AstraZeneca Highlights Hematology Portfolio at ASH 2024 with Calquence and Novel Therapies
Key Insights
AstraZeneca will present AMPLIFY Phase III trial results, reinforcing CALQUENCE® as a leading BTK (search) inhibitor in frontline chronic lymphocytic leukemia (search) with a fixed-duration regimen.
New data on next-generation cell therapy AZD0120 and T-cell engager AZD0486 will demonstrate promising early results in multiple types of blood cancer.
Long-term data for VOYDEYA™ as add-on to ULTOMIRIS® or SOLIRIS® will show low rates of breakthrough hemolysis and sustained quality-of-life improvements in PNH patients with extravascular hemolysis.
AstraZeneca is set to showcase new data from its hematology portfolio and pipeline at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition, December 7-10, 2024. The presentations will feature 57 abstracts across 13 approved and potential new medicines, including data from Alexion, AstraZeneca's rare disease group.
CALQUENCE Combinations in CLL and MCL
Interim results from the AMPLIFY Phase III trial will be presented, demonstrating the potential of fixed-duration CALQUENCE (acalabrutinib) in combination with venetoclax, with or without obinutuzumab, for previously untreated adults with chronic lymphocytic leukemia (search) (CLL). The study compares this regimen to standard chemoimmunotherapy. Updated analysis from the ECHO Phase III trial will highlight CALQUENCE in combination with bendamustine and rituximab as a first-line treatment for mantle cell lymphoma (search) (MCL), demonstrating high rates of undetectable minimal residual disease (MRD).
Results from the ChangE Phase III trial, evaluating CALQUENCE compared with chlorambucil plus rituximab in first-line CLL patients in China, will also be shared.
Advancing T-Cell Engagers and CAR T-Cell Therapy
Two oral presentations will share results for the novel CD19xCD3 bispecific T-cell engager AZD0486, highlighting its potential as a new treatment option for B-cell malignancies (search). Phase I results demonstrate a 96% overall response rate and 85% complete response rate in patients with relapsed/refractory follicular lymphoma (search) (R/R FL) at doses of 2.4 mg and above. Interim Phase I results will also show the early potential of AZD0486 in patients with heavily pretreated diffuse large B-cell lymphoma (DLBCL). The data also reinforces the safety profile of AZD0486, with cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) events effectively mitigated by the double step-up dosing schedule.
Early data for AZD0120 (GC012F), a novel BCMAxCD19 dual-targeting autologous CAR T-cell therapy, will show potential as a first-line therapy for elderly patients with newly diagnosed transplant-ineligible multiple myeloma (search) (MM). Preliminary results from an ongoing investigator-initiated trial of AZD0120 suggest deep responses and an acceptable safety profile, with no ICANS and no ≥Grade 2 CRS events observed in this patient population.
Preclinical data will be presented on AZD5492, a next-generation CD8 selective, CD20 (search)-targeting T-cell engager, designed using AstraZeneca’s innovative Target Induced T-cell Activating Nanobody (TITAN) platform. AZD5492 is currently being evaluated in Phase I clinical trials in R/R Non-Hodgkin lymphoma (search) (NHL) and CLL.
VOYDEYA in Paroxysmal Nocturnal Hemoglobinuria (PNH)
Data will be presented detailing breakthrough hemolysis (BTH) events from the ALPHA trial, evaluating VOYDEYA (danicopan) as an add-on to ULTOMIRIS (ravulizumab-cwvz) or SOLIRIS (eculizumab) in PNH patients experiencing clinically significant extravascular hemolysis (EVH). The data shows that 5/84 patients (6.0%) in the ALPHA trial experienced one or more BTH events. Most BTH events (6/7 or 85.7%) in the ALPHA trial were either mild or moderate, and all events were resolved without transfusion, dose modification, or treatment withdrawal.
Long-term patient-reported outcomes from the ALPHA trial will demonstrate that VOYDEYA as an add-on to ULTOMIRIS or SOLIRIS resulted in sustained improvements in fatigue, quality of life, and physical function for up to 72 weeks in PNH patients with clinically significant EVH.
Advancing Understanding of Rare Diseases
A U.S. retrospective chart review will provide real-world evidence showing hematologic and renal improvements in adults with atypical hemolytic uremic syndrome (search) (aHUS) who switched to ULTOMIRIS after short-term use of SOLIRIS, with early responses and continued improvements through one year of treatment with ULTOMIRIS.