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Article: Authors' reply: Perspective: The approval and withdrawal of melphalan flufenamide (melflufen): Implications for the state of the FDA.

Schjesvold, Fredrik H / Bakker, Nicolaas A / Sonneveld, Pieter

2022 Volume 25, Page(s) 101528

Language	English
Publishing date	2022-09-07
Publishing country	United States
Document type	Letter
ZDB-ID	2443840-6
ISSN	1936-5233
ISSN	1936-5233
DOI	10.1016/j.tranon.2022.101528
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Article ; Online: Melflufen in multiple myeloma: the conclusion matters - Authors' reply.

Schjesvold, Fredrik H / Bakker, Nicolaas A / Sonneveld, Pieter

The Lancet. Haematology

2022 Volume 9, Issue 4, Page(s) e244–e245

MeSH term(s)	Humans ; Melphalan/analogs & derivatives ; Multiple Myeloma/drug therapy ; Phenylalanine/analogs & derivatives
Chemical Substances	melflufen (3412470A0V) ; Phenylalanine (47E5O17Y3R) ; Melphalan (Q41OR9510P)
Language	English
Publishing date	2022-03-28
Publishing country	England
Document type	Letter ; Comment
ISSN	2352-3026
ISSN (online)	2352-3026
DOI	10.1016/S2352-3026(22)00071-0
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Article ; Online: Health-related quality of life in relapsed/refractory multiple myeloma treated with melflufen and dexamethasone: analyses from the phase III OCEAN study.

Schjesvold, Fredrik H / Ludwig, Heinz / Delimpasi, Sossana / Robak, Pawel / Coriu, Daniel / Tomczak, Waldemar / Pour, Ludek / Spicka, Ivan / Dimopoulos, Meletios-Athanasios / Masszi, Tamas / Chernova, Natalia G / Sandberg, Anna / Thuresson, Marcus / Norin, Stefan / Bakker, Nicolaas A / Mateos, Maria-Victoria / Richardson, Paul G / Sonneveld, Pieter

Haematologica

2024

Abstract: Not available. ...

Abstract	Not available.
Language	English
Publishing date	2024-02-29
Publishing country	Italy
Document type	Journal Article
ZDB-ID	2333-4
ISSN	1592-8721 ; 0017-6567 ; 0390-6078
ISSN (online)	1592-8721
ISSN	0017-6567 ; 0390-6078
DOI	10.3324/haematol.2023.284635
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Article ; Online: PORT: A Randomized, Cross-Over, Phase 2 Study of Melflufen Peripheral Versus Central Intravenous Administration in Patients With Relapsed/Refractory Multiple Myeloma.

Pour, Ludek / Micheva, Ilina / Usenko, Ganna / Mikala, Gabor / Masszi, Tamas / Simeonova, Kameliya / Thuresson, Marcus / Huledal, Gunilla / Norin, Stefan / Bakker, Nicolaas A / Minarik, Jiri

Clinical lymphoma, myeloma & leukemia

2024

Abstract: Background: Melflufen, a first-in-class alkylating peptide-drug conjugate, rapidly enters tumor cells and metabolizes to melphalan. In previous studies, melflufen was administered via central venous catheter (CVC). However, administration by peripheral ... ...

