Latest news with #Gazyvaro
Yahoo
07-03-2025
- Business
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Pharma Stock Roundup: BAYRY's Q4 Results, ABBV's Obesity Deal & More
This week, Bayer BAYRY announced its fourth-quarter and full-year 2024 results. AbbVie ABBV announced a licensing deal with Danish firm Gubra for an amylin-targeting obesity treatment, which marked the company's entry into the obesity space. Novo Nordisk NVO announced that it is cutting the price of its popular obesity injection, Wegovy, for the uninsured following a similar move by rival Eli Lilly. J&J JNJ discontinued a phase III study on a candidate being evaluated as an adjunctive treatment for major depressive disorder (aMDD). The FDA accepted Roche's RHHBY application seeking expanded use of its lymphoma drug, Gazyva/Gazyvaro, for the treatment of lupus nephritis. Here's a recap of the week's most important stories. Novo Nordisk is launching a new direct-to-patient online pharmacy called NovoCare, which will offer Wegovy at a discounted price of $499 per month, less than half of its listed price. This offer is for patients who do not have insurance coverage and pay by cash as well as those with insurance but have no coverage for obesity medicines. The website provides an option for these patients to have their injections delivered to their homes. Novo Nordisk's announcement follows a similar move by rival Eli Lilly. Last week, Lilly also announced that it is reducing the prices of its 7.5 mg and 10 mg single-dose vials of obesity treatment Zepbound to $499 per month for customers paying through a new self-pay program called LillyDirect Self-Pay Pharmacy Solutions. Bayer's fourth-quarter core earnings of €1.05 per share declined 43.2% year over year. Sales of €11.7 billion rose 0.1% on a currency and portfolio-adjusted basis. Sales in the Crop Science segment decreased 2.3%. Pharmaceuticals segment sales increased 2.4%, while Consumer Health sales declined 0.9% on a currency and portfolio-adjusted basis. In the Pharmaceuticals segment, sales of new products, cancer drug Nubeqa and kidney drug, Kerendia, remained strong, offsetting the loss of exclusivity impact on sales of oral anticoagulant Xarelto. The pace of growth in the Consumer Health business has slowed down. The Crop Science business was adversely impacted by lower prices in the crop protection business due to competitive pricing pressure. Bayer issued a financial guidance for 2025. The company expects 2025 to be a 'pivotal year' and the most difficult in terms of financial performance. Sales are expected to be in the range of €45-€47 billion in 2025. Core EPS is projected to be in the band of €4.50-€5.00. Bayer expects its performance to improve from 2026. AbbVie in-licensed rights to develop a phase I candidate, GUB014295, a long-acting amylin analog for the treatment of obesity from Danish biotech, Gubra. AbbVie will lead the development of the candidate. For the deal, which marks AbbVie's entry into the obesity space, it will make an upfront payment of $350 million to Gubra. It will also pay milestone payments of up to $1.875 billion to Gubra. The FDA accepted a supplemental biologics license application (sBLA) seeking approval for Roche's Gazyva/Gazyvaro for the treatment of lupus nephritis. The sBLA was based on based on data from the phase III REGENCY study. The FDA's decision on the sBLA is expected by October 2024. A similar application is also under review in the EU. Gazyva/Gazyvaro is presently approved for treating various types of lymphoma. J&J announced the discontinuation of the phase III VENTURA program on pipeline candidate, aticaprant, for aMDD. The decision to end the program was based on the lack of sufficient efficacy observed in the target patient population. Data from the study showed that aticaprant was safe and well tolerated. J&J, Novo Nordisk, Roche, AbbVie and Bayer carry a Zacks Rank #3 (Hold) each. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. The NYSE ARCA Pharmaceutical Index has risen 2% in the past five trading sessions. Large Cap Pharmaceuticals Industry 5YR % Return Here's how the eight major stocks performed in the previous five trading sessions. Image Source: Zacks Investment Research In the last five trading sessions, Merck rose the most (3.8%), while Novo Nordisk declined the most (1.3%). In the past six months, AbbVie rose the most (7.3%), while Novo Nordisk declined the most (33.3%). (See the last pharma stock roundup here: LLY Ups U.S. Manufacturing Investments & More) Watch this space for regular pipeline and regulatory updates next week. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Roche Holding AG (RHHBY) : Free Stock Analysis Report Johnson & Johnson (JNJ) : Free Stock Analysis Report Novo Nordisk A/S (NVO) : Free Stock Analysis Report Bayer Aktiengesellschaft (BAYRY) : Free Stock Analysis Report AbbVie Inc. (ABBV) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research
