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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Clinical Trials associated with Polatuzumab Vedotin-Piiq

NCT06594939

/ Not yet recruitingPhase 2IIT

Multicenter Phase II Study of Mosunetuzumab and Polatuzumab Vedotin With Split-Dose CHP Chemotherapy for Elderly Patients With Diffuse Large B-Cell Lymphoma

This single-arm, interventional phase 2 study is designed to evaluate whether the inclusion of mosunetuzumab subcutaneous and polatuzumab vedotin (Mosun-Pola) to a split-dose CHP chemotherapy backbone will improve outcomes for elderly patients with a new diagnosis of diffuse large B-cell lymphoma.

Start Date01 Oct 2025

Sponsor / Collaborator

Medical College of Wisconsin

NCT07034508

/ Not yet recruitingPhase 2IIT

An Open-Label, Multicentre, Randomized Phase II Non-Inferiority Trial Comparing 4 vs 6 Cycles of CHP (21-Day Intervals) Both Combined With 6 Cycles of Polatuzumab Vedotin and Rituximab in Previously Untreated Diffuse Large B-Cell Lymphoma Patients With IPI 0-1

This is an open-label, multicentre, randomized phase II non-inferiority trial aiming to compare the efficacy and safety of 4 versus 6 cycles of CHP (administered at 21-day intervals), both in combination with 6 cycles of polatuzumab vedotin and rituximab, in previously untreated patients with diffuse large B-cell lymphoma (DLBCL) and an International Prognostic Index (IPI) score of 0-1. The study's primary objective is to determine if shorter CHP duration can achieve comparable outcomes to the standard 6-cycle regimen when combined with polatuzumab vedotin and rituximab

Start Date20 Jun 2025

Sponsor / Collaborator-

NCT07012980

/ Not yet recruitingPhase 2IIT

Efficacy and Safety of Glofitamab, Polatuzumab Vedotin and Zanubrutinib in the First-line Treatment of Elderly Patients With Diffuse Large B-cell Lymphoma (DLBCL): A Single-center, Single-arm, Prospective, Phase II Trial

This study aims to assess the efficacy and safety of the chemotherapy-light combination of glofitamab, polatuzumab vedotin and zanubrutinib (GPZ) in elderly patients with previously untreated diffuse large B-cell lymphoma.

Start Date01 Jun 2025

Sponsor / Collaborator

BeOne Medicines Ltd.

100 Clinical Results associated with Polatuzumab Vedotin-Piiq

100 Translational Medicine associated with Polatuzumab Vedotin-Piiq

100 Patents (Medical) associated with Polatuzumab Vedotin-Piiq

760

Literatures (Medical) associated with Polatuzumab Vedotin-Piiq

31 Dec 2025·mAbs

A bispecific antibody-drug conjugate targeting pCAD and CDH17 has antitumor activity and improved tumor-specificity

Author: Gesner, Thomas ; Logel, Claude ; Xie, Kathleen T. ; Cebe, Regis ; Wu, Nila C. ; Li, Xun ; Shi, Xingyi ; Velazquez, Roberto ; Simmons, Quincey ; Tschantz, William R. ; Hainzl, Dominik ; Barzaghi-Rinaudo, Patrizia ; Sagar, Vivek ; Korn, Joshua ; Malamas, Anthony ; Mercan, Samuele ; Green, Andrew ; McLaughlin, Margaret ; Huber, Thomas ; Mueller, Kathrin ; Synan, Alyssa ; D’Alessio, Joseph A.

P-cadherin (pCAD) and LI-cadherin (CDH17) are cell-surface proteins belonging to the cadherin superfamily that are both highly expressed in colorectal cancer.This co-expression profile presents a novel and attractive opportunity for a dual targeting approach using an antibody-drug conjugate (ADC).In this study, we used a unique avidity-driven in vitro screening approach to generate pCAD x CDH17 bispecific antibodies that selectively target cells expressing both antigens over cells expressing only pCAD or only CDH17.Based on in vitro binding and inhibition of cell proliferation results, we selected a lead bispecific antibody to link to the cytotoxic payload monomethyl auristatin E (MMAE) to generate a pCAD x CDH17 bispecific MMAE ADC.In in vivo dual flank mouse models, we demonstrated antitumor activity of the bispecific ADC in tumors expressing both antigens but not in tumors expressing only pCAD or only CDH17.Overall, the preclin. data presented here support the proof-of-concept bispecific antibody discovery approach, demonstrating a rational design for screening antibodies by prioritizing cross-arm avid IgGs to target dual-pos. cells.