Abstract	Background: Melflufen, a first-in-class alkylating peptide-drug conjugate, rapidly enters tumor cells and metabolizes to melphalan. In previous studies, melflufen was administered via central venous catheter (CVC). However, administration by peripheral venous catheter (PVC) may be preferable. Patients and methods: PORT was a two-period, phase 2 crossover study of CVC versus PVC melflufen administration in patients with relapsed/refractory multiple myeloma. Adults with ≥ 2 prior therapies refractory to/intolerant of an immunomodulatory drug and a proteasome inhibitor were randomized 1:1 to weekly oral dexamethasone plus melflufen (40 mg) via CVC or PVC infusion on day 1 of 28-day cycle 1. In cycle 2, patients continued dexamethasone and crossed over to the other melflufen administration route. In cycle 3, all patients received melflufen until progression; PVC or CVC routes were allowed based upon investigator decision. Pharmacokinetic sampling was performed during and after melflufen infusion. Primary endpoints were melphalan pharmacokinetic parameters (C Results: The 90% CIs for adjusted geometric mean ratios for pharmacokinetic parameters following CVC versus PVC administration were within the 0.8-1.25 bioequivalence range (C Conclusion: Melflufen PVC and CVC administrations are bioequivalent based on melphalan pharmacokinetic parameters. Melflufen via PVC was well tolerated, with no infusion-related reactions or new safety signals and may represent an alternative route of administration.
Language	English
Publishing date	2024-02-23
Publishing country	United States
Document type	Journal Article
ZDB-ID	2540992-X
ISSN	2152-2669 ; 2152-2650
ISSN (online)	2152-2669
ISSN	2152-2650
DOI	10.1016/j.clml.2024.02.012
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Article ; Online: ANCHOR: melflufen plus dexamethasone and daratumumab or bortezomib in relapsed/refractory multiple myeloma: final results of a phase I/IIa study.

Ocio, Enrique M / Efebera, Yvonne A / Hájek, Roman / Straub, Jan / Maisnar, Vladimir / Eveillard, Jean-Richard / Karlin, Lionel / Mateos, María-Victoria / Oriol, Albert / Ribrag, Vincent / Richardson, Paul G / Norin, Stefan / Obermüller, Jakob / Bakker, Nicolaas A / Pour, Luděk

Haematologica

2024 Volume 109, Issue 3, Page(s) 867–876

Abstract: Melphalan flufenamide (melflufen), a first-in-class, alkylating peptide-drug conjugate, demonstrated clinical benefit in combination with dexamethasone in triple-class refractory multiple myeloma (MM). The phase I/IIa ANCHOR study evaluated melflufen (30 ...

Abstract	Melphalan flufenamide (melflufen), a first-in-class, alkylating peptide-drug conjugate, demonstrated clinical benefit in combination with dexamethasone in triple-class refractory multiple myeloma (MM). The phase I/IIa ANCHOR study evaluated melflufen (30 or 40 mg) and dexamethasone (40 mg with daratumumab; 20 mg followed by 40 mg with bortezomib; dose reduced if aged ≥75 years) in triplet combination with daratumumab (16 mg/kg; daratumumab arm) or bortezomib (1.3 mg/m2; bortezomib arm) in patients with relapsed/refractory MM refractory to an immunomodulatory agent and/or a proteasome inhibitor and who had received one to four prior lines of therapy. Primary objectives were to determine the optimal dose of melflufen in triplet combination (phase I) and overall response rate (phase IIa). In total, 33 patients were treated in the daratumumab arm and 23 patients received therapy in the bortezomib arm. No dose-limiting toxicities were reported at either melflufen dose level with either combination. With both triplet regimens, the most common grade ≥3 treatment-emergent adverse events were thrombocytopenia and neutropenia; thrombocytopenia was the most common treatment-emergent adverse event leading to treatment discontinuation. In the daratumumab arm, patients receiving melflufen 30 mg remained on treatment longer than those receiving the 40-mg dose. In the daratumumab arm, the overall response rate was 73% and median progression-free survival was 12.9 months. Notably, in the bortezomib arm, the overall response rate was 78% and median progression-free survival was 14.7 months. Considering the totality of the data, melflufen 30 mg was established as the recommended dose for use with dexamethasone and daratumumab or bortezomib for future studies in relapsed/refractory MM.
MeSH term(s)	Humans ; Antibodies, Monoclonal ; Bortezomib/therapeutic use ; Dexamethasone/therapeutic use ; Melphalan/analogs & derivatives ; Multiple Myeloma/diagnosis ; Multiple Myeloma/drug therapy ; Neoplasms, Plasma Cell ; Neutropenia/chemically induced ; Phenylalanine/analogs & derivatives ; Thrombocytopenia ; Aged ; Antineoplastic Combined Chemotherapy Protocols/adverse effects
Chemical Substances	Antibodies, Monoclonal ; Bortezomib (69G8BD63PP) ; daratumumab (4Z63YK6E0E) ; Dexamethasone (7S5I7G3JQL) ; melflufen (3412470A0V) ; Melphalan (Q41OR9510P) ; Phenylalanine (47E5O17Y3R)
Language	English
Publishing date	2024-03-01
Publishing country	Italy
Document type	Clinical Trial, Phase I ; Clinical Trial, Phase II ; Journal Article
ZDB-ID	2333-4
ISSN	1592-8721 ; 0017-6567 ; 0390-6078
ISSN (online)	1592-8721
ISSN	0017-6567 ; 0390-6078
DOI	10.3324/haematol.2023.283490
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Article ; Online: Efficacy and safety of melflufen plus daratumumab and dexamethasone in relapsed/refractory multiple myeloma: results from the randomized, open-label, phase III LIGHTHOUSE study.

