Unmet Need in Relapsed Refractory DLBCL Video
Leukaemia & Lymphoma
Haematology is a complex and challenging area of medicine that encompasses different diseases ranging from cancers of the blood to bleeding disorders such as haemophilia. Though diverse in nature, what is often common across many of these diseases is the serious impact they can have on either a patient’s survival or quality of life. Blood cancers represent the fifth most common cause of cancer-related death worldwide, with the three most common types being lymphoma, leukaemia and myeloma.
Learn more about the latest advances in Roche haematology research.
Improved treatments are needed for R/R NHL. Schuster and colleagues report updated clinical data from Group B (Cycle 1 step-up dosing) of the Phase I/Ib GO29781 study of mosunetuzumab in R/R indolent and aggressive NHL patients.
The aim of this study was to explore the effect of HEMLIBRA (emicizumab) prophylaxis on bone and joint health in adult/adolescent persons with hemophilia A without FVIII inhibitors
This analysis assessed whether fixed-duration venetoclax plus rituximab improves patient survival versus standard bendamustine-rituximab in the Phase III MURANO study (NCT02005471), when all patients had been off venetoclax treatment for median 22 months
A modified one-stage FVIII assay for the quantification of emicizumab plasma concentration was developed using an on-board 1:8 plasma sample pre-dilution followed by the standard one-stage FVIII test. This study evaluates the performance of a dedicated calibrator and controls (r2 Diagnostics) for emicizumab quantification in plasma samples carried out on the BCS® XP analyzer (Siemens).
Emicizumab has demonstrated efficacy in bleed prevention when administered subcutaneously 1.5 mg/kg once weekly, 3 mg/kg every two weeks (Q2W), and 6 mg/kg every four weeks (Q4W) in persons with haemophilia A (PwHA) with or without FVIII inhibitors. These dosing regimens were selected based on an exposure-repeated time-to-event model developed from bleed data collected in a phase I/II study in a small group of PwHA receiving weekly emicizumab doses of either 0.3, 1 or 3 mg/kg. This analysis presents the updated exposure–response relationship for bleeding events using a much larger database including data from PwHA from phase I/II and phase III studies.
The safety and efficacy of emicizumab has been demonstrated in persons with haemophilia A (PwHA) with or without FVIII inhibitors across all age groups in the HAVEN 1–4 studies. This presentation details the long-term efficacy and safety of emicizumab across the HAVEN 1–4 studies.
This is an ongoing multicenter phase I dose escalation trial investigating the safety, tolerability, pharmacokinetics (PK), biomarkers and antitumor activity of CD20-TCB in patients with heavily pre-treated NHL. Safety and efficacy data are presented
POLARIX (NCT03274492) will evaluate the efficacy, safety, pharmacokinetics, and patient-reported outcomes of 1.8mg/kg pola + chemoimmunotherapy (R-CHP) compared with SOC chemoimmunotherapy (R-CHOP) in previously untreated patients with intermediate- to high-risk CD20-positive DLBCL. This Trial in Progress presentation covers the study design, key inclusion/exclusion criteria, study endpoints and treatment schedule.
The phase 3 MabCute trial (NCT01461928) evaluated the efficacy and safety of prolonged R-SC maintenance after standard R-SC-based induction and maintenance in relapsed or refractory patients with indolent non-Hodgkin lymphoma. Primary analysis results are presented.
MIRROS is a randomized Phase III trial investigating the effects of idasanutlin (MDM2 antagonist) in combination with cytarabine versus placebo in combination with cytarabine in patients with relapsed or refractory AML. This Trial in Progress poster presents the MIRROS study design, including eligibility criteria, study endpoints, the futility interim analysis and enrollment status.
POLARIX (NCT03274492) will evaluate the efficacy, safety, pharmacokinetics, and patient-reported outcomes of 1.8mg/kg pola + chemoimmunotherapy (R-CHP) compared with SOC chemoimmunotherapy (R-CHOP) in previously untreated patients with intermediate- to high-risk CD20-positive DLBCL. This Trial in Progress poster presents the study design, key inclusion/exclusion criteria, study endpoints and treatment schedule.
The presentation reports the safety and efficacy results from the interim analysis of a phase I/II study of polatuzumab vedotin + obinutuzumab + lenalidomide in patients with relapsed/refractory follicular lymphoma. Interim safety and efficacy data are presented.
In the phase III GALLIUM trial (NCT01332968), we evaluated the performance and treatment-dependence of two high-risk follicular lymphoma models in patients with follicular lymphoma who were treated with obinutuzumab- or rituximab-based immunochemotherapy, plus maintenance. Data presented highlight the challenges of building high-risk signatures for patients independent of treatment.
This exploratory analysis investigated the primary refractory population from the phase 3 GOYA trial (NCT01287741), with the aim to describe the lymphoma characteristics for this population and identify risk factors for primary chemorefractoriness.
The presentation reports a post-hoc analysis, obtained after follow-up from the randomised phase 3 MURANO study, of patients with R/R CLL who received ibrutinib following fixed-duration venetoclax. Data on eight patients are presented.