Abstract
3 min readIntroduction: Anemia and fatigue are known to impair quality of life in patients with WM. Ibrutinib, a first-in-class, once-daily inhibitor of BTK, is approved in the EU for the treatment of WM after ≥1 prior therapy or as first-line therapy in patients unsuitable for chemoimmunotherapy. In the US, ibrutinib is approved for the treatment of WM as a single agent or in combination with rituximab. In patients with rituximab-refractory WM, single-agent ibrutinib induced clinically meaningful improvements in PROs (Trotman, EHA 2017). In the iNNOVATE study, the combination of ibrutinib and rituximab (IR) produced higher rates of sustained hemoglobin improvement and clinically meaningful improvements in PROs when compared with placebo-rituximab (R) (Dimopoulos NEJM 2018). Here, we report a more detailed analysis of PROs from iNNOVATE. Methods: Patients with symptomatic WM requiring therapy were randomized to once-daily oral ibrutinib (420 mg) or placebo; both groups were given rituximab (375 mg/m2/week IV at weeks 1–4 and 17–20). PRO measures included FACIT-Fatigue (FACIT-F), FACT-An total score (TS) and anemia subscale score (AS), and the visual analog scale (EQ-VAS) and utility score (EQ-US) of EQ-5D-5L (© EuroQol Research Foundation. EQ-5D™ is a trademark of the EuroQol Research Foundation). Conclusions: Clinical response and improvements in anemia with IR are consistent with more patients showing clinically meaningful improvements in PROs vs R. Changes in IgM were also found to correlate with improvements in PROs. Keywords: ibrutinib; rituximab; Waldenström's macroglobulinemia (WM). Disclosures: Tedeschi, A: Consultant Advisory Role: AbbVie, Gilead, Janssen SpA, and Sunesis; Other Remuneration: Speakers' bureau for Janssen. Dimopoulos, M: Consultant Advisory Role: Amgen, Bristol-Myers Squibb, Celgene, Janssen, Novartis and Takeda; Honoraria: Amgen, Bristol-Myers Squibb, Celgene, Janssen and Takeda. Trotman, J: Research Funding: Pharmacyclics LLC, an AbbVie Company. García-Sanz, R: Consultant Advisory Role: Bristol-Myers Squibb and Takeda; Honoraria: Amgen, Janssen, and Takeda; Research Funding: Gilead and Incyte, and institution research funding from Amgen and Janssen; Other Remuneration: Patents, royalties, or other intellectual property for IVS (Biomed 2 - Euroclonality); travel expenses from Janssen and Takeda. Macdonald, D: Consultant Advisory Role: Janssen; Honoraria: AbbVie, Gilead, Roche and Teva. Heffner, L: Consultant Advisory Role: Pharmacyclics LLC, an AbbVie Company; Research Funding: Amgen, ADC Therapeutics, Biotest, Genentech, Gilead, Idera, Kite, Micromet, Pfizer, and Pharmacyclics LLC, an AbbVie Company; Other Remuneration: Travel expenses from Pharmacyclics LLC, an AbbVie Company. Tam, C: Honoraria: Janssen, and Pharmacyclics LLC, an AbbVie Company; Research Funding: Janssen. Varettoni, M: Consultant Advisory Role: Janssen and Roche; Other Remuneration: Travel expenses from Gilead and Janssen. Palomba, M: Consultant Advisory Role: Celgene, Merck, and Pharmacyclics LLC, an AbbVie Company; Honoraria: Juno and Seres; Other Remuneration: Patents, royalties, or other intellectual property for Juno and Seres. Matous, J: Consultant Advisory Role: Celgene; Other Remuneration: Speakers' bureau for Celgene. Shustik, C: Consultant Advisory Role: Amgen, Celgene, and Takeda. Kastritis, E: Consultant Advisory Role: Amgen, Genesis Pharma, Janssen, Prothena and Takeda; Honoraria: Amgen and Takeda; Other Remuneration: Travel expenses from Janssen and Takeda. Treon, S: Consultant Advisory Role: Janssen and Pharmacyclics LLC, an AbbVie Company; Research Funding: Pharmacyclics LLC, an AbbVie Company; Other Remuneration: Expert testimony for Johnson & Johnson; travel expenses from Janssen and Pharmacyclics LLC, an AbbVie Company. Li, J: Employment Leadership Position: Pharmacyclics LLC, an AbbVie Company; Stock Ownership: AbbVie, AcelRx, Agenus, Akebia, BeiGene, Celgene, Fibrogen, Gilead, La Jolla Pharmaceutical, Merk, Nektar, and TG Therapeutics. Poulsen, E: Employment Leadership Position: AbbVie and Pharmacyclics LLC, an AbbVie Company; Stock Ownership: AbbVie. Hauns, B: Employment Leadership Position: Pharmacyclics Switzerland GmbH; Stock Ownership: AbbVie. Buske, C: Consultant Advisory Role: Gilead, Janssen, Pfizer, Roche; Research Funding: Janssen, Roche; Other Remuneration: Speakers' bureau for Gilead, Janssen, Pfizer, and Roche. Leblond, V: Consultant Advisory Role: AbbVie, Gilead, Janssen, and Roche; Honoraria: AbbVie, Amgen, Gilead, Janssen, and Roche; Research Funding: AbbVie, Janssen, and Roche; Other Remuneration: Speakers' bureau for AbbVie, Gilead, and Janssen; travel expenses from AbbVie and Roche.
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