Pour, Luděk / Szarejko, Monika / Bila, Jelena / Schjesvold, Fredrik H / Spicka, Ivan / Maisnar, Vladimir / Jurczyszyn, Artur / Grudeva-Popova, Zhanet / Hájek, Roman / Usenko, Ganna / Thuresson, Marcus / Norin, Stefan / Jarefors, Sara / Bakker, Nicolaas A / Richardson, Paul G / Mateos, Maria-Victoria

Haematologica

2024 Volume 109, Issue 3, Page(s) 895–905

Abstract: Melphalan flufenamide (melflufen), a first-in-class alkylating peptide-drug conjugate, plus dexamethasone was approved in Europe for use in patients with triple-class refractory relapsed/refractory multiple myeloma (RRMM) with ≥3 prior lines of therapy ... ...

Abstract	Melphalan flufenamide (melflufen), a first-in-class alkylating peptide-drug conjugate, plus dexamethasone was approved in Europe for use in patients with triple-class refractory relapsed/refractory multiple myeloma (RRMM) with ≥3 prior lines of therapy and without prior autologous stem cell transplantation (ASCT) or with a time to progression >36 months after prior ASCT. The randomized LIGHTHOUSE study (NCT04649060) assessed melflufen plus daratumumab and dexamethasone (melflufen group) versus daratumumab in patients with RRMM with disease refractory to an immunomodulatory agent and a proteasome inhibitor or who had received ≥3 prior lines of therapy including an immunomodulatory agent and a proteasome inhibitor. A partial clinical hold issued by the US Food and Drug Administration for all melflufen studies led to financial constraints and premature study closure on February 23rd 2022 (data cut-off date). In total, 54 of 240 planned patients were randomized (melflufen group, N=27; daratumumab group, N=27). Median progression-free survival (PFS) was not reached in the melflufen group versus 4.9 months in the daratumumab group (Hazard Ratio: 0.18 [95% Confidence Interval, 0.05-0.65]; P=0.0032) at a median follow-up time of 7.1 and 6.6 months, respectively. Overall response rate (ORR) was 59% in the melflufen group versus 30% in the daratumumab group (P=0.0300). The most common grade ≥3 treatment-emergent adverse events in the melflufen group versus daratumumab group were neutropenia (50% vs. 12%), thrombocytopenia (50% vs. 8%), and anemia (32% vs. 19%). Melflufen plus daratumumab and dexamethasone demonstrated superior PFS and ORR versus daratumumab in RRMM and a safety profile comparable to previously published melflufen studies.
MeSH term(s)	Humans ; Antibodies, Monoclonal ; Dexamethasone/therapeutic use ; Hematopoietic Stem Cell Transplantation ; Melphalan/analogs & derivatives ; Multiple Myeloma/diagnosis ; Multiple Myeloma/drug therapy ; Neoplasms, Plasma Cell ; Neutropenia ; Phenylalanine/analogs & derivatives ; Proteasome Inhibitors ; Transplantation, Autologous ; United States ; Antineoplastic Combined Chemotherapy Protocols/adverse effects
Chemical Substances	Antibodies, Monoclonal ; daratumumab (4Z63YK6E0E) ; Dexamethasone (7S5I7G3JQL) ; melflufen (3412470A0V) ; Melphalan (Q41OR9510P) ; Phenylalanine (47E5O17Y3R) ; Proteasome Inhibitors
Language	English
Publishing date	2024-03-01
Publishing country	Italy
Document type	Clinical Trial, Phase III ; Journal Article ; Randomized Controlled Trial
ZDB-ID	2333-4
ISSN	1592-8721 ; 0017-6567 ; 0390-6078
ISSN (online)	1592-8721
ISSN	0017-6567 ; 0390-6078
DOI	10.3324/haematol.2023.283509
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Article ; Online: Melflufen in relapsed/refractory multiple myeloma refractory to prior alkylators: A subgroup analysis from the OCEAN study.

