FCRL5

Analysis from MonumenTAL-1 study showed patients with relapsed or refractory multiple myeloma treated with TALVEY™ were subsequently treated effectively with several classes of therapy, including CAR-T Additional presentations at the 2023 ASH Annual Meeting showed potential improvement in adverse events among patients who received reduced intensity dosing and first-ever results from TALVEY™ combination study SAN DIEGO, Dec. 11, 2023 /PRNewswire/ -- Johnson & Johnson announced today an analysis from the Phase 1/2 MonumenTAL-1 study of TALVEY™ (talquetamab-tgvs) in patients with relapsed or refractory multiple myeloma (RRMM) showed that patients treated with TALVEY™ were subsequently treated effectively with several classes of therapy, including anti-B-cell maturation antigen (BCMA) chimeric antigen receptor T-cell (CAR-T) therapy as well as BCMA and anti-Fc receptor-like protein 5 (FcRH5) bispecific antibodies, after TALVEY™ treatment.1 These data, featured in a poster presentation at the 2023 American Society of Hematology (ASH) Annual Meeting (Abstract #2007), highlight the versatility of TALVEY™ when used before or after BCMA-directed CAR-T and bispecifics in triple-class exposed patients with RRMM.1 Additional results from the MonumenTAL-1 study, also featured in a poster presentation, support the overall versatility of TALVEY™ by showing continued strong efficacy among patients with prior exposure to T-cell redirection therapy (TCR) (Abstract #3377).2 In MonumenTAL-1, 297 patients with no prior exposure to TCR received TALVEY™ at the recommended Phase 2 dose (RP2D) of 0.8 mg/kg biweekly (Q2W) [n=154] or 0.4 mg/kg weekly (QW) [n=143].1 Patients in the study received a median of five prior lines of therapy; 75 percent of patients were triple-class refractory; 29 percent were penta-drug refractory; and 12 percent had prior belantamab mafodotin exposure.1 Overall, 162 patients received at least one subsequent antimyeloma therapy (SAT) after TALVEY™ discontinuation, including chemotherapy-based regimens (n=48); a proteasome inhibitor- (PI), an immunomodulatory drug- (IMiD), or other anti-neoplastic–containing regimen (n=44); anti-CD38 mAb-containing regimens (n=27); bispecific antibodies (n=23; n=19 anti–BCMA; n=4 anti–FcRH5); CAR-T therapy (n=17; including n=9 anti–BCMA-targeting CAR-T); or anti-BCMA antibody-drug conjugates (n=9).1 Results show that patients who discontinued TALVEY™ were able to achieve a response with SATs, including 65 percent (11/17) of patients who received subsequent CAR-T cell therapy, of whom 35 percent achieved a complete response (CR) or better.1 Patients treated with anti-BCMA bispecific antibodies as the first SAT achieved an overall response rate (ORR) of 58 percent (11/19), and 75 percent (3/4) responded to anti-FcRH5 bispecific antibody therapy as the first SAT.1 A separate updated analysis of the MonumenTAL-1 study, focused on safety and efficacy of TALVEY™ in patients with RRMM after prior TCRs (n=70), showed continued strong efficacy of TALVEY™ across populations exposed to TCR (predominantly anti-BCMA), with an ORR of 73 percent and median duration of response (mDOR) of more than 1 year in the post–CAR-T cell therapy setting.2 More than 56 percent of patients exposed to prior bispecific antibody responded.2 "Results from the MonumenTAL-1 analyses support the versatility of talquetamab either before or after BCMA-directed CAR-T and bispecifics in patients with triple-class exposed relapsed or refractory multiple myeloma," said Ajai Chari, M.D., Director of Multiple Myeloma Program, Professor of Clinical Medicine at the University of California, San Francisco.‡ "Talquetamab presents a new treatment option for patients and physicians who want to save BCMA-directed for later lines of therapy." Data from the Pivotal Phase 1/2 MonumenTAL-1 Study Highlight Reported Continued Efficacy of TALVEY™ with Reduced Intensity Dosing An oral presentation at ASH 2023 highlighted results from 50 patients in the Phase 1/2 MonumenTAL-1 study who were switched to reduced intensity dosing based on meeting specific response criteria or to mitigate treatment-emergent adverse events (TEAEs) such as oral-, nail- and/or skin-related TEAEs, which may be related to expression of GPRC5D (Abstract #1010).3 Patients whose dose was reduced maintained durable responses to TALVEY™ treatment.3 Two additional cohorts, which were conducted to examine the impact of prospective reduction in dosing intensity after response was achieved, included 24 patients with a median follow-up of 13.2 months.3 In total, 79 percent (19/24) of patients achieved a partial response (PR) or better and switched from 0.8 mg/kg Q2W to either 0.4 mg/kg Q2W or 0.8 mg/kg Q4W.3 Following the change in dosing, at six months, mDOR was not reached.3 Patients who prospectively switched to reduced dosing intensity trended towards improved resolution of GPRC5D-related TEAEs, except for weight loss (prospective: 12.5 percent resolved and without dose reduction: 18.9 percent resolved).3 Resolution of TEAEs occurred for oral-toxicities (33.3 percent and 26.9 percent); nail-toxicities (11.1 percent and 12.0 percent) and non-rash skin-toxicities (50.0 percent and 15.3 percent), in the prospective and without dose reduction cohorts, respectivly.3 Thus, improvement or resolution of oral-, nail-, and skin-related TEAEs was observed over time in some patients in the prospective reduced and less frequent dosing cohorts.3 These results show the potential of modifying the TALVEY™ dose, after a response is achieved, as a strategy to manage oral-, nail-, and skin-related TEAEs and improve patient experience without compromising efficacy.3 First-ever Results from Study of TALVEY™ and IMiD Combination Show Promising Overall Response Rate in Patients with RRMM Results from the Phase 1b MonumenTAL-2 study of TALVEY™ and pomalidomide for the treatment of patients with RRMM highlight the potential to combine TALVEY™ with other anti-myeloma