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

Budget impact of introducing glofitamab for treatment of relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy in the United States

Article

Author: Li, Jia ; Mahmoudjafari, Zahra ; Masaquel, Anthony ; Parisé, Hélène ; Bercaw, Eric ; Bognar, Katalin ; Wang, Si-Tien

BACKGROUND:

Glofitamab is a T-cell engaging bispecific monoclonal antibody that was granted accelerated approval from the United States Food and Drug Administration for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified or large B-cell lymphoma arising from follicular lymphoma, after ≥2 lines of systemic therapy (3L+).

METHODS:

A budget impact model was developed for a hypothetical blended commercial/Medicare health plan with 1,000,000 members. Comparators were axicabtagene ciloleucel (Axi-cel), lisocabtagene maraleucel (Liso-cel), tisagenlecleucel (Tisa-cel), loncastuximab tesirine, polatuzumab vedotin + bendamustine + rituximab, rituximab + gemcitabine + oxaliplatin, tafasitamab + lenalidomide, and epcoritamab (Epcor). Total costs included those for drugs, wastage, administration, grade ≥3 adverse reactions, and all-grade cytokine release syndrome) and routine care. Market shares were based on internal projections and expert opinions. Total and per-member per-month (PMPM) net budget impacts over 3 years were calculated.

RESULTS:

Approximately nine patients were projected to be eligible for 3L + DLBCL treatment in a health plan of 1,000,000 members. The introduction of glofitamab as a treatment option resulted in estimated total and PMPM cost savings of $728,697 and -$0.0202, respectively, over 3 years. Costs were reduced across all cost categories but particularly in drug costs. Among the newer therapies, total 3-year cost per treated patient was lowest for glofitamab: $226,658 versus Tisa-cel = $564,113; Axi-cel = $540,002; Liso-cel = $516,272; and Epcor = $335,293. Across all sensitivity analyses, the inclusion of glofitamab had minimal PMPM budget impact, ranging from -$0.0256 to -$0.0108.

CONCLUSIONS:

With the lowest 3-year total cost per treated patient among the newer therapies, glofitamab being an available option in the 3L + DLBCL market is estimated to save a hypothetical 1,000,000-member health plan $728,697 in cumulative total costs and $0.0202 in PMPM costs over 3 years.

01 Dec 2025·Blood Research

Real-world effectiveness and safety of rituximab and reduced-dose CHP with polatuzumab vedotin (pola-R-CHP) in patients aged > 80 years with diffuse large B-cell lymphoma: a retrospective analysis

Article

Author: Tsunoda, Shun ; Kamata, Wataru ; Togano, Tomiteru ; Sato, Shuku ; Tamai, Yotaro

Abstract:

Purpose:

The efficacy and safety of polatuzumab vedotin combined with rituximab, cyclophosphamide, doxorubicin, and prednisolone (pola-R-CHP) in patients aged ≥ 80 years with untreated diffuse large B-cell lymphoma (DLBCL) remain largely unexplored.

Methods:

In this study, we administered a reduced-dose pola-R-CHP regimen to 38 patients with DLBCL aged > 80 years. Extending the findings of the POLARIX trial in this older individuals’ cohort, we conducted a retrospective analysis to assess the efficacy and safety of the treatment in a real-world clinical setting.

Results:

After 12 months, the overall and progression-free survival rates were 86.2% (95% confidence interval [CI]: 70.0–94.0) and 78.5% (95% CI: 59.2–89.5), respectively. Although the incidence of febrile neutropenia was relatively high (32%), an increased risk was observed in patients with an average relative dose intensity of < 70%, even with reduced treatment intensity. Notably, none of the patients required a dose reduction of polatuzumab vedotin owing to peripheral neuropathy.

