{"id":9824,"date":"2026-02-17T02:13:38","date_gmt":"2026-02-17T02:13:38","guid":{"rendered":"https:\/\/www.europesays.com\/ch\/9824\/"},"modified":"2026-02-17T02:13:38","modified_gmt":"2026-02-17T02:13:38","slug":"roche-to-present-46-abstracts-12-orals-at-ash-meeting","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/ch\/9824\/","title":{"rendered":"Roche to Present 46 Abstracts, 12 Orals at ASH Meeting"},"content":{"rendered":"<p>&#13;<br \/>\n    &#13;<br \/>\n&#13;<br \/>\n    &#13;<br \/>\n&#13;<\/p>\n<p>Roche (OTCQX: RHHBY) will present 46 abstracts, including 12 oral presentations, at ASH 2025 (6-9 Dec 2025) covering haemophilia A, lymphoma and multiple myeloma.<\/p>\n<p>Key items: Hemlibra post\u2011marketing BEYOND ABR data report low bleeding rates and improved joint health after switching from factor VIII; NXT007 positive phase I\/II results support planned Phase III in 2026; SPK-8011QQ shows enhanced preclinical potency with Phase IIb planned for 2026; lymphoma and myeloma programs (Lunsumio, Columvi, cevostamab, mosunetuzumab, polatuzumab) report longer\u2011term follow\u2011up, QoL and subgroup analyses. Regulatory note: Columvi+GemOx is approved in 49 countries, and the US supplemental BLA received a Complete Response Letter on 2 July 2025.<\/p>\n<p>&#13;<br \/>\n            Loading&#8230;&#13;\n          <\/p>\n<p>          Loading translation&#8230;<\/p>\n<p>          Positive<br \/>\n          &#13;<br \/>\n            &#13;<br \/>\n                    Columvi plus GemOx approved in 49 countries for R\/R DLBCL&#13;<br \/>\n            &#13;<br \/>\n                    Hemlibra BEYOND ABR shows low bleeding rates and improved joint health after switching&#13;<br \/>\n            &#13;<br \/>\n                    NXT007 phase I\/II positive results support planned Phase III in 2026&#13;<br \/>\n            &#13;<\/p>\n<p>          Negative<br \/>\n          &#13;<br \/>\n            &#13;<br \/>\n                    US supplemental BLA for Columvi+GemOx received a Complete Response Letter on 2 July 2025&#13;<br \/>\n            &#13;<br \/>\n                    Key programs (SPK-8011QQ, NXT007, cevostamab) remain in clinical development with Phase II\/III starts planned in 2026, exposing timelines to trial risk&#13;<br \/>\n            &#13;<\/p>\n<p class=\"argus-explanation-text\">&#13;<br \/>\n      &#13;<br \/>\n      &#13;<br \/>\n      On the day this news was published, RHHBY declined 0.62%, reflecting a mild negative market reaction.&#13;<br \/>\n      &#13;<br \/>\n      &#13;<br \/>\n      &#13;<br \/>\n      &#13;<br \/>\n      &#13;<br \/>\n      &#13;<br \/>\n      &#13;\n    <\/p>\n<p class=\"argus-source\">&#13;<br \/>\n      Data tracked by <a href=\"https:\/\/www.stocktitan.net\/scanner\/momentum\" class=\"argus-link\" rel=\"nofollow noopener\" target=\"_blank\">StockTitan Argus<\/a> on the day of publication.&#13;\n    <\/p>\n<p>&#13;<br \/>\n&#13;<br \/>\n&#13;<br \/>\n&#13;<br \/>\n&#13;<br \/>\n  &#13;<br \/>\n&#13;<br \/>\n&#13;<br \/>\n    &#13;<br \/>\n    &#13;<br \/>\n    &#13;<br \/>\n&#13;<br \/>\n    &#13;<br \/>\n      11\/03\/2025 &#8211; 09:00 AM&#13;<br \/>\n    &#13;<br \/>\n&#13;<br \/>\n    Findings further demonstrate the effectiveness of Roche\u2019s approved medicines in advancing treatment standards for people with blood disordersData from innovative pipeline signals progress toward improved outcomes in haemophilia A, lymphoma, and multiple myeloma\u00a0  <\/p>\n<p>Basel, 3 November 2025 &#8211; Roche (SIX: RO, ROG; OTCQX: <a href=\"https:\/\/www.stocktitan.net\/overview\/RHHBY\/\" title=\"View RHHBY stock overview\" class=\"symbol-link\" rel=\"nofollow noopener\" target=\"_blank\">RHHBY<\/a>) announced today that it will showcase 46 abstracts, including 12 oral presentations, from its industry-leading haematology portfolio at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition, held 6-9 December 2025 in Orlando, Florida, US.