therapies.4 These data, from the first-ever study of a regimen combining a GPRC5D-targeted therapy and an immunomodulatory agent, were featured as an oral presentation at the 2023 ASH Annual Meeting (Abstract #1014).4 Patients in the Phase 1b MonumenTAL-2 study (n=35) were treated with subcutaneous (SC) TALVEY™ at the RP2D of 0.8 mg/kg Q2W (n=19) or 0.4 mg/kg QW (n=16) with step-up doses, plus two milligrams of oral pomalidomide daily.4 With a median follow-up of 15 months in the QW cohort (n=16), the overall response rate was 94 percent among response-evaluable patients, 63 percent achieved a CR or better, and 88 percent of responders achieved a very good partial response (VGPR) or better.4 With a median follow-up of 11.1 months in the Q2W cohort (n=19), the ORR was 84 percent in response-evaluable patients, with 37 percent achieving a CR or better and 68 percent achieving a VGPR or better.4 Overall response rates were consistent across patient subgroups, including patients treated with prior pomalidomide or CAR-T cell therapy.4 Responses in both patient cohorts were rapid, with a median time to first response of 1.7 months (range, 0.9–3.3) in the QW cohort and 1.2 months (range, 0–4.8) in the Q2W cohort.4 At nine months, 100 percent of responders maintained their response in the QW cohort and 84 percent maintained response in the Q2W cohort.4 mDOR and progression-free survival (PFS) were not reached, and 9-month PFS rates observed in the QW and Q2W cohorts were 94 percent and 76 percent, respectively.4 "Findings from the MonumenTAL-2 and MonumenTAL-1 studies demonstrate the versatility of TALVEY across patient subgroups, showing the efficacy, manageable safety profile and effect of TALVEY on B-cell preservation," said Christoph Heuck, M.D., Vice President, Hematology Clinical Development, Johnson & Johnson Innovative Medicine. "The promising early results observed with the combination of TALVEY and pomalidomide, even in patients who had previously received pomalidomide or CAR-T cell therapy, reinforce our scientific strategy in focusing on improving upon and deepening responses through combination regimens." The most common adverse events across both cohorts were oral related (86 percent); cytokine release syndrome (CRS; 74 percent; 3 percent Grade 3/4); neutropenia (63 percent).4 Most common grade 3/4 hematologic AEs were neutropenia (54 percent), anemia (26 percent), and thrombocytopenia (20 percent).4 Nail, skin, and rash toxicities occurred in 69 percent, 74 percent, and 20 percent of patients, respectively; the majority were Grade 1/2 with no discontinuations.4 Grade 1 immune effector cell-associated neurotoxicity syndrome occurred in three patients.4 Infections occurred in 80 percent of patients (23 percent Grade 3/4); most common were pneumonia (23 percent) and upper respiratory tract infection (23 percent).4 Adverse events led to TALVEY™ dose reduction or schedule change in 34 percent of patients and dose reduction of pomalidomide in 46 percent of patients.4 In total, four patients discontinued treatment. One patient died due to pulmonary embolism.4 A bout TALVEY™ TALVEY™ (talquetamab-tgvs) received approval from the U.S. FDA in August 2023 as a first-in-class GPRC5D-targeting bispecific antibody for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.5 The European Commission (EC) granted conditional marketing authorization (CMA) of TALVEY™ ▼ (talquetamab) in August 2023 as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM) who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.6 TALVEY™ is a bispecific T-cell engaging antibody that binds to the CD3 receptor expressed on the surface of T-cells and G protein-coupled receptor class C group 5 member D (GPRC5D), a novel multiple myeloma target which is highly expressed on the surface of multiple myeloma cells and non-malignant plasma cells, as well as some healthy tissues such as epithelial cells of the skin and tongue. For more information, visit . About MonumenTAL-1 MonumenTAL-1 (Phase 1: NCT03399799, Phase 2: NCT04634552) is a Phase 1/2 single-arm, open-label, multicohort, multicenter dose-escalation study involving more than 300 patients.7,8 Phase 1 evaluated the safety and efficacy of TALVEY™ in adults with relapsed or refractory multiple myeloma who received three or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.1,2 The study excluded patients who experienced T-cell redirection therapy within 3 months, prior Grade 3 or higher CRS related to any T-cell redirection therapy, an autologous stem cell transplant within the 12 weeks, an allogenic stem cell transplant within the 6 months, Eastern Cooperative Oncology Group (ECOG) performance score of 3 or higher, stroke or seizure within 6 months, CNS involvement or clinical signs of meningeal involvement of multiple myeloma, plasma cell leukemia, or active or documented history of autoimmune disease (exception of vitiligo, resolved childhood atopic dermatitis or resolved Grave's Disease that is euthyroid based on clinical and laboratory testing).7,8 Phase 2 of the study evaluated the efficacy of TALVEY™ in participants with relapsed or refractory multiple myeloma at the recommended Phase 2 dose(s) (RP2Ds), established as SC 0.4 mg/kg weekly and 0.8 mg/kg every two weeks, respectively. Efficacy was based on overall response rate (ORR) and duration of response (DOR) as assessed by an Independent Review Committee using the International Myeloma Working Group (IMWG) criteria.3 About MonumenTAL-2 The MonumenTAL-2 (NCT05050097) study is an ongoing Phase 1 study of subcutaneous talquetamab in combination with carfilzomib, daratumumab SC, lenalidomide or pomalidomide for the treatment of patients with multiple myeloma. The primary objective of the MonumenTAL-2 study is to identify and characterize the safety of the treatment combinations. Secondary objectives of the MonumenTAL-2 study include overall response rates, duration of response and time to response. About Multiple Myeloma Multiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.9 In multiple myeloma, these plasma cells change, spread rapidly and replace normal cells in the bone marrow with tumors.10 Multiple myeloma is the third most common blood cancer and remains an incurable disease.11 In 2023, it is estimated that more than 35,000 people will be diagnosed with multiple myeloma in the U.S. and more than 12,000 people will die from the disease.12 People living with multiple myeloma have a five-year relative survival rate of 59.8 percent.13 While some people diagnosed with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels and kidney problems or infections.14,15 TALVEY™ IMPORTANT SAFETY INFORMATION INDICATION AND USAGE TALVEY™ (talquetamab-tgvs) is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS: None. WARNINGS AND PRECAUTIONS Cytokine Release Syndrome (CRS): TALVEY™ can cause cytokine release syndrome, including life-threatening or fatal reactions. In the clinical trial, CRS occurred in 76% of patients who received TALVEY™ at the recommended dosages, with Grade 1 CRS occurring in 57% of patients, Grade 2 in 17%, and Grade 3 in 1.5%. Recurrent CRS occurred in 30% of patients. CRS occurred in 33% of patients with step-up dose 3 in the biweekly dosing schedule (N=153). CRS occurred in 30% of patients with the first 0.4 mg/kg treatment dose and in 12% of patients treated with the first 0.8 mg/kg treatment dose. The CRS rate for both dosing schedules combined was less than 3% for each of the remaining doses in Cycle 1 and less than 3% cumulatively from Cycle 2 onward. The median time to onset of CRS was 27 (range: 0.1 to 167) hours from the last dose, and the median duration was 17 (range: 0 to 622) hours. Clinical signs and symptoms of CRS include but are not limited to pyrexia, hypotension, chills, hypoxia, headache, and tachycardia. Potentially life-threatening complications of CRS may include cardiac dysfunction, acute respiratory distress syndrome, neurologic toxicity, renal and/or hepatic failure, and disseminated intravascular coagulation (DIC). Initiate therapy with step-up dosing and administer pre-treatment medications (corticosteroids, antihistamine, and antipyretics) prior to each dose of TALVEY™ in the step-up dosing schedule to reduce the risk of CRS. Monitor patients following administration accordingly. In patients who experience CRS, pre-treatment medications should be administered prior to the next TALVEY™ dose. Counsel patients to seek medical attention should signs or symptoms of CRS occur. At the first sign of CRS, immediately evaluate patient for hospitalization and institute treatment with supportive care based on severity, and consider further management per current practice guidelines. Withhold TALVEY™ until CRS resolves or permanently discontinue based on severity. Neurologic Toxicity including ICANS: TALVEY™ can cause serious or life-threatening neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), including fatal reactions. In the clinical trial, neurologic toxicity occurred in 55% of patients who received the recommended dosages, with Grade 3 or 4 neurologic toxicity occurring in 6% of patients. The most frequent neurologic toxicities were headache (20%), encephalopathy (15%), sensory neuropathy (14%), and motor dysfunction (10%). ICANS was reported in 9% of 265 patients where ICANS was collected and who received the recommended dosages. Recurrent ICANS occurred in 3% of patients. Most patients experienced ICANS following step-up dose 1 (3%), step-up dose 2 (3%), step-up dose 3 of the biweekly dosing schedule (1.8%), or the initial treatment dose of the weekly dosing schedule (2.6%) (N=156) or the biweekly dosing schedule (3.7%) (N=109). The median time to onset of ICANS was 2.5 (range: 1 to 16) days after the most recent dose with a median duration of 2 (range: 1 to 22) days. The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS. Clinical signs and symptoms of ICANS may include but are not limited to confusional state, depressed level of consciousness, disorientation, somnolence, lethargy, and bradyphrenia. Monitor patients for signs and symptoms of neurologic toxicity during treatment. At the first sign of neurologic toxicity, including ICANS, immediately evaluate the patient and provide supportive care based on severity; withhold or permanently discontinue TALVEY™ based on severity and consider further management per current practice guidelines. [see Dosage and Administration (2.5)]. Due to the potential for neurologic toxicity, patients receiving TALVEY™ are at risk of depressed level of consciousness. Advise patients to refrain from driving or operating heavy or potentially dangerous machinery during the step-up dosing schedule and for 48 hours after completion of the step-up dosing schedule, and in the event of new onset of any neurological symptoms, until symptoms resolve. TECVAYLI® and TALVEY™ REMS: TALVEY™ is available only through a restricted program under a REMS, called the TECVAYLI® and TALVEY™ REMS because of the risks of CRS and neurologic toxicity, including ICANS. Further information about the TECVAYLI® and TALVEY™ REMS program is available at or by telephone at 1-855-810-8064. Oral Toxicity and Weight Loss: TALVEY™ can cause oral toxicities, including dysgeusia, dry mouth, dysphagia, and stomatitis. In the clinical trial, 80% of patients had oral toxicity, with Grade 3 occurring in 2.1% of patients who received the recommended dosages. The most frequent oral toxicities were dysgeusia (49%), dry mouth (34%), dysphagia (23%), and ageusia (18%). The median time to onset of oral toxicity was 15 (range: 1 to 634) days, and the median time to resolution to baseline was 43 (1 to 530) days. Oral toxicity did not resolve to baseline in 65% of patients. TALVEY™ can cause weight loss. In the clinical trial, 62% of patients experienced weight loss of 5% or greater, regardless of having an oral toxicity, including 28% of patients with Grade 2 (10% or greater) weight loss