148

News (Medical) associated with Polatuzumab Vedotin-Piiq

31 Jul 2025

·www.biospace.com

FDA Issued Myeloma, Alzheimer’s Approvals in July but Rejected Two CGTs

iStock, Grandbrothers The FDA greenlit multiple new drugs this month and issued some notable label expansions including for Eli Lilly’s Kisunla. Meanwhile, the regulator turned away a cell therapy for Duchenne muscular dystrophy and a gene therapy for the rare disease Sanfilippo syndrome. Amid an exodus of employees —not to mention the official start of Health Secretary Robert F. Kennedy Jr.’s overhaul of the agency—the FDA issued several key verdicts this month. Among the standout decisions are a Duchenne muscular dystrophy rejection, a dosing modification for an anti-amyloid Alzheimer’s therapy and an approval for the first-ever on-demand oral therapy for hereditary angioedema. Read below for more. Regeneron’s Bispecific Notches Accelerated Approval for Multiple Myeloma Drug: Lynozyfic Decision: New drug approved Date: July 2 To kick off the month, the FDA handed Regeneron a modest win in multiple myeloma with its approval of linvoseltamab, a bispecific antibody targeting both BCMA and CD3 proteins, for patients with relapsed or refractory multiple myeloma., The regulator’s greenlight for the drug, to be marketed as Lynozyfic, was supported by data from the Phase I/II LINKER-MM1 study that demonstrated a 70% objective response rate, including a 45% complete response rate or better. In a prepared statement alongside its announcement of the approval, Regeneron CEO George Yancopoulos said that with this efficacy profile, “Lynozyfic is poised to potentially become a new standard of care for multiple myeloma.” In a July 2 note, analysts at BMO Capital Markets called the approval a “small win” for Regeneron, with Lynozyfic being a “minor contributor to the company’s broader product portfolio.” BMO models around $600 million in potential revenues for Lynozyfic. The peak forecast for Lynozyfic is modest in part because it trails Johnson & Johnson’s Tecvayli , which was approved in 2022, giving it a three-year head start. Regeneron has emphasized the greater convenience of its product, however. According to the pharma, Lynozyfic is the first and so far only bispecific with this mode of action that can be dosed every two weeks, with the possibility of extending to every four weeks if a patient achieves very good partial response or better. Despite Interference, KalVista Gets Delayed Nod for Only On-Demand HAE Pill Drug: Ekterly Decision: New drug approved Date: July 7 TK weeks after the PDUFA deadline passed, the FDA signed off on KalVista’s sebetralstat, to be marketed under the brand name Ekterly, as the first and only oral on-demand therapy for acute hereditary angioedema (HAE) attacks. The approval comes after the regulator in June had to push back its decision date for the drug, pointing to “heavy workload and limited resources,” KalVista said at the time. There had also been some internal disagreement over the verdict, with Commissioner Marty Makary reportedly trying to get the application denied, according to Endpoints News , which cited anonymous sources at the agency. Makary relented after senior staff raised potential legal issues about his interference. The Department of Health and Human Services has denied these claims, with a spokesperson telling Endpoints that they are “totally false and untrue.” Results of the Phase III KONFIDENT study supported Ekterly’s approval. Results presented in February 2024 showed that both 300-mg and 600-mg doses of Ekterly achieved symptom relief significantly more rapidly , with a median of 1.61 hours and 1.79 hours, respectively, versus 6.72 hours for the placebo group. The open-label KONFIDENT-S trial bolstered these findings, demonstrating that in the real-world setting, Ekterly can help patients address HAE attacks within a median of 10 minutes of onset. KONFIDENT is the largest HAE program ever conducted, KalVista claims. PTC Wins Phenylketonuria Nod for Sephience Drug: Sephience Decision: New drug approved Date: July 28 On July 28, the FDA signed off on PTC Therapeutics’ sepiapterin, which will now be marketed under the brand name Sephience, for the treatment of adults and children with phenylketonuria (PKU). The approval, the biotech noted, grants Sephience a broad label and allows its use for addressing hyperphenylalaninemia in patients 1 month of age and older. This broad labeling, CEO Matthew