<\/p>\n<p>\u201cThe data we will present at this year\u2019s ASH meeting underscore our commitment to driving innovation across haematology and reflect meaningful progress towards improved treatment of multiple blood disorders,\u201d said Levi Garraway, MD, PhD, Roche\u2019s Chief Medical Officer and Head of Global Product Development.<\/p>\n<p>Key presentations include:<\/p>\n<p>Haemophilia A\u00a0<\/p>\n<p>  Hemlibra\u00ae (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\u2019s next-generation investigational bispecific antibody to normalise haemostasis.12-14\u00a0These 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\u2019s 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.\u00a0  <\/p>\n<p>Lymphoma\u00a0<\/p>\n<p>  Lunsumio\u00ae (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.16Lunsumio plus Polivy\u00ae (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.18Columvi\u00ae (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\u00ae\/Rituxan\u00ae (rituximab) and GemOx, including people with second-line DLBCL and primary refractory disease or early relapse.*19-20\u00a0  <\/p>\n<p>Multiple myeloma<\/p>\n<p>  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.21First 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.22These 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. <br \/>\u00a0\u00a0  <\/p>\n<p>Overview of key presentations featuring Roche medicines<\/p>\n<p>   Medicine    Abstract   title    Abstract   number\/presentation details    cevostamab    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    #252 oral presentation<\/p>\n<p>\u00a0<\/p>\n<p>Session: 654. Multiple   Myeloma: Pharmacologic Therapies: Advances in Treatment Strategies for   Relapsed\/Refractory Multiple Myeloma<\/p>\n<p>\u00a0<\/p>\n<p>Saturday 6 December 2025<\/p>\n<p>\u00a0<\/p>\n<p>3:15pm EST  <\/p>\n<p>  Subcutaneous cevostamab   demonstrates manageable safety and clinically meaningful activity in   relapsed\/refractory multiple myeloma (RRMM): First results from the phase Ib   CAMMA 3 study    #700 oral presentation<\/p>\n<p>\u00a0<\/p>\n<p>Session: 654. Multiple   Myeloma: Pharmacologic Therapies: Bi, Tri and Beyond: Innovations in   Bispecific and Trispecific Antibodies for Multiple Myeloma<\/p>\n<p>\u00a0<\/p>\n<p>Sunday 7 December 2025<\/p>\n<p>\u00a0<\/p>\n<p>5:15pm EST  <\/p>\n<p>  Columvi\u00ae (glofitamab)    CRS-RS.5p predictive model   informs risk stratification and cytokine release syndrome management   following glofitamab treatment in patients with relapsed or refractory   diffuse large B-cell lymphoma    #2559 poster presentation<\/p>\n<p>\u00a0<\/p>\n<p>Session: 803. Emerging Tools,   Techniques, and Artificial Intelligence in Hematology: Poster I<\/p>\n<p>\u00a0<\/p>\n<p>Saturday 6 December 2025<\/p>\n<p>\u00a0<\/p>\n<p>5:30pm-7:30pm EST  <\/p>\n<p>  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    #3743 poster presentation<\/p>\n<p>\u00a0<\/p>\n<p>Session: 629. Aggressive   Lymphomas, Immunotherapy including Bispecific Antibodies: Poster II<\/p>\n<p>\u00a0<\/p>\n<p>Sunday 7 December 2025<\/p>\n<p>\u00a0<\/p>\n<p>6pm-8pm EST  <\/p>\n<p>  