and 2.7% of patients with Grade 3 (20% or greater) weight loss. The median time to onset of Grade 2 or higher weight loss was 67 (range: 6 to 407) days, and the median time to resolution was 50 (range: 1 to 403) days. Weight loss did not resolve in 57% of patients who reported weight loss. Monitor patients for signs and symptoms of oral toxicity. Counsel patients to seek medical attention should signs or symptoms of oral toxicity occur and provide supportive care as per current clinical practice, including consultation with a nutritionist. Monitor weight regularly during therapy. Evaluate clinically significant weight loss further. Withhold TALVEY™ or permanently discontinue based on severity. Infections: TALVEY™ can cause infections, including life-threatening or fatal infections. Serious infections occurred in 16% of patients, with fatal infections in 1.5% of patients. Grade 3 or 4 infections occurred in 17% of patients. The most common serious infections reported were bacterial infection (8%), which included sepsis and COVID-19 (2.7%). Monitor patients for signs and symptoms of infection prior to and during treatment with TALVEY™ and treat appropriately. Administer prophylactic antimicrobials according to local guidelines. Withhold or consider permanently discontinue TALVEY™ as recommended, based on severity. Cytopenias: TALVEY™ can cause cytopenias, including neutropenia and thrombocytopenia. In the clinical trial, Grade 3 or 4 decreased neutrophils occurred in 35% of patients, and Grade 3 or 4 decreased platelets occurred in 22% of patients who received TALVEY™. The median time to onset for Grade 3 or 4 neutropenia was 22 (range: 1 to 312) days, and the median time to resolution to Grade 2 or lower was 8 (range: 1 to 79) days. The median time to onset for Grade 3 or 4 thrombocytopenia was 12 (range: 2 to 183) days, and the median time to resolution to Grade 2 or lower was 10 (range: 1 to 64) days. Monitor complete blood counts during treatment and withhold TALVEY™ as recommended, based on severity. Skin Toxicity: TALVEY™ can cause serious skin reactions, including rash, maculo-papular rash, erythema, and erythematous rash. In the clinical trial, skin reactions occurred in 62% of patients, with grade 3 skin reactions in 0.3%. The median time to onset was 25 (range: 1 to 630) days. The median time to improvement to grade 1 or less was 33 days. Monitor for skin toxicity, including rash progression. Consider early intervention and treatment to manage skin toxicity. Withhold TALVEY™ as recommended based on severity. Hepatotoxicity: TALVEY™ can cause hepatotoxicity. Elevated ALT occurred in 33% of patients, with grade 3 or 4 ALT elevation occurring in 2.7%; elevated AST occurred in 31% of patients, with grade 3 or 4 AST elevation occurring in 3.3%. Grade 3 or 4 elevations of total bilirubin occurred in 0.3% of patients. Liver enzyme elevation can occur with or without concurrent CRS. Monitor liver enzymes and bilirubin at baseline and during treatment as clinically indicated. Withhold TALVEY™ or consider permanent discontinuation of TALVEY™, based on severity [see Dosage and Administration (2.5)]. Embryo-Fetal Toxicity: Based on its mechanism of action, TALVEY™ may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with TALVEY™ and for 3 months after the last dose. Adverse Reactions: The most common adverse reactions (≥20%) are pyrexia, CRS, dysgeusia, nail disorder, musculoskeletal pain, skin disorder, rash, fatigue, weight decreased, dry mouth, xerosis, dysphagia, upper respiratory tract infection, diarrhea, hypotension, and headache. The most common Grade 3 or 4 laboratory abnormalities (≥30%) are lymphocyte count decreased, neutrophil count decreased, white blood cell decreased, and hemoglobin decreased. Please read full Prescribing Information , including Boxed Warning, for TALVEY™. About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at or at . Follow us at @JanssenUS and @JNJInnovMed. Janssen Research & Development, LLC and Janssen Biotech, Inc. are both Johnson & Johnson companies. Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of TALVEY™ (talquetamab-tgvs). The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections Janssen Research & Development, LLC, Janssen Biotech, Inc., and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 1, 2023, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at , or on request from Johnson & Johnson. None of Janssen Research & Development, LLC, Janssen Biotech, Inc., nor Johnson & Johnson undertake to update any forward-looking statement as a result of new information or future events or developments. ‡ Dr. Ajai Chari has provided consulting, advisory, and speaking services to Janssen; he has not been paid for any media work. SOURCE Johnson & Johnson

Longer-term data from pivotal studies of fixed-duration Columvi and Lunsumio continue to show durable responses in people with heavily pre-treated lymphomas1,2New data reinforce the potential of combination regimens in earlier treatment settings and add to the robust body of evidence supporting ongoing Phase III studies3,4,5,6 Basel, 11 December 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that new data from its CD20xCD3 T-cell engaging bispecific antibody programme, including eight oral presentations, were presented at the 65th American Society of Hematology (ASH) Annual Meeting & Exposition, 9-12 December 2023. Based on 32-month and 3-year follow-ups of two pivotal studies for fixed-duration treatments of Columvi® (glofitamab) and Lunsumio® (mosunetuzumab), respectively, data show that remissions were maintained in the majority of patients with heavily pre-treated lymphomas.1,2 Additionally, new early-phase data of novel Columvi or Lunsumio combination regimens support ongoing investigation in Phase III studies in earlier lines of diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL).3,4,5,6“Updated data from pivotal studies of Columvi and Lunsumio continue to provide compelling