Yahoo
07-02-2025
- Business
- Yahoo
New England Journal of Medicine publishes new data for Roche's Gazyva/Gazyvaro which shows superiority over standard therapy in people with active lupus nephritis
Nearly half of patients on Gazyva/Gazyvaro plus standard therapy achieved a complete renal response (CRR), with a statistically significant and clinically meaningful improvement, compared to standard treatment alone1 Analysis showed consistent CRR benefit across patient subgroups, highlighting potential to treat a broad patient population with high unmet need1 Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody in a phase III study to demonstrate CRR benefit,1 which is associated with preservation of kidney function and delay or prevention of end-stage kidney disease Basel, 7 February 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that a detailed analysis of its phase III REGENCY trial of Gazyva®/Gazyvaro® (obinutuzumab) in people with active lupus nephritis (LN) was published in the New England Journal of Medicine.1 The study demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of complete renal response (CRR), showing that 46.4% of people treated with Gazyva/Gazyvaro plus standard therapy (mycophenolate mofetil and glucocorticoids) achieved CRR at 76 weeks compared with 33.1% of people treated with standard therapy alone (adjusted difference 13.4%, 95% CI, 2.0%-24.8%; P=0.0232). This was accompanied by clinically meaningful improvements in complement levels and reductions in anti-dsDNA, markers of disease activity and inflammation.1 Data were presented at the World Congress of Nephrology (WCN) 2025 and are being shared with health authorities, including the US Food and Drug Administration (FDA) and the European Medicines Agency. 'The fact that nearly half of lupus nephritis patients achieved a complete renal response, together with clinically meaningful benefits observed consistently across subgroups, indicates superior disease control with Gazyva/Gazyvaro compared to standard treatment alone,' said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. 'Lupus nephritis disproportionately affects younger women, mostly women of colour, often leading to end-stage kidney disease. Our goal is to address this urgent need by providing a more effective treatment option.' 'The positive REGENCY study results confirmed the findings of an earlier trial that administration of obinutuzumab, a therapy which targets B cells, benefitted patients with lupus nephritis more than standard treatment alone,' said Dr. Richard Furie, the Marilyn and Barry Rubenstein Chair in Rheumatology and Chief of the Division of Rheumatology at Northwell Health, US. 'It is also gratifying to see that patients who received obinutuzumab were not only more likely to achieve the desired outcome but were able to taper corticosteroids at the same time.' Gazyva/Gazyvaro's safety profile was consistent with the well-characterised profile observed in its haematology-oncology indications. Key secondary endpoints showed that at week 76, patients who received Gazyva/Gazyvaro plus standard therapy were more likely to achieve CRR, with a successful reduction of corticosteroid use than standard therapy alone.1 In addition, a higher proportion of patients showed improvement in proteinuric response when treated with Gazyva/Gazyvaro plus standard therapy versus standard therapy alone.1 These endpoints are important indicators for achieving better disease control in lupus nephritis. As seen in pre-specified subgroup analyses, a benefit in CRR with Gazyva/Gazyvaro over standard therapy alone was consistent across all subgroups of patients, including indicators of more active lupus nephritis, Class IV lupus nephritis, concomitant Class V disease, higher baseline proteinuria levels, and/or greater serologic activity.1 Further results for key secondary endpoints can be found in the table below and additional post hoc analysis is ongoing. Key secondary endpoints Obinutuzumab (n=135)Response % (95% CI) Placebo (n=136)Response % (95% CI) Treatment Difference(95% CI) P value CRR with prednisone taper(prednisone ≤7.5 mg/day Week 64 through Week 76) 42.7 (34.3, 51.1) 30.9 (23.1, 38.7) 11.9 (0.6, 23.2) 0.0421 Proteinuric