Glofitamab in combination   with polatuzumab vedotin demonstrates high and durable efficacy in patients   with relapsed\/refractory (R\/R) large B-cell lymphoma (LBCL) in the   second-line (2L) and third-line and later (3L+) setting: A subgroup analysis    #5510 poster presentation<\/p>\n<p>\u00a0<\/p>\n<p>Session: 629. Aggressive   Lymphomas, Immunotherapy including Bispecific Antibodies: Poster III<\/p>\n<p>\u00a0<\/p>\n<p>Monday 8 December 2025<\/p>\n<p>\u00a0<\/p>\n<p>6pm-8pm EST  <\/p>\n<p>  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    #5519 poster presentation<\/p>\n<p>\u00a0<\/p>\n<p>Session: 629. Aggressive   Lymphomas, Immunotherapy including Bispecific Antibodies: Poster III<\/p>\n<p>\u00a0<\/p>\n<p>Monday 8 December 2025<\/p>\n<p>\u00a0<\/p>\n<p>6pm-8pm EST  <\/p>\n<p>  Hemlibra\u00ae (emicizumab)    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\u00a0    #1285 poster presentation<\/p>\n<p>\u00a0<\/p>\n<p>Session: 322. Hemophilia A   and B: Clinical and Epidemiological: Poster III<\/p>\n<p>\u00a0<\/p>\n<p>Saturday 6 December 2025<\/p>\n<p>\u00a0<\/p>\n<p>5:30pm-7:30pm EST  <\/p>\n<p>  Lunsumio\u00ae (mosunetuzumab)    Fixed treatment duration   subcutaneous mosunetuzumab monotherapy in elderly\/unfit patients with   previously untreated diffuse large B-cell lymphoma: Interim results from the   Phase II MorningSun study    #62 oral presentation<\/p>\n<p>\u00a0<\/p>\n<p>Session: 629. Aggressive   Lymphomas, Immunotherapy including Bispecific Antibodies: Overcoming Barriers   in Frontline Therapy: Bispecific Antibodies for Older Adults with DLBCL<\/p>\n<p>\u00a0<\/p>\n<p>Saturday 6 December 2025<\/p>\n<p>\u00a0<\/p>\n<p>9:45am EST  <\/p>\n<p>  Fixed-duration subcutaneous   (SC) mosunetuzumab, with maintenance therapy, in patients (pts) with   previously untreated high-tumor burden follicular lymphoma (HTB FL): Longer   follow-up and exploratory circulating tumor (ct)DNA analysis of the Phase II   MorningSun study    #228 oral presentation<\/p>\n<p>\u00a0<\/p>\n<p>Session: 623. Mantle Cell,   Follicular, Waldenstrom&#8217;s, and Other Indolent B Cell Lymphomas: Clinical and   Epidemiological: FL and WM<\/p>\n<p>\u00a0<\/p>\n<p>Saturday 6 December 2025<\/p>\n<p>\u00a0<\/p>\n<p>3:15pm EST  <\/p>\n<p>  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    #1020 oral presentation<\/p>\n<p>\u00a0<\/p>\n<p>Session: 629. Aggressive   Lymphomas, Immunotherapy including Bispecific Antibodies: Improving Outcomes   in Rare Large Cell Lymphomas<\/p>\n<p>\u00a0<\/p>\n<p>Monday 8 December 2025<\/p>\n<p>\u00a0<\/p>\n<p>5:45pm EST  <\/p>\n<p>  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     #1800 poster presentation<\/p>\n<p>\u00a0<\/p>\n<p>Session: 623. Mantle Cell,   Follicular, Waldenstrom&#8217;s, and Other Indolent B Cell Lymphomas: Clinical and   Epidemiological: Poster I<\/p>\n<p>\u00a0<\/p>\n<p>Saturday 6 December 2025<\/p>\n<p>\u00a0<\/p>\n<p>5:30pm-7:30pm EST  <\/p>\n<p>  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    #5509 poster presentation<\/p>\n<p>\u00a0<\/p>\n<p>Session: 629. Aggressive   Lymphomas, Immunotherapy including Bispecific Antibodies: Poster III<\/p>\n<p>\u00a0<\/p>\n<p>Monday 8 December 2025<\/p>\n<p>\u00a0<\/p>\n<p>6pm-8pm EST  <\/p>\n<p>  Fixed treatment duration   mosunetuzumab continues to demonstrate clinically meaningful outcomes in   patients with relapsed\/refractory (R\/R) follicular lymphoma (FL) after \u22652   prior therapies: 5-year follow-up of a pivotal Phase II study    #5352 poster presentation<\/p>\n<p>\u00a0<\/p>\n<p>Session: 