evidence for how fixed-duration therapies can deliver sustained, long-term benefit for people with difficult-to-treat lymphomas,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Our data at ASH also demonstrate progress in evaluating our bispecific antibodies in earlier stages of disease and additional types of lymphoma so more people can benefit from our therapies.”Longer follow-up data from pivotal studies of fixed-duration Columvi and Lunsumio show benefit is maintained beyond the end of treatmentExtended follow-up data from the pivotal Phase II NP30179 study of Columvi administered for up to 12 cycles (approximately eight months) in patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) who have received at least two prior lines of therapy showed favourable long-term outcomes. After a median follow-up of 32 months, 55% of patients with a complete response (CR) were in remission at 24 months. Most of these patients remained progression-free and alive 18 months after completing the fixed-duration treatment. In patients who had received prior chimeric antigen receptor (CAR) T-cell therapy, the median duration of CR was 22.0 months (95% confidence interval [CI]: 6.7–not reached). No new safety signals were observed since the previous analysis.1Data from a three-year follow-up analysis of the pivotal Phase II GO29781 study of Lunsumio in patients with R/R FL who have received at least two prior lines of therapy were presented. Results showed continued durable responses and a manageable safety profile after treatment (up to approximately 12 months), with 59% of patients completing treatment after eight cycles (approximately five months). 72.7% of the patients with a CR were alive and without disease progression, 30 months after their first response. In the overall population, median progression-free survival (PFS) was 24 months (95% CI: 12.0–not evaluable [NE]) and overall survival (OS) was not yet reached. No new safety signals were observed since the previous analysis.2Additional data presented reinforce the potential of novel combination regimens in earlier treatment settingsDiffuse large B-cell lymphomaData from the Phase Ib/II GO40516 study of Lunsumio plus Polivy® (polatuzumab vedotin) in patients with R/R LBCL were presented and simultaneously published in Nature Medicine.3,7 Results showed that at 24 months median follow-up, the median PFS was 11.4 months (95% CI: 6.2–18.7), and median OS was 23.3 months (95% CI: 14.8–NE), highlighting the combination’s potential in R/R LBCL. The overall safety profile of patients with R/R LBCL treated with Lunsumio plus Polivy was manageable. Cytokine release syndrome (CRS) events were generally low grade (Grade 1: 10.2%; Grade 2: 5.1%; Grade 3: 3.1%).3 Lunsumio in combination with Polivy is being evaluated as an outpatient therapy for patients with R/R DLBCL in the ongoing Phase III SUNMO study.Results from both arms of the Phase Ib NP40126 study evaluating Columvi in combination with MabThera®/Rituxan® (rituximab), cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP), and Columvi in combination with Polivy plus MabThera/Rituxan, cyclophosphamide, doxorubicin and prednisone (Pola+R-CHP) in previously untreated DLBCL were presented. After a median of 12 months follow-up, data from the Columvi plus Pola+R-CHP arm showed that 91.7% of patients had a CR with no progression observed. Of the patients with a CR, 95.5% were still in remission, with a 12-month PFS rate of 91.5%. Safety profiles were highly consistent with earlier analyses from this study.4 These data support the ongoing Phase III SKYGLO study in previously untreated DLBCL.Follicular lymphomaThe Phase II MorningSun study, evaluating a subcutaneous (SC) formulation of Lunsumio in patients with selected B-cell non-Hodgkin lymphomas, showed that SC Lunsumio is active and has a manageable safety profile in patients with first-line (1L) low-tumour burden FL. Data showed that 83.3% of patients achieved a complete metabolic response (95% CI: 62.6-95.3) and responses were ongoing at data cut-off. CRS was generally low grade (Grade 1: 36.7%; Grade 2: 6.7%) and occurred in cycle one only.5 Subcutaneous Lunsumio is also being investigated in combination with oral lenalidomide in 1L FL in the Phase Ib/II CO41942 study. New data demonstrated promising efficacy and manageable safety; data showed that 89.2% of patients achieved a CR and CRS events were either Grade 1 (47.5%) or 2 (2.5%), all of which were confined to cycles one to two.6 The data support further investigation of this SC formulation of Lunsumio and highlight its potential as a tailored monotherapy or combination outpatient therapy for FL, including in community practices.5,6Totality of data presented underscores the strength of Roche's broad, industry-leading development programme, which aims to address the diverse needs, preferences and experiences of people with blood cancersBoth Columvi and Lunsumio are being investigated in Phase III studies that will expand the understanding of their impact in earlier lines of treatment. This includes the Phase III STARGLO study evaluating Columvi in combination with GemOx in patients with R/R DLBCL who are ineligible for autologous stem cell transplant; the Phase III SKYGLO study evaluating the efficacy and safety of Columvi plus Pola+R-CHP in previously untreated DLBCL; the Phase III GLOBRYTE study evaluating Columvi monotherapy in R/R mantle cell lymphoma; the Phase III SUNMO study investigating Lunsumio plus Polivy in R/R DLBCL; and the Phase III CELESTIMO study investigating Lunsumio plus lenalidomide in patients with R/R FL.About Columvi® (glofitamab)Columvi is a CD20xCD3 T-cell engaging bispecific antibody designed to target CD3 on the surface of T-cells and CD20 on the surface of B-cells. Columvi was designed with a novel 2:1 structural format. This T-cell engaging bispecific antibody is engineered to have one region that binds to CD3, a protein on T-cells, a type of immune cell, and two regions