The late-breaking oral session at the 2022 European Hematology Association (EHA) Congress allowed investigators to present lately emerging information from abstracts submitted just after the deadline. The shows involved results from the phase 3 GAIA trial in serious lymphocytic leukemia (CLL), the phase 3 Dedication demo in several myeloma, and a examine of a one-dose procedure for transfusion-dependent beta-thalassemia and severe sickle cell disease (SCD).
Period 3 Dedication Demo in Freshly Identified Several Myeloma
This presentation by Paul Richardson, MD, of Dana-Farber Cancer Institute, focused on success of the 56-web-site trial on the effects of allogeneic stem cell transplant (ASCT) in conjunction with lenalidomide (Revlimid), bortezomib (Velcade), and dexamethasone (RVd) triple therapy in a number of myeloma. Amongst 357 sufferers who gained RVd by yourself and 365 who received RVd and ASCT, the investigators noticed a significant advantage in development-no cost survival (PFS) among the these with both equally RVd and ASCT, at 67.5 months vs 46.2 in individuals getting just RVd (HR of PFS with ASCT, 1.53). However, there was no in general survival (OS) reward with ASCT, and the price of hematologic secondary second key malignancies was greater in the ASCT group.
Richardson mentioned some tendencies that are not definitive owing to tiny sample sizes but nevertheless intriguing, namely that subgroups of African American contributors and individuals with a high body mass index experienced narrower HRs of the PFS finish stage. He named for additional investigation on these hypothesis-producing designs, as nicely as studies of ASCT and RVd with lengthier observe-up.
PFS in Phase 3 GAIA/CLL13 Trial
Barbara Eichhorst, MD, of the University Hospital Cologne, offered details on the stop point of PFS in this 4-arm review of in good shape patients with CLL that in comparison obinutuzumab and venetoclax (Gazyva and Venclexta GV) with or without the need of ibrutinib (GV + ibrutinib, GIV) vs chemoimmunotherapy (CIT) in the very first line of therapy. Results exposed very last yr confirmed the superiority of GV and GIV vs CIT in terms of the undetectable small residual sickness close level, and Eichhorst presented new information confirming that the conclude stage of PFS was also achieved, with HRs of progression of .32 for GIV and .42 for GV vs CIT about a median stick to-up of 38.8 months.
In response to an audience query about no matter if ibrutinib adds adequate efficacy to warrant its inclusion the program given its inclination to maximize the threat of an infection, Eichhorst explained that a head-to-head comparison of GV vs GIV is forthcoming and facts may possibly be introduced at subsequent year’s congress.
Solitary-Dose CTX001 for Transfusion-Dependent Βeta-Thalassemia and Extreme SCD
Next, Franco Locatelli, MD, PhD, of the University of Rome, presented conclusions on the protection and efficacy of CTX001 (exa-cel), a mobile therapy that utilizes CRISPR/Cas-9–mediated enhancing of BCL11A to raise hemoglobin concentrations in erythroid cells. Among the 44 patients with transfusion-dependent beta-thalassemia (TDT) and 31 individuals with significant SCD, CTX001 appeared to be successful and well tolerated, meeting its primary close points in both of those examine groups. After a median adhere to-up of 11.9 months, 42 of the 44 people with TDT had been transfusion free, and the remaining 2 professional reductions of 75% and 89% in transfusion volume, respectively. All sufferers with SCD were absolutely free of vaso-occlusive crises following a median follow-up of 10.2 months.
Locatelli mentioned that these findings display “successful and durable” editing of prolonged-time period hematopoietic stem cells, indicating CTX011’s potential to supply a practical overcome to sufferers with these hematological ailments.
Evolutionary Landscape of Clonal Hematopoiesis in More mature Folks
Isabelle van Zeventer, PhD applicant at College Medical Middle Groningen, offered results on a cohort of 3359 local community-dependent more mature members to examine the age-similar emergence of clonal hematopoiesis (CH), which occurs when peripheral blood cells undergo genetic variations that could improve the possibility of hematologic malignancy. She spelled out that people today with current CH at baseline had a larger hazard of obtaining new mutations, and by linking the cohort’s data to the national most cancers registry of the Netherlands, the investigators identified 74 new malignancies (35 myeloid, 39 lymphoid) over a median of 7.7 years of abide by-up.
Various mutational characteristics of CH are related with various amounts of hazard, so clinicians could want to look at checking or intervention for these with a high-chance mutational pattern, van Zeventer explained. Curiously, classic cancer chance things this sort of as smoking and chubby had no outcome on clonal advancement and mutation.
Section 3 Results of Leniolisib in Individuals With Activated PI3K Delta Syndrome
V. Koneti Rao, MD, of the Countrywide Institutes of Wellbeing, shipped his presentation nearly from Bethesda, Maryland, in which he in-depth findings of the investigational drug leniolisib in people with the scarce activated PI3K delta syndrome, which can final result in lymphoproliferation, infections, and gastrointestinal, lung, and liver sickness. In the trial of 31 clients randomized to obtain leniolisib or placebo for 12 weeks, the investigational drug amplified the proportion of naïve B cells and lowered lymphadenopathy (ie, measurement of index lymph nodes), whereas lymph node dimensions tended to improve in the placebo team.
Leniolisib was affiliated with transient neutropenia that then fixed, and was normally perfectly tolerated, with a really serious adverse event amount lower than that of the placebo arm. Rao famous that the study group is now providing enrollment in an open up-label extension demo specified these encouraging results.
Comparing Regimens in Superior-chance Burkitt Lymphoma
Finally, Martine Chamuleau, MD, PhD, of Amsterdam University Healthcare Centre, introduced success from the initial randomized future demo comparing 2 chemotherapy regimens in large-danger Burkitt lymphoma. In arm A, clients acquired either cyclophosphamide, doxorubicin, vincristine, rituximab, and methotrexate (R-CODOX-M) or etoposide, ifosfamide, cytarabine, and rituximab (R-IVAC) in arm 2, they been given rituximab, etoposide, doxorubicin, vincristine, prednisolone, and cyclophosphamide (DA-EPOCH-R). The PFS and OS outcomes have been similar in equally arms, with slight but nonsignificant rewards in favor of R-CODOX-M and R-IVAC (PFS: P = .38 OS: P = .85). Even so, clients acquiring R-CODOX-M or R-IVAC seasoned larger toxicity and extra infectious really serious adverse occasions and much more generally needed transfusions or hospitalization as opposed with patients getting DA-EPOCH-R.
As a result, Chamuleau concluded that presented the equivalent survival results, the DA-EPOCH-R regimen appears to be preferable supplied its lessen possibility of toxicity.
As the session drew to a near, chair Kirsten Grønbæk, MD, College of Copenhagen, introduced the winner of the EHA bowling competition (Frank Leebeek, MD, PhD, of Erasmus University in Rotterdam) and thanked the attendees for “coming to Vienna and producing this this kind of a great conference.”