Klein said in a prepared statement, points to “the potential of Sephience to meet the significant unmet need of PKU patients.” Data from the Phase III APHENITY trial supported Sephience’s approval. PKU is caused by a deficiency of phenylalanine hydroxylase, leading to the accumulation of phenylalanine in patients’ tissues and body fluids. Results posted in October 2024 showed Sephience could cut phenylalanine by 63% in treated patients. This effect was stronger in study participants with classic PKU, with phenylalanine reduction reaching 69%. Almost 85% of patients achieved phenylalanine levels lower than 360 µmol/L, in line with treatment guidelines. Lilly, Moderna, Bayer, GSK Win Expanded Labels for Key Assets July 9: Eli Lilly’s Kisunla The FDA signed off on a new dosing regimen for Eli Lilly’s Alzheimer’s disease therapy Kisunla. This modified schedule involves a more gradual titration of the drug, which according to the pharma lowers the risk of amyloid-related imaging abnormalities indicative of fluid accumulation (ARIA-E). Data from the TRAILBLAZER-ALZ 6 study supported this change, showing that at week 24, ARIA-E was detected in 14% of patients treated with the gradual titration of Kisunla, as opposed to 24% of those on the initially approved dosing schedule. By week 52, ARIA-E was reported in 16% and 25% of the respective groups. July 10: Moderna’s Spikevax Moderna likewise won a major label expansion this month, with the FDA granting full approval for its COVID-19 vaccine Spikevax in children 6 months through 11 years of age who are at high risk of getting infected. Spikevax was previously available for this age group only under an Emergency Use Authorization. Spikevax’s full approval comes after two key approvals for Moderna’s mRNA vaccine pipeline last month. The first was for its next-generation COVID-19 shot mNEXSPIKE , which is now cleared for older adults 65 and above, as well as people 12 through 64 years of age who have at least one underlying risk factor. The second was for its respiratory syncytial virus shot, mResvia , which secured broader coverage to include at-risk adults aged 18 through 59 years. July 14: Bayer’s Kerendia Also securing a key expansion this month is Bayer’s Kerendia, which the FDA gave a new indication : to reduce the risk of cardiovascular death, hospitalization for heart failure and urgent visits for heart failure in adult heart failure patients with left ventricular ejection fraction of at least 40%. In the Phase III FINEARTS-HF study, Kerendia elicited a significant 16% reduction in the trial’s primary endpoint, a composite of worsening heart failure events and cardiovascular death. Kerendia likewise resulted in an 18% drop in worsening heart failure events. Kerendia was first approved in July 2021 , indicated to lower the risk of sustained kidney function decline, end-stage kidney disease, cardiovascular death, heart failure hospitalization and non-fatal myocardial infarction in patients with chronic kidney disease associated with type 2 diabetes. July 17: GSK’s Shingrix Arguably one of the biggest label expansions this month is for GSK’s shingles shot Shingrix, for which the FDA greenlit a prefilled syringe formulation . This new version, according to the pharma’s press release, simplifies the immunization process for healthcare professionals by removing the need to reconstitute separate vials of the vaccine. Approved in October 2017 , Shingrix is a recombinant herpes zoster vaccine indicated for the prevention of shingles in seniors 50 years and older. The vaccine has also since been expanded to cover at-risk adults 18 years and above. Shingrix is one of GSK’s best-performing assets and has already comfortably passed the blockbuster mark. Last year, the product brought in nearly $4.5 billion in sales. Capricor Suffers 40% Hit After FDA Thumbs Down DMD Cell Therapy Drug: Deramiocel Decision: New cell therapy rejected Date: July 11 Aside from important approvals, the FDA also issued critical rejections in July, often with harsh consequences on a company’s stock. One clear example of this is Capricor Therapeutics, which was proposing the investigational cell therapy deramiocel to treat cardiomyopathy in patients with Duchenne muscular dystrophy. The FDA handed Capricor a complete response letter (CRL) on July 11, sending the biotech’s stock freefalling 40% that day. Capricor has yet to recover. As of writing, the company has dipped some 6.3% further. The FDA’s rejection was based on Capricor’s data package for deramiocel, which the regulator said fell short of the “statutory requirement for substantial evidence of effectiveness.” The CRL also cited certain deficiencies regarding deramiocel’s chemistry, manufacturing, and controls. Capricor claimed at the time of the rejection that it had already addressed these concerns, but that the FDA was not able to review these submissions “due to the timing of the CRL issuance.” The rejection came as a surprise to Capricor, CEO Linda Marbán said in a prepared statement at the time. “We have followed their guidance throughout the process,” she said, noting that prior to the CRL the review of deramiocel “had advanced without major issues, including a pre-licensure inspection and completion of the mid-cycle review.” As in the case of KalVista’s Ekterly, deramiocel has been the subject of some internal disagreement at the FDA. Nicole Verdun, the former top regulator of cell and gene therapies at the FDA’s Center for Biologics Evaluation and Research (CBER), had previously scheduled an advisory committee meeting for the application, which new CBER leader Vinay Prasad later cancelled. Verdun was subsequently pushed out of the agency. Ultragenyx Misses Out on Rare Genetic Disease Approval Drug: UX111 Decision: New gene therapy rejected Date: July 11 Ultragenyx reported on July 11 that the FDA had declined to approve UX111, its gene therapy for Sanfilippo syndrome type A, a rare and genetic metabolic disorder that manifests as a broad range of symptoms, including developmental delays and progressive intellectual disability. According to the biotech, the rejection was not linked to its data package for UX111. “The FDA has acknowledged that the neurodevelopmental outcome data provided to date are robust and the biomarker data provide additional supportive evidence,” a statement from Ultragenyx read. Instead, the CRL cited manufacturing issues that were “not directly related to the quality of the product,” Ultragenyx said. “The company believes that these observations are readily addressable.” Ultragenyx added that the company will work to resolve these issues “in the next few months,” building up to a resubmission for UX111. The rare disease biotech expects to undergo another six-month review period after refiling for approval. The rejection capped off a difficult week for Ultragenyx, which on July 9 reported that its Phase II/III osteogenesis imperfecta study for the anti-sclerostin antibody UX143 would be moving to its final analysis. William Blair analysts at the time took this to mean that the trial failed to meet an efficacy threshold that would have otherwise warranted its early termination. As of writing, Ultragenyx’s shares have slid 33% since the osteogenesis imperfect announcement. Roche’s Earlier-Stage Push for Columvi Falls Short Drug: UX111 Decision: Label expansion rejected Date: July 21 The FDA has rejected Roche and subsidiary Genentech’s proposal to use the bispecific antibody Columvi as part of a second-line treatment regimen in patients with diffuse large B cell lymphoma. The Complete Response Letter cited insufficient evidence to support the use of Columvi in this indication in the U.S. patient population. Roche used data from the Phase III STARGLO study to support its application. Results showed that patients treated with the Columvi combo saw a 41% drop in the risk of death compared with those who received rituximab, gemcitabine and oxaliplatin. The Columvi-based regimen likewise hit secondary endpoints, including progression-free survival. Despite these results, the FDA’s Oncologic Drugs Advisory Committee (ODAC) in May voted 8–1 against Columvi’s expansion, raising concerns about the applicability of the drug’s efficacy data in the U.S. In STARGLO’s intention-to-treat population, only 25 of more than 270 participants were from North America. Columvi remains approved as a third-line treatment option for diffuse large B cell lymphoma (DLBCL) under the FDA’s accelerated pathway program. Roche and Genentech are also studying Columvi in the Phase III SKYGLO study , which combines the bispecific with Polivy, Rituxan, cyclophosphamide, doxorubicin and prednisone for the treatment of patients with large B cell lymphoma. The companies are in discussions with the FDA to use SKYGLO as the new postmarketing requirement to convert the third-line DLBCL indication to a full approval, as per their July 21 announcement.