that bind to CD20, a protein on B-cells, which can be healthy or malignant. This dual-targeting brings the T-cell in close proximity to the B-cell, activating the release of cancer cell-killing proteins from the T-cell. A clinical development programme for Columvi is ongoing, investigating the molecule as a monotherapy and in combination with other medicines for the treatment of people with B-cell non-Hodgkin lymphomas, including diffuse large B-cell lymphoma and other blood cancers.About Lunsumio® (mosunetuzumab)Lunsumio is a first-in-class CD20xCD3 T-cell engaging bispecific antibody designed to target CD3 on the surface of T-cells and CD20 on the surface of B-cells. This dual-targeting activates and redirects a patient’s existing T-cells to engage and eliminate target B-cells by releasing cytotoxic proteins into the B-cells. A robust clinical development programme for Lunsumio is ongoing, investigating the molecule as a monotherapy and in combination with other medicines, for the treatment of people with B-cell non-Hodgkin lymphomas, including follicular lymphoma and diffuse large B-cell lymphoma, and other blood cancers.About Polivy® (polatuzumab vedotin)Polivy is a first-in-class anti-CD79b antibody-drug conjugate (ADC). The CD79b protein is expressed in the majority of B-cells, an immune cell impacted in some types of non-Hodgkin lymphoma (NHL), making it a promising target for the development of new therapies. Polivy binds to cancer cells such as those expressing CD79b and destroys these B-cells through the delivery of an anti-cancer agent, which is thought to minimise the effects on normal cells. Polivy is being developed by Roche using Seagen ADC technology and is currently being investigated for the treatment of several types of NHL.About Roche in haematologyRoche has been developing medicines for people with malignant and non-malignant blood diseases for more than 20 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), Lunsumio® (mosunetuzumab) and Columvi® (glofitamab). Our pipeline of investigational haematology medicines includes T-cell engaging bispecific antibody cevostamab, targeting both FcRH5 and CD3, Tecentriq® (atezolizumab), and crovalimab, an anti-C5 antibody engineered to optimise complement inhibition. 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. In recognising our endeavour to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the thirteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work.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] Hutchings M, et al. Glofitamab Monotherapy in Relapsed or Refractory Large B-Cell Lymphoma: Extended Follow-Up from a Pivotal Phase II Study and Subgroup Analyses in Patients with Prior Chimeric Antigen Receptor T-Cell Therapy and by Baseline Total Metabolic Tumor Volume. Presented at: ASH Annual Meeting and Exposition; 2023 Dec 9-12. Abstract #433.[2] Schuster S, et al. Mosunetuzumab Monotherapy Continues to Demonstrate Durable Responses in Patients with Relapsed and/or Refractory Follicular Lymphoma after ≥2 Prior Therapies: 3-Year Follow-up from a Pivotal Phase II Study. Presented at: ASH Annual Meeting and Exposition; 2023 Dec 9-12. Abstract #603.[3] Budde E, et al. Mosunetuzumab Plus Polatuzumab Vedotin Demonstrates a Favorable Safety Profile and Efficacy in Patients (Pts) with Relapsed or Refractory (R/R) Large B-Cell Lymphoma (LBCL): Primary Analysis of a Phase Ib/II Study. Presented at: ASH Annual Meeting and Exposition; 2023 Dec 9-12. Abstract #613.[4] Topp M, et al. Glofitamab Plus R-CHOP Induces High Response Rates with a Manageable Safety Profile in Patients with Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL): A 12-Month Analysis from a Phase Ib Study. Presented at: ASH Annual Meeting and Exposition; 2023 Dec 9-12. Abstract #3085.[5] Flinn I, et al. Subcutaneous Mosunetuzumab Is Active and Has a Manageable Safety Profile in Patients with Previously Untreated, Low-Tumor Burden Follicular Lymphoma: Initial Results from the Phase II Morningsun Study. Presented at: ASH Annual Meeting and Exposition; 2023 Dec 9-12. Abstract #3029.[6] Morschhauser F, et al. Preliminary Findings of a Phase Ib/II Trial Indicate Manageable Safety and Promising Efficacy for Mosunetuzumab in Combination with Lenalidomide (M+Len) in Previously Untreated (1L) Follicular Lymphoma (FL). Presented at: ASH Annual Meeting and Exposition; 2023 Dec 9-12. Abstract #605.[7] Budde LE et al. Mosunetuzumab with polatuzumab vedotin in relapsed or refractory aggressive large B cell lymphoma: a phase 1b/2 trial. Nature Medicine. 2023. https://doi.org/10.1038/s41591-023-02726-5 Roche Global Media RelationsPhone: +41 61 688 8888 / e-mail: media.relations@roche.com Hans Trees, PhDPhone: +41 79 407 72 58 Simon GoldsboroughPhone: +44 797 32 72 915 Karsten KleinePhone: +41 79 461 86 83 Nina MählitzPhone: +41 79 327 54 74 Kirti PandeyPhone: +49 172 6367262 Dr. Rebekka SchnellPhone: +41 79 205 27 03 Sileia UrechPhone: +41 79 935 81 48 Roche Investor Relations Dr. Bruno Eschli Phone: +41 61 68-75284 e-mail: bruno.eschli@roche.com Dr. Sabine BorngräberPhone: +41 61 68-88027 e-mail: sabine.borngraeber@roche.com Dr. Birgit MasjostPhone: +41 61 68-84814e-mail: birgit.masjost@roche.com Dr. Gerard Tobin Phone: +41 61 68-72942 e-mail: gerard.tobin@roche.com Investor Relations North America Loren KalmPhone: +1 650 225 3217 e-mail: kalm.loren@gene.com Attachment 11122023_MR ASH 2023_Bispecifics_en