response at Week 76 (UPCR <0.8 g/g) 55.5 (47.1, 64.0) 41.9 (33.6, 50.2) 13.7 (2.0, 25.4) 0.0227 Change in eGFR from baseline to Week 76, adjusted mean 2.31 (2.71) -1.54 (2.71) 3.84 (-1.83, 9.51) 0.1842 Death or renal-related events through Week 76 18.9 (12.1, 25.6) 35.6 (27.5, 43.8) -16.83 (-27.4, -6.2) 0.0026* ORR at Week 50 59.1 (50.8, 67.4) 50.7 (42.2, 59.2) 8.4 (-3.4, 20.1) 0.1670 Change in FACIT-F from baseline to Week 76, adjusted mean 1.8 (1.2) 3.1 (1.2) -1.4 (-3.9, 1.2) 0.2991 * Statistical significance cannot be claimed as endpoints earlier in the hierarchy were not metLupus nephritis is a potentially life-threatening manifestation of an autoimmune disease that affects approximately 1.7 million people worldwide, predominantly women, mostly of colour and childbearing age.2-5 Despite current treatment options, up to a third of people will develop end-stage kidney disease within 10 years, where dialysis or transplant are the only available options and the risk of mortality is high.6 Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody to demonstrate a CRR benefit in a randomised phase III study in lupus nephritis.1 Based on data from the phase II NOBILITY study, Gazyva/Gazyvaro was granted Breakthrough Therapy Designation by the US FDA in 2019.7 In addition to REGENCY, Gazyva/Gazyvaro is being investigated in children and adolescents with lupus nephritis, people with membranous nephropathy, childhood-onset idiopathic nephrotic syndrome and systemic lupus erythematosus, an autoimmune disease that commonly affects the kidneys and can lead to lupus nephritis.8-11 About the REGENCY studyREGENCY [NCT04221477] is a phase III, randomised, double-blind, placebo-controlled, multicentre study investigating the efficacy and safety of Gazyva®/Gazyvaro® (obinutuzumab) plus standard therapy (mycophenolate mofetil and glucocorticoids) in people with active/chronic International Society of Nephrology/Renal Pathology Society 2003 proliferative Class III or IV lupus nephritis, with or without Class V. The study enrolled 271 people, who were randomised 1:1 to receive either biannual intravenous dosing of Gazyva/Gazyvaro plus standard therapy or placebo plus standard therapy. REGENCY was designed based on robust phase II data and conducted during the COVID-19 pandemic. The study population was representative of the real-world population of people with lupus nephritis. The primary endpoint was the proportion of people who achieved a complete renal response (CRR) at 76 weeks. Key secondary endpoints included the proportion of people who achieved CRR at week 76 with successful reduction of corticosteroid use (prednisone taper); the proportion who achieved proteinuric response at 76 weeks; mean change in estimated glomerular filtration rate at 76 weeks; mean change in FACIT-F at week 76; death or renal-related events through week 76 and overall renal response at 50 weeks. Safety and tolerability were also assessed. About Gazyva/Gazyvaro in kidney diseasesGazyva®/Gazyvaro® (obinutuzumab) is a Type II engineered humanised monoclonal antibody designed to attach to CD20, a protein found on certain types of B cells.12 In lupus nephritis, disease-causing B cells drive persistent inflammation that damages the kidneys.13 We can target an underlying cause of lupus nephritis to help gain better control of the disease by depleting disease-causing B cells. Data suggest that Gazyva/Gazyvaro depletes disease-causing B cells, helping to limit further damage to the kidneys and potentially preventing or delaying progression to end-stage kidney disease.12-14 Gazyva/Gazyvaro is already approved in 100 countries for various types of lymphoma. In the United States, Gazyva is part of a collaboration between Genentech and Biogen. About lupus nephritisLupus nephritis is a potentially life-threatening manifestation of systemic lupus erythematosus, an autoimmune disease that commonly affects the kidneys.2 Lupus nephritis affects approximately 1.7 million people worldwide. In lupus nephritis, disease-causing B cells drive persistent inflammation that damages the kidneys.3,4 Lupus nephritis has a profound impact on the lives and outlook of those affected; even with the latest treatments, the damage to the kidneys usually gets worse over time, with up to a third of people progressing to end-stage kidney disease within 10 years, where the only options are dialysis or transplant, and the risk of mortality is high.6 Lupus nephritis predominantly affects women, mostly women of colour and usually of childbearing age.5 Currently, there is no cure.6 About Roche in