Ibrutinib followed by ofatumumab consolidation in previously untreated patients with chronic lymphocytic leukemia (CLL) : GELLC-7 trial from the Spanish group of CLL (GELLC)
Abrisqueta, Pau (Vall d'Hebron Institut d'Oncologia)
González Barca, Eva (Hospital Universitari de Bellvitge)
Ferrá, Christelle (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Ríos-Herranz, Eduardo (Hospital Universitario Virgen de Valme (Sevilla, Andalusia))
Fernández de la Mata, Margarita (Hospital Universitario Reina Sofía (Còrdova, Espanya))
Delgado, Julio (Hospital Clínic i Provincial de Barcelona)
Andreu, Rafael (Hospital Universitari i Politècnic La Fe (València))
Hernández-Rivas, José Ángel (Hospital Universitario Infanta Leonor)
Terol, María José (Hospital Clínic Universitari (València))
Navarro, Almudena (Hospital Universitario de Salamanca)
Vidriales, M. Belén (Hospital Universitario de Salamanca)
Baltasar, Patricia (Hospital Universitario La Paz (Madrid))
De la Serna, Javier (Instituto de Investigación Sanitaria Hospital 12 de Octubre (i+12))
Ramírez, Á.ngel (Hospital Universitario Central de Asturias)
Ballester, C. (Hospital Universitari Son Espases (Palma de Mallorca, Balears))
Moreno, Carol (Hospital de la Santa Creu i Sant Pau (Barcelona, Catalunya))
García-Marco, J.A. (Hospital Universitario Puerta de Hierro Majadahonda (Madrid))
Córdoba, Raúl (Hospital Universitario Fundación Jiménez Díaz)
Yáñez, Lucrecia (Hospital Universitario Marqués de Valdecilla (Santander, Cantabria))
Casado, Luis Felipe (Hospital General Universitario de Toledo)
González, Marcos (Hospital Universitario de Salamanca)
Bosch Albareda, Francesc 1947- (Vall d'Hebron Institut d'Oncologia)
Universitat Autònoma de Barcelona

Data:	2024
Resum:	BTK inhibitors have been concurrently administered with anti-CD20 monoclonal antibodies (mAbs) in chronic lymphocytic leukemia (CLL). However, the optimal regimen for combining these two drugs remains pending. Methods: This multi-center phase 2 study aimed to analyze whether consolidation with ofatumumab improved the response in patients with CLL receiving front-line treatment with ibrutinib. Patients received 12 cycles of ibrutinib monotherapy. Those who achieved CR after this induction were maintained on ibrutinib. Conversely, those who did not attain CR continued with ibrutinib in addition to a consolidation, which involved 7 doses of ofatumumab. The primary objective was the complete response (CR) rate at cycle 20. This study is registered within the EU Clinical Trials Register (EudraCT 2016-004937-26). Findings: Between September 8, 2017, and May 21, 2018, 84 patients (median age, 69 years) were included. After completion of 12 cycles of ibrutinib (n = 80), 4 patients (5%) were in CR, 67 (84%) in partial response (PR), and 6 patients (7%) had a PR with lymphocytosis (PRL). After consolidation with ofatumumab, 20 patients improved the response from PR to CR and 6 patients with PRL obtained a PR. Seventy-one patients (85%) completed 20 cycles of treatment, with a CR rate of 24/71 (34%). According to the intention-to-treat analysis at cycle 20, the ORR was 69/84 (82. 2%), with a CRR of 24/84 (28. 6%). Progression-free survival and overall survival at 48-months were 89. 9% (CI: 82. 4-95. 5) and 92. 2% (CI: 85. 3-97. 1), respectively. Interpretation: These findings underscore the potential for a consolidation strategy in CLL, wherein the addition of a mAb in patients with low tumor burden might enhance the quality of the response. Funding: The study was funded by Janssen that also supplied ibrutinib, whereas ofatumumab was supplied by Novartis.
Ajuts:	Instituto de Salud Carlos III PI17/00943 Instituto de Salud Carlos III PI18/01392 Instituto de Salud Carlos III PI22/01204
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Chronic lymphocytic leukemia ; Consolidation ; Treatment
Publicat a:	EClinicalMedicine, Vol. 73 (july 2024) , p. 102642, ISSN 2589-5370

DOI: 10.1016/j.eclinm.2024.102642
PMID: 38841711

9 p, 600.8 KB

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