Phase III HAVEN 7 primary data presented at ASH 2023 provide additional confidence in the favourable efficacy and safety profile of subcutaneous Hemlibra given soon after birth 1At nearly two years median follow-up in the descriptive, single-arm study, no babies experienced spontaneous bleeds requiring treatment, and all treated bleeds were as a result of trauma 1Safety results were consistent with previous studies of Hemlibra, with no new safety signals observed 1The HAVEN 7 study was developed in collaboration with the haemophilia A community, to generate additional evidence for the prophylactic treatment of infants with haemophilia A Basel, 09 December 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the primary analysis of the Phase III HAVEN 7 study reinforced the efficacy and safety of Hemlibra® (emicizumab) in previously untreated or minimally treated infants with severe haemophilia A without factor VIII inhibitors. Results showed that Hemlibra achieved meaningful bleed control in babies up to 12 months of age, and was well tolerated.1 The new data were presented at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition taking place 9-12 December 2023, in San Diego, California, and included in the press programme. “Haemophilia A can have a devastating impact on any patient, but this is especially true for infants, where the emotional and physical stress due to frequent hospital visits, treatment administration and other worries can be distressing for babies and their parents and caregivers,” said Steven Pipe, MD, professor of paediatrics and pathology at the University of Michigan. “These results reinforce the benefit of starting prophylaxis as soon as possible after birth, as well as for the use of subcutaneous treatments, which are especially valuable in young babies where access to veins can be very difficult.” The burden of severe haemophilia A in babies and on their parents and caregivers is significant. The World Federation of Haemophilia treatment guidelines consider the standard of care in haemophilia to be regular prophylaxis initiated at a young age, as studies have shown this improves long-term outcomes, while reducing the risk of intracranial haemorrhage.[2-4] However, for many babies with haemophilia A, prophylaxis is not started until after the first year of life because of the high treatment burden.[5-8] Hemlibra, which is already approved and being used to treat babies with haemophilia A, provides a flexible treatment option that can be administered subcutaneously from birth at different dosing frequencies.9 “The results of HAVEN 7 provide additional confidence in the efficacy and safety profile of Hemlibra for babies with severe haemophilia A, and add to its extensive clinical and real-world evidence across all ages,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Conducted in collaboration with the haemophilia A community, this trial reflects our ongoing commitment to listen and respond to the needs of those impacted by this condition, in hopes of advancing treatment standards even further.” The HAVEN 7 study is a Phase III, descriptive, single-arm study, set up in collaboration with the haemophilia A community to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of subcutaneous Hemlibra in infants with severe haemophilia A without factor VIII inhibitors. These results, which included data from 55 participants, showed that at 101.9 weeks median follow-up, 54.5% of participants (n=30) did not have any bleeds that required treatment, while 16.4% (n=9) did not have any treated or untreated bleeds at all. There were no spontaneous bleeds requiring treatment in any participant, and all treated bleeds were as a result of trauma. A total of 207 bleeds occurred in 46 participants (83.6%); 87.9% of these were as a result of trauma. Model-based annualised bleeding rate (95% CI) was 0.4 (0.30–0.63) for treated bleeds. No new safety signals were observed and there were no treatment-related serious adverse events, intracranial haemorrhages or deaths reported. Just 3.6% of participants (n=2) tested positive for factor VIII inhibitors, which may be a consequence of reduced factor VIII usage in participants treated with Hemlibra, and no participant tested positive for anti-drug antibodies.[1] Results were consistent with positive results from the interim analysis and from previous Phase III HAVEN studies.10-14 The results of additional research on biomarkers in the HAVEN 7 study were also presented at ASH, and were supportive of the study’s primary efficacy analysis. This additional research showed that the pharmacodynamic profiles of Hemlibra in babies were consistent with those previously observed in older children and adults with haemophilia A. The data showed that Hemlibra exhibits the expected pharmacodynamic response, despite the reduced presence of the clotting factors that Hemlibra binds to in this age group.15 The Phase III HAVEN 7 study results complement data from the broader, pivotal HAVEN clinical programme, providing insights into the evolution of haemophilia A in babies, and the impact of initiating preventative treatment from birth. The primary analysis is being followed by a seven year extension period.1 Hemlibra continues to redefine standards of care in haemophilia A, as a flexible treatment option approved across all ages and stages of life, regardless of inhibitor status and at different dosing frequencies. It is approved for the routine prophylaxis of people with haemophilia A in more than 115 countries worldwide. It has been studied in one of the largest clinical trial programmes in people with haemophilia A with and without factor VIII inhibitors, including eight Phase III studies.About Hemlibra® (emicizumab) Hemlibra is a bispecific factor IXa- and factor X-directed antibody. It is designed to bring together factor IXa and factor X, proteins involved in the natural coagulation cascade, and restore the blood clotting process for people with haemophilia A. Hemlibra is a prophylactic (preventative) treatment that can be administered by an injection of a ready-to-use solution under the skin (subcutaneously) once-weekly, every two weeks, or every four weeks (after an initial once-weekly dose for the first four weeks).9 Hemlibra was created by Chugai Pharmaceutical Co., Ltd. and is being co-developed globally by Chugai, Roche and Genentech. It is marketed in the United States by Genentech as Hemlibra (emicizumab-kxwh), with kxwh as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the U.S. Food and Drug