Roche to showcase new data across its haematology portfolio highlighting progress in haemophilia, lymphoma and myeloma at ASH 2025

Roche announced that it will showcase 46 abstracts, including 12 oral presentations, from its industry-leading haematology portfolio at the 67^th American Society of Hematology (ASH) Annual Meeting and Exposition, held 6-9 December 2025 in Orlando, Florida, US.

“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.

Key presentations include:

Haemophilia A

• Hemlibra® (emicizumab): New post-marketing data from the Beyond ABR study show that, in the first year after switching to Hemlibra prophylaxis from factor VIII prophylaxis, people with various levels of baseline joint impairment had low bleeding rates, associated with overall improvements in joint health, and a shift towards higher activity levels.¹ These findings add to the wealth of clinical and real-world evidence in support of Hemlibra as it continues to redefine standards of care for people living with haemophilia A.^2-11
• NXT007: Positive phase I/II results, including new data from a global study in people with haemophilia A with and without factor VIII inhibitors, suggest the potential of Roche’s next-generation investigational bispecific antibody to normalise haemostasis.^12-14 These data support the progression of NXT007 into phase III clinical development planned for 2026, including a head-to-head study against Hemlibra.
• SPK-8011QQ: Pre-clinical data on Roche’s next-generation investigational AAV gene therapy, show significantly enhanced haemostatic potency compared with SPK-8011 (dirloctocogene samoparvovec) in ex vivo and in vivo mouse models.¹⁵ Findings support the ongoing evaluation of SPK-8011QQ, furthering previous learnings on the safety and durability of SPK-8011, with phase IIb study initiation planned for 2026.

Lymphoma

• Lunsumio® (mosunetuzumab): Preliminary data from the US extension arm of the phase III CELESTIMO study investigating Lunsumio plus lenalidomide, in people with second-line or later (2L+) relapsed or refractory (R/R) follicular lymphoma (FL), support its potential as an effective and well-tolerated outpatient treatment option.¹⁶
• Lunsumio plus Polivy® (polatuzumab vedotin): Long-term follow-up data from the phase Ib/II GO40516 study demonstrate sustained improvements in objective response rate (ORR) and progression-free survival with this combination in people with 2L+ large B-cell lymphoma (LBCL).¹⁷ Additionally, 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 R/R LBCL.¹⁸
• Columvi® (glofitamab): 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 (GemOx) for people with R/R diffuse large B-cell lymphoma (DLBCL) compared with MabThera®/Rituxan® (rituximab) and GemOx, including people with second-line DLBCL and primary refractory disease or early relapse.*^19-20

Multiple myeloma

• Cevostamab: Clinical and exploratory biomarker analysis from the phase Ib CAMMA-1 study shows investigational cevostamab in combination with pomalidomide and dexamethasone induces high ORR, very good partial response (VGPR) or better rates, and durable remissions, in R/R multiple myeloma.²¹
• First data from the phase Ib CAMMA-3 study highlight that subcutaneous cevostamab monotherapy delivers deep and durable responses in people with late-line R/R multiple myeloma.²²
• These data support the progression of cevostamab in combination with pomalidomide and dexamethasone into phase III clinical development for people with 2L+ R/R multiple myeloma, with study initiation planned for 2026.

View an overview of key presentations featuring Roche medicines HERE.