Schjesvold, Fredrik H / Ludwig, Heinz / Mateos, Maria-Victoria / Larocca, Alessandra / Abdulhaq, Haifaa / Norin, Stefan / Thuresson, Marcus / Bakker, Nicolaas A / Richardson, Paul G / Sonneveld, Pieter

European journal of haematology

2023 Volume 112, Issue 3, Page(s) 402–411

Abstract: Melphalan flufenamide (melflufen), a first-in-class alkylating peptide-drug conjugate, plus dexamethasone demonstrated superior progression-free survival (PFS), but not overall survival (OS), versus pomalidomide plus dexamethasone in relapsed/refractory ... ...

Abstract	Melphalan flufenamide (melflufen), a first-in-class alkylating peptide-drug conjugate, plus dexamethasone demonstrated superior progression-free survival (PFS), but not overall survival (OS), versus pomalidomide plus dexamethasone in relapsed/refractory multiple myeloma in the OCEAN study. Time to progression (TTP) <36 months after a prior autologous stem cell transplantation (ASCT) was a negative prognostic factor for OS with melflufen. This post hoc exploratory analysis evaluated patients refractory to prior alkylators (e.g., cyclophosphamide and melphalan) in OCEAN. In 153 patients refractory to prior alkylators (melflufen, n = 78; pomalidomide, n = 75), the melflufen and pomalidomide arms had similar median PFS (5.6 months [95% CI, 4.2-8.3] vs. 4.7 months [95% CI, 3.1-7.3]; hazard ratio [HR], 0.92 [95% CI, 0.63-1.33]) and OS (23.4 months [95% CI, 14.4-31.7] vs. 20.0 months [95% CI, 12.0-28.7]; HR, 0.92 [95% CI, 0.62-1.38]). Among alkylator-refractory patients with a TTP ≥ 36 months after a prior ASCT or no prior ASCT (melflufen, n = 54; pomalidomide, n = 53), the observed median PFS and OS were longer in the melflufen arm than the pomalidomide arm. The safety profile of melflufen was consistent with previous reports. These results suggest that melflufen is safe and effective in patients with alkylator-refractory disease, suggesting differentiated activity from other alkylators.
MeSH term(s)	Humans ; Multiple Myeloma/diagnosis ; Multiple Myeloma/drug therapy ; Melphalan/therapeutic use ; Melphalan/analogs & derivatives ; Alkylating Agents/therapeutic use ; Hematopoietic Stem Cell Transplantation ; Dexamethasone/adverse effects ; Transplantation, Autologous ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Phenylalanine/analogs & derivatives ; Thalidomide/analogs & derivatives
Chemical Substances	melflufen (3412470A0V) ; Melphalan (Q41OR9510P) ; pomalidomide (D2UX06XLB5) ; Alkylating Agents ; Dexamethasone (7S5I7G3JQL) ; Phenylalanine (47E5O17Y3R) ; Thalidomide (4Z8R6ORS6L)
Language	English
Publishing date	2023-11-15
Publishing country	England
Document type	Journal Article
ZDB-ID	392482-8
ISSN	1600-0609 ; 0902-4441
ISSN (online)	1600-0609
ISSN	0902-4441
DOI	10.1111/ejh.14127
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Article ; Online: Benefit Versus Risk Assessment of Melflufen and Dexamethasone in Relapsed/Refractory Multiple Myeloma: Analyses From Longer Follow-up of the OCEAN and HORIZON Studies.