Administration. About haemophilia A Haemophilia A is an inherited, serious disorder in which a person’s blood does not clot properly, leading to uncontrolled and often spontaneous bleeding. Haemophilia A affects around 900,000 people worldwide.2,16 The burden of severe haemophilia A in infants and on their parents and caregivers is significant. People with haemophilia A either lack or do not have enough of a clotting protein called factor VIII. In a healthy person, when a bleed occurs, factor VIII brings together the clotting factors IXa- and X, which is a critical step in the formation of a blood clot to help stop bleeding. Depending on the severity of their symptoms, people with haemophilia A can bleed frequently, especially into their joints or muscles.17 These bleeds can present a significant health concern as they often cause pain and can lead to chronic swelling, deformity, reduced mobility and long-term joint damage.18 A serious complication of treatment is the development of inhibitors to factor VIII replacement therapies. Inhibitors are antibodies developed by the body’s immune system that bind to and block the efficacy of replacement factor VIII, making it difficult, if not impossible, to obtain a level of factor VIII sufficient to control bleeding.2 About Roche in haematologyRoche has been developing medicines for people with malignant and non-malignant blood diseases for more than 20 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), Lunsumio® (mosunetuzumab) and Columvi® (glofitamab). Our pipeline of investigational haematology medicines includes T-cell engaging bispecific antibody cevostamab, targeting both FcRH5 and CD3, Tecentriq® (atezolizumab), a monoclonal antibody designed to bind with PD-L1, and crovalimab, an anti-C5 antibody engineered to optimise complement inhibition. 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. In recognising our endeavour to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the thirteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work. 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] Pipe S, et al. Emicizumab Prophylaxis for the Treatment of Infants with Severe Hemophilia A without Factor VIII Inhibitors: Results from the Primary Analysis of the HAVEN 7 Study. Presented at American Society of Hematology (ASH) congress; 2023 December 10. Abstract 505.[2] Srivastava A, et al. WFH guidelines for the management of hemophilia, 3rd edition. Haemophilia. 2020;26 (Suppl 6): 1-158.[3] Manco-Johnson MJ, et al. Prophylaxis versus episodic treatment to prevent joint disease in boys with severe hemophilia. New England Journal of Medicine. 2007;357(6):535–544.[4] Andersson NG, et al. Intracranial haemorrhage in children and adolescents with severe haemophilia A or B – the impact of prophylactic treatment. British Journal of Haematology. 2017;179(2):298–307; 4.[5] Spagrud LJ, et al. Pain, distress, and adult-child interaction during venipuncture in pediatric oncology: an examination of three types of venous access. Journal of Pain and Symptom Management. 2008;36:173–84.[6] Van den Berg HM, et al. Timing of inhibitor development in more than 1000 previously untreated patients with severe hemophilia A. Blood 2019;134:317–320.[7] Valentino LA & Kapoor M. Central venous access devices in patients with hemophilia. Expert Rev Med Devices 2005;2:699–711.[8] Mancuso M, et al. Prophylaxis in children with haemophilia in an evolving treatment landscape. Haemophilia. 2021;27:889–896.[9] Hemlibra SmPC [Internet; cited 2023 December] Available from: https://www.medicines.org.uk/emc/product/9043/smpc[10] Pipe S, 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. Presented at American Society of Hematology (ASH) virtual congress; 2022 December 10. Abstract 187.[11] Mancuso ME, et al. Emicizumab Prophylaxis in Adolescent/Adult Patients with Hemophilia A Previously Receiving Episodic or Prophylactic Bypassing Agent Treatment: Updated Analyses from the HAVEN 1 Study. Blood. 2017;130 (Supplement 1):1071.[12] Young G, et al. Emicizumab prophylaxis provides flexible and effective bleed control in children with hemophilia A with inhibitors: results from the HAVEN 2 study. Blood. 2018;132 (Supplement 1):632.[13] Mahlangu J, et al. Emicizumab Prophylaxis in Patients Who Have Hemophilia A without Inhibitors. N Engl J Med. 2018;379:811-822.[14] Pipe S, et al. Efficacy, safety, and pharmacokinetics of emicizumab prophylaxis given every 4 weeks in people with haemophilia A (HAVEN 4): a multicentre, open-label, non-randomised phase 3 study. The Lancet Haematology. 2019; DOI:https://doi.org/10.1016/S2352-3026(19)30054-7.[15] Pipe S, et al. Pharmacodynamic Biomarkers in Infants with Hemophilia A Receiving Emicizumab in HAVEN 7. Presented at American Society of Hematology (ASH) congress; 2023 December 09. Abstract P1238.[16] Iorio A, et al. Establishing the Prevalence and Prevalence at Birth of Hemophilia in Males. Ann Intern Med. 2019;171(8):540-546.[17] NHS. Symptoms of haemophilia [Internet; cited 2023 December]. Available from: https://www.nhs.uk/conditions/haemophilia/symptoms/.[18] Franchini M, et al. Haemophilia A in the third millennium. Blood Rev. 2013; 179-84. Roche Global Media RelationsPhone: +41 61 688 8888 / e-mail: media.relations@roche.com Hans Trees, PhDPhone: +41 79 407 72 58 Dr. Rebekka SchnellPhone: +41 79 205 27 03 Simon GoldsboroughPhone: +44 797 32 72 915 Karsten KleinePhone: +41 79 461 86 83 Nina MählitzPhone: +41 79 327 54 74 Kirti PandeyPhone: +49 172 6367262 Sileia UrechPhone: +41 79 935 81 48 Roche Investor Relations Dr. Bruno Eschli Phone: +41 61 68-75284 e-mail: bruno.eschli@roche.com Dr. Sabine BorngräberPhone: +41 61 68-88027 e-mail: sabine.borngraeber@roche.com Dr. Birgit MasjostPhone: +41 61 68-84814e-mail: birgit.masjost@roche.com Dr. Gerard Tobin Phone: +41 61 68-72942 e-mail: gerard.tobin@roche.com Investor Relations North America Loren KalmPhone: +1 650 225 3217 e-mail: kalm.loren@gene.com Attachment 09122023_MR_ASH Hemlibra HAVEN 7_en