623. Mantle Cell,   Follicular, Waldenstrom&#8217;s, and Other Indolent B Cell Lymphomas: Clinical and   Epidemiological: Poster III<\/p>\n<p>\u00a0<\/p>\n<p>Monday 8 December 2025<\/p>\n<p>\u00a0<\/p>\n<p>6pm-8pm EST  <\/p>\n<p>  Fixed-duration subcutaneous   mosunetuzumab continues to demonstrate high rates of durable responses in   patients with relapsed\/refractory follicular lymphoma after \u22652 prior   therapies: 3-year follow-up from a pivotal Phase II study    #5353 poster presentation<\/p>\n<p>\u00a0<\/p>\n<p>Session: 623. Mantle Cell,   Follicular, Waldenstrom&#8217;s, and Other Indolent B Cell Lymphomas: Clinical and   Epidemiological: Poster III<\/p>\n<p>\u00a0<\/p>\n<p>Monday 8 December 2025<\/p>\n<p>\u00a0<\/p>\n<p>6pm-8pm EST  <\/p>\n<p>  Lunsumio \/\u00a0 Columvi    Patients with   relapsed\/refractory (R\/R) diffuse large B-cell lymphoma (DLBCL) preferred   fixed-duration treatments with less frequent administrations in the era of   novel bispecific antibodies (BsAbs)    #6179 poster presentation<\/p>\n<p>\u00a0<\/p>\n<p>Session: 902. Health Services   and Quality Improvement: Lymphoid Malignancies: Poster III<\/p>\n<p>\u00a0<\/p>\n<p>Monday 8 December 2025<\/p>\n<p>\u00a0<\/p>\n<p>6pm-8pm EST  <\/p>\n<p>  Diverse preferences for   treatment options in relapsed\/refractory (R\/R) follicular lymphoma (FL):   Survey results from patients in the United States (US)    #6180 poster presentation <\/p>\n<p>\u00a0<\/p>\n<p>Session: 902. Health Services   and Quality Improvement: Lymphoid Malignancies: Poster III<\/p>\n<p>\u00a0<\/p>\n<p>Monday 8 December 2025<\/p>\n<p>\u00a0<\/p>\n<p>6pm-8pm EST  <\/p>\n<p>  Differences in   patient-reported time toxicity between bispecific antibody (BsAb) options:   Impact of treatment duration and dosing frequency on patient-reported time   burden in relapsed\/refractory (R\/R) follicular lymphoma (FL) and diffuse   large B-cell lymphoma (DLBCL)    #6181 poster presentation<\/p>\n<p>\u00a0<\/p>\n<p>Session: 902. Health Services   and Quality Improvement: Lymphoid Malignancies: Poster III<\/p>\n<p>\u00a0<\/p>\n<p>Monday 8 December 2025<\/p>\n<p>\u00a0<\/p>\n<p>6pm-8pm EST  <\/p>\n<p>  NXT007    NXT007 prophylaxis in people   with hemophilia A with or without FVIII inhibitors: a global phase I\/II   multiple-ascending-dose study    #302 oral   presentation<\/p>\n<p>\u00a0<\/p>\n<p>Session: 322.   Hemophilia A and B: Clinical and Epidemiological: Prophylaxis Across the Age   Spectrum<\/p>\n<p>\u00a0<\/p>\n<p>Saturday 6   December 2025<\/p>\n<p>\u00a0<\/p>\n<p>4:15pm EST  <\/p>\n<p>  Ex Vivo Evaluation of the   Procoagulant Effect of NXT007 Prophylaxis in People with Hemophilia A without   Factor VIII Inhibitors: Phase I\/II Study (NXTAGE)    #3061 poster   presentation<\/p>\n<p>\u00a0<\/p>\n<p>Session: 322.   Hemophilia A and B: Clinical and Epidemiological: Poster II<\/p>\n<p>\u00a0<\/p>\n<p>Sunday 7 December   2025<\/p>\n<p>\u00a0<\/p>\n<p>6pm-8pm EST  <\/p>\n<p>  Pharmacodynamic biomarkers in   people with hemophilia A receiving multiple ascending doses of NXT007    #4841 poster   presentation<\/p>\n<p>\u00a0<\/p>\n<p>Session: 322.   