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Sökning: WFRF:(Rodas A) > (2020-2023) > Phase II LEAP-004 S...

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FältnamnIndikatorerMetadata
00005912naa a2200673 4500
001oai:gup.ub.gu.se/322475
003SwePub
008240528s2023 | |||||||||||000 ||eng|
009oai:lup.lub.lu.se:4f9f631a-b120-4533-90c7-97c9fa91c736
0247 a https://gup.ub.gu.se/publication/3224752 URI
0247 a https://doi.org/10.1200/JCO.22.002212 DOI
0247 a https://lup.lub.lu.se/record/4f9f631a-b120-4533-90c7-97c9fa91c7362 URI
040 a (SwePub)gud (SwePub)lu
041 a eng
042 9 SwePub
072 7a ref2 swepub-contenttype
072 7a art2 swepub-publicationtype
1001 a Arance, Anau Hospital Clínic of Barcelona,Edith Cowan University4 aut
2451 0a Phase II LEAP-004 Study of Lenvatinib Plus Pembrolizumab for Melanoma With Confirmed Progression on a Programmed Cell Death Protein-1 or Programmed Death Ligand 1 Inhibitor Given as Monotherapy or in Combination.
264 1c 2023
520 a Effective treatments are needed for melanoma that progresses on inhibitors of programmed cell death protein-1 (PD-1) or its ligand (PD-L1). We conducted the phase II LEAP-004 study to evaluate the combination of the multikinase inhibitor lenvatinib and the PD-1 inhibitor pembrolizumab in this population (ClinicalTrials.gov identifier: NCT03776136).Eligible patients with unresectable stage III-IV melanoma with confirmed progressive disease (PD) within 12 weeks of the last dose of a PD-1/L1 inhibitor given alone or with other therapies, including cytotoxic T-cell lymphocyte-associated antigen 4 (CTLA-4) inhibitors, received lenvatinib 20 mg orally once daily plus ≤ 35 doses of pembrolizumab 200 mg intravenously once every 3 weeks until PD or unacceptable toxicity. The primary end point was objective response rate (ORR) per RECIST, version 1.1, by independent central review.A total of 103 patients were enrolled and treated. The median study follow-up was 15.3 months. ORR in the total population was 21.4% (95% CI, 13.9 to 30.5), with three (2.9%) complete responses and 19 (18.4%) partial responses. The median duration of response was 8.3 months (range, 3.2-15.9+). ORR was 33.3% in the 30 patients with PD on prior anti-PD-1 plus anti-CTLA-4 therapy. The median progression-free survival and overall survival in the total population were 4.2 months (95% CI, 3.8 to 7.1) and 14.0 months (95% CI, 10.8 to not reached), respectively. Grade 3-5 treatment-related adverse events occurred in 47 (45.6%) patients, most commonly hypertension (21.4%); one patient died from a treatment-related event (decreased platelet count).Lenvatinib plus pembrolizumab provides clinically meaningful, durable responses in patients with advanced melanoma with confirmed PD on prior PD-1/L1 inhibitor-based therapy, including those with PD on anti-PD-1 plus anti-CTLA-4 therapy. The safety profile was as expected. These data support lenvatinib plus pembrolizumab as a potential regimen for this population of high unmet need.
650 7a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Cancer och onkologi0 (SwePub)302032 hsv//swe
650 7a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Cancer and Oncology0 (SwePub)302032 hsv//eng
653 a Humans
653 a Immune Checkpoint Inhibitors
653 a therapeutic use
653 a B7-H1 Antigen
653 a Melanoma
653 a drug therapy
653 a Apoptosis Regulatory Proteins
653 a therapeutic use
7001 a de la Cruz-Merino, Luis4 aut
7001 a Petrella, Teresa Mu Sunnybrook Health Sciences Centre4 aut
7001 a Jamal, Rahimau University Of Montreal Health Center (CRCHUM)4 aut
7001 a Ny, Lars,d 1967u Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för onkologi,Institute of Clinical Sciences, Department of Oncology,Sahlgrenska University Hospital4 aut0 (Swepub:gu)xnylai
7001 a Carneiro, Anau Lund University,Lunds universitet,Lunds Melanomstudiegrupp,Forskargrupper vid Lunds universitet,LUCC: Lunds universitets cancercentrum,Övriga starka forskningsmiljöer,Melanom,Sektion I,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Lund Melanoma Study Group,Lund University Research Groups,LUCC: Lund University Cancer Centre,Other Strong Research Environments,Melanoma,Section I,Department of Clinical Sciences, Lund,Faculty of Medicine,Skåne University Hospital4 aut0 (Swepub:lu)med-ace
7001 a Berrocal, Alfonso4 aut
7001 a Márquez-Rodas, Ivanu Hospital Gregorio Maranon4 aut
7001 a Spreafico, Annau Princess Margaret Hospital University of Toronto4 aut
7001 a Atkinson, Victoriau University of Queensland4 aut
7001 a Costa Svedman, Fernandau Karolinska University Hospital4 aut
7001 a Mant, Andrewu Monash University4 aut
7001 a Khattak, Muhammad A4 aut
7001 a Mihalcioiu, Catalinu Royal Victoria Hospital, Montreal4 aut
7001 a Jang, Sekwon4 aut
7001 a Cowey, C Lance4 aut
7001 a Smith, Alan D4 aut
7001 a Hawk, Natalynu Eisai Inc.4 aut
7001 a Chen, Keu Merck Sharp And Dohme Corp., US4 aut
7001 a Diede, Scott Ju Merck Sharp And Dohme Corp., US4 aut
7001 a Krepler, Clemensu Merck Sharp And Dohme Corp., US4 aut
7001 a Long, Georgina Vu University of Sydney4 aut
7102 a Hospital Clínic of Barcelonab Edith Cowan University4 org
7730 t Journal of clinical oncology : official journal of the American Society of Clinical Oncologyg 41:1, s. 75-85q 41:1<75-85x 1527-7755
7730 t Journal of Clinical Oncologyg 41:1, s. 75-85q 41:1<75-85x 0732-183X
8564 u http://dx.doi.org/10.1200/JCO.22.00221y FULLTEXT
8564 8u https://gup.ub.gu.se/publication/322475
8564 8u https://doi.org/10.1200/JCO.22.00221
8564 8u https://lup.lub.lu.se/record/4f9f631a-b120-4533-90c7-97c9fa91c736

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