Ibrutinib followed by ofatumumab consolidation in previously untreated patients with chronic lymphocytic leukemia (CLL): GELLC-7 trial from the Spanish group of CLL (GELLC).

Autor:	Abrisqueta P; Department of Hematology, Vall d'Hebron Institute of Oncology (VHIO), Hospital Universitari Vall d'Hebron, Barcelona, Spain., González-Barca E; Department of Hematology, Instititut Catala D'Oncologia, Hospital Duran i Reynals, IDIBELL, Universitat de Barcelona, Barcelona, Spain., Ferrà C; Department of Hematology, Instititut Catala D'Oncologia, Hospital Germans Trias i Pujol, Universitat de Vic/Universitat Central de Catalunya, Barcelona, Spain., Ríos-Herranz E; Department of Hematology, Hospital Nuestra Señora de Valme, Sevilla, Spain., Fernández de la Mata M; Department of Hematology, Hospital Universitario Reina Sofía, Córdoba, Spain., Delgado J; Department of Hematology, Hospital Clínic, Barcelona, Spain., Andreu R; Department of Hematology, Hospital Universitario La Fe, Valencia, Spain., Hernández-Rivas JÁ; Department of Hematology, Hospital Universitario Infanta Leonor, Madrid, Spain., Terol MJ; Department of Hematology, Hospital Clínico Universitario de Valencia, Valencia, Spain., Navarro A; Department of Hematology, Hospital Universitario de Salamanca-IBSAL, CIC- IBMCC (USAL-CSIC) CIBERONC, Salamanca, Spain., Vidriales MB; Department of Hematology, Hospital Universitario de Salamanca-IBSAL, CIC- IBMCC (USAL-CSIC) CIBERONC, Salamanca, Spain., Baltasar P; Department of Hematology, Hospital Universitario La Paz, Madrid, Spain., De la Serna J; Department of Hematology, Hospital Universitario 12 de Octubre, Madrid, Spain., Ramírez Á; Department of Hematology, Hospital Universtiario Central de Asturias, Oviedo, Spain., Ballester C; Department of Hematology, Hospital Universitari Son Espases, Palma, Spain., Moreno C; Department of Hematology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain., García-Marco JA; Department of Hematology, Hospital Universitario Puerta de Hierro, Majadahonda, Spain., Córdoba R; Department of Hematology, Fundación Jiménez Díaz, Madrid, Spain., Yáñez L; Department of Hematology, Hospital Universitario Marqués de Valdecilla, Santander, Spain., Casado LF; Department of Hematology, Hospital General Universitario de Toledo, Toledo, Spain., González M; Department of Hematology, Hospital Universitario de Salamanca-IBSAL, CIC- IBMCC (USAL-CSIC) CIBERONC, Salamanca, Spain., Bosch F; Department of Hematology, Vall d'Hebron Institute of Oncology (VHIO), Hospital Universitari Vall d'Hebron, Barcelona, Spain.
Jazyk:	angličtina
Zdroj:	EClinicalMedicine [EClinicalMedicine] 2024 May 25; Vol. 73, pp. 102642. Date of Electronic Publication: 2024 May 25 (Print Publication: 2024).
DOI:	10.1016/j.eclinm.2024.102642
Abstrakt:	Background: 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. Competing Interests: P.A. Consulting/advisory: Roche, Genmab, Janssen, BMS, AbbVie, AstraZeneca, BeiGene; Honoraria: Roche, Genmab, Janssen, BMS, AbbVie, AstraZeneca, Gilead, Incyte. E.G-B. Consultancy: Janssen, Abbvie, Gilead, Kiowa, EUSAPharma, Incyte, Lilly, Beigene, Novartis; Speaker: Janssen, Abbvie, Takeda, Kiowa, Roche, EUSAPharma, Incyte, Astra-Zeneca; Travel: Janssen, Abbvie, EUSAPharma. C. F: Consulting/advisory: Janssen, AbbVie, AstraZeneca, Gilead; Honoraria: Roche, Janssen, AbbVie, AstraZeneca, Gilead, BeiGene. R.A. Consulting/advisory: Roche, Janssen, AbbVie, AstraZeneca, Takeda. JAH-R. Consultant: Janssen, Roche, Abbvie, Gilead, BMS/Celgene, Amgen, Takeda, Rovi, AstraZeneca, Beigene, Sandoz Novartis, Celltrion, EusaPharm, Sanofi, Lilly, Menarini Stemline; Speaker's Bureau: Janssen, Roche, Abbvie, Gilead, BMS/Celgene, Amgen, Takeda, AstraZeneca, Beigene, Lilly; Grant/Research Support: BMS/Celgene, Janssen, Sanofi. A.R. Honoraria: Janssen, BMS, Novartis, Roche, EUSA Pharma, Abbvie, Astra Zeneca, Sanofi, Takeda, Incyte, GSK Consulting/Advisory: Janssen, BMS, Pfizer, Roche, Abbvie, Gilead, Novartis, Takeda; Astra Zeneca, Beigene. L.F.C. Advisory, consultancy and research founding: Janssen, Roche, Abvvie, Beigene, Astra-Zeneca and Loxo. F.B. has received research funding and honoraria from Roche, Celgene, Takeda, AstraZeneca, Novartis, Abbvie and Janssen. The other authors have no conflicts of interest to declare. (© 2024 The Author(s).)
Databáze:	MEDLINE
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