Hemophilia A and B: Clinical and Epidemiological: Poster III<\/p>\n<p>\u00a0<\/p>\n<p>Monday 8 December   2025<\/p>\n<p>\u00a0<\/p>\n<p>6pm-8pm EST  <\/p>\n<p>  Polivy\u00ae (polatuzumab vedotin)    Transcriptional profiling   refines DLBCL classification and identifies subtypes with distinct   therapeutic vulnerabilities    #49 oral presentation<\/p>\n<p>\u00a0<\/p>\n<p>Session: 621. Lymphomas:   Translational \u2013 Molecular and Genetic &#8211; Subtyping strategies to unlock new   therapeutic vulnerabilities<\/p>\n<p>\u00a0<\/p>\n<p>Saturday 6 December 2025<\/p>\n<p>\u00a0<\/p>\n<p>9:30am EST  <\/p>\n<p>  Assessment of the prognostic   value of FDG PET-derived markers and responses in POLARIX    #5329 poster presentation<\/p>\n<p>\u00a0<\/p>\n<p>Session: 622. Lymphomas:   Translational \u2013 Non-Genetic: Poster III<\/p>\n<p>\u00a0<\/p>\n<p>Monday 8 December 2025<\/p>\n<p>\u00a0<\/p>\n<p>6pm-8pm EST  <\/p>\n<p>  SPK-8011QQ    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    #1068 oral   presentation<\/p>\n<p>\u00a0<\/p>\n<p>Session: 801.   Gene Therapies: Technological Developments in Gene Therapy<\/p>\n<p>\u00a0<\/p>\n<p>Monday 8 December   2025<\/p>\n<p>\u00a0<\/p>\n<p>5:45pm EST  <\/p>\n<p>  Venclexta\u00ae\/<br \/>Venclyxto\u00ae (venetoclax)**    Long-term immune   reconstitution and final 1-year follow-up after fixed-duration   venetoclax-obinutuzumab (VenO) in first-line (1L) chronic lymphocytic   leukemia (CLL): results from the Phase III CRISTALLO trial    #682 oral   presentation<\/p>\n<p>\u00a0<\/p>\n<p>Session: 642.   Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Frontline   Treatment Strategies for CLL<\/p>\n<p>\u00a0<\/p>\n<p>Sunday 7 December   2025<\/p>\n<p>\u00a0<\/p>\n<p>5:15pm EST  <\/p>\n<p>  Results from PARADIGM &#8211; a   phase 2 randomized study comparing venetoclax and azacitidine to conventional   induction chemotherapy for newly diagnosed fit adults with acute myeloid   leukemia    Plenary session<\/p>\n<p>\u00a0<\/p>\n<p>Sunday 7 December 2025<\/p>\n<p>\u00a0<\/p>\n<p>2pm-4pm EST  <\/p>\n<p>  Fixed-duration versus   continuous targeted treatment for previously untreated chronic lymphocytic   leukemia: Results from the randomized CLL17 trial    Plenary session<\/p>\n<p>\u00a0<\/p>\n<p>Sunday 7 December 2025<\/p>\n<p>\u00a0<\/p>\n<p>2pm-4pm EST  <\/p>\n<p>*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.<\/p>\n<p>**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.<br \/>\u00a0<\/p>\n<p>About Roche in haematology<br \/>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\u00ae\/Rituxan\u00ae (rituximab), Gazyva\u00ae\/Gazyvaro\u00ae (obinutuzumab), Polivy\u00ae (polatuzumab vedotin), Venclexta\u00ae\/Venclyxto\u00ae (venetoclax) in collaboration with AbbVie, Hemlibra\u00ae (emicizumab), PiaSky\u00ae (crovalimab), Lunsumio\u00ae (mosunetuzumab) and Columvi\u00ae (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.<\/p>\n<p>About Roche <br \/>Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world\u2019s 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.<\/p>\n<p>For over 125 years, sustainability has been an integral part of Roche\u2019s 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. <\/p>\n<p>Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. <\/p>\n<p>For more information, please visit <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=kxhPjFJqTHtJR-vsRkRyyd07nbwXFYc4dFFEVYfjvIg0ZHKptZKmoASiv-wbnt5QUAs0Yvt1kS0F5oI8yBwnxg==\" rel=\"nofollow noopener\" target=\"_blank\">www.roche.com<\/a>.<\/p>\n<p>All trademarks used or mentioned in this release are protected by law. <\/p>\n<p>References<br \/>[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.<br \/>[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\u200b\u200b-2242. <br \/>[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.<br \/>[4] N\u00e9grier 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.\u00a0<br \/>[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\u2013459.