Phase 3Drug ApprovalClinical ResultVaccineAccelerated Approval

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

21 Jul 2025

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Lack of US Data Stymie Roche’s Earlier-Stage Lymphoma Push for Columvi

iStock, leolintang Roche and Genentech were unable to sufficiently demonstrate the benefit of using Columvi in an earlier treatment setting for DLBCL in a U.S. population, according to the FDA. The FDA has rejected Roche and subsidiary Genentech’s proposal to use the bispecific antibody Columvi as part of a second-line treatment regimen in patients with diffuse large B cell lymphoma. In its complete response letter, the regulator cited insufficient evidence to support the use of Columvi in this indication in the U.S. patient population, according to Roche’s news release on Friday. Columvi is approved as a third-line treatment option for diffuse large B cell lymphoma (DLBCL) under the FDA’s accelerated pathway program. Despite Friday’s rejection, Columvi “remains under accelerated approval for people with third-line or later DLBCL,” as per the company’s news release. Delivered intravenously, Columvi is a bispecific antibody that targets both CD20, found on the surface of B cells, and CD3, expressed by T cells. This mechanism of action allows the drug to activate cancer-killing T cells and bring them closer to the malignant B cells. In 2021, Roche and Genentech kicked off the Phase III STARGLO study, combining Columvi with gemcitabine and oxaliplatin to treat patients with relapsed or refractory DLBCL. STARGLO formed the foundation of the Columvi application, and results showed that patients treated with the Columvi combo saw a 41% drop in the risk of death compared with those who received rituximab, gemcitabine and oxaliplatin. The Columvi-based regimen likewise hit secondary endpoints, including progression-free survival. Despite these results, the FDA’s Oncologic Drugs Advisory Committee (ODAC) in May voted 8–1 against Columvi’s expansion, raising concerns about the applicability of the drug’s efficacy data in the U.S. In STARGLO’s intention-to-treat population, only 25 of more than 270 participants were from North America. Ravi Madan, a “no” vote who heads Prostate Cancer Clinical Research at the National Cancer Institute, said at the time of the ODAC meeting that drug sponsors should make “deliberate decisions” to make sure that their studies “apply to the U.S. population.” Trial demography appears to be an increasingly pressing concern at the FDA. At another ODAC meeting last week to assess GSK’s application for its antibody-drug conjugate Blenrep for multiple myeloma, committee member Daniel Spratt of Western Reserve University brought up enrollment issues. GSK’s “clinical development program enrolled almost no patients in the United States,” he said. “This is the United States FDA, so the proposed patient population [are] the United States patients,” Spratt noted. Poor enrollment from a U.S. population “precludes any assessment of the [drug’s] benefit-risk pro the U.S.” Aside from STARGLO, Roche and Genentech are also testing Columvi in the Phase III SKYGLO study , which combines the bispecific with Polivy, Rituxan, cyclophosphamide, doxorubicin and prednisone for the treatment of patients with large B cell lymphoma. The companies are in discussions with the FDA to use SKYGLO as the new postmarketing requirement for Columvi, as per Friday’s release.

Phase 3ADCAccelerated ApprovalDrug ApprovalClinical Result

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
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
B-cell lymphoma refractory	Phase 3	United States	Hoffmann-La Roche, Inc.	25 Apr 2022
B-cell lymphoma refractory	Phase 3	China	Hoffmann-La Roche, Inc.	25 Apr 2022
B-cell lymphoma refractory	Phase 3	Japan	Hoffmann-La Roche, Inc.	25 Apr 2022
B-cell lymphoma refractory	Phase 3	Argentina	Hoffmann-La Roche, Inc.	25 Apr 2022
B-cell lymphoma refractory	Phase 3	Brazil	Hoffmann-La Roche, Inc.	25 Apr 2022
B-cell lymphoma refractory	Phase 3	Canada	Hoffmann-La Roche, Inc.	25 Apr 2022
B-cell lymphoma refractory	Phase 3	Israel	Hoffmann-La Roche, Inc.	25 Apr 2022
B-cell lymphoma refractory	Phase 3	Mexico	Hoffmann-La Roche, Inc.	25 Apr 2022
B-cell lymphoma refractory	Phase 3	New Zealand	Hoffmann-La Roche, Inc.	25 Apr 2022
B-cell lymphoma refractory	Phase 3	Peru	Hoffmann-La Roche, Inc.	25 Apr 2022

