PracticeUpdate: Conference Series - EHA 2018

Tisagenlecleucel Improves Quality of Life for Young Patients with Refractory B-Cell Acute Lymphoblastic Leukemia Improvements in QOL were sustained at both 9 and 12months

A fter tisagenlecleucel infusion, mean- ingful, even dramatic, improvements in quality of life (QOL) have been observed in pediatric and young adult patients with relapsed or refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL) who achieved complete remission with or without blood count recovery. The research team, led by André Baruchel, with the Pediatric Hematology- Immunology Department at Robert Debré University Hospital in Paris, found improvements in QOL observed at day 28 and months 3 and 6 were still sustained 9 and 12 months later. A global trial, ELIANA, evaluated the efficacy and safety of tisagenlecleu- cel (formerly CTL019) in pediatric and young adult patients with R/R B-ALL. Tisagenlecleucel is an autologous T-cell

chimeric antigen receptor therapy target- ing CD19+ cells. The goal of this study was to evaluate patient-reported QOL before and after infusion with tisagenlecleucel. As of April 25 2017, the data cutoff date, an overall remission rate (including both complete remission and complete blood count recovery of 81% at ≤ 3 months was reported. However, the researchers noted in their abstract, Improvement of Patient-Reported Quality of Life Following Tisagenlecleucel Infusion in Pediatric and Young Adult Patients With Relapsed/ Refractory B-Cell Acute Lymphoblastic Leukemia , “Increasingly, patient quality of life has become an important component in evaluating new oncology therapies.” Infused patients were 3–23 years old with CD19+ B-ALL and were chemore- fractory, relapsed after allogeneic stem

cell transplant (SCT), or otherwise inel- igible for SCT. Patients ≥ 8 years old completed the Pediatric Quality of Life Inventory (PedsQL) and the EuroQOL (EQ-5D/EQ-5D-Y) at baseline, day 28, and months 3, 6, 9, and 12 to evaluate QOL. Baruchel et al noted that both instruments are validated measures of QOL and were summarized with descriptive statistics at the cross-sectional level and through changes from baseline. The minimal clinically important differ- ences for the PedsQL and the EuroQOL visual analog scale (EQ-VAS) are 4.4

Consider ObinutuzumabPlus Chlorambucil for First-Line Treatment for CLL Obinutuzumab plus chlorambucil provide clinicallymeaningful benefits in CLL patients with comorbidities A combination of obinutuzumab plus chlorambucil (G-Clb) should be considered a first-line treatment for chronic lymphocytic leukemia (CLL) patients with comorbidities.

A slower-growing form of CLL produces an increased number of lymphocytes, but a normal or slightly below normal level of red cells, platelets, and neutrophils in the blood. This form of the disease can remain stable for years. The faster-grow- ing form of CLL, however, has too many cells in the blood that block normal cell production. As a result, the number of fully functioning red cells and platelet levels drop below normal. This phase III study conducted by Goede et al evaluated the efficacy and safety of obinutuzumab, a glycoengineered type II anti-CD20 monoclonal antibody developed as an effective treatment for CLL, in combination with chlorambucil (Clb) and rituximab (R) plus Clb (R-Clb)

In their abstract, Overall Survival Benefit of Obinutuzumab Over Rituximab When Combined With Chlorambucil in Patients With Chronic Lymphocytic Leukemia and Comorbidities: Final Survival Analysis of the Cll11 Study , the research team stated that G-Clb yields clinically meaningful ben- efits in CLL patients with comorbidities. CLL, the most common form of leukemia in adults, occurs when the DNA of a developing stem cell in the bone marrow is damaged. Because CLL does not com- pletely interfere with the growth of mature red cells, white cells, and platelets, it is generally less severe than acute leukemia.

The investigators, led by Valentin Goede, MD, a hematologist/oncologist in the Department of Internal Medicine with the University Hospital of Cologne in Germany, presented the findings from the final analysis of the CLL11 study. The research team suggested that obinutu- zumab should be the preferred anti-CD20 antibody in future combination regimens for CLL.

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PRACTICEUPDATE CONFERENCE SERIES • EHA 2018