<br \/>[6] Jim\u00e9nez-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.\u00a0<br \/>[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\u2019 Organisation (UKHCDO). Presented at: International Society for Thrombosis and Haemostasis (ISTH) Congress; 2021 July 17 \u2013 21. Abstract #PB0511.<br \/>[8] Khairnar R, et al. Improvement in Annualized Bleed Rate in Patients with Hemophilia A Initiating Emicizumab \u2013 Physician Reported Outcomes from the Adelphi Hemophilia A Disease Specific Programme\u2122. Presented at: American Society of Hematology (ASH) Annual Meeting and Exposition; 2021 December 11 \u2013 14. Abstract #P1961.<br \/>[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 \u2013 8467. <br \/>[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\u20134). Blood 2020; 136 (Supplement 1): 3\u20135.<br \/>[11] Makris M, et al. Emicizumab and thrombosis: The story so far. J Thromb Haemost. 2019;17:1269-72.<br \/>[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.<br \/>[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.<br \/>[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.<br \/>[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.<br \/>[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.<br \/>[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.<br \/>[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.<br \/>[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.<br \/>[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.<br \/>[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.<br \/>[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. <\/p>\n<p>\u00a0<br \/>Roche Global Media Relations<br \/>Phone: +41 61 688 8888 \/ e-mail: media.relations@roche.com<\/p>\n<p>   Hans Trees, PhD<br \/>Phone:   +41 79 407 72 58    Sileia Urech<br \/>Phone:   +41 79 935 81 48\u00a0    Nathalie Altermatt<br \/>Phone:   +41 79 771 05 25    Lorena Corfas<br \/>Phone:   +34 620 29 25 51\u00a0    Simon Goldsborough<br \/>Phone:   +44 797 32 72 915    Karsten Kleine<br \/>Phone:   +41 79 461 86 83\u00a0    Kirti Pandey<br \/>Phone:   +49 172 6367262\u00a0    Yvette Petillon<br \/>Phone:   +41 79 961 92 50    Dr Rebekka Schnell<br \/>Phone:   +41 79 205 27 03    \u00a0   <\/p>\n<p>Roche Investor Relations<\/p>\n<p>   Dr Bruno Eschli<br \/>Phone:   +41 61 68-75284<br \/>e-mail:   bruno.eschli@roche.com    Dr Sabine   Borngr\u00e4ber<br \/>Phone: +41 61 68-88027<br \/>e-mail: <a href=\"https:\/\/www.stocktitan.net\/news\/RHHBY\/mailto:sabine.borngraeber@roche.com\" rel=\"nofollow noopener\" target=\"_blank\">sabine.borngraeber@roche.com<\/a>\u00a0    Dr Birgit Masjost<br \/>Phone:   +41 61 68-84814<br \/>e-mail:   birgit.masjost@roche.com    \u00a0   <\/p>\n<p>Investor Relations North America<\/p>\n<p>   Loren Kalm<br \/>Phone:   +1 650 225 3217<br \/>e-mail:   kalm.loren@gene.com<br \/>  \u00a0  <\/p>\n<p>        <a rel=\"nofollow noopener\" target=\"_blank\" href=\"https:\/\/ml-eu.globenewswire.com\/Resource\/Download\/660c82b0-090f-476d-8873-0cb72e1ff5f0\">Media Investor Release ASH 2025 curtain raiser English<\/a><\/p>\n<p><img decoding=\"async\" loading=\"lazy\" alt=\"\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=MTAwMTEzNjU1OSM0MDIyNTg2MTcjMjAwMTA0OA==\"\/> <br \/><img decoding=\"async\" loading=\"lazy\" alt=\"\" src=\"https:\/\/www.europesays.com\/ch\/wp-content\/uploads\/2026\/02\/1771294418_114_F-Hoffmann-La-Roche-Ltd.png\" referrerpolicy=\"no-referrer-when-downgrade\"\/>&#13;<br \/>\n&#13;<br \/>\n&#13;<br \/>\n    &#13;<br \/>\n      &#13;<br \/>\n&#13;<br \/>\n&#13;<br \/>\n&#13;<br \/>\n  &#13;<br \/>\n&#13;<\/p>\n<p>&#13;<br \/>\n    FAQ  &#13;\n  <\/p>\n<p>&#13;<br \/>\n  &#13;<br \/>\n  &#13;<\/p>\n<p>        What clinical data will Roche (RHHBY) present for Hemlibra at ASH 2025?