Sonneveld, Pieter / Richardson, Paul G / Ludwig, Heinz / Dimopoulos, Meletios-Athanasios / Schjesvold, Fredrik H / Hájek, Roman / Abdulhaq, Haifaa / Thuresson, Marcus / Norin, Stefan / Bakker, Nicolaas A / Mateos, Maria-Victoria

Clinical lymphoma, myeloma & leukemia

2023 Volume 23, Issue 9, Page(s) 687–696

Abstract: Introduction: Melphalan flufenamide (melflufen), a first-in-class alkylating peptide-drug conjugate, plus dexamethasone demonstrated superior progression-free survival (PFS) but directionally different overall survival (OS) favoring pomalidomide (hazard ...

Abstract	Introduction: Melphalan flufenamide (melflufen), a first-in-class alkylating peptide-drug conjugate, plus dexamethasone demonstrated superior progression-free survival (PFS) but directionally different overall survival (OS) favoring pomalidomide (hazard ratio [HR], 1.10) in OCEAN. Methods: These analyses further investigated prognostic subgroups impacting survival in updated data from the randomized, phase 3 OCEAN study (NCT03151811; date: February 3, 2022) and the phase 2 HORIZON study (NCT02963493; date: February 2, 2022). Results: In OCEAN, subgroups prognostic for OS were age (P = .011; <65 years favored pomalidomide) and no previous autologous stem cell transplant (ASCT) or progression >36 months after ASCT (P = .001; favored melflufen). Overall, 245 of 495 (49%) patients randomized had received a previous ASCT, of which 202 (82%) had progressed within 36 months following their ASCT. When excluding patients who had progressed <36 months post-ASCT (melflufen group, n = 145; pomalidomide group, n = 148), median OS was 23.6 months with melflufen and 19.8 months with pomalidomide (HR, 0.83 [95% CI, 0.62-1.12]; P = .22). Among patients with triple-class refractory disease in HORIZON, patients who had progressed <36 months post-ASCT (n = 58) had a lower response rate and shorter duration of response and PFS than the remaining patients (n = 52). Safety was consistent with previous reports. Conclusion: These analyses demonstrate a consistent benefit for melflufen and dexamethasone in patients with relapsed/refractory multiple myeloma who have not received an ASCT or progressed >36 months after receiving an ASCT (ClinicalTrials.gov identifier: NCT03151811).
MeSH term(s)	Humans ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Dexamethasone/therapeutic use ; Follow-Up Studies ; Melphalan/therapeutic use ; Multiple Myeloma/drug therapy ; Risk Assessment ; Transplantation, Autologous ; Clinical Trials, Phase II as Topic ; Clinical Trials, Phase III as Topic ; Randomized Controlled Trials as Topic
Chemical Substances	Dexamethasone (7S5I7G3JQL) ; melflufen (3412470A0V) ; Melphalan (Q41OR9510P) ; pomalidomide (D2UX06XLB5)
Language	English
Publishing date	2023-05-06
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2540992-X
ISSN	2152-2669 ; 2152-2650
ISSN (online)	2152-2669
ISSN	2152-2650
DOI	10.1016/j.clml.2023.05.004
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Article ; Online: What Ingredients Have You Used to Prepare This Delicious Lunch? A Critical Look Behind a Meta-analysis.

