Abstracts Clinical Lymphoma, Myeloma & Leukemia September 2023 S330 ibrutinib dose modification may be an effective treatment strategy in the real world. Funding: Janssen Scientific Affairs, LLC Keywords: CLL, chronic lymphocytic leukemia, real-world dosing, ibrutinib, dose modification, outcomes CLL-586 Real‑World Dosing Patterns and Outcomes Among Patients With Chronic Lymphocytic Leukemia With or Without Dose Adjustment of First‑Line Ibrutinib Kerry Rogers MD1, Xiaoxiao Lu MD PhD2, Bruno Emond MSc3, Zhijie Ding PhD2, Patrick Lefebvre MA3, MarieHélène Lafeuille MA3, Heena Mavani PharmD2, Zaina Qureshi PhD2, Nilanjan Ghosh MD4 1The Ohio State University, Columbus, USA. 2Janssen Scientific Affairs, Horsham, USA. 3Analysis Group, Inc., Montréal, Canada. 4Levine Cancer Institute, Charlotte, USA Context: In patients with chronic lymphocytic leukemia (CLL), ibrutinib dosage may be adjusted to prevent recurrence or worsening of adverse events, while preserving efficacy. Objective: This realworld study described outcomes in patients with CLL treated with first-line ibrutinib who did or did not have dose adjustment. Design: Electronic medical records from the Acentrus database (1/1/2016-4/30/2022) were used to identify patients with CLL who initiated first-line ibrutinib (index date). Patients: The first 6 months post-index were used to identify patients who received ibrutinib and maintained on a starting dose (420 mg/day) or with a dose adjustment. Outcomes: Proportion of days covered (PDC), medication possession ratio (MPR), and time-to-next treatment (TTNT) were described and reported for patients with and without dose adjustment, in all patients and in the subgroup with high cardiovascular (CV) risk (ie, pre-existing CV comorbidity or a high CV risk score). Results: Overall, 1,171 patients with CLL initiated first-line ibrutinib at 420 mg/day: 1,038 (88.6%) remained on 420 mg/day for ≥6 months, 229 (19.6%) had a dose adjustment at any time post-index, and 126 (10.8%) had dose adjustment during the first 6 months. In patients with dose adjustment, mean PDC (overall, 0.81; CV subgroup, 0.78) and MPR (overall, 0.84; CV subgroup, 0.81) were nominally higher than the corresponding values in patients without dose adjustment (PDC: overall, 0.70; CV subgroup, 0.69; MPR: overall, 0.73; CV subgroup, 0.72). Median TTNT was not reached in either cohort and 12-month TTNT rates were similar (dose adjustment: overall, 89.1%; CV subgroup, 92.7%; without dose adjustment: overall, 92.5%; CV subgroup, 92.0%). Conclusion: Among patients with CLL who received firstline ibrutinib, 19.6% had a dose adjustment. Those with a dose adjustment had nominally higher treatment adherence with no detriment to TTNT compared to those who maintained the starting dose, regardless of CV risk. These findings are consistent with other real-world studies and suggest that dose adjustment of ibrutinib does not have a negative impact on its effectiveness. Sponsorship: Janssen Scientific Affairs, LLC Keywords: CLL, dose adjustment, real-world dosing, ibrutinib, chronic lymphocytic leukemia, outcomes CLL-587 Real‑World Treatment Outcomes in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Who Were Treated With First‑Line Single‑Agent Ibrutinib vs Chemoimmunotherapy Ruibin Wang PhD1, Zhijie Ding PhD2, Xiaoxiao Lu MD PhD2, Heena Mavani PharmD2, Jinghua He PhD1, Zaina Qureshi PhD2, Javier Pinilla MD3 1Janssen Scientific Affairs, Titusville, USA. 2Janssen Scientific Affairs, Horsham, USA. 3H. Lee Moffitt Cancer Center and Research Institute, Tampa, USA Context: Real-world evidence on Bruton tyrosine kinase inhibitor treatment vs chemoimmunotherapy (CIT) for CLL/SLL patients has been limited to certain practice settings; research using a large and more comprehensive data source is warranted. Objective: Evaluate treatment outcomes among CLL/SLL patients treated with first-line (1L) ibrutinib (IBR) or CIT using US claims data from the Komodo Health payer-complete dataset, derived from >150 private insurers and >140 million insured individuals from 2015 to 2022 (study period). Design: Retrospective cohort study. Patients: Adult CLL/SLL patients who initiated 1L single-agent IBR or CIT (defined as no prior CLL/SLL treatment for ≥12 months in baseline period) on or after March 2016 until October 2022 (intake aligned with FDA approval of IBR in 1L CLL/SLL then 12-month baseline period). Cohorts were balanced on baseline characteristics using inverse probability of treatment weights. Outcomes: Timeto-next treatment (TTNT) was defined as the time from initiation (index date) of 1L treatment to treatment add-on or switch to a next line of therapy ≥29 days post-index and was compared using Cox proportional hazards models. Results: 3570 1L IBR- and 2391 CIT-treated patients were included (mean age 68 vs 64 years, 63% vs 66% male, and mean Quan-Charlson Comorbidity Index score 2.87 vs 3.05, respectively). Median follow-up was 26 vs 31 months, and 13% vs 26% of patients recorded a next treatment during the study period for IBR and CIT, respectively. At 1-, 3-, and 5-year post-index, the probabilities (95% confidence interval [CI]) of not initiating a new treatment were 92% (91%–93%), 83% (81%–84%) and 76% (73%–78%) vs 88% (87%–89%), 70% (68%–73%) and 56% (53%–60%) for the IBR and CIT cohorts, respectively. After controlling for baseline characteristics, patients in the IBR cohort were significantly less likely to initiate the next line of therapy during the study period (hazard ratio 0.61; [95% CI, 0.54–0.69], P<0.001). Conclusions: 1L single-agent IBR was associated with a significantly lower risk of advancing to next line of treatment compared to CIT in this large claims-based data set, reinforcing real-world effectiveness of 1L IBR for CLL in an insured US patient population. Funding: Janssen Scientific Affairs, LLC Keywords: CLL, chronic lymphocytic leukemia, real-world, ibrutinib, chemoimmunotherapy
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