PracticeUpdate: Conference Series - EHA 2018

ƒ ƒ Month 6: PedsQL, 17; EQ-VAS, 16 ƒ ƒ Month 9: PedsQL, 18; EQ-VAS, 19 ƒ ƒ Month 12: PedsQL, 27; EQ-VAS, 25 The percentage of patients who achieved the normative mean or greater (PedsQL, ≥ 83; EQ-VAS, ≥ 86.3) increased from 12% at baseline to 64% by month 12 for the PedsQL total score and 18% at base- line to 64% by month 12 for the EQ-VAS total score. “Sustained improvements in patient QOL were observed for each PedsQL subscale,” the researchers stated in their abstract. “Notable decreases in the proportion of problems reported by responding patients in each of the EQ-5D dimensions were observed at each time point.” Updated results for the international ELIANA clinical trial, a single arm, open-label, multi-center, phase II study, were published earlier this year in The New England Journal of Medicine. In the analysis of 75 infused patients with three or more months of follow-up, tis- agenlecleucel, trademarked as Kymriah, demonstrated an overall remission rate of 81% (95% CI 71%–89%). Sixty percent of patients achieved complete remission and 21% of patients achieved complete remission with incomplete blood count recovery, with no minimal residual disease detected among all responding patients. Median follow-up was 13.1 months.

and 7–10, respectively. The normative mean values for healthy children are 83 and 86.2 for the PedsQL and EQ-VAS, respectively. At the EHA Congress, the researchers reported changes in QOL in patients with a best overall response of complete remission with and without blood count recovery. At the data cutoff, 75 of 92 enrolled patients had been infused. Of these infused patients, 58 patients (77%) who were ≥ 8 years old completed QOL instruments; 48 (83%) of whom were responders (CR/CRi). Mean baseline vs Clb alone (Stage 1). As well the use of G-Clb was compared to R-Clb (Stage 2) in patients with previously untreated CLL and comorbidities. Patients were randomized 1:2:2 to receive six 28-day cycles (C) of Clb, R-Clb or G-Clb. The dosing schedule was as follows: ƒ ƒ Clb (0.5 mg/kg) was administered orally on Day 1 and D15 of C1–6. ƒ ƒ R was administered intravenously (IV) at a dose of 375 mg/m 2 on D1 of C1 and 500 mg/m 2 on D1 of C2–6. ƒ ƒ Obinutuzumab (1000 mg) was adminis- tered IV on D1 (dose split over two days; 100 mg D1, 900 mg D2), D8 and D15 of C1, and D1 of C2–6. A total of 781 patients were enrolled and received treatment (median: age, 73 years; CIRS score, 8; CrCl, 62 mL/min). Eligible patients had previously untreated CD20+ CLL, a total cumulative illness rating scale (CIRS) score of > 6 and/or a

scores for responding patients were 58 and 68 for the PedsQL and EQ-VAS, respectively. Mean baseline scores for nonresponding patients (n=10) were 60 and 63 for the PedsQL and EQ-VAS scales, respectively. “Both assessments demonstrated clinically meaningful improvements in the QOL of responders,” the researchers stated. The mean changes from baseline were as follows: ƒ ƒ At day 28: PedsQL, 6; EQ-VAS, 11 ƒ ƒ Month 3: PedsQL, 13.5; EQ-VAS, 16.5

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" Notably, G-Clb also provided a clinically meaningful improvement in overall survival compared with R-Clb. Two- and five-year survival rates were 91% vs 84% and 66% vs 57% for G-Clb vs R-Clb, respectively. "

outcomes compared with R-Clb (n=330). Notably, G-Clb also provided a clinically meaningful improvement in overall sur- vival compared with R-Clb. Two- and five-year survival rates were 91% vs 84% and 66% vs 57% for G-Clb vs R-Clb, respectively. Overall, the study found that fewer patients died in the G-Clb arm (37%) than in the R-Clb arm (45%). During the survival follow-up period, the most common cause of death was disease progression (G-Clb, 10%; R-Clb, 15%).

creatinine clearance (CrCl) of < 70 mL/ min. “The primary endpoint was investi- gator-assessed progression-free survival,” the investigators noted in their abstract. Secondary endpoints included overall survival, time to new treatment and safety. After a median observation time of 62.5 months, treatment with G-Clb (n=238) was associated with improved outcomes compared with Clb alone (n=118). After a median observation time of 59.4 months, G-Clb (n=333) also demonstrated a clinically meaningful improvement in

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EHA 2018 • PRACTICEUPDATE CONFERENCE SERIES