Liu, Weiming / Bakker, Nicolaas A / Groen, Rob J M

Annals of surgery

2015 Volume 262, Issue 6, Page(s) e113–4

MeSH term(s)	Disease Management ; Drainage/methods ; Hematoma, Subdural, Chronic/surgery ; Humans
Language	English
Publishing date	2015-12
Publishing country	United States
Document type	Comment ; Letter
ZDB-ID	340-2
ISSN	1528-1140 ; 0003-4932
ISSN (online)	1528-1140
ISSN	0003-4932
DOI	10.1097/SLA.0000000000000754
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Article ; Online: Effectiveness of Upadacitinib in Patients with Atopic Dermatitis including those with Inadequate Response to Dupilumab and/or Baricitinib: Results from the BioDay Registry.

Boesjes, Celeste M / Van der Gang, Liana F / Zuithoff, Nicolaas P A / Bakker, Daphne S / Spekhorst, Lotte S / Haeck, Inge / Kamsteeg, Marijke / De Graaf, Marlies / De Bruin-Weller, Marjolein S

Acta dermato-venereologica

2023 Volume 103, Page(s) adv00872

Abstract: Clinical trials showed that upadacitinib, a selective Janus kinase-1 inhibitor, is effective for treatment of moderate-to-severe atopic dermatitis. However, daily practice studies are limited. This multicentre prospective study evaluated the ... ...

Abstract	Clinical trials showed that upadacitinib, a selective Janus kinase-1 inhibitor, is effective for treatment of moderate-to-severe atopic dermatitis. However, daily practice studies are limited. This multicentre prospective study evaluated the effectiveness of 16 weeks of upadacitinib treatment for moderate-to-severe atopic dermatitis in adult patients, including those with previous inadequate response to dupilumab and/or baricitinib, in daily practice. A total of 47 patients from the Dutch BioDay registry treated with upadacitinib were included. Patients were evaluated at baseline, and after 4, 8 and 16 weeks of treatment. Effectiveness was assessed by clinician- and patient-reported outcome measurements. Safety was assessed by adverse events and laboratory assessments. Overall, the probabilities (95% confidence intervals) of achieving Eczema Area and Severity Index ≤ 7 and Numerical Rating Scale - pruritus ≤ 4 were 73.0% (53.7-86.3) and 69.4% (48.7-84.4), respectively. The effectiveness of upadacitinib was comparable in patients with inadequate response to dupilumab and/or baricitinib and in patients who were naïve for these treatments or who had stopped such treatments due to adverse events. Fourteen (29.8%) patients discontinued upadacitinib due to ineffectiveness, adverse events or both (8.5%, 14.9% and 6.4%, respectively). Most frequently reported adverse events were acneiform eruptions (n = 10, 21.3%), herpes simplex (n = 6, 12.8%), nausea and airway infections (both n = 4, 8.5%). In conclusion, upadacitinib is an effective treatment for patients with moderate-to-severe atopic dermatitis, including those with previous inadequate response to dupilumab and/or baricitinib treatment.
MeSH term(s)	Adult ; Humans ; Dermatitis, Atopic/diagnosis ; Dermatitis, Atopic/drug therapy ; Prospective Studies ; Double-Blind Method ; Treatment Outcome ; Severity of Illness Index
Chemical Substances	dupilumab (420K487FSG) ; baricitinib (ISP4442I3Y) ; upadacitinib (4RA0KN46E0)
Language	English
Publishing date	2023-02-16
Publishing country	Sweden
Document type	Multicenter Study ; Journal Article
ZDB-ID	80007-7
ISSN	1651-2057 ; 0001-5555
ISSN (online)	1651-2057
ISSN	0001-5555
DOI	10.2340/actadv.v103.5243
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