<\/p>\n<p>&#13;<br \/>\n          Roche will present BEYOND ABR post\u2011marketing data showing low bleeding rates and improved joint health in the first year after switching to Hemlibra.&#13;\n        <\/p>\n<p>    &#13;<br \/>\n  &#13;<\/p>\n<p>        When is Roche planning Phase III for NXT007 (RHHBY)?<\/p>\n<p>&#13;<br \/>\n          Roche plans to progress NXT007 into Phase III in 2026 following positive phase I\/II results.&#13;\n        <\/p>\n<p>    &#13;<br \/>\n  &#13;<\/p>\n<p>        What is the regulatory status of Columvi plus GemOx referenced by Roche (RHHBY)?<\/p>\n<p>&#13;<br \/>\n          Columvi plus GemOx is approved in 49 countries for R\/R DLBCL, and the US supplemental BLA received a Complete Response Letter on 2 July 2025.&#13;\n        <\/p>\n<p>    &#13;<br \/>\n  &#13;<\/p>\n<p>        Which Roche (RHHBY) lymphoma medicines have long\u2011term follow\u2011up data at ASH 2025?<\/p>\n<p>&#13;<br \/>\n          Roche will present long\u2011term and subgroup follow\u2011up for Columvi, Lunsumio, mosunetuzumab and combinations with polatuzumab.&#13;\n        <\/p>\n<p>    &#13;<br \/>\n  &#13;<\/p>\n<p>        What multiple myeloma data is Roche (RHHBY) presenting at ASH 2025?<\/p>\n<p>&#13;<br \/>\n          Roche will present CAMMA\u20111 biomarker analyses and CAMMA\u20113 subcutaneous cevostamab data showing deep, durable responses and support for planned Phase III initiation in 2026.&#13;\n        <\/p>\n<p>    &#13;<br \/>\n  &#13;<\/p>\n<p>        Will Roche (RHHBY) report gene\u2011therapy updates for haemophilia A at ASH 2025?<\/p>\n<p>&#13;<br \/>\n          Yes; preclinical SPK\u20118011QQ data showing enhanced haemostatic potency will be presented, with a Phase IIb study planned for 2026.&#13;\n        <\/p>\n<p>    &#13;<br \/>\n  &#13;<br \/>\n&#13;<br \/>\n&#13;<br \/>\n    &#13;<br \/>\n&#13;<\/p>\n","protected":false},"excerpt":{"rendered":"&#13; &#13; &#13; &#13; &#13; Roche (OTCQX: RHHBY) will present 46 abstracts, including 12 oral presentations, at ASH&hellip;\n","protected":false},"author":2,"featured_media":115,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[124],"tags":[7675,3324,7674,7666,7665,7671,4063,6861,7670,7667,6851,7668,7669,7672,7676,151,134,7673],"class_list":{"0":"post-9824","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-roche","8":"tag-12-oral-presentations","9":"tag-3324","10":"tag-46-abstracts","11":"tag-67th-ash","12":"tag-ash-annual-meeting","13":"tag-cevostamab","14":"tag-columvi","15":"tag-hematology","16":"tag-hemlibra","17":"tag-hemophilia-a","18":"tag-lunsumio","19":"tag-lymphoma","20":"tag-multiple-myeloma","21":"tag-nxt007","22":"tag-orlando","23":"tag-rhhby","24":"tag-roche","25":"tag-spk-8011qq"},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/posts\/9824","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/comments?post=9824"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/posts\/9824\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/media\/115"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/media?parent=9824"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/categories?post=9824"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/tags?post=9824"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}