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NEWS Manual	Not Applicable	Mantle cell lymphoma refractory \| Mantle cell lymphoma recurrent	-	Mosun SC + Pola	rzvdlxmelo(jpkwoiopet) = akennydezi bllkgoljgw (fedvmxzncn ) View more	Positive	27 Jun 2025
NCT05171647 (SUNMO, BusinessWire) Manual	Phase 3	Large B-cell lymphoma	-	Lunsumio® (mosunetuzumab-axgb) + Polivy® (polatuzumab vedotin-piiq)	onuyuyxfjm(javejushxo) = rgdcuvrbho wizckrhxwf (dcczgsfrnv, 5.6 - 17.6) View more	Positive	20 Jun 2025
NCT05171647 (SUNMO, BusinessWire) Manual	Phase 3	Large B-cell lymphoma	-	Rituxan® (rituximab) + gemcitabine and oxaliplatin (R-GemOx)	onuyuyxfjm(javejushxo) = hgfirxrhhv wizckrhxwf (dcczgsfrnv, 2.9 - 4.1) View more	Positive	20 Jun 2025
NCT04182204 (POLARGO, EHA2025) Manual	Phase 3	Diffuse large B-cell lymphoma refractory	255	Pola-R-GemOx	rsznxlkhhg(jjwalfjsgn) = dqrzvtysow eertgpcask (tcpwbbgfcr, 13.3 - NE) View more	Positive	13 Jun 2025
NCT04182204 (POLARGO, EHA2025) Manual	Phase 3	Diffuse large B-cell lymphoma refractory	255	R-GemOx	rsznxlkhhg(jjwalfjsgn) = nvlmzxrrgf eertgpcask (tcpwbbgfcr, 8.9 - 15.8) View more	Positive	13 Jun 2025
EHA2025 Manual	Clinical	Mantle cell lymphoma refractory \| Mantle cell lymphoma recurrent Last line	9	Polatuzumab vedotin + Obinutuzumab + Chemotherapy	sgoeocfwmf(npwskruese) = mnyokfajhu mcsfahmhge (ullqkoivib ) View more	Positive	14 May 2025
EHA2025 Manual	Clinical	Diffuse Large B-Cell Lymphoma First line	52	Polatuzumab Vedotin + chemotherapy	lmwwnbktfa(ajtzlrsvvi) = ahoanvxixu bbdghtqukx (cmxszpafmv )	Positive	14 May 2025
EHA2025 Manual	Clinical	Diffuse Large B-Cell Lymphoma First line	52	Conventional chemotherapy	lmwwnbktfa(ajtzlrsvvi) = wcdhnraiio bbdghtqukx (cmxszpafmv )	Positive	14 May 2025
EHA2025 Manual	Clinical	Diffuse large B-cell lymphoma refractory \| Diffuse large B-cell lymphoma recurrent Second line	90	Pola-RB (Polatuzumab Vedotin+ Rituximab+Bendamustine)Bendamustine)	jejzcxkpvi(bfcnloxkav) = mqjenilalm drchbdpbgs (ivcwfzcuud ) View more	Positive	14 May 2025
EHA2025 Manual	Not Applicable	Diffuse Large B-Cell Lymphoma First line	16	dr-Pola-R-CHP	ogpkwypgdo(ijxbpodjjk) = yjaqtlzbsu cwqvladmem (bgxgeoakwk, 34 - 80) View more	Positive	14 May 2025
NCT05283720 (EPCORE NHL-5, EHA2025) Manual	Phase 1/2	Diffuse Large B-Cell Lymphoma First line	37	Epcoritamab + Polatuzumab VedotinPolatuzumab Vedotin + Rituximab + Cyclophosphamide + Doxorubicin + Prednisone	ldwhylqtyu(oukcyxfzpj) = mlfjezmhll zkdjubydqd (hkkxwkfzdp ) View more	Positive	14 May 2025
NCT06176729 (EHA2025) Manual	Phase 2	Diffuse Large B-Cell Lymphoma First line	36	Polatuzumab vedotin+rituximab+lenalidomide(POLA-R2)lenalidomide(POLA-R2)	fvtspxwgup(ujvkqbnwme) = izrknruesx jfgxbgibfe (rzzfnybcjn ) View more	Positive	14 May 2025
NCT05940064 (EHA2025) Manual	Phase 2	Diffuse Large B-Cell Lymphoma First line	19	polatuzumab vedotin+zanubrutinib +rituximab（Pola-ZR）rituximab（Pola-ZR）	npqfpycqus(mfqgbjshpi) = ueksjhintq akecertsge (tqdymsnrrl ) View more	Positive	14 May 2025

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