kidney diseasesFor 20 years, we have combined innovation, scientific expertise and commitment to patients to address unmet needs in kidney diseases. Our industry-leading pipeline includes several ongoing phase I-III clinical studies of immune-mediated investigational therapies with the aim of bringing innovative new treatment options to people living with kidney and kidney-related diseases, including lupus nephritis, membranous nephropathy, immunoglobulin A nephropathy, childhood-onset idiopathic nephrotic syndrome and systemic lupus erythematosus (SLE), an autoimmune disease that can lead to lupus nephritis. Our pipeline also includes Sefaxersen (ASO factor B), an antisense oligonucleotide therapy being investigated in people with primary immunoglobulin A nephropathy at high risk of progression, Lunsumio® (mosunetuzumab), a first-in-class CD20xCD3 T-cell engaging bispecific antibody being investigated in SLE, RG6382, a CD19xCD3 T-cell engaging bispecific antibody being investigated in SLE, and P-CD19CD20-ALLO1, an allogeneic dual CAR-T therapy being investigated in SLE. 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 All trademarks used or mentioned in this release are protected by [1] Furie RA, et al. Efficacy and safety of obinutuzumab in active lupus nephritis. NEJM. [Internet; cited February 2025]. Available at: [2] Hocaoglu et al. Incidence, prevalence, and mortality of lupus nephritis: a population-based study over four decades—The Lupus Midwest Network (LUMEN). Arthritis Rheumatol. 202;75(4):567–73.[3] Tian J, et al. Global epidemiology of systemic lupus erythematosus: a comprehensive systematic analysis and modelling study. Ann Rheum Dis. 2023;82:351-56.[4] Hoi A, et al. Systemic lupus erythematosus. The Lancet. 2024;403(10441):2326-38.[5] Anders HJ, et al. Lupus nephritis. Nat Rev Dis Primers. 2020;6(1):7. doi: 10.1038/s41572-019-0141-9.[6] Mok C, et al. Treatment of lupus nephritis: consensus evidence and perspectives. Nat Rev Rheumatol. 2023;19:227-38.[7] Roche. FDA grants Breakthrough Therapy Designation for Roche's Gazyva (obinutuzumab) in Lupus Nephritis. 2019. [Internet, cited February 2025]. Available from: A study to evaluate the efficacy, safety, and pharmacokinetics of obinutuzumab in adolescents with active class III or IV lupus nephritis and the safety and PK of obinutuzumab in pediatric participants (POSTERITY). [Internet; cited February 2025]. Available from: A study evaluating the efficacy and safety of obinutuzumab in participants with primary membranous nephropathy (MAJESTY). [Internet; cited February 2025]. Available from: Clinical A study to evaluate the efficacy and safety of obinutuzumab versus MMF in participants with childhood onset idiopathic nephrotic syndrome (INShore). [Internet; cited February 2025]. Available from: A study to evaluate the efficacy and safety of obinutuzumab in participants with systemic lupus erythematosus (ALLEGORY). [Internet; cited February 2025]. Available from: Herter S, et al. Preclinical activity of the type II CD20 antibody GA101 (obinutuzumab) compared with rituximab and ofatumumab in vitro and in xenograft models. Mol Cancer Ther. 2013;12(10):2031-42.[13] Atisha-Fregoso Y, et al. Meant to B: B cells as a therapeutic target in systemic lupus erythematosus. J Clin Invest. 2021;131(12):e149095.[14] Furie RA, et al. B-cell depletion with obinutuzumab for the treatment of proliferative lupus nephritis: a randomised, double-blind, placebo-controlled trial. Ann Rheum Dis. 2022;81(1):100-7. Roche Global Media RelationsPhone: +41 61 688 8888 / e-mail: 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 Nina MählitzPhone: +41 79 327 54 74 Kirti PandeyPhone: +49 172 6367262 Yvette PetillonPhone: +41 79 961 92 50 Dr Rebekka SchnellPhone: +41 79 205 27 03 Roche Investor Relations Dr Bruno EschliPhone: +41 61 68-75284e-mail: Dr Sabine BorngräberPhone: +41 61 68-88027e-mail: Dr Birgit MasjostPhone: +41 61 68-84814e-mail: Relations North America Loren KalmPhone: +1 650 225 3217e-mail: 20250207_REGENCY NEJMSign in to access your portfolio
Yahoo
07-02-2025
- Business
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New England Journal of Medicine publishes new data for Roche's Gazyva/Gazyvaro which shows superiority over standard therapy in people with active lupus nephritis
