A Phase III Multicenter Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Teriflunomide In Adult Patients With Relapsing Multiple Sclerosis

Start Date28 Feb 2023

Sponsor / Collaborator

Hoffmann-La Roche, Inc.

100 Clinical Results associated with Fenebrutinib

100 Translational Medicine associated with Fenebrutinib

100 Patents (Medical) associated with Fenebrutinib

Literatures (Medical) associated with Fenebrutinib

01 Sep 2025·EUROPEAN JOURNAL OF PHARMACOLOGY

Next generation Bruton's tyrosine kinase inhibitors – characterization of in vitro potency and selectivity

Article

Author: Angst, Daniela ; Cenni, Bruno ; Pulz, Robert

Bruton's tyrosine kinase (BTK) mediates B cell receptor and Fc receptor signaling and is a key regulator of autoimmunity and allergy. A series of novel BTK inhibitors (BTKi) are currently in development for non-oncologic indications with covalent-irreversible (remibrutinib, evobrutinib, tolebrutinib, orelabrutinib), covalent-reversible (rilzabrutinib), and non-covalent reversible (fenebrutinib) binding modes. This study characterizes their in vitro potency and selectivity profiles under the same conditions to minimize assay differences across the different binding modes. Covalent BTKi showed human in vitro blood BTK binding in a time- and concentration-dependent manner with remibrutinib being the most potent and fastest in onset of action. Cellular BTK pathway inhibition was determined in human blood B cells and basophils, and for covalent BTKi correlated well with BTK binding. In contrast to the covalent-irreversible remibrutinib, the non-covalent reversible fenebrutinib showed rapid loss of cellular BTK inhibition after washout. Kinase selectivity was assessed in a binding screen across the human kinome, followed by quantification of binding affinities for a selection of kinases. BTKi ranked in their selectivity as follows (most selective to least): remibrutinib, fenebrutinib, evobrutinib, orelabrutinib, rilzabrutinib and tolebrutinib. These data suggest that next generation BTKi show important differences in their in vitro target binding and selectivity when compared under the same conditions.

01 Aug 2025·LANCET NEUROLOGY

Safety and efficacy of fenebrutinib in relapsing multiple sclerosis (FENopta): a multicentre, double-blind, randomised, placebo-controlled, phase 2 trial and open-label extension study.

Article

Author: Habek, Mario ; Kuruvilla, Denison ; Qi, Qi ; Hua, Le H ; Budincevic, Hrvoje ; Xu, Yan ; Goodyear, Alexandra ; Dufek, Michal ; Drulovic, Jelena ; Mitzner, Maresa Caunt ; Bar-Or, Amit ; Ratchford, John N ; Weber, Martin S ; Napieralski, Julie ; Thomas, Piia ; Harp, Christopher T ; Chen, Ying-Fang ; Clayton, David ; Oh, Jiwon

BACKGROUND:

The prospect for Bruton's tyrosine kinase (BTK) inhibition to meaningfully affect relapsing multiple sclerosis has recently been questioned due to inconsistent findings in the magnitude and sustainability of the effect of BTK inhibitors on disease activity. We assessed the safety, efficacy, and CSF drug concentrations of fenebrutinib, a highly selective, noncovalent, reversible BTK inhibitor, in patients with relapsing multiple sclerosis.

METHODS:

This multicentre, double-blind, randomised, placebo-controlled, phase 2 trial (FENopta) was conducted at 18 community centres and hospitals across six countries in Europe and North America. Patients with relapsing multiple sclerosis aged 18-55 years with an Expanded Disability Status Scale (EDSS) score of 0·0-5·5, and recent documented disease activity, were randomly assigned (2:1) to oral fenebrutinib (200 mg twice daily) or placebo for 12 weeks, using permuted blocks and stratified by the presence or absence of T1 gadolinium-enhancing (Gd+) lesions on the brain MRI at screening. The randomisation sequence was generated by an interactive voice or web response system and both patients and investigators were masked to treatment allocation. Participants could enter an optional open-label extension study to receive fenebrutinib for up to 192 weeks. The primary efficacy endpoint was the total number of new T1 Gd+ lesions on brain MRI at weeks 4, 8, and 12; with additional MRI assessments at 48-week intervals during the open-label extension. Efficacy analyses were done on randomised patients with evaluable post-baseline MRIs; safety analyses used the safety-evaluable population. This study is registered with ClinicalTrials.gov, NCT05119569, and EudraCT, 2021-003772-14; recruitment is closed and the trial is ongoing.

FINDINGS:

Between March 1, 2022 and March 29, 2023, 109 patients with relapsing multiple sclerosis were randomly assigned treatment: 73 received fenebrutinib and 36 received placebo. 106 patients had evaluable post-baseline brain MRI scans and were assessed for efficacy in the fenebrutinib group (n=70) and placebo group (n=36). The combined number of new T1 Gd+ lesions at weeks 4, 8, and 12 were 0·077 (95% CI 0·043-0·135) in the fenebrutinib group and 0·245 (0·144-0·418) in the placebo group (69% relative reduction [95% CI 34-85]; p=0·0022). During the open-label extension, through week 48, the unadjusted annualised relapse rate was 0·04 and 95 (96%) of 99 patients were relapse-free. During the double-blind treatment phase, the most common adverse events that were more frequent in the fenebrutinib group than in the placebo group were hepatic enzyme elevations (four [6%] vs 0), headache (three [4%] vs one [3%]), and nasopharyngitis (two [3%] vs 0); no serious adverse events or deaths occurred.

INTERPRETATION:

Fenebrutinib was well tolerated and exerted an early, robust, and sustained effect of limiting new focal brain lesions. Further studies are needed to better characterise the safety and efficacy of fenebrutinib on both relapsing multiple sclerosis and non-relapsing progressive multiple sclerosis.

FUNDING:

F. Hoffmann-La Roche.

01 May 2025·Clinical and Translational Allergy

Biological and target synthetic treatments for chronic spontaneous urticaria: A systematic review and network meta‐analysis

Article

Author: Song, Xiaoting ; Peng, Chengyue ; Zhang, Peixin ; Zheng, Yaqi ; Zhang, Litao ; Huang, Xiaojie ; Tan, Yen ; Zhao, Zuotao ; Liao, Shuanglu

Abstract:

Background:

Most biological and synthetic target‐specific drugs for antihistamine‐refractory chronic spontaneous urticaria (CSU) have not been compared head‐to‐head. This systematic review and network meta‐analysis evaluated their relative efficacy and safety.

Methods:

Searches were conducted on PubMed, Embase, Web of Science and Cochrane library databases to March 25, 2024 for randomized trials. A random‐effects model was used to calculate the network estimates reported as mean differences (MD) and odds ratios (OR) with corresponding 95% CIs. Main outcomes included the weekly urticaria activity score (UAS7), adverse events (AEs) and serious adverse events (SAEs).

Results:

23 randomized clinical trials with 6933 participants that compared 26 different interventions or dosages and placebos were included. Omalizumab 300 mg [MD −10.07, 95% CI (−11.35; −8.82)] continues to demonstrate superior efficacy compared with placebo. Remibrutinib, at doses of 35 mg once daily [MD −7.80, 95% CI (−12.76; −2.51)], 25 mg twice daily [MD −7.69, 95% CI (−9.85; −5.76)], and 10 mg twice daily [MD −7.61, 95% CI (−12.59; −2.47)], had the best overall performance for efficacy and safety. Dupilumab, fenebrutinib, and rilzabrutinib also showed greater efficacy than placebo. The results were similar for the proportion of patients who achieved UAS7 ≤ 6 or UAS7 = 0. No significant differences were found among all treatment comparisons for AEs and SAEs.

Conclusion:

The findings of this study indicate that the biological agent omalizumab 300 mg and the oral small molecule remibrutinib at doses of 35 mg, 25 mg, or 10 mg are recommended for patients with antihistamine‐refractory CSU.

Trial Registration:

PROSPERO: CRD42024516289

News (Medical) associated with Fenebrutinib

25 Jul 2025

·www.fiercebiotech.com

\'We will crack gene therapy\': Elevidys fallout doesn\'t dent Roche\'s hopes for modality

Roche Pharma CEO Teresa Graham spoke to Fierce Biotech on the sidelines of the company\'s first-half earnings event.\n The uncertainty around the future of Elevidys hasn’t destroyed Roche’s belief in the potential of gene therapies, the Swiss company’s head of pharma has told Fierce Biotech, as the pharma continues to expand its research reach outside of its traditional oncology focus.Roche and its partner Sarepta Therapeutics both paused trials of Elevidys back in April following the death of a 16-year-old patient in the U.S. Since then, Roche—which markets the drug outside of the U.S.—has stopped all ex-U.S. distribution of the drug in the commercial setting for non-ambulatory patients, while the FDA requested that Sarepta halt Elevidys shipments in the U.S. Earlier this week, Roche paused shipments in all patients in countries where Elevidys’ approvals referenced the FDA.But Roche Pharma CEO Teresa Graham denied Fierce’s suggestion that the issues around Elevidys have altered how the company views gene therapy as a modality.“It doesn’t, actually,” Graham told Fierce in an interview at Roche’s headquarters in Basel, Switzerland on Thursday.“The reality is that gene therapy will be an important modality in the treatment of human health,” Graham continued. “There is a lot of promise in gene therapy. I think what the entire industry is learning is that, scientifically, it\'s just a little harder than we might have thought.” Even before the latest difficulties with Elevidys, Roche had announced a “fundamental reorganization” of Spark Therapeutics, the gene therapy unit the Swiss pharma bought for $4.3 billion in 2019. That overhaul closely followed Roche’s decision to end work on a hemophilia A gene therapy candidate, which was a focus of the Spark acquisition.Roche’s move came against a backdrop of wider industry retreat from gene therapy, with Pfizer pulling its FDA-approved hemophilia B treatment Beqvez. Bluebird bio, a gene therapy pioneer once valued at $10 billion at its peak, was sold for just $49 million upfront to private equity firms.But Roche still sees potential in the modality, according to Graham.“I am firmly convicted that over time we will crack gene therapy and we will be able to deliver really meaningful treatments to patients,” she said.Graham spoke to Fierce on the sidelines of the company’s first-half earnings event, where Roche CEO Thomas Schinecker reminded journalists that 760 boys have successfully received Elevidys in the ambulatory setting.“I\'m really hopeful that we can find a path forward for this medicine,” Graham said in the interview on Thursday. “We clearly need to talk to regulators; we clearly need to have some good conversations about the safety—but we do firmly believe in the risk-benefit of this product.”Not all regulators sound ready to be convinced, with the European Medicines Agency (EMA) announcing Friday morning that it won\'t recommend Elevidys for approval in the ambulatory setting. Roche said in a statement that it “plans to continue to work with the EMA to explore a potential path forward.” Mixed results from emerging pipeline Another drug that Roche is keeping faith in is the Parkinson’s disease prospect prasinezumab. The future of the Prothena Biosciences–partnered asset looked in doubt after the anti-alpha-synuclein antibody failed a phase 2 study in December 2024.But Roche is giving prasinezumab a second chance, with plans to launch a phase 3 trial by the end of the year off the back of an analysis of data from the failed study. Specifically, the pharma pointed to longer-term follow-up data from an open-label portion of the study suggesting a clinical benefit on top of symptomatic treatment in early-stage Parkinson’s.“Given the dramatic unmet need in Parkinson\'s, it does feel like it would be a miss not to explore this,” Graham explained.“There\'s only really been minor improvements in treatments for these patients over the last 50 years, and, in every conversation I\'ve had with [key opinion leaders], they have really encouraged us to take this forward,” she said.“There\'s a little bit of a finger feel that there\'s something there, and we\'re only really ever going to be able to pull the signal out in a phase 3,” Graham added. Roche had less faith in CT-173, an early-stage obesity drug picked up as part of its $2.7 billion acquisition of Carmot Therapeutics in 2023. The Swiss pharma had previously touted the long-acting PYY analog’s potential to drive weight loss past the GLP-1 plateau, but Graham announced at the earnings event that Roche would no longer take CT-173 into human trials after assessing its “developability and competitiveness.”Despite this early-stage setback, Graham still feels that combinations offer Roche a path to carving out its own corner of the increasingly crowded obesity space.“Obesity is inherent in something like 200 other diseases,” she said. “So the ability to actually look at where we believe our portfolio in combination with other drugs can really help address some of these comorbidities is one of the more exciting pieces.”“This is an incredibly big market,” Graham added. “It is very diverse. There are a lot of scientific pathways to explore here.”One of those pathways is amylin, a hormone involved in the regulation of food intake. In March, Roche paid Zealand Pharma $1.6 billion for the long-acting amylin analog petrelintide. Graham sees the drug’s potential growing as the obesity market segments among patients “looking for maybe different depths of weight loss or different tolerability profiles.”Meanwhile, Roche has yet to make a final call on whether to take the GLP-1/GIP receptor agonist CT-388—another Carmot asset—into a phase 3 obesity trial, but Graham said the company is “right on the cusp” of taking that program forward.“We plan to make those decisions later this year, and, once we get rolling here, I think you\'re really going to see us flesh out our [obesity] strategy,” she said. When it comes to bringing new drugs into Roche’s pipeline, Graham was tight-lipped on which of the company’s five core focus areas—neurology, oncology/hematology, immunology, ophthalmology and CVRM (cardiovascular renal metabolic)—the company is prioritizing for M&A.“Clearly, within our five therapeutic areas, there are definitely places where we would like to bring in additional assets,” she told Fierce. “As Thomas [Schinecker] said, we look at an unbelievably large number of deals every year, and are constantly on the hunt, not only for things that will fit that strategy but things that are truly transformational.”With such a multifaceted pipeline, what are the readouts Graham is most excited about?“It\'s like trying to choose your favorite child,” she said, before name-checking the recent “super exciting” phase 2 results for the BTK inhibitor fenebrutinib in relapsing multiple sclerosis (MS). “It could be a really huge step forward for MS patients,” she explained.There’s also the “high-risk, high-reward bet” on the Parkinson’s drug prasinezumab, said Graham, who ended by referencing the IgG1 monoclonal antibody afimkibart.Along with CT-388 and the Alzheimer’s disease prospect trontinemab, afimkibart was one of the assets Roche fast-tracked as part of its reallocation of R&D resources.“I\'m an immunology girl at heart—it’s where I started my career,” Graham explained. “There\'s so much opportunity in the immunological space and so many diseases that we could potentially tackle with afimki.”

$\'We will crack gene therapy\': Elevidys fallout doesn\'t dent Roche\'s hopes for modality$

AcquisitionPhase 2Phase 3

24 Jul 2025

·www.globenewswire.com

[Ad hoc announcement pursuant to Art. 53 LR] Roche continues strong momentum with 7% growth (CER) in the first half of 2025

Basel, 24 July 2025 Group sales grew by 7%1 at constant exchange rates (CER; 4% in CHF), driven by strong demand for medicines.Pharmaceuticals Division sales rose by 10% (6% in CHF), with Phesgo (breast cancer), Xolair (food allergies), Hemlibra (haemophilia A), Vabysmo (severe eye diseases) and Ocrevus (multiple sclerosis) being the top growth drivers.Diagnostics Division sales were stable (-3% in CHF) as strong demand for pathology solutions and blood screening tests offset the impact of healthcare pricing reforms in China.Core operating profit increased by 11% (6% in CHF), driven by higher sales and effective cost management.Core earnings per share showed significant growth of 12% (8% in CHF); IFRS net income jumped by 23% (17% in CHF).Outlook for 2025 confirmed.Highlights: US approval for Susvimo for diabetic retinopathy, a potentially blinding eye diseaseEU approval for Itovebi for a type of advanced breast cancer and Evrysdi tablet for spinal muscular atrophyCHMP recommendation for EU label update for Phesgo for breast cancer to allow at-home administrationAdvancement of key molecules into phase III development: prasinezumab for early-stage Parkinsonߴs disease and zosurabalpin for life-threatening bacterial infectionsPositive data on several therapies: Lunsumio and Polivy combination and Columvi for blood cancer, Tecentriq for lung cancer, Itovebi and Perjeta for breast cancer and fenebrutinib for multiple sclerosis and NXT007 for haemophilia AIntroduction of innovative Elecsys PRO-C3 test to improve precision in evaluating liver fibrosis severityAnnouncement of new collaboration with Broad Clinical Labs to accelerate adoption of cutting-edge SBX sequencing technologyUS approval for VENTANA MET (SP44) RxDx Assay as the first companion diagnostic to identify a form of lung cancer in patients eligible for targeted treatmentUS Breakthrough Device Designation for first AI-driven companion diagnostic for non-small cell lung cancer Outlook for 2025 confirmedRoche (SIX: RO, ROG; OTCQX: RHHBY) expects an increase in Group sales in the mid single digit range (CER). Core earnings per share are targeted to develop in the high single digit range (CER). Roche expects to further increase its dividend in Swiss francs. Key figures CHF millions % change January–June 2025 2024 At CER1 In CHF Group sales 30,944 29,848 7 4 Pharmaceuticals Division 23,985 22,637 10 6 Diagnostics Division 6,959 7,211 0 -3 Core operating profit 12,010 11,293 11 6 Core EPS – diluted (CHF) 11.08 10.23 12 8 IFRS net income 7,832 6,697 23 17 Roche CEO Thomas Schinecker: “Roche’s strong growth momentum continued in the second quarter, driven by the strong growth of 11% at constant exchange rates in our Pharmaceuticals Division. We received numerous important approvals and reported positive data in disease areas with high unmet medical need. Over the past six months, we have made significant progress in our pipeline and advanced four potentially practice-changing therapies into the final phase of clinical development, based on encouraging data: NXT007 in haemophilia A, trontinemab in Alzheimer’s disease, prasinezumab in early-stage Parkinson’s disease, and zosurabalpin, a novel antibiotic that could become the first in over 50 years to tackle a type of bacteria that has become resistant to most other treatments. We are confident in our continued strong momentum and resilience of our business due to our innovative on-market portfolio and pipeline. Based on these strong results, we confirm our full-year outlook.” Group resultsIn the first half of 2025, Roche achieved sales growth of 7% (4% in CHF) to CHF 30.9 billion due to strong demand for pharmaceutical products. Core operating profit increased by 11% (6% in CHF) to CHF 12.0 billion, driven by higher sales and effective cost management. The appreciation of the Swiss franc against most currencies, notably the US dollar, had an adverse impact on the results when reported in Swiss francs compared to constant exchange rates. Core earnings per share increased by 12% (8% in CHF). IFRS net income increased by 23% (17% in CHF) to CHF 7.8 billion, driven by the strong operating performance and lower impairment charges related to intangible assets. Sales in the Pharmaceuticals Division increased by 10% (6% in CHF) to CHF 24.0 billion, with medicines for severe diseases continuing their strong growth. The top five growth drivers – Phesgo, Xolair, Hemlibra, Vabysmo and Ocrevus – achieved total sales of CHF 10.6 billion. This represents an increase of CHF 1.7 billion at CER compared to the first half of 2024. This more than compensated for the total decrease of CHF 0.3 billion (CER) in sales of the ‘loss of exclusivity (LOE)’ products – the decline in sales of Avastin (various types of cancer), Herceptin (breast and gastric cancer), MabThera/Rituxan (blood cancer, rheumatoid arthritis), Lucentis (severe eye diseases) and Esbriet (lung disease) was partially offset by an increase in sales of Actemra/RoActemra (rheumatoid arthritis). In the United States, sales rose by 10% due to continued growth of Xolair and continuing uptake of Hemlibra, Ocrevus, Vabysmo and Phesgo. This growth more than compensated for the decline in sales of medicines with expired patents. Sales in Europe grew 5% as the continued roll-out of Vabysmo and the continuing uptake of Ocrevus, Polivy and Phesgo more than compensated for lower sales of Perjeta (breast cancer) due to ongoing conversion of patients to Phesgo and the impact of biosimilar competition on Actemra/RoActemra sales. In Japan, sales increased by 5%, mainly due to the strong uptake of Phesgo, Vabysmo and PiaSky (paroxysmal nocturnal haemoglobinuria). Sales growth was partially offset by the decline in sales of Perjeta due to continued conversion of patients to Phesgo and of Avastin because of biosimilar erosion. Sales in the International region grew by 14%, led by Phesgo, Hemlibra, Xofluza (influenza), Vabysmo and Elevidys (Duchenne muscular dystrophy). In China, sales rose by 9%, driven by the uptake of Phesgo, strong sales of Xofluza and the roll-out of Polivy and Vabysmo. The Diagnostics Division’s sales remained stable (-3% in CHF) at CHF 7.0 billion as growth in demand for pathology solutions and blood screening tests offset the impact of healthcare pricing reforms in China. Sales in the Europe, Middle East and Africa (EMEA) region increased by 5%, driven by higher sales of clinical chemistry and immunodiagnostic products. In North America, sales increased by 6%, with growth across customer areas. Sales in Asia-Pacific decreased by 15% due to healthcare pricing reforms in China. Latin America sales grew by 14%. Pharmaceuticals: key developments Compound Milestone Regulatory ItovebiBreast cancer European Commission approves Itovebi for people with ER-positive, HER2-negative, advanced breast cancer with a PIK3CA mutation Approval based on INAVO120 data showing that the regimen based on Itovebi more than doubled progression-free survival compared with palbociclib and fulvestrant alone. Up to 40% of ER-positive breast cancers have a PIK3CA mutation and are associated with poor prognosis; this approval helps address an urgent unmet need.Itovebi is the first PI3K-targeted therapy to significantly extend survival, reinforcing the need for biomarker testing at diagnosis. More information: Media Release, 23 July 2025 EvrysdiSpinal muscular atrophy Evrysdi tablet approved by European Commission as first and only tablet for spinal muscular atrophy (SMA) Simplified storage and administration of new tablet formulation may provide greater freedom and independence for people with SMA.Evrysdi tablet offers the same efficacy and safety demonstrated in available oral solution.Evrysdi is the only non-invasive disease-modifying SMA treatment, with more than 18,000 people with SMA treated globally to date. More information: Media Release, 4 June 2025 SusvimoSevere eye diseases FDA approves Susvimo for diabetic retinopathy Susvimo can help people with diabetic retinopathy maintain their vision and prevent progression to blindness with only one treatment every nine months.The innovative technology of Susvimo via the Port Delivery Platform may offer an alternative to regular eye injections in the US.Diabetic retinopathy affects almost 10 million people in the US and is the third FDA-approved indication for Susvimo, which is also approved for treating neovascular or ‘wet’ age-related macular degeneration and diabetic macular oedema. More information: Media Release, 22 May 2025 ColumviBlood cancer Update on FDA Advisory Committee meeting on Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) Columvi is the first bispecific antibody to show a statistically significant and clinically meaningful 41% survival benefit in R/R DLBCL in the phase III STARGLO study.There is an urgent need for effective, immediately available therapies that are broadly accessible to people with transplant-ineligible R/R DLBCL.This first-of-its-kind Columvi combination could provide a much-needed, off-the-shelf and fixed-duration treatment option for patients who face poor prognosis.The clinical and disease characteristics of the overall population enrolled in this multiregional clinical trial are representative and applicable to US patients. More information: Media Release, 20 May 2025 Pharmaceuticals sales Sales CHF millions As % of sales % change January–June 2025 2024 2025 2024 At CER In CHF Pharmaceuticals Division 23,985 22,637 100.0 100.0 10 6 United States 12,670 11,882 52.8 52.5 10 7 Europe 4,566 4,425 19.0 19.5 5 3 Japan 1,425 1,366 5.9 6.0 5 4 International 5,324 4,964 22.3 22.0 14 7 International: Asia-Pacific, CEETRIS (Central Eastern Europe, Türkiye, Russia and Indian subcontinent), Latin America, Middle East, Africa, Canada, others Top 20 best-selling pharmaceuticals Total United States Europe Japan International CHF m % CHF m % CHF m % CHF m % CHF m % OcrevusMultiple sclerosis 3,506 8 2,462 5 706 12 - - 338 19 HemlibraHaemophilia A 2,421 17 1,324 11 493 7 183 8 421 66 VabysmoEye diseases (nAMD, DME, RVO) 2,067 18 1,450 9 378 33 70 31 169 118 TecentriqCancer immunotherapy 1,733 -1 819 -6 434 3 174 -4 306 13 Perjeta2Breast cancer 1,613 -12 677 1 282 -16 37 -44 617 -18 Xolair2Asthma, food allergies 1,445 34 1,445 34 - - - - - - Actemra/RoActemra2RA, COVID-19 1,279 4 619 7 308 -14 152 5 200 26 PhesgoBreast cancer 1,197 55 348 39 401 15 90 80 358 182 Kadcyla2Breast cancer 1,037 9 396 7 266 -6 45 -2 330 28 EvrysdiSpinal muscular atrophy 869 7 309 12 292 4 46 5 222 5 AlecensaLung cancer 802 8 276 20 133 -7 100 5 293 7 PolivyBlood cancer 730 46 327 32 160 90 99 8 144 88 MabThera/Rituxan2Blood cancer, RA 630 -8 387 -6 70 -8 7 -14 166 -11 Herceptin2Breast and gastric cancer 560 -21 121 -10 150 -1 4 -51 285 -32 Activase/TNKase2Cardiac diseases 550 -4 527 -3 - - - - 23 -25 Avastin2Various cancer types 522 -17 156 -20 26 -40 76 -25 264 -9 Gazyva/Gazyvaro2Blood cancer 490 14 253 20 121 1 17 20 99 14 Pulmozyme2Cystic fibrosis 239 11 167 22 34 -12 - -18 38 -3 CellCept2Immunosuppressant 196 2 9 -17 65 12 24 35 98 -6 Madopar2Parkinson’s disease 193 1 - - 46 -5 - - 147 4 DME: diabetic macular edema / nAMD: neovascular or ‘wet’ age-related macular degeneration / RVO: retinal vein occlusion / RA: rheumatoid arthritis Diagnostics: key developments Product Milestone SBX sequencing technologyGenetic disorders Roche announces new collaboration with Broad Clinical Labs to accelerate adoption of cutting-edge SBX sequencing technology The strategic collaboration with Broad Clinical Labs will explore and develop applications using Roche’s SBX sequencing technology, with an initial focus on critically ill newborns and their parents.Whole-genome sequencing can help diagnose babies with suspected genetic disorders, such as cystic fibrosis and sickle cell disease.This project will explore how this technology could become part of routine clinical practice for newborns, as well as its use in other research applications. More information: Media Release, 23 May 2025 VENTANA MET (SP44) RxDx AssayLung cancer FDA approves VENTANA MET (SP44) RxDx Assay as the first companion diagnostic to identify non-squamous non-small cell lung cancer patients eligible for targeted treatment The VENTANA MET (SP44) RxDx Assay detects the MET (also known as c-Met) protein, which is over-expressed in some patients with non-squamous non-small cell lung cancer.The MET protein serves as a predictive biomarker for the likelihood of a patient’s response to c-Met-targeted therapy.As the leader in companion diagnostics, Roche offers a broad CDx portfolio that helps enable informed clinical decisions and improved patient outcomes. More information: Media Release, 14 May 2025 Elecsys PRO-C3 testLiver fibrosis Roche introduces the innovative Elecsys PRO-C3 test to improve precision in evaluating liver fibrosis severity Elecsys PRO-C3, used with the ADAPT formula (age, diabetes status, PRO-C3, platelets), assesses the severity of liver fibrosis – a disease responsible for approximately one in every 25 deaths worldwide.The test delivers results in just 18 minutes on Roche’s cobas analysers, providing a fast and reliable diagnostic method.The test enables earlier identification of patients with significant liver fibrosis, potentially improving outcomes through timely management and access to emerging therapies. More information: Media Release, 6 May 2025 VENTANA TROP2 (EPR20043) RxDx deviceLung cancer FDA grants Roche Breakthrough Device Designation for the first AI-driven companion diagnostic for non-small cell lung cancer The VENTANA TROP2 (EPR20043) RxDx device is an immunohistochemistry assay combined with a digital pathology algorithm to determine patient treatment. The device uses AI-based image analysis with a level of diagnostic precision not possible with traditional manual scoring methods. This Breakthrough Device Designation demonstrates Roche’s continued innovation in companion diagnostics and digital pathology to enable more precise diagnosis in oncology. More information: Media Release, 29 April 2025 Chest pain triage algorithmAcute coronary syndrome Roche receives CE mark for its chest pain triage algorithm to enhance detection of acute coronary syndrome Roche, in collaboration with Universitätsklinikum Heidelberg, has developed a chest pain triage algorithm – a CE-marked IVD medical device set to transform cardiac care.This novel algorithm offers a standardised assessment, helping emergency room doctors to make confident clinical decisions in ruling in or ruling out heart attacks (acute myocardial infarction).Cardiovascular disease causes a third of worldwide deaths, with chest pain being the second highest reason for emergency department visits. More information: Media Release, 23 April 2025 PhesgoBreast cancer CHMP recommends EU label update for Phesgo to allow administration outside clinical settings Positive recommendation is based on clinical, real-world and bioequivalence data supporting feasibility and safety of the administration of Phesgo outside clinical settings, for example at home.Phesgo label expansion delivers on patients’ preference for at-home administration and is an important step in freeing up cancer care capacity in clinical settings.Phesgo has the potential to reduce treatment administration costs by up to 80% in Western Europe, and 85% of patients prefer subcutaneous over intravenous administration. More information: Media Release, 30 April 2025 Phase III, pivotal and other key read-outs AstegolimabChronic obstructive pulmonary disease (COPD) Roche provides update on astegolimab in chronic obstructive pulmonary disease The pivotal phase IIb ALIENTO study met the primary endpoint of a statistically significant reduction in the annualised exacerbation rate (AER) at 52 weeks when astegolimab was given every two weeks.The phase III ARNASA study did not meet the primary endpoint of a statistically significant reduction in the AER at 52 weeks.The safety profile of astegolimab was consistent with previously reported data, with no new safety signals identified. More information: Media Release, 21 July 2025 NXT007Haemophilia A Early data suggest NXT007 may have the potential to provide haemostatic normalisation in people with haemophilia A Positive phase I/II data presented at the 2025 International Society on Thrombosis and Haemostasis (ISTH) Congress show NXT007 achieved no bleeds requiring treatment in the highest-dose groups in people with haemophilia A.The NXT007 clinical development programme aims to normalise haemostasis and minimise treatment burden.Three phase III clinical studies on NXT007, a next-generation bispecific antibody, are set to begin in 2026. More information: Media Release, 23 June 2025 Lunsumio and PolivyBlood cancer Lunsumio and Polivy combination significantly prolongs remission for people with relapsed or refractory large B-cell lymphoma Pivotal phase III SUNMO study demonstrated an 11.5-month median progression-free survival – three times longer than R-GemOx.This well-tolerated investigational combination therapy avoids traditional chemotherapy and may be suitable for outpatient community care.These data demonstrate Roche’s commitment to providing options for diverse patient and healthcare system needs in this difficult-to-treat lymphoma. More information: Media Release, 20 June 2025 PrasinezumabParkinson’s disease Roche to advance prasinezumab into phase III development for early-stage Parkinson’s disease Results from phase IIb PADOVA and longer-term follow-up data suggest clinical benefit on top of symptomatic treatment in early-stage Parkinson’s disease.Prasinezumab is a potential first-in-class anti-alpha-synuclein antibody targeting a known biological driver of Parkinson’s disease progression.Parkinson’s disease affects over 10 million people globally and significant unmet need remains. More information: Media Release, 16 June 2025 TecentriqLung cancer Tecentriq combined with lurbinectedin shows significant survival benefit in extensive-stage small cell lung cancer (ES-SCLC) 46% reduction in the risk of disease progression or death, and 27% reduction in the risk of death, in an aggressive cancer type with limited survival and few treatment options.First phase III study in ES-SCLC first-line maintenance to demonstrate clinically meaningful improvements in both progression-free and overall survival. Data were presented in an oral session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in The Lancet. More information: Media Release, 3 June 2025 ItovebiBreast cancer New data show Itovebi significantly extended survival in a certain type of HR-positive advanced breast cancer The regimen based on Itovebi reduced the risk of death by more than 30% in people with PIK3CA-mutated HR-positive, HER2-negative advanced breast cancer, compared with palbociclib and fulvestrant alone.The PIK3CA mutation is found in approximately 40% of HR-positive advanced breast cancers and is associated with a poor prognosis.New data were presented in an oral session at the 2025 ASCO Annual Meeting and published in The New England Journal of Medicine. More information: Media Release, 31 May 2025 FenebrutinibMultiple sclerosis Fenebrutinib maintains near-complete suppression of disease activity and disability progression for up to two years in people with relapsing multiple sclerosis Patients on fenebrutinib had low relapse rates with data showing no active brain lesions or disability progression after nearly two years of treatment.Phase III studies for fenebrutinib in relapsing and primary progressive multiple sclerosis are expected to start reading out at year end. More information: Media Release, 30 May 2025 ColumviBlood cancer New two-year follow-up data show Columvi extends overall survival in relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) patients Updated data from the pivotal phase III STARGLO study continue to demonstrate a clinically meaningful improvement in overall survival with a 40% survival benefit for people with R/R DLBCL who are not candidates for transplant.89% of patients whose cancer had fully responded at the end of treatment with Columvi in combination with chemotherapy were still alive and 82% showed no signs of cancer one year post-treatment.Timely initiation of effective therapy at relapse or after initial therapy failure is critical for this aggressive, life-threatening disease. Results demonstrate the potential of the Columvi combination as a much-needed, off-the-shelf and fixed-duration treatment option. More information: Media Release, 23 May 2025 PerjetaBreast cancer Ten-year APHINITY data show regimen based on Perjeta reduced the risk of death by 17% in people with HER2-positive early-stage breast cancer Long-term follow-up in this curative setting demonstrated clinically meaningful survival benefit when adjuvant Perjeta was added to Herceptin and chemotherapy.21% reduction in the risk of death was seen in the pre-specified subgroup of people with lymph node-positive disease. More information: Media Release, 13 May 2025 Other Executive changes Changes to the Roche Enlarged Corporate Executive Committee Johannes (Hans) Clevers, MD, PhD, Head of Roche Pharma Research and Early Development (pRED) and member of the Enlarged Corporate Executive Committee, will be retiring from Roche. Barbara Schädler, Head of Group Communications and member of Roche’s Enlarged Corporate Executive Committee, will retire from the company at the end of the year. More information: Media Release, 30 June 2025 ElevidysDuchenne muscular dystrophy Roche provides safety update on Elevidys gene therapy for Duchenne muscular dystrophy in non-ambulatory patients After a thorough clinical review, the benefit-risk profile of Elevidys in non-ambulatory patients with Duchenne has been re-assessed following two cases of fatal acute liver failure.Effective immediately, dosing of non-ambulatory patients, irrespective of age, is paused in the clinical setting; dosing of non-ambulatory patients is discontinued in the commercial setting.Roche is working closely with relevant health authorities, investigators and prescribing physicians to ensure they are informed and patient care is being appropriately modified.The benefit-risk profile of Elevidys treatment in ambulatory Duchenne patients remains positive and treatment guidance is unchanged. More information: Media Release, 15 June 2025 XofluzaInfluenza The New England Journal of Medicine publishes phase III data showing single-dose Xofluza significantly reduces influenza virus transmission Detailed results from the CENTERSTONE trial show treatment with Xofluza reduced the odds of transmission, or spread, of the influenza virus from an infected person to household members by 32%.CENTERSTONE is the first global phase III trial that demonstrates the benefit of an antiviral in reducing the spread of a respiratory virus.Reducing the spread of infection within households could help limit transmission within institutions and communities, potentially easing the burden of both seasonal and pandemic influenza on healthcare systems. More information: Media Release, 25 April 2025 Diagnostics sales Sales CHF millions As % of sales % change January–June 2025 2024 2025 2024 At CER In CHF Diagnostics Division 6,959 7,211 100.0 100.0 0 -3 Customer areas3 Core Lab 3,839 4,072 55.2 56.5 -2 -6 Molecular Lab 1,250 1,257 18.0 17.4 3 -1 Near Patient Care 1,018 1,094 14.6 15.2 -3 -7 Pathology Lab 852 788 12.2 10.9 12 8 Regions Europe, Middle East, Africa 2,485 2,431 35.7 33.7 5 2 North America 2,235 2,163 32.1 30.0 6 3 Asia-Pacific 1,729 2,102 24.9 29.2 -15 -18 Latin America 510 515 7.3 7.1 14 -1 More information on Roche performance in the first half of 2025: HY 2025 Finance ReportHY 2025 presentationAppendix with tables 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] Unless otherwise stated, all growth rates and comparisons to the previous year in this document are at constant exchange rates (CER: average rates 2024) and all total figures quoted are reported in CHF.[2] Products launched before 2015.[3] Core Lab: diagnostics solutions in the areas of immunoassays, clinical chemistry and CustomBiotech.Molecular Lab: diagnostics solutions for pathogen detection and monitoring, donor screening, sexual health and genomics, genomic tumour profiling.Near Patient Care: diagnostics solutions in emergency rooms, medical practices and directly with patients, including integrated personalised diabetes management.Pathology Lab: diagnostics solutions for tissue biopsies and companion diagnostics.In 2025, sales in the Pathology Lab customer area include sales previously reported in the Molecular Lab customer area to foster business transparency and harmonisation in the use of solutions in the area of cervical intraepithelial neoplasia technology (CINtec). The comparative information for 2024 has been restated accordingly.In 2025, sales in the Core Lab customer area include sales previously reported in the Near Patient Care customer area to centralise digital healthcare solutions within Roche Information Solutions. The comparative information for 2024 has been restated accordingly Cautionary statement regarding forward-looking statementsThis document contains certain forward-looking statements. These forward-looking statements may be identified by words such as ‘believes’, ‘expects’, ‘anticipates’, ‘projects’, ‘intends’, ‘should’, ‘seeks’, ‘estimates’, ‘future’ or similar expressions or by discussion of, among other things, strategy, goals, plans or intentions. Various factors may cause actual results to differ materially in the future from those reflected in forward-looking statements contained in this document, such as: (1) pricing and product initiatives of competitors; (2) legislative and regulatory developments and economic conditions; (3) delay or inability in obtaining regulatory approvals or bringing products to market; (4) fluctuations in currency exchange rates and general financial market conditions; (5) uncertainties in the discovery, development or marketing of new products or new uses of existing products, including without limitation negative results of clinical trials or research projects, unexpected side effects of pipeline or marketed products; (6) increased government pricing pressures; (7) interruptions in production; (8) loss of or inability to obtain adequate protection for intellectual property rights; (9) litigation; (10) loss of key executives or other employees; and (11) adverse publicity and news coverage. The statement regarding earnings per share growth is not a profit forecast and should not be interpreted to mean that Roche’s earnings or earnings per share for this or any subsequent period will necessarily match or exceed the historical published earnings or earnings per share of Roche. Roche Global Media RelationsPhone: +41 61 688 8888 / e-mail: media.relations@roche.com Hans Trees, PhDPhone: +41 79 407 72 58 Sileia UrechPhone: +41 79 935 81 48 Nathalie AltermattPhone: +41 79 771 05 25 Lorena CorfasPhone: +41 79 568 24 95 Simon GoldsboroughPhone: +44 797 32 72 915 Karsten KleinePhone: +41 79 461 86 83 Dr Rebekka SchnellPhone: +41 79 205 27 03 Kirti PandeyPhone: +49 172 636 72 62 Yvette PetillonPhone: +41 79 961 92 50 Roche Investor Relations Dr Bruno EschliPhone: +41 61 687 52 84e-mail: bruno.eschli@roche.com Dr Sabine BorngräberPhone: +41 61 688 80 27e-mail: sabine.borngraeber@roche.com Dr Birgit MasjostPhone: +41 61 688 48 14e-mail: birgit.masjost@roche.com Investor Relations North America Loren KalmPhone: +1 650 225 32 17e-mail: kalm.loren@gene.com Attachments Media Investor Release Roche HY results 2025 English Communications appendix tables_HY 2025_Sales_Results

Clinical ResultDrug ApprovalPhase 3Phase 2

30 May 2025

·endpoints.news

Roche’s 96-week data for multiple sclerosis drug; ZymeWorks claims $20M milestone

Plus, news about Diakonos Oncology and Coherus: Roche’s longer-term data for multiple sclerosis drug: The Swiss drugmaker’s BTK inhibitor fenebrutinib achieved an annualized relapse rate of 0.06 in 93 people with relapsing multiple sclerosis who were followed for up to 96 weeks. The number equates to roughly one relapse every 17 years. The patients were enrolled in the open-label extension portion of the Phase 2 FENopta trial. — Ayisha Sharma Zymeworks clinches $20M milestone for China approval: BeOne Medicines, formerly known as BeiGene, secured a conditional China approval for the HER2-targeted bispecific antibody zanidatamab in certain biliary tract cancers. BeOne is partnered with the Canadian biotech. Besides the $20 million, Zymeworks is eligible for a further $144 million in milestones under the terms of its pact with BeOne. — Ayisha Sharma Diakonos Oncology secures $20M financing for brain tumor asset: The Houston-based biotech plans to use the proceeds to fund an ongoing Phase 2 trial of dubodencel in glioblastoma and expand the program into other indications, including refractory melanoma. The private placement was supported by new investors Baylor College of Medicine, the Brain Tumor Investment Fund and the Buttonwood Titan QC Fund. — Ayisha Sharma Coherus BioSciences updates its name: The biotech officially changed its name to “Coherus Oncology,” to better reflect its focus on developing immuno-oncology therapies. — Jaimy Lee

Phase 2Clinical ResultDrug ApprovalLicense out/inImmunotherapy

100 Deals associated with Fenebrutinib

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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Multiple sclerosis relapse	Phase 3	United States	Hoffmann-La Roche, Inc.	17 Mar 2021
Multiple sclerosis relapse	Phase 3	China	Hoffmann-La Roche, Inc.	17 Mar 2021
Multiple sclerosis relapse	Phase 3	Argentina	Hoffmann-La Roche, Inc.	17 Mar 2021
Multiple sclerosis relapse	Phase 3	Dominican Republic	Hoffmann-La Roche, Inc.	17 Mar 2021
Multiple sclerosis relapse	Phase 3	Finland	Hoffmann-La Roche, Inc.	17 Mar 2021
Multiple sclerosis relapse	Phase 3	Germany	Hoffmann-La Roche, Inc.	17 Mar 2021
Multiple sclerosis relapse	Phase 3	Hong Kong	Hoffmann-La Roche, Inc.	17 Mar 2021
Multiple sclerosis relapse	Phase 3	Hungary	Hoffmann-La Roche, Inc.	17 Mar 2021
Multiple sclerosis relapse	Phase 3	Italy	Hoffmann-La Roche, Inc.	17 Mar 2021
Multiple sclerosis relapse	Phase 3	Kenya	Hoffmann-La Roche, Inc.	17 Mar 2021

Clinical Result

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05119569 (FENopta, Company_Website) Manual	Phase 2	Multiple sclerosis relapse	99	fenebrutinib	svokjlquuo(odbamjvdnk) = xolwvfsbvh rbxgeocnnf (ufijvnsgvs )	Positive	30 May 2025
NCT05119569 (FENopta, AAN2025)	Phase 2	Multiple sclerosis relapse	99	Fenebrutinib 200 mg	uxezgkwylr(qgcvygoead) = An asymptomatic alanine transaminase elevation occurred newly in one OLE participant (1%) that resolved rscwcskqxi (obfownmhjg ) View more	Positive	07 Apr 2025
				Placebo
NCT05119569 (FENopta-OLE, GlobeNewswire) Manual	Phase 2	Multiple sclerosis relapse	109	Fenebrutinib	zfbbnpcwig(pgerwohuvq) = zeqejrhmjc llveuqpfvc (vjzwakbxvy ) View more	Positive	04 Sep 2024
AAN2024	Phase 1	-	-	Fenebrutinib 400 mg	ypkeharkcy(saojiphpsg) = Both doses were well tolerated, and no serious adverse events (AEs), AEs of special interest or Grade ≥2 AEs were reported mvzmmluowr (rftdybdrmh )	Positive	09 Apr 2024
				Fenebrutinib 700 mg
NCT04586010 (FENhance, Biospace) Manual	Phase 3	Multiple sclerosis relapse	-	fenebrutinib	hxxxhqitzy(rgknchonri) = gbgcrsamri ofjirnkkmd (eeyyyxzujq )	Negative	05 Dec 2023
NCT05119569 (FENopta, ECTRIMS2023) Manual	Phase 2	Multiple Sclerosis	106	Fenebrutinib 200 mg	zlebrqnpix(mwizswkqph) = kerqhvprci gbmgugpesb (voisvsvprf ) View more	Positive	17 Oct 2023
				Placebo	zlebrqnpix(mwizswkqph) = ofqzspzjzt gbmgugpesb (voisvsvprf ) View more
NCT03407482 (CTgov)	Phase 2	Systemic Lupus Erythematosus	160	GDC-0853	vjlrnmdxvm = xyayepaxue yessiszdrz (jdzcsohhgr, yueewtbtvz - prirmzirde) View more	-	19 Dec 2020
NCT03137069 (CTgov)	Phase 2	Chronic Urticaria	134	Placebo (Cohort 1: Placebo)	orhlkhbwwn(wydktrntvp) = fbtddxjilg fhmpeawsqm (fljssnybbo, 13.49) View more	-	29 Sep 2020
				GDC-0853 (Cohort 1: GDC-0853 200mg BID)	orhlkhbwwn(wydktrntvp) = wlzvffuxgh fhmpeawsqm (fljssnybbo, 9.74) View more
NCT03693625 (CTgov)	Phase 2	Chronic Urticaria	31	GDC-0853 (Parent Study: GDC-0853)	ptyfvempwh = egstkdseod rcfxmxwyzf (fopljusnxe, zamrcmfhyw - ijmmxsjzic) View more	-	25 Sep 2020
				GDC-0853 (Parent Study: Placebo)	ptyfvempwh = jckkxercje rcfxmxwyzf (fopljusnxe, nosxzhjlot - gpsujtxxly) View more
NCT02983227 (CTgov)	Phase 2	Rheumatoid Arthritis	496	GDC-0853 (GDC-0853 (200mg BID) Cohort 1)	bbifkseqwb = xtnqnxnegp oflahpklha (kulvmmoxqf, agowlbaeep - onxibviefv) View more	-	03 Aug 2020
				GDC-0853 (GDC-0853 (200mg BID) Cohort 2)	bbifkseqwb = lpkfgyqjin oflahpklha (kulvmmoxqf, qycdegasrj - hyjsdgcrww) View more

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