F. Hoffmann-La Roche Ltd

Roche to present new data from its broad and innovative haematology portfolio at ASH 2025

• Findings further demonstrate the effectiveness of Roche’s approved medicines in advancing treatment standards for people with blood disorders
  
  
• Data from innovative pipeline signals progress toward improved outcomes in haemophilia A, lymphoma, and multiple myeloma 

Basel, 3 November 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today 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.
    

Overview of key presentations featuring Roche medicines

*Based on the STARGLO data, Columvi in combination with GemOx is approved in 49 countries for the treatment of R/R DLBCL including the EU, UK, Australia and Canada. On 2 July 2025, the US Food and Drug Administration issued a Complete Response Letter for the supplemental Biologics License Application for Columvi in combination with GemOx for this indication.

**Venclexta/Venclyxto is being developed by AbbVie and Roche. It is jointly commercialised by AbbVie and Genentech, a member of the Roche Group, in the US, and commercialised by AbbVie outside of the US.
 

About Roche in haematology
Roche has been developing medicines for people with malignant and non-malignant blood diseases for more than 25 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera®/Rituxan® (rituximab), Gazyva®/Gazyvaro® (obinutuzumab), Polivy® (polatuzumab vedotin), Venclexta®/Venclyxto® (venetoclax) in collaboration with AbbVie, Hemlibra® (emicizumab), PiaSky® (crovalimab), Lunsumio® (mosunetuzumab) and Columvi® (glofitamab). Our pipeline of investigational haematology medicines includes T-cell-engaging bispecific antibody cevostamab, targeting both FcRH5 and CD3, and off-the-shelf allogeneic CAR-T therapies. Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further.


