker, Kevin Liu6, Peter Hellemans6, Tara Masterson6, Pamela L. Clemens6, Andrew Farnsworth6, Hareth Nahi7, Jesús F. San-Miguel8 •
Icahn School of Medicine at Mount Sinai1, Carolinas Healthcare System2, VU University Medical Center3, Emory University4, University of Southern Denmark5, Janssen Pharmaceutica6, Karolinska University Hospital7, University of Navarra8
01 Jun 2018-Journal of Clinical Oncology
TL;DR: Intravenous administration of DARA 16 mg/kg is approved as monotherapy and in combination with standard of care regimens for RRMM and the phase 1b PAVO study (NCT02519452) shows encouraging results.
Abstract: 8013Background: Intravenous (IV) administration of DARA 16 mg/kg is approved as monotherapy and in combination with standard of care regimens for RRMM. The phase 1b PAVO study (NCT02519452) demonst...

13 citations

Journal Article•DOI•
Pharmacokinetics (PK) of Subcutaneous Daratumumab in Patients with Relapsed or Refractory (RR) Multiple Myeloma (MM): Primary Clinical Pharmacology Analysis of the Open-Label, Multicenter, Phase 1b Study (PAVO)

[...]

Pamela L. Clemens1, Steven Xu1, Melody Luo1, Ajai Chari2, Saad Z. Usmani, Maria-Victoria Mateos, Niels W.C.J. van de Donk3, Jonathan L. Kaufman4, Philippe Moreau, Albert Oriol, Torben Plesner5, Lotfi Benboubker, Jesús F. San-Miguel6, X. Yu-Nien Sun1, Andrew Farnsworth1, Tara Masterson1, Peter Hellemans1, Ming Qi1, Hareth Nahi7 •
Janssen Pharmaceutica1, Icahn School of Medicine at Mount Sinai2, VU University Medical Center3, Emory University4, University of Southern Denmark5, University of Navarra6, Karolinska University Hospital7
29 Nov 2018-Blood
TL;DR: The clinical pharmacology of SC DARA is presented, including the development of a combined IV-SC population PK (PPK) model and simulated PK profiles indicated that both DARA MD doses result in smaller peak-to-trough fluctuation compared to IV dosing, and that 1,800 mg provides higher Ctrough throughout the dosing period without increasing Cmax compared toIV dosing.

8 citations

Journal Article•DOI•
Long-Lasting Remissions for Myeloma Patients on Daratumumab Therapy from the GEN501 and GEN503 Trials

[...]

Agoston Gyula Szabo, Monique C. Minnema1, Hareth Nahi2, Torben Plesner3•
Utrecht University1, Karolinska Institutet2, University of Southern Denmark3
29 Nov 2018-Blood
TL;DR: Eight of ten patients achieved a longer response to DARA therapy with or without LEN and DEX than to any previous regimen, and all ten patients are still treated with DARA intravenously every four weeks.

2 citations

Journal Article•DOI•
Subcutaneous Daratumumab in Patients with Relapsed or Refractory Multiple Myeloma: Part 2 Safety and Efficacy Update of the Open-Label, Multicenter, Phase 1b Study (PAVO)

[...]

Ajai Chari1, Maria-Victoria Mateos, Niels W.C.J. van de Donk2, Jonathan L. Kaufman3, Philippe Moreau, Albert Oriol, Torben Plesner4, Lotfi Benboubker, Hareth Nahi5, Jie Tang6, Peter Hellemans6, Brenda Tromp6, Pamela L. Clemens6, Andrew Farnsworth6, Jesús F. San-Miguel7, Saad Z. Usmani •
Icahn School of Medicine at Mount Sinai1, VU University Medical Center2, Emory University3, University of Southern Denmark4, Karolinska University Hospital5, Janssen Pharmaceutica6, University of Navarra7
29 Nov 2018-Blood
TL;DR: Usmani et al. as mentioned in this paper evaluated a mix-and-deliver formulation of Daratumumab (DARA) and recombinant human hyaluronidase enzyme PH20 (rHuPH20) for patients with relapsed/refractory (RR) multiple myeloma (MM) and newly diagnosed MM.

1 citations