Roche announced it will showcase 46 abstracts, including 12 oral presentations, from its hematology portfolio at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition, held December 6-9, 2025 in Orlando, Florida. The presentations span multiple blood disorders including hemophilia A, lymphoma, and multiple myeloma, reflecting the company's broad therapeutic approach across hematologic conditions.
"The data we will present at this year's ASH meeting underscore our commitment to driving innovation across haematology and reflect meaningful progress towards improved treatment of multiple blood disorders," said Levi Garraway, MD, PhD, Roche's Chief Medical Officer and Head of Global Product Development.
Hemophilia A Pipeline Advances
NXT007 Shows Promise in Phase I/II Studies
Positive phase I/II results for NXT007, Roche's next-generation investigational bispecific antibody, suggest the potential to normalize hemostasis in people with hemophilia A with and without factor VIII inhibitors. The global study data support the progression of NXT007 into phase III clinical development planned for 2026, including a head-to-head study against Hemlibra.
Gene Therapy Platform Enhancement
Pre-clinical data on SPK-8011QQ, Roche's next-generation investigational AAV gene therapy, show significantly enhanced hemostatic potency compared with SPK-8011 (dirloctocogene samoparvovec) in ex vivo and in vivo mouse models. These findings support the ongoing evaluation of SPK-8011QQ, with phase IIb study initiation planned for 2026.
Hemlibra Real-World Evidence
New post-marketing data from the Beyond ABR study demonstrate that people with various levels of baseline joint impairment had low bleeding rates in the first year after switching to Hemlibra prophylaxis from factor VIII prophylaxis. The data showed overall improvements in joint health and a shift towards higher activity levels, adding to the clinical and real-world evidence supporting Hemlibra's role in redefining standards of care for people living with hemophilia A.
Lymphoma Treatment Developments
Lunsumio Combination Strategies
Preliminary data from the US extension arm of the phase III CELESTIMO study investigating Lunsumio plus lenalidomide in people with second-line or later relapsed or refractory follicular lymphoma support its potential as an effective and well-tolerated outpatient treatment option.
Long-term follow-up data from the phase Ib/II GO40516 study demonstrate sustained improvements in objective response rate and progression-free survival with Lunsumio plus Polivy in people with second-line or later large B-cell lymphoma. Patient-reported outcomes from the phase III SUNMO study show treatment with Lunsumio plus Polivy was associated with delayed deterioration in physical function and improvements in fatigue, pain, and emotional function in people with transplant-ineligible relapsed or refractory large B-cell lymphoma.
Columvi Long-Term Efficacy
Three-year follow-up and subgroup analyses from the phase III STARGLO study show continued superior survival outcomes with Columvi in combination with gemcitabine and oxaliplatin for people with relapsed or refractory diffuse large B-cell lymphoma compared with rituximab and gemcitabine/oxaliplatin. The benefits were observed in people with second-line DLBCL and primary refractory disease or early relapse.
Multiple Myeloma Pipeline Progress
Cevostamab Advances to Phase III
Clinical and exploratory biomarker analysis from the phase Ib CAMMA-1 study shows investigational cevostamab in combination with pomalidomide and dexamethasone induces high objective response rates, very good partial response or better rates, and durable remissions in relapsed or refractory multiple myeloma.
First data from the phase Ib CAMMA-3 study highlight that subcutaneous cevostamab monotherapy delivers deep and durable responses in people with late-line relapsed or refractory multiple myeloma. These data support the progression of cevostamab in combination with pomalidomide and dexamethasone into phase III clinical development for people with second-line or later relapsed or refractory multiple myeloma, with study initiation planned for 2026.
Comprehensive Hematology Portfolio
Roche's hematology portfolio includes approved medicines such as rituximab, obinutuzumab, polatuzumab vedotin, venetoclax (in collaboration with AbbVie), emicizumab, crovalimab, mosunetuzumab, and glofitamab. The pipeline includes T-cell-engaging bispecific antibody cevostamab, targeting both FcRH5 and CD3, and off-the-shelf allogeneic CAR-T therapies.
The company has been developing medicines for people with malignant and non-malignant blood diseases for more than 25 years. The ASH presentations represent continued investment in bringing innovative treatment options to patients across a wide range of hematologic diseases, with the scientific expertise and breadth of portfolio providing opportunities to develop combination regimens aimed at improving patient outcomes.