About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References
[1] Kruse-Jarres R, et al. Evolution of joint health and physical activity in people with hemophilia A without factor VIII inhibitors switching to emicizumab prophylaxis: A second interim analysis of the BEYOND ABR study. To be presented at: ASH Annual Meeting; 2025 Dec 6-9; Orlando, FL, USA. Abstract #1285.
[2] Callaghan MU, Negrier C, Paz-Priel I, et al. Long-term outcomes with emicizumab prophylaxis for hemophilia A with or without FVIII inhibitors from the HAVEN 1-4 studies. Blood. 2021;137(16):2231​​-2242.
[3] Wang S, et al. A Randomized, Multicenter, Open-label, Phase III Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Prophylactic Emicizumab Versus No Prophylaxis in Persons with Hemophilia A in the Asia-Pacific region (HAVEN 5). Research and practice in thrombosis and haemostasis, 2020, 4(SUPPL 1), 480.
[4] Négrier C, et al. Emicizumab in people with moderate or mild haemophilia A (HAVEN 6): a multicentre, open-label, single-arm, phase 3 study. Lancet Haematol. 2023 Mar;10(3):e168-e177. 
[5] Pipe S.W, et al. Emicizumab Prophylaxis for the Treatment of Infants with Severe Hemophilia A without Factor VIII Inhibitors: Results from the Interim Analysis of the HAVEN 7 Study. Blood 2022; 140 (Supplement 1): 457–459.
[6] Jiménez-Yuste V, et al. Safety and efficacy of long-term emicizumab prophylaxis in hemophilia A with factor VIII inhibitors: A phase 3b, multicenter, single-arm study (STASEY). Res Pract Thromb Haemost. 2022 Nov 14;6(8):e12837. 
[7] Wall C, et al. Efficacy and Safety of Emicizumab Prophylaxis in Severe Haemophilia A without Inhibitors: A Report from the UK Haemophilia Centre Doctors’ Organisation (UKHCDO). Presented at: International Society for Thrombosis and Haemostasis (ISTH) Congress; 2021 July 17 – 21. Abstract #PB0511.
[8] Khairnar R, et al. Improvement in Annualized Bleed Rate in Patients with Hemophilia A Initiating Emicizumab – Physician Reported Outcomes from the Adelphi Hemophilia A Disease Specific Programme™. Presented at: American Society of Hematology (ASH) Annual Meeting and Exposition; 2021 December 11 – 14. Abstract #P1961.
[9] Poon M-C, et al. Real-World Outcomes of Emicizumab in Hemophilia A with or without FVIII Inhibitors from the Canadian Hemophilia Bleeding Disorder Registry. 2022. Blood. 140 (1); 8465 – 8467.
[10] Callaghan MU, et al. Safety and Efficacy of Emicizumab in Persons with Hemophilia A With or Without FVIII Inhibitors: Pooled Data from Four Phase III Studies (HAVEN 1–4). Blood 2020; 136 (Supplement 1): 3–5.
[11] Makris M, et al. Emicizumab and thrombosis: The story so far. J Thromb Haemost. 2019;17:1269-72.
[12] Mancuso ME, et al. NXT007 prophylaxis in people with hemophilia A with or without FVIII inhibitors: a global phase I/II multiple-ascending-dose study. To be presented at: ASH Annual Meeting; 2025 Dec 6-9; Orlando, FL, USA. Abstract #302.
[13] Kiialainen A, et al. Pharmacodynamic biomarkers in people with hemophilia A receiving multiple ascending doses of NXT007. To be presented at: ASH Annual Meeting; 2025 Dec 6-9; Orlando, FL, USA. Abstract #4841.
[14] Nogami K, et al. Ex Vivo Evaluation of the Procoagulant Effect of NXT007 Prophylaxis in People with Hemophilia A without Factor VIII Inhibitors: Phase I/II Study (NXTAGE). To be presented at: ASH Annual Meeting; 2025 Dec 6-9; Orlando, FL, USA. Abstract #3061.
[15] Frey N, et al. Preclinical evaluation of SPK-8011QQ, an adeno-associated virus gene therapy for people with hemophilia A leveraging the dirloctocogene samoparvovec platform encoding an activated protein C-resistant B-domain deleted factor VIII. To be presented at: ASH Annual Meeting; 2025 Dec 6-9; Orlando, FL, USA. Abstract #1068.
[16] Sano D, et al. Promising response rates and manageable safety with mosunetuzumab plus lenalidomide (Mosun-Len) in patients with relapsed/refractory (R/R) follicular lymphoma (FL): US extension cohort from the Phase III CELESTIMO study. To be presented at: ASH Annual Meeting; 2025 Dec 6-9; Orlando, FL, USA. Abstract #1800.
[17] Ghosh N, et al. Long-term follow-up with sustained progression-free survival (PFS) benefit after subcutaneous (SC) mosunetuzumab in combination with polatuzumab vedotin compared with rituximab plus polatuzumab vedotin in patients with relapsed or refractory (R/R) B-cell non-Hodgkin Lymphoma. To be presented at: ASH Annual Meeting; 2025 Dec 6-9; Orlando, FL, USA. Abstract #1020.
[18] Buddle LE, et al. Improvements in health-related quality of life (HRQoL) in the SUNMO study: subcutaneous (SC) mosunetuzumab plus polatuzumab vedotin (Mosun-Pola) versus rituximab, gemcitabine and oxaliplatin (R-GemOx) in patients (pts) with relapsed/refractory (R/R) large B-cell lymphoma (LBCL) after at least one prior therapy. To be presented at: ASH Annual Meeting; 2025 Dec 6-9; Orlando, FL, USA. Abstract #5509.
[19] Abramson JS, et al. Sustained clinical benefit of glofitamab plus gemcitabine and oxaliplatin (GemOx) versus rituximab plus GemOx (R-GemOx) in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL): 3-year follow-up of STARGLO. To be presented at: ASH Annual Meeting; 2025 Dec 6-9; Orlando, FL, USA. Abstract #5519.
[20] Abdulhaq H, et al. Glofitamab plus gemcitabine and oxaliplatin (GemOx) vs rituximab (R)-GemOx in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL): Efficacy and safety in patient subgroups. To be presented at: ASH Annual Meeting; 2025 Dec 6-9; Orlando, FL, USA. Abstract #3743.
[21] Harrison S, et al. Tumor clearance, T-cell fitness and minimal residual disease (MRD) outcomes in patients with relapsed/refractory multiple myeloma (RRMM) treated with cevostamab plus pomalidomide and dexamethasone: Biomarker analyses from CAMMA 1 arm b. To be presented at: ASH Annual Meeting; 2025 Dec 6-9; Orlando, FL, USA. Abstract #252.
[22] Ho J, et al. Subcutaneous cevostamab demonstrates manageable safety and clinically meaningful activity in relapsed/refractory multiple myeloma (RRMM): First results from the phase Ib CAMMA 3 study. To be presented at: ASH Annual Meeting; 2025 Dec 6-9; Orlando, FL, USA. Abstract #700.

 
Roche Global Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Roche Investor Relations

Investor Relations North America

Attachment

• Media Investor Release ASH 2025 curtain raiser English