Nearly half of patients on Gazyva/Gazyvaro plus standard therapy achieved a complete renal response (CRR), with a statistically significant and clinically meaningful improvement, compared to standard treatment alone1 Analysis showed consistent CRR benefit across patient subgroups, highlighting potential to treat a broad patient population with high unmet need1 Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody in a phase III study to demonstrate CRR benefit,1 which is associated with preservation of kidney function and delay or prevention of end-stage kidney disease Basel, 7 February 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that a detailed analysis of its phase III REGENCY trial of Gazyva®/Gazyvaro® (obinutuzumab) in people with active lupus nephritis (LN) was published in the New England Journal of Medicine.1 The study demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of complete renal response (CRR), showing that 46.4% of people treated with Gazyva/Gazyvaro plus standard therapy (mycophenolate mofetil and glucocorticoids) achieved CRR at 76 weeks compared with 33.1% of people treated with standard therapy alone (adjusted difference 13.4%, 95% CI, 2.0%-24.8%; P=0.0232). This was accompanied by clinically meaningful improvements in complement levels and reductions in anti-dsDNA, markers of disease activity and inflammation.1 Data were presented at the World Congress of Nephrology (WCN) 2025 and are being shared with health authorities, including the US Food and Drug Administration (FDA) and the European Medicines Agency. 'The fact that nearly half of lupus nephritis patients achieved a complete renal response, together with clinically meaningful benefits observed consistently across subgroups, indicates superior disease control with Gazyva/Gazyvaro compared to standard treatment alone,' said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. 'Lupus nephritis disproportionately affects younger women, mostly women of colour, often leading to end-stage kidney disease. Our goal is to address this urgent need by providing a more effective treatment option.' 'The positive REGENCY study results confirmed the findings of an earlier trial that administration of obinutuzumab, a therapy which targets B cells, benefitted patients with lupus nephritis more than standard treatment alone,' said Dr. Richard Furie, the Marilyn and Barry Rubenstein Chair in Rheumatology and Chief of the Division of Rheumatology at Northwell Health, US. 'It is also gratifying to see that patients who received obinutuzumab were not only more likely to achieve the desired outcome but were able to taper corticosteroids at the same time.' Gazyva/Gazyvaro's safety profile was consistent with the well-characterised profile observed in its haematology-oncology indications. Key secondary endpoints showed that at week 76, patients who received Gazyva/Gazyvaro plus standard therapy were more likely to achieve CRR, with a successful reduction of corticosteroid use than standard therapy alone.1 In addition, a higher proportion of patients showed improvement in proteinuric response when treated with Gazyva/Gazyvaro plus standard therapy versus standard therapy alone.1 These endpoints are important indicators for achieving better disease control in lupus nephritis. As seen in pre-specified subgroup analyses, a benefit in CRR with Gazyva/Gazyvaro over standard therapy alone was consistent across all subgroups of patients, including indicators of more active lupus nephritis, Class IV lupus nephritis, concomitant Class V disease, higher baseline proteinuria levels, and/or greater serologic activity.1 Further results for key secondary endpoints can be found in the table below and additional post hoc analysis is ongoing. Key secondary endpoints Obinutuzumab (n=135)Response % (95% CI) Placebo (n=136)Response % (95% CI) Treatment Difference(95% CI) P value CRR with prednisone taper(prednisone ≤7.5 mg/day Week 64 through Week 76) 42.7 (34.3, 51.1) 30.9 (23.1, 38.7) 11.9 (0.6, 23.2) 0.0421 Proteinuric response at Week 76 (UPCR <0.8 g/g) 55.5 (47.1, 64.0) 41.9 (33.6, 50.2) 13.7 (2.0, 25.4) 0.0227 Change in eGFR from baseline to Week 76, adjusted mean 2.31 (2.71) -1.54 (2.71) 3.84 (-1.83, 9.51) 0.1842 Death or renal-related events through Week 76 18.9 (12.1, 25.6) 35.6 (27.5, 43.8) -16.83 (-27.4, -6.2) 0.0026* ORR at Week 50 59.1 (50.8, 67.4) 50.7 (42.2, 59.2) 8.4 (-3.4, 20.1) 0.1670 Change in FACIT-F from baseline to Week 76, adjusted mean 1.8 (1.2) 3.1 (1.2) -1.4 (-3.9, 1.2) 0.2991 * Statistical significance cannot be claimed as endpoints earlier in the hierarchy were not metLupus nephritis is a potentially life-threatening manifestation of an autoimmune disease that affects approximately 1.7 million people worldwide, predominantly women, mostly of colour and childbearing age.2-5 Despite current treatment options, up to a third of people will develop end-stage kidney disease within 10 years, where dialysis or transplant are the only available options and the risk of mortality is high.6 Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody to demonstrate a CRR benefit in a randomised phase III study in lupus nephritis.1 Based on data from the phase II NOBILITY study, Gazyva/Gazyvaro was granted Breakthrough Therapy Designation by the US FDA in 2019.7 In addition to REGENCY, Gazyva/Gazyvaro is being investigated in children and adolescents with lupus nephritis, people with membranous nephropathy, childhood-onset idiopathic nephrotic syndrome and systemic lupus erythematosus, an autoimmune disease that commonly affects the kidneys and can lead to lupus nephritis.8-11 About the REGENCY studyREGENCY [NCT04221477] is a phase III, randomised, double-blind, placebo-controlled, multicentre study investigating the efficacy and safety of Gazyva®/Gazyvaro® (obinutuzumab) plus standard therapy (mycophenolate mofetil and glucocorticoids) in people with active/chronic International Society of Nephrology/Renal Pathology Society 2003 proliferative Class III or IV lupus nephritis, with or without Class V. The study enrolled 271 people, who were randomised 1:1 to receive either biannual intravenous dosing of Gazyva/Gazyvaro plus standard therapy or placebo plus standard therapy. REGENCY was designed based on robust phase II data and conducted during the COVID-19 pandemic. The study population was representative of the real-world population of people with lupus nephritis. The primary endpoint was the proportion of people who achieved a complete renal response (CRR) at 76 weeks. Key secondary endpoints included the proportion of people who achieved CRR at week 76 with successful reduction of corticosteroid use (prednisone taper); the proportion who achieved proteinuric response at 76 weeks; mean change in estimated glomerular filtration rate at 76 weeks; mean change in FACIT-F at week 76; death or renal-related events through week 76 and overall renal response at 50 weeks. Safety and tolerability were also assessed. About Gazyva/Gazyvaro in kidney diseasesGazyva®/Gazyvaro® (obinutuzumab) is a Type II engineered humanised monoclonal antibody designed to attach to CD20, a protein found on certain types of B cells.12 In lupus nephritis, disease-causing B cells drive persistent inflammation that damages the kidneys.13 We can target an underlying cause of lupus nephritis to help gain better control of the disease by depleting disease-causing B cells. Data suggest that Gazyva/Gazyvaro depletes disease-causing B cells, helping to limit further damage to the kidneys and potentially preventing or delaying progression to end-stage kidney disease.12-14 Gazyva/Gazyvaro is already approved in 100 countries for various types of lymphoma. In the United States, Gazyva is part of a collaboration between Genentech and Biogen. About lupus nephritisLupus nephritis is a potentially life-threatening manifestation of systemic lupus erythematosus, an autoimmune disease that commonly affects the kidneys.2 Lupus nephritis affects approximately 1.7 million people worldwide. In lupus nephritis, disease-causing B cells drive persistent inflammation that damages the kidneys.3,4 Lupus nephritis has a profound impact on the lives and outlook of those affected; even with the latest treatments, the damage to the kidneys usually gets worse over time, with up to a third of people progressing to end-stage kidney disease within 10 years, where the only options are dialysis or transplant, and the risk of mortality is high.6 Lupus nephritis predominantly affects women, mostly women of colour and usually of childbearing age.5 Currently, there is no cure.6 About Roche in kidney diseasesFor 20 years, we have combined innovation, scientific expertise and commitment to patients to address unmet needs in kidney diseases. Our industry-leading pipeline includes several ongoing phase I-III clinical studies of immune-mediated investigational therapies with the aim of bringing innovative new treatment options to people living with kidney and kidney-related diseases, including lupus nephritis, membranous nephropathy, immunoglobulin A nephropathy, childhood-onset idiopathic nephrotic syndrome and systemic lupus erythematosus (SLE), an autoimmune disease that can lead to lupus nephritis. Our pipeline also includes Sefaxersen (ASO factor B), an antisense oligonucleotide therapy being investigated in people with primary immunoglobulin A nephropathy at high risk of progression, Lunsumio® (mosunetuzumab), a first-in-class CD20xