RegulationBreakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), PRIME (European Union), Conditional marketing approval (China), Orphan Drug (Japan), Orphan Drug (South Korea), Priority Review (Australia), Priority Review (United States)

Structure/Sequence

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Sequence Code 31655L

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Sequence Code 9976257H

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110

Clinical Trials associated with Polatuzumab Vedotin-Piiq

NCT07714421

/ Not yet recruitingPhase 1IIT

A Phase I Study of Single Agent Epcoritamab Followed by Epcoritamab Plus Pola-R-Mini-CHP for Elderly/Unfit Patients With Previously Untreated DLBCL

This phase I trial tests the safety, side effects and best dose of epcoritamab alone and epcoritamab with polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone (pola-R- mini-CHP) for the treatment of diffuse large B cell lymphoma (DLBCL) in elderly or unfit patients. Epcoritamab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Polatuzumab vedotin is a monoclonal antibody, called polatuzumab, linked to a chemotherapy drug, called monomethyl auristatin E. Polatuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as B-cell receptors, and delivers monomethyl auristatin E to kill them. Rituximab is a monoclonal antibody. It binds to a protein called cluster of differentiation antigen 20 (CD20), which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells. It may also lower the body's immune response. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's DNA and may kill cancer cells. It also blocks a certain enzyme needed for cell division and deoxyribonucleic acid (DNA) repair. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Epcoritamab alone and epcoritamab with pola-R-mini-CHP may be safe, tolerable and/or effective in treating DLBCL in elderly or unfit patients.

Start Date08 Dec 2026

Sponsor / Collaborator

Jonsson Comprehensive Cancer Center

[+1]

NCT07638722

/ Not yet recruitingPhase 2IIT

MOZART MZL: A Randomized Phase II Study Evaluating Mosunetuzumab Alone and in Combination With Either Zanubrutinib or Polatuzumab Vedotin for the Treatment of Patients With Relapsed/Refractory Marginal Zone Lymphoma

This phase II trial compares the effect of mosunetuzumab alone to mosunetuzumab with zanubrutinib or polatuzumab vedotin in patients with marginal zone lymphoma that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). Mosunetuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Zanubrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell (a type of white blood cells) cancers such as marginal zone lymphoma at abnormal levels. This may help keep cancer cells from growing and spreading. Polatuzumab vedotin is a monoclonal antibody, called polatuzumab, linked to a drug, called monomethyl auristatin E. Polatuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD79B receptors, and delivers monomethyl auristatin E to kill them. Giving mosunetuzumab alone or with zanubrutinib or polatuzumab vedotin may work well for treating relapsed or refractory marginal zone lymphoma.

Start Date03 Oct 2026

Sponsor / Collaborator

SWOG

[+1]

NCT07702851

/ Not yet recruitingPhase 2IIT

A PROSPECTIVE MULTICENTER PHASE 2 STUDY OF THE CHEMOTHERAPY-FREE COMBINATION OF POLATUZUMAB VEDOTIN AND GLOFITAMAB IN PATIENTS WITH RELAPSED OR REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA WITHIN 12 MONTHS OF R-CHOP TREATMENT

Patients with diffuse large B-cell lymphoma (DLBCL) who are primary refractory to first-line R-CHOP therapy or relapse within 12 months after R-CHOP have a poor prognosis and limited treatment options. Conventional salvage chemotherapy has limited efficacy, and CAR-T cell therapy may be limited by manufacturing time, accessibility, and patient condition. Therefore, an immediately available, chemotherapy-free treatment strategy that may reduce the cumulative toxicity of conventional cytotoxic chemotherapy is needed.
Polatuzumab vedotin is a CD79b-targeted antibody-drug conjugate that delivers a cytotoxic agent to malignant B cells, and glofitamab is a CD20×CD3 bispecific antibody that activates T cells and induces immune-mediated antitumor activity. The combination of these two agents may provide complementary antitumor effects through direct tumor cell killing and T-cell-mediated immune response.
This single-arm, open-label, phase 2 study will evaluate the efficacy and safety of polatuzumab vedotin in combination with glofitamab in patients with DLBCL who are primary refractory to or relapse within 12 months after first-line R-CHOP therapy. Approximately 47 participants will be enrolled. The primary endpoint is the complete response rate at the end of treatment, as assessed by the investigator according to Lugano 2014 criteria.

Start Date01 Sep 2026

Sponsor / Collaborator

Yonsei University

100 Clinical Results associated with Polatuzumab Vedotin-Piiq

100 Translational Medicine associated with Polatuzumab Vedotin-Piiq

100 Patents (Medical) associated with Polatuzumab Vedotin-Piiq

747

Literatures (Medical) associated with Polatuzumab Vedotin-Piiq

01 Jul 2026·Physiological Reports

Physiologically relevant media are associated with overlapping metabolic responses in primary human hepatocytes and Huh7 cells

Article

Author: Sanna, Fabio ; Dennis, Kaitlyn M. J. H. ; Smith, Kieran ; Nagarajan, Shilpa R. ; Hodson, Leanne ; Cross, Eloise ; Westcott, Felix

Abstract:

The initiation and progression of metabolic dysfunction‐associated steatotic liver disease (MASLD) is challenging to study in vivo in humans, and robust in vitro high‐fidelity disease models are limited. Although primary human hepatocytes (PHH) are often considered to be the gold standard, immortalized hepatic cell lines are often utilized because of their scalability and experimental tractability. Therefore, the aim of this study was to compare the metabolic responses of PHHs with our characterized Huh7‐based model when exposed to the physiologically relevant fatty acid (FA) mixtures. PHH and Huh7 cells were treated with 2% human serum and a combination of sugar and FAs enriched in either unsaturated (OPLA) or saturated (POLA) FAs for 4 or 7 days, respectively. Stable isotope tracers were utilized to investigate basal changes in hepatocyte metabolism in response to different treatment regimes. Changes in cell viability, media biochemistry, intracellular metabolism, lipid droplet morphology, and gene expression were quantified. Huh7 cells had greater viability than PHH, while NEFA uptake and triglyceride secretion were similar. Both OPLA and POLA increased the proportion of large lipid droplets in Huh7 cells, whereas only OPLA produced comparable effects in PHH. Despite higher baseline TG in PHH, both models showed similar lipid composition, de novo lipogenic responses, and glycogen levels. Compared to Huh7 cells, PHH exhibited higher media 3‐hydroxybutyrate, lower media lactate, reduced glucose uptake, and donor‐dependent transcriptomic variability. Our data demonstrate that Huh7 cells are metabolically adaptable and, when cultured in physiologically relevant media, metabolic readouts are more similar to those observed in PHH cells, thus making Huh7 a potentially useful workhorse model to investigate relevant pathways that may underpin the development of MASLD. Progress in MASLD research is constrained by limited access to human liver tissue and the scarcity of robust in vitro models. Although PHHs are considered the gold standard, they can be limited by poor viability and donor‐to‐donor variability. Huh7 cells are metabolically flexible and can recapitulate key metabolic responses of PHH when exposed to physiologically‐relevant chronic culture conditions, making them an alternative to PHH that is a scalable and reproducible model for investigating intrahepatic triglyceride (IHCTG) accumulation and MASLD progression.

01 Jul 2026·INTERNAL MEDICINE

Hereditary Neuropathy with Liability to Pressure Palsies Unmasked by Polatuzumab Vedotin-containing Chemotherapy

Article

Author: Yoshikawa, Masaaki ; Suzuyama, Kohei ; Hoshino, Yuki ; Goto, Yuta ; Shichijo, Chika ; Ide, Toshihiro ; Kawanami, Takeru ; Koike, Haruki ; Hirahara, Rintaro

We report the case of a 49-year-old man with hereditary neuropathy with liability to pressure palsies unmasked by polatuzumab vedotin-containing chemotherapy. Neuropathic symptoms were predominant in areas surrounding the right and left ulnar nerves after the first course of chemotherapy. However, they progressed in a stepwise manner, involving other limb regions, after the second and third courses. Nerve conduction studies revealed demyelinating neuropathy conspicuous at the compression sites, and fluorescence in situ hybridization showed deletion of the PMP22 gene. This case underscores the importance of considering the development or exacerbation of hereditary neuropathies including hereditary neuropathy with liability to pressure palsies in patients receiving polatuzumab vedotin.

01 Jul 2026·International Journal of Clinical Oncology

Emerging treatment strategies for newly diagnosed diffuse large B-cell lymphoma

Review

Author: Miyazaki, Kana

Abstract:

Despite recent progress in improving patient survival, the outcomes in approximately 40% of patients with diffuse large B-cell lymphoma (DLBCL) remain poor. For many years, R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) has been the standard first-line treatment for DLBCL; however, pola-R-CHP (polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone) has recently emerged as a new treatment option. In parallel, novel molecularly targeted therapies that target signaling pathways, cellular antigens, and epigenetic regulators associated with high-risk DLBCL are in development. Treatment strategies tailored to the cell of origin or to specific molecular subtypes are also being explored using subtype-specific targeted agents. In addition, agents that have demonstrated efficacy in patients with relapsed or refractory DLBCL—such as the anti-CD19 antibody tafasitamab and immunomodulatory drugs such as golcadomide—are currently under investigation for use in newly diagnosed patients. Immunotherapies, including anti-CD19-chimeric antigen receptor-T therapy and CD20×CD3 bispecific antibodies (BsAbs), have significantly improved outcomes in patients with relapsed or refractory disease and are now under evaluation as early-line therapies. BsAbs can enable more flexible treatment strategies, including combination regimens with cytotoxic or chemotherapy-free approaches. This review summarizes recent advances and ongoing trials that are investigating novel therapeutic strategies for newly diagnosed DLBCL that may soon be incorporated into clinical practice.

188

News (Medical) associated with Polatuzumab Vedotin-Piiq

23 Jul 2026

·www.biospace.com

[Ad hoc announcement pursuant to Art. 53 LR] Roche’s strong momentum continues in the first half of 2026, delivering +6% sales growth at constant exchange rates; -2% in CHF due to the significant appreciation of the Swiss franc

Group sales were +6% at constant exchange rates (CER) 1 , -2% when reported in CHF and +8% in USD 2 , in the first six months, driven by high demand for innovative medicines and diagnostics. Pharmaceuticals Division sales were +6% at CER, -1% when reported in CHF and +8% in USD, due to continued high growth in sales of our medicines across disease areas; Xolair (allergic asthma, chronic hives, food allergies), Hemlibra (haemophilia A), Ocrevus (multiple sclerosis), Phesgo (breast cancer) and Vabysmo (severe eye diseases) were the top growth drivers. Diagnostics Division sales were +3% at CER, -3% when reported in CHF and +6% in USD, driven by demand for immunodiagnostic and clinical chemistry products as well as pathology and molecular solutions. Core operating profit was +10% at CER, -1% when reported in CHF, driven by higher sales and other revenue; IFRS operating profit was -6% in CHF due to the appreciation of the Swiss franc. Core earnings per share were +9% at CER (-2% in CHF); IFRS diluted earnings per share were -8% in CHF due to the appreciation of the Swiss franc. Highlights: US Priority Reviews for giredestrant in an early-stage breast cancer, Enspryng in thyroid eye disease, Tecentriq in colon cancer as well as Gazyva/Gazyvaro in idiopathic nephrotic syndrome and primary membranous nephropathy, two autoimmune diseases affecting the kidneys US acceptance of a supplemental Biologics License Application for the Lunsumio and Polivy combination for blood cancer and Gazyva/Gazyvaro for systemic lupus erythematosus Positive phase III data on divarasib in lung cancer; presentation of promising data on fenebrutinib in multiple sclerosis (phase III), Gazyva/Gazyvaro in three autoimmune diseases (phase III) and enicepatide (CT-388) and petrelintide in obesity (phase II) Launch of Axelios 1 , a transformative next-generation sequencing platform based on the innovative SBX technology, enabling the fastest DNA sequencing at scale EU CE mark for two blood tests: Elecsys pTau217 to detect Alzheimer’s pathology and Elecsys IGRA TB to identify latent tuberculosis infection US approval for Ventana PTEN (SP218) RxDx Assay , the first companion diagnostic to assess the levels of a key protein in prostate cancer Global collaboration agreement with Nurix Therapeutics for the BTK degrader bexobrutideg across malignant haematology, immunology and neurology Agreement to acquire PathAI to transform AI-driven diagnostics Outlook for 2026 confirmed. Outlook for 2026 Roche (SIX: RO, ROP; OTCQX: RHHBY) expects an increase in Group sales in the mid single digit range (CER) for 2026. 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 2026 2025 At CER 1 In CHF In USD Group sales 30,364 30,944 6 -2 8 Pharmaceuticals Division 23,629 23,985 6 -1 8 Diagnostics Division 6,735 6,959 3 -3 6 Core operating profit 11,856 12,010 10 -1 Core EPS – diluted (CHF) 10.85 11.08 9 -2 IFRS operating profit 9,671 10,330 6 -6 Roche CEO Thomas Schinecker : “Our strong momentum continued in the first half of the year, driven by a 6% sales increase at constant exchange rates and significant positive pipeline development. We reported positive phase III data for divarasib , reinforcing its potential as a best-in-class therapy in advanced lung cancer. Our regulatory momentum accelerated significantly as the US FDA granted five Priority Reviews: giredestrant in early-stage breast cancer, Enspryng in thyroid eye disease, Tecentriq in colon cancer and Gazyva/Gazyvaro in two autoimmune kidney diseases. In Diagnostics, we reached major milestones with the launch of our transformative, highly cost-effective Axelios 1 sequencing solution, alongside EU CE mark for key diagnostic tests, including the Elecsys pTau217 blood test for Alzheimer’s pathology and the Elecsys IGRA TB blood test, which delivers automated, scalable latent tuberculosis screening to laboratories worldwide. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); Backed by our robust pipeline, we are well-positioned for sustained future growth. We confirm our outlook.” Group results In the first six months of 2026, Roche sales were +6% at CER, -2% when reported in CHF, to CHF 30.4 billion due to strong demand for pharmaceutical products and diagnostic solutions. The appreciation of the Swiss franc against most currencies, notably the US dollar, had a significant impact on the results reported in Swiss francs compared to constant exchange rates. Core operating profit was +10% at CER (-1% in CHF) to CHF 11.9 billion, driven by higher sales and other revenue. Core earnings per share were +9% at CER (-2% in CHF). IFRS operating profit was -6% in CHF to CHF 9.7 billion. IFRS diluted earnings per share were -8% in CHF. The IFRS results were impacted by the appreciation of the Swiss franc. Sales in the Pharmaceuticals Division were +6% at CER, -1% when reported in CHF, to CHF 23.6 billion, with our medicines across disease areas continuing their strong growth. The top five growth drivers – Xolair, Hemlibra, Ocrevus, Phesgo and Vabysmo – achieved total sales of CHF 11.0 billion, an increase of 12% at CER, or 4% in CHF, compared to the first six months of 2025. Sales of products with expired patents (Avastin, Herceptin, MabThera/Rituxan, Lucentis and Actemra/RoActemra) were CHF 2.6 billion, a decrease of 8% at CER, or 15% in CHF, compared to the first six months of 2025. In the United States , sales were +6% at CER, -3% when reported in CHF, due to continued growth of Xolair, Hemlibra, Polivy (blood cancer) and Tecentriq. This growth more than compensated for the lower sales of Perjeta (breast cancer) and Kadcyla (breast cancer) as well as the impact of biosimilar erosion on Actemra/RoActemra (rheumatoid arthritis). Sales in Europe were +1% at CER, or -1% when reported in CHF, as demand for Ocrevus, Evrysdi (spinal muscular atrophy) and Phesgo more than offset the impact of lower sales of Actemra/RoActemra due to biosimilar competition and Perjeta because of the conversion of patients to Phesgo. In Japan , sales were +11% at CER, -5% when reported in CHF, mainly due to product supply to third parties, as well as the uptake of Elevidys (Duchenne muscular dystrophy) and continued growth of Lunsumio (blood cancer), Vabysmo and Hemlibra. Sales in the International region were +10% at CER, or +4% when reported in CHF, led by Phesgo, Vabysmo, Hemlibra, Ocrevus and Polivy. In China, sales were -9% at CER, or -12% when reported in CHF, due to the base effect of a severe flu season in 2025 on Xofluza sales. The Diagnostics Division’s sales were +3% at CER, -3% when reported in CHF, to CHF 6.7 billion, driven by growth in demand for immunodiagnostic and clinical chemistry products as well as pathology and molecular solutions. This growth more than offset the impact of healthcare pricing reforms in China. Sales in the Europe, Middle East and Africa (EMEA) region were +3% at CER, -1% when reported in CHF, driven by higher sales of immunodiagnostic products, the clinical chemistry portfolio and molecular solutions. In North America , sales were +8% at CER, -1% when reported in CHF, due to growth across the Core Lab and Pathology Lab customer areas. Sales in Asia-Pacific were -5% at CER, or -12% when reported in CHF, mainly due to the healthcare pricing reforms in China, partially offset by growth in demand for clinical chemistry and immunodiagnostic products across the rest of the region. In Latin America , sales were +10% at CER, or +5% when reported in CHF. Pharmaceuticals: key developments Compound Milestone Regulatory Gazyva/Gazyvaro Several autoimmune diseases FDA grants Priority Review for Roche’s Gazyva/Gazyvaro for adults with primary membranous nephropathy (pMN) The Priority Review decision is based on results from the phase III MAJESTY study, where Gazyva/Gazyvaro achieved significantly higher complete remission rates at two years compared to tacrolimus. If approved, Gazyva/Gazyvaro will be the first FDA-approved therapy for pMN, following global approvals in lupus nephritis and ongoing regulatory filings in systemic lupus erythematosus and idiopathic nephrotic syndrome. pMN is a chronic autoimmune disease with no FDA- or EMA-approved therapies to date; when left untreated, up to 30% of patients progress to kidney failure over a period of 10 years. More information: Media Release , 15 July 2026 Enspryng Thyroid eye disease FDA grants Priority Review for Enspryng, the first and only at-home subcutaneous treatment option for thyroid eye disease (TED) The filing application is based on improvements seen across key efficacy endpoints from the global phase III SatraGO-1 and SatraGO-2 studies, including proptosis (bulging eyes) and diplopia (double vision) in active TED. Enspryng has the potential to become the first at-home subcutaneous disease-modifying standard of care for TED. TED is an autoimmune disease affecting approximately 155 out of every 100,000 people that can lead to facial disfigurement and vision-threatening complications if left untreated. More information: Media Release , 30 June 2026 Lunsumio and Polivy Blood cancer FDA accepts supplemental Biologics License Application for Lunsumio and Polivy combination for relapsed or refractory large B-cell lymphoma (LBCL) Filing acceptance is based on data from the phase III SUNMO study, where subcutaneous Lunsumio VELO plus Polivy demonstrated a 59% reduction in risk of disease progression or death. People with relapsed or refractory LBCL represent a population with one of the highest unmet needs in lymphoma and require timely access to effective therapies. If approved, this outpatient-ready regimen could enable access to care in the community setting, where most US patients receive treatment. More information: Media release , 18 June 2026 Tecentriq Colon cancer FDA grants Priority Review for Tecentriq for a certain type of stage III colon cancer Filing acceptance is based on data from the phase III Alliance ATOMIC study showing Tecentriq plus chemotherapy reduced recurrence or death risk by 50% versus chemotherapy alone. Nearly one in three patients with stage III colon cancer relapses within five years, highlighting a critical need for new adjuvant treatment options. If approved, Tecentriq plus chemotherapy could provide a new standard of care for the treatment of stage III dMMR/MSI-H colon cancer after surgery. More information: Media Release , 11 June 2026 Giredestrant Breast cancer FDA accepts New Drug Application for giredestrant in ER-positive early-stage breast cancer, the first and only oral selective oestrogen receptor degrader with positive phase III results in the curative setting Filing acceptance, under Priority Review, is based on phase III data showing giredestrant reduced the risk of invasive disease recurrence or death by 30% compared with standard-of-care endocrine therapy. Giredestrant represents the first significant advance in adjuvant endocrine therapy in over 20 years. Giredestrant has the potential to become a new standard-of-care in the adjuvant setting; more than 90% of ER-positive breast cancer cases are diagnosed at an early stage (I‒III). The FDA has set a Prescription Drug User Fee Act date of 30 November 2026. More information: Media Release , 2 June 2026 Phase III, pivotal and other key read-outs Divarasib Lung cancer Divarasib shows superiority in head-to-head phase III trial against approved KRAS G12C inhibitors in non-small cell lung cancer Phase III (Krascendo 1) demonstrates best-in-class potential for patients with previously treated advanced KRAS G12C non-small cell lung cancer. Divarasib showed clinically meaningful improvements in progression-free survival compared to approved KRAS G12C inhibitors; no new safety signals were observed. Statistical significance for overall survival was achieved at the interim analysis in this poor-prognosis patient population. More information: Media Release , 2 July 2026 Fenebrutinib Multiple sclerosis Fenebrutinib significantly reduces relapses versus standard of care to approximately one every 17 years in relapsing multiple sclerosis (RMS) Late-breaking phase III FENhance 1 and 2 study results showed superiority of investigational fenebrutinib compared to teriflunomide in reducing relapses and brain lesions in RMS. Both studies showed positive trends in reducing disability progression with fenebrutinib compared to teriflunomide. Fenebrutinib could become a first-in-class BTK inhibitor and the first and only high-efficacy oral medication for both RMS and primary progressive multiple sclerosis (PPMS). More information: Media Release , 22 April 2026 Other Alzheimer’s integrated portfolio presentation Roche presents new data on Alzheimer’s disease from across its integrated pharmaceuticals and diagnostics portfolio at AAIC Five oral presentations in a featured research session highlighted trontinemab, including new long-term data from the phase Ib/IIa Brainshuttle AD study and the design of phase III PrevenTRON study in preclinical Alzheimer’s disease. New data on Roche’s CE-marked Elecsys pTau217 blood test were presented on its use for the diagnosis of Alzheimer’s disease in both primary and secondary care. More information: Media Release , 7 July 2026 Nurix Therapeutics collaboration Roche announces global collaboration with Nurix Therapeutics to co-develop and co-commercialise potential best-in-class BTK degrader bexobrutideg across malignant haematology, immunology and neurology Agreement offers potential best-in-class targeted protein degrader therapy option for people living with B-cell malignancies. Collaboration adds to Roche’s oncology pipeline and offers potential indications in immunology (chronic spontaneous urticaria) and neurology (multiple sclerosis). Bexobrutideg utilises a novel approach to eliminate the Bruton’s tyrosine kinase (BTK) protein, potentially overcoming existing resistance mechanisms found with current standard-of-care BTK inhibitors. More information: Media Release , 8 June 2026 Obesity portfolio data presentation Roche presents new data advancing its obesity portfolio at the American Diabetes Association’s 2026 scientific sessions Late-breaking phase II data highlight enicepatide’s (CT-388) efficacy and safety, reinforcing its potential to deliver best-in-class weight loss across a broad population of people living with overweight or obesity. Late-breaking data from the phase II ZUPREME-1 trial showcase petrelintide’s efficacy, safety and compelling tolerability profile, which has the potential to redefine the weight management experience for people living with overweight or obesity. A phase II multi-arm trial evaluating enicepatide and petrelintide fixed-dose combinations will be initiated in the coming months to develop a differentiated treatment option. More information: Media Release , 1 June 2026 Oncology portfolio data presentation Roche presents new data at ASCO 2026, reinforcing giredestrant’s potential to transform the treatment paradigm in early breast cancer New data were presented from the lidERA study on giredestrant’s potential as a new standard of care for adjuvant ER-positive breast cancer across all menopausal stages. Primary results were presented from the persevERA study on the numerical improvement in progression-free survival observed with first-line giredestrant plus palbociclib in advanced, endocrine-sensitive disease. Overall, Roche highlighted data on nine approved and investigational medicines – including bispecific antibodies, antibody-drug conjugates and brain-permeable molecules – that target urgent needs in breast, blood, lung and other cancers. More information: Media Release , 19 May 2026 Ophthalmology portfolio data presentation Roche presents extensive data showcasing its industry-leading ophthalmology portfolio at ARVO 2026 New real-world data confirm the potent retinal drying of Vabysmo in neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular edema (DME). Key data for Susvimo demonstrate its potential to provide lasting disease control through continuous delivery, while reducing treatment burden. Roche presented more than 45 abstracts at ARVO 2026, including 20 oral presentations across five retinal conditions. More information: Media Release , 30 April 2026 Pharmaceuticals sales Sales CHF millions As % of sales % change January–June 2026 2025 2026 2025 At CER In CHF Pharmaceuticals Division 23,629 23,985 100.0 100.0 6 -1 United States 12,229 12,670 51.8 52.8 6 -3 Europe 4,520 4,566 19.1 19.0 1 -1 Japan 1,360 1,425 5.8 5.9 11 -5 International 5,520 5,324 23.3 22.3 10 4 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 % Ocrevus Multiple sclerosis 3,470 7 2,300 2 758 10 - - 412 30 Hemlibra Haemophilia A 2,492 11 1,313 9 502 4 171 9 506 26 Vabysmo Eye diseases (nAMD, DME, RVO) 2,059 8 1,333 1 386 5 75 26 265 65 Tecentriq Cancer immunotherapy 1,704 6 815 9 410 -3 146 -2 333 17 Xolair 3 Chronic hives, food allergies 1,673 27 1,673 27 - - - - - - Perjeta 3 Breast cancer 1,389 -7 551 -11 238 -14 24 -23 576 0 Phesgo Breast cancer 1,318 18 318 0 425 9 88 15 487 47 Actemra/RoActemra 3 RA, COVID-19 1,074 -9 515 -9 238 -21 140 8 181 -3 Evrysdi Spinal muscular atrophy 968 17 323 15 335 17 39 -1 271 25 Kadcyla 3 Breast cancer 916 -6 310 -14 248 -4 39 2 319 3 Polivy Blood cancer 808 20 381 28 128 -18 98 16 201 47 Alecensa Lung cancer 795 6 261 4 126 -4 93 8 315 13 MabThera/Rituxan 3 Blood cancer, RA 609 5 402 14 62 -9 6 -11 139 -10 Activase/TNKase 3 Cardiac diseases 555 11 531 11 - - - - 24 12 Gazyva/Gazyvaro 3 Blood cancer, lupus nephritis 489 7 240 4 117 -1 17 14 115 21 Herceptin 3 Breast and gastric cancer 462 -12 94 -14 136 -7 2 -36 230 -14 Avastin 3 Various cancer types 414 -15 125 -12 35 37 36 -44 218 -13 Pulmozyme 3 Cystic fibrosis 204 -8 145 -5 29 -11 - 26 30 -18 Columvi Blood cancer 196 70 91 28 53 116 - - 52 173 Enspryng Acute inflammation of brain, spinal cord and optic nerves 195 22 50 20 23 20 79 18 43 37 DME: diabetic macular edema / nAMD: neovascular or ‘wet’ age-related macular degeneration / RVO: retinal vein occlusion / RA: rheumatoid arthritis Diagnostics: key developments Product Milestone cobas HDV test Roche introduces cobas hepatitis D virus (HDV) test, the first fully automated diagnostic solution to identify the most severe form of viral hepatitis The new test enables clinicians to reliably diagnose HDV and monitor patients’ treatment response. Hepatitis D affects nearly 12 million people globally and is considered the most aggressive form of viral hepatitis, often leading to liver failure and cancer faster than other types. The cobas HDV test is the first high-throughput, fully automated HDV assay on the market, addressing the urgent need for a consistent, widely accessible solution and expanding access to critical testing just as new treatments for the disease become available. More information: Media Release , 14 July 2026 Elecsys IGRA TB test Roche receives CE mark for blood test to identify tuberculosis infection The Elecsys IGRA TB test expands global access to tuberculosis infection testing, advancing progress towards the World Health Organization’s elimination targets. Performed on Roche’s industry-leading and widely available cobas immunoassay systems, the test enables laboratories to meet growing tuberculosis infection testing needs by reducing reliance on manual workflows through automation and digital solutions. The new solution provides rapid, high-throughput and cost-effective tuberculosis testing, delivers reliable results in under 24 hours and cuts standard processing times in half to just 19 minutes per patient. More information: Media Release , 9 July 2026 Axelios 1 sequencing platform Roche announces the launch of Axelios 1, a transformative next-generation sequencing platform Axelios 1 delivers a unique combination of accuracy, speed, scalability and cost efficiency, giving laboratories of all sizes the freedom to customise their workflows and explore a wider array of applications. Powered by innovative SBX technology, the platform is capable of end-to-end, same-day whole-genome sequencing in research workflows, with accurate results within hours. The Axelios 1 platform holds promise for research laboratories today, and potentially for a broad range of clinical settings in the future. More information: Media Release , 29 June 2026 Ventana PTEN (SP218) RxDx Assay Roche receives FDA approval for the first companion diagnostic to assess PTEN protein in people living with prostate cancer The new Ventana PTEN (SP218) RxDx Assay fulfills an unmet medical need by helping clinicians identify patients with PTEN protein loss who may benefit from combination treatment with Truqap. In prostate cancer, PTEN protein loss is associated with faster disease progression and reduced benefit from current standard-of-care treatments. The FDA approval reinforces Roche’s leadership in companion diagnostics and its ongoing commitment to expanding personalised healthcare to improve patient outcomes. More information: Media Release , 12 June 2026 Liver Disease Panel Roche launches the Liver Disease Panel, the first suite of certified algorithms to support chronic liver disease (CLD) management Roche introduces the first comprehensive library of certified healthcare algorithms to support CLD management. The Liver Disease Panel includes LiverPRO — a certified algorithm developed by the health tech company Evido — requiring only age and routine blood markers for the timely detection of liver fibrosis. With CLD affecting 1.5 billion people worldwide, the non-invasive panel solution covers care along the patient pathway from fibrosis risk identification to the surveillance of liver cancer. More information: Media Release , 27 May 2026 Elecsys pTau217 test Roche receives CE mark for new blood test to detect Alzheimer’s pathology: Elecsys plasma phosphorylated-tau 217 (pTau217) Elecsys pTau217 is the first blood test for Alzheimer’s disease pathology with a single‑assay design, intended to rule in and rule out amyloid pathology across primary and secondary care, offering faster diagnosis for millions of patients around the world. While maintaining accuracy comparable to spinal fluid diagnostics against the gold standard PET-CT scans, the Elecsys pTau217 test offers a more convenient, minimally invasive alternative via a routine blood draw. Diagnosing dementia currently takes 3.5 years on average, and an estimated 75% of people living with dementia remain undiagnosed. Elecsys pTau217 offers a simple blood test to aid in earlier, more accessible Alzheimer’s disease diagnosis for millions of patients around the world. More information: Media Release , 12 May 2026 PathAI agreement Roche enters into a definitive merger agreement to acquire PathAI to transform AI-driven diagnostics PathAI’s best-in-class Image Management System (IMS) with advanced AI analysis and workflow capabilities will complement Roche’s digital pathology portfolio to drive laboratory efficiency. Combining Roche’s strong position in companion diagnostics and PathAI’s advanced AI platform helps accelerate clinical therapy development, foster the discovery of new biomarkers and create novel diagnostic tools. These integrated capabilities will accelerate the shift from broad intervention towards personalised healthcare for patients. More information: Media Release , 7 May 2026 Diagnostics sales Sales CHF millions As % of sales % change January–June 2026 2025 2026 2025 At CER In CHF Diagnostics Division 6,735 6,959 100.0 100.0 3 -3 Customer areas Core Lab 3,756 3,839 55.8 55.2 4 -2 Molecular Lab 1,196 1,250 17.7 18.0 3 -4 Near Patient Care 909 1,018 13.5 14.6 -5 -11 Pathology Lab 874 852 13.0 12.2 11 3 Regions Europe, Middle East, Africa 2,466 2,485 36.6 35.7 3 -1 North America 2,211 2,235 32.8 32.1 8 -1 Asia-Pacific 1,522 1,729 22.6 24.9 -5 -12 Latin America 536 510 8.0 7.3 10 5 More information on Roche’s performance in the first six months of 2026: Half-Year 2026 Presentation Half-Year 2026 Presentation with appendix Half-Year 2026 Finance Report Appendix with tables About Roche Roche (SIX: RO, ROP; OTCQX: RHHBY) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions. Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceuticals Divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them. Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market. For more information, please visit . All trademarks used or mentioned in this release are protected by law. References [1] CER (Constant Exchange Rates). The percentage changes at constant exchange rates are calculated using simulations by reconsolidating both the 2026 and 2025 results at constant exchange rates (the average rates for the year ended 31 December 2025). For the definition of CER, see page 178 of the Roche Finance Report 2025. [2] USD (US dollars). The percentage changes for selected sales figures in US dollars are calculated by translating both the 2026 and 2025 sales figures at the respective average US dollar exchange rate for the period in question. This supplementary information is provided to assist readers when assessing comparability with other companies. [3] Products launched before 2015. Cautionary statement regarding forward-looking statements This 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 Relations Phone: +41 61 688 88 88 / e-mail: media.relations@roche.com Hans Trees, PhD Phone: +41 79 407 72 58 Lorena Corfas Phone: +41 79 568 24 95 Simon Goldsborough Phone: +44 797 32 72 915 Karsten Kleine Phone: +41 79 461 86 83 Kirti Pandey Phone: +41 79 398 38 53 Yvette Petillon Phone: +41 79 961 92 50 Dr Rebekka Schnell Phone: +41 79 205 27 03 Irène Stephan Phone: +41 79 377 83 75 Roche Investor Relations Dr Bruno Eschli Phone: +41 61 687 52 84 E-mail: bruno.eschli@roche.com Dr Sabine Borngräber Phone: +41 61 688 80 27 E-mail: sabine.borngraeber@roche.com Dr Birgit Masjost Phone: +41 61 688 48 14 E-mail: birgit.masjost@roche.com Investor Relations North America Loren Kalm Phone: +1 650 225 32 17 E-mail: kalm.loren@gene.com Attachments Media & Investor Release Roche HY 2026 EN Communications appendix tables_HY_Results_13072026

Clinical ResultPhase 2Phase 3Drug Approval

30 Jun 2026

·www.fiercepharma.com

After monotherapy failure, AbbVie and Genmab tout Epkinly combo win in DLBCL

Despite a recent failure as a second-line monotherapy in diffuse B-cell lymphoma (DLBLC), a positive phase 3 combination trial for AbbVie and Genmab’s Epkinly has renewed confidence ahead of its high-stakes first-line readout. Epkinly, used together with lenalidomide (Revlimid), significantly reduced the risk of progression or death by 60% compared with the R-GemOx regimen in the phase 3 Epcore DLBCL-4 trial, and has therefore met its primary endpoint, AbbVie and Genmab announced Monday. Patients enrolled in the trial had DLBCL following at least one prior line of therapy. R-GemOx is a combination of rituximab plus gemcitabine and oxaliplatin. The 60% number is based on trial censoring rules meant for the FDA. For regulators outside the U.S., the progression-free survival (PFS) improvement was similar, at 56%. No information on overall survival, a key secondary endpoint, was provided in a June 29 release. The safety profile of the combo was consistent with previous knowledge of the individual agents, the companies said. For analysts at Jefferies, Leerink Partners and William Blair, the positive Epcore DLBCL-4 trial increased their optimism ahead of the upcoming, critical Epcore DLBCL-2 trial readout in first-line DLBCL, expected this year for Epkinly alongside the R-CHOP regimen. Previously, the surprise failure of the Epcore DLBCL-1 trial for Epkinly monotherapy shook some investors’ confidence in the CD20xCD3 T-cell engager in a competitive field. According to results presented this month at the European Hematology Association annual meeting, Epkinly as a single agent improved PFS by 26% over the physician’s choice of either R-GemOx or a bendamustine-rituximab combo. However, Epkinly failed to show a statistically significant OS, the trial’s primary endpoint. In a phenomenon that likely disadvantaged Epkinly in the OS comparison, subsequent treatment with bispecific or cell therapy was received by 26% of patients in the control arm, versus 6% in the Epkinly arm. The latest trial win tees up increased competition between AbbVie/Genmab and Roche. In a Tuesday note to clients, Jefferies analysts estimated that Epkinly’s second-line combo regimen represents 15% of the drug’s total market opportunity, or about $700 million in peak sales. In second-line DLBCL, the FDA last year refused to approve Roche’s Columvi, in combination with GemOx. Even though the phase 3 Starglo trial linked the Columvi regimen to a statistically significant OS improvement, the FDA flagged an imbalance in results reported from the U.S. and Asia, which appeared to have driven the benefit. Roche is having another go with the FDA for its other CD20xCD3 bispecific, Lunsumio. In the phase 3 Sunmo study, Lunsumio plus Roche’s antibody-drug conjugate Polivy delivered a 59% PFS benefit over R-GemOx in second- or later-line DLBCL. The FDA accepted Roche’s application earlier this month, with a decision expected by Feb. 9, 2027. In their Tuesday note, Jefferies analysts pointed out that some physicians wish to save Polivy until later lines of therapy. For their part, William Blair analysts argued that combining subcutaneous Epkinly with oral lenalidomide offers “a simplified regimen suitable for outpatient administration.” By comparison, Roche’s Sunmo regimen requires intravenous infusion of Polivy.

Phase 3Clinical ResultADC

30 Jun 2026

·www.biospace.com

ADC Therapeutics Announces Completion of Enrollment in LOTIS-7 Phase 1b ZYNLONTA® Combination Trial

100 r/r DLBCL patients treated at the selected 150 µg/kg dose of ZYNLONTA® plus glofitamab Full data expected in fourth quarter of 2026 LAUSANNE, Switzerland , June 30, 2026 /PRNewswire/ -- ADC Therapeutics SA (NYSE: ADCT), a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), today announced the completion of enrollment in the LOTIS-7 Phase 1b open-label clinical trial evaluating the safety and efficacy of ZYNLONTA® (loncastuximab tesirine-lpyl) in combination with the bispecific antibody glofitamab (COLUMVI®) in patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (r/r DLBCL). LOTIS-7 trial enrollment is now complete with 100 r/r DLBCL patients dosed at the selected 150 µg/kg dose of ZYNLONTA plus glofitamab. Enrollment occurred in 30 total sites with 70% of patients in the US and 30% in the EU. The study enrolled patients with baseline characteristics similar to other bispecific combination studies in this space and included 46% relapsed and 54% primary refractory patients with a median age of 66 years. Primary endpoints of the study include safety and tolerability. Secondary endpoints include overall response rate, duration of response, complete response, relapse free survival, progression-free survival, and overall survival, as well as pharmacokinetics and immunogenicity. As part of the study protocol, anti-infective prophylaxis, intravenous immunoglobulin (in patients experiencing B-cell loss with an increased risk of infection) and vaccination are strongly recommended. "We are excited by the previously reported data from this study which demonstrated an 89.8% ORR and 77.6% CR and a manageable safety pro the 49 efficacy-evaluable patients with a minimum of 6 months of follow-up," said Mohamed Zaki, MD, PhD, Chief Medical Officer of ADC Therapeutics. "We continue to believe this ZYNLONTA combination has the potential to be the best-in-class bispecific antibody-based combination in 2L+ DLBCL. With enrollment now complete, we look forward to sharing more comprehensive results from LOTIS-7 later this year." Further to the previously reported results from LOTIS-7 demonstrating promising clinical activity for the combination of ZYNLONTA plus glofitamab in patients with r/r DLBCL, the Company plans to share full data from LOTIS-7 at a medical meeting and submit the results for publication by the end of 2026. In addition, the Company plans to assess potential regulatory and compendia pathways for the combination. About LOTIS-7 LOTIS-7 is a Phase 1b global multicenter, multi-arm study in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL) including Part 1 (dose escalation) and Part 2 (dose expansion). The three dosing arms include ZYNLONTA plus polatuzumab vedotin, ZYNLONTA plus glofitamab, and ZYNLONTA plus mosunetuzumab T-cell-engaging bispecific monoclonal antibodies (BsAbs). Enrollment in LOTIS-7 includes Part 1 of the study with a 3+3 dose escalation in 3L+ heavily pre-treated patients with ZYNLONTA doses starting at 90 µg/kg and then proceeding to 120 µg/kg and 150 µg/kg. Part 2 includes dose expansion in 2L+ large B-cell lymphoma in the ZYNLONTA plus glofitamab arm at dose levels determined from Part 1 (120 µg/kg and 150 µg/kg of ZYNLONTA plus the approved dosing of glofitamab). For more information about the LOTIS-7 trial, visit clinicaltrials.gov (NCT04970901). About ZYNLONTA ® ZYNLONTA® is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The potent payload binds to DNA minor groove with little distortion, remaining less visible to DNA repair mechanisms. This ultimately results in cell cycle arrest and tumor cell death. The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with difficult-to-treat disease, including patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/triple hit genetics and patients who had stem cell transplant and CAR-T therapy prior to their treatment with ZYNLONTA. This indication is approved by the FDA under accelerated approval and in the European Union under conditional approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Please see full prescribing information including important safety information about ZYNLONTA at . ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy. About ADC Therapeutics ADC Therapeutics (NYSE: ADCT) is a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), transforming treatment for patients through our focused portfolio with ZYNLONTA (loncastuximab tesirine-lpyl). ADC Therapeutics' CD19-directed ADC ZYNLONTA received accelerated approval by the FDA and conditional approval from the European Commission for the treatment of relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy. ZYNLONTA is also in development in combination with other agents and in earlier lines of therapy. Headquartered in Lausanne (Biopôle), Switzerland, with operations in New Jersey, ADC Therapeutics is focused on driving innovation in ADC development with specialized capabilities from clinical to manufacturing and commercialization. Learn more at and follow us on LinkedIn . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. In some cases you can identify forward-looking statements by terminology such as "may", "will", "should", "would", "expect", "intend", "plan", "anticipate", "believe", "estimate", "predict", "potential", "seem", "seek", "future", "continue", or "appear" or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to: whether future LOTIS-7 results will be consistent with or different from the prior disclosure, the timing, results and publication of the full LOTIS-7 trial; the adequacy of the LOTIS-5 clinical trial data to support full regulatory approval and our ability to maintain accelerated approval in the United States and foreign jurisdictions for our product; the timing, content and outcome of meetings with and feedback or other communications provided by regulatory authorities including U.S. FDA; the timing, submission and acceptance of an sBLA submission related to LOTIS-5 and potential approval; the actual and perceived benefit-risk pro ZYNLONTA as studied in the LOTIS-5 trial; the assessment of the data from LOTIS-5 study, including additional analyses of outcomes observed for safety, efficacy and within key geographic regions and across certain patient sub-populations; the path for full regulatory approval for ZYNLONTA in the United States and foreign jurisdictions; our ability to identify and execute value-maximizing options and the cost and impact of such options; our expected cash runway into at least 2028; our ability to comply with the terms of our indebtedness; changes in our regulatory and commercial strategy; the Company's ability to sustain or grow ZYNLONTA® revenue in the United States and potential peak revenue; the ability of our partners to commercialize ZYNLONTA® in foreign markets, the timing and amount of future revenue and payments to us from such partnerships and their ability to obtain regulatory approval for ZYNLONTA® in foreign jurisdictions; the timing and results of the Company's clinical trials; the timing, publication and results of investigator-initiated trials including those studying FL and MZL and the potential regulatory and/or compendia strategy and the future opportunity; the timing and outcome of regulatory submissions for the Company's products or product candidates; actions by the FDA or foreign regulatory authorities; projected revenue and expenses; the Company's indebtedness, including HealthCare Royalty Management and Blue Owl and Oaktree facilities, and the restrictions imposed on the Company's activities by such indebtedness, the ability to comply with the terms of the various agreements and repay such indebtedness and the significant cash required to service such indebtedness; and the Company's ability to obtain financial and other resources for its research, development, clinical, and commercial activities; and the uncertainties of international trade policies, including tariffs, sanctions, trade barriers and most favored nation drug pricing and the potential impact they may have on our business, financial condition, and results of operations. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K and in the Company's other periodic and current reports and filings with the U.S. Securities and Exchange Commission. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this document. CONTACT: Investors & Media Nicole Riley ADC Therapeutics Nicole.Riley@adctherapeutics.com +1 862-926-9040 View original content to download multimedia: SOURCE ADC Therapeutics SA

ADCPhase 1ImmunotherapyAccelerated ApprovalDrug Approval

100 Deals associated with Polatuzumab Vedotin-Piiq

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KEGG	Wiki	ATC	Drug Bank
-	Polatuzumab Vedotin-Piiq	L01XC	DB12240

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Large B-cell lymphoma	Japan	Chugai Pharmaceutical Co., Ltd.	23 Mar 2026
High grade B-cell lymphoma	United States	Genentech, Inc.	18 Mar 2026
Diffuse large B-cell lymphoma refractory	China	Roche China Holding Ltd.	10 Mar 2026
Refractory Lymphoma	Canada	Hoffmann-La Roche Ltd.	09 Jul 2020
Diffuse large B-cell lymphoma recurrent	European Union	Roche Registration GmbH	16 Jan 2020
Diffuse large B-cell lymphoma recurrent	Iceland	Roche Registration GmbH	16 Jan 2020
Diffuse large B-cell lymphoma recurrent	Liechtenstein	Roche Registration GmbH	16 Jan 2020
Diffuse large B-cell lymphoma recurrent	Norway	Roche Registration GmbH	16 Jan 2020
Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type	European Union	Roche Registration GmbH	16 Jan 2020
Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type	Iceland	Roche Registration GmbH	16 Jan 2020
Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type	Liechtenstein	Roche Registration GmbH	16 Jan 2020
Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type	Norway	Roche Registration GmbH	16 Jan 2020
Diffuse Large B-Cell Lymphoma	United States	Genentech, Inc.	10 Jun 2019

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Refractory Aggressive Non-Hodgkin Lymphoma	Phase 3	United States	Hoffmann-La Roche, Inc.	25 Apr 2022
Refractory Aggressive Non-Hodgkin Lymphoma	Phase 3	China	Hoffmann-La Roche, Inc.	25 Apr 2022
Refractory Aggressive Non-Hodgkin Lymphoma	Phase 3	Japan	Hoffmann-La Roche, Inc.	25 Apr 2022
Refractory Aggressive Non-Hodgkin Lymphoma	Phase 3	Argentina	Hoffmann-La Roche, Inc.	25 Apr 2022
Refractory Aggressive Non-Hodgkin Lymphoma	Phase 3	Brazil	Hoffmann-La Roche, Inc.	25 Apr 2022
Refractory Aggressive Non-Hodgkin Lymphoma	Phase 3	Canada	Hoffmann-La Roche, Inc.	25 Apr 2022
Refractory Aggressive Non-Hodgkin Lymphoma	Phase 3	Israel	Hoffmann-La Roche, Inc.	25 Apr 2022
Refractory Aggressive Non-Hodgkin Lymphoma	Phase 3	Mexico	Hoffmann-La Roche, Inc.	25 Apr 2022
Refractory Aggressive Non-Hodgkin Lymphoma	Phase 3	New Zealand	Hoffmann-La Roche, Inc.	25 Apr 2022
Refractory Aggressive Non-Hodgkin Lymphoma	Phase 3	Peru	Hoffmann-La Roche, Inc.	25 Apr 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


POLARIX (ASCO2026)	Not Applicable	High grade B-cell lymphoma	19,327	Pola-R-CHP	xblllxjidn(lszdsukeqa) = thjnakulzm hmpvgdxcnj (ifdlreuvmd ) View more	Positive	29 May 2026
				R-CHOP	xblllxjidn(lszdsukeqa) = fjnahlrskx hmpvgdxcnj (ifdlreuvmd ) View more
NCT05169658 (RESPONSE-ADAPTED TREATMENT WITH MOSUNETUZUMAB, CTgov)	Phase 2	Follicular Lymphoma \| Indolent B-Cell Non-Hodgkin Lymphoma \| Marginal Zone B-Cell Lymphoma	42	FDG-Positron Emission Tomography+Mosunetuzumab+Polatuzumab Vedotin+Obinutuzumab	edzqidizrw = gdntzfbvmr ymsjpzcdqf (ghagldhkbz, vruxgztaqv - uljckrdvdv) View more	-	13 May 2026
EHA2026	Not Applicable	Diffuse Large B-Cell Lymphoma First line	55	Pola-R-CHP	hdtwdsrvsi(yglggofggq) = ehxljrwjvv tooqiufysg (dvzzybvcww ) View more	Positive	12 May 2026
				R-CHOP/R-miniCHOP	hdtwdsrvsi(yglggofggq) = heekiiqoto tooqiufysg (dvzzybvcww ) View more
EHA2026	Not Applicable	Diffuse Large B-Cell Lymphoma First line	103	Polatuzumab vedotin in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (pola-R-CHP)	xigptzzsnp(wesczuyliw) = dxvwdgbxom rzovafkxln (ooohzeptop ) View more	Positive	12 May 2026
EHA2026	Phase 2	Diffuse Large B-Cell Lymphoma First line	39	Polatuzumab vedotin+Orelabrutinib+Rituximab	riswiarmwe(esovrjzcag) = taqwtmsyfn glwichkbbk (bbyedinyvg ) View more	Positive	12 May 2026
				Polatuzumab vedotin+Orelabrutinib+Rituximab (aged ≥80)	mokxfpvnqf(pmoulefujn) = bccgczmxka ppwkwxoxax (xazifvnywm )
EHA2026	Not Applicable	EBV-Related Post-Transplant Lymphoproliferative Disorder	3	Polatuzumab vedotin and rituximab with dose-adjusted chemotherapy	kxxvicrbva(pqpysdyzwb) = Grade 3-4 neutropenia occurred in 3/3 patients but was manageable with growth factor support. No grade ≥3 peripheral neuropathy was observed. Importantly, no events of acute graft rejection, treatment-related graft failure, or irreversible hepatotoxicity were recorded. Infections were managed with standard antimicrobials, and no treatment-related mortality occurred. zirbwkkmny (mxybaqwrsi )	Positive	12 May 2026
EHA2026	Not Applicable	Large B-cell lymphoma	625	Polatuzumab Vedotin + Rituximab + Cyclophosphamide + Doxorubicin + Vincristine Sulfate + Sphingosine-1-Phosphate Lyase Inhibitor + Prednisone	wxhsxiffqh(rsokevipen) = lfgprpmbkv zwahbzsxxs (pjkautcxdq ) View more	Positive	12 May 2026
				Rituximab + Cyclophosphamide + Doxorubicin + Vincristine Sulfate + Sphingosine-1-Phosphate Lyase Inhibitor + Prednisone	wxhsxiffqh(rsokevipen) = ebnilkvelu zwahbzsxxs (pjkautcxdq ) View more
EHA2026	Not Applicable	Diffuse Large B-Cell Lymphoma First line	236	Pola-R-CHP	xtywsfcybk(vltoilrqcf) = yddhuffujg fkgogkddpd (pbpzqzthpl ) View more	Positive	12 May 2026
				R-CHOP	xtywsfcybk(vltoilrqcf) = lxpxrhdabf fkgogkddpd (pbpzqzthpl ) View more
NCT04332822 (POLAR BEAR, EHA2026)	Phase 3	Diffuse Large B-Cell Lymphoma First line	300	Pola-R-miniCHP	pksjgxhnpe(bekzfvnzhp) = cjncjmhsrb kdratzcttt (fwizbbdsbp ) View more	Positive	12 May 2026
				R-miniCHOP	pksjgxhnpe(bekzfvnzhp) = vmrvdljsig kdratzcttt (fwizbbdsbp )
EHA2026	Not Applicable	Diffuse Large B-Cell Lymphoma	206	Polatuzumab vedotin with bendamustine and rituximab (Pola-BR)	mamyawwxyv(xffsjkgutd) = gvucnknquj osmgadripp (nqrrlkljqs ) View more	Positive	12 May 2026
				Tafasitamab plus lenalidomide (Tafa-Len)	mamyawwxyv(xffsjkgutd) = lfhvyyfgpb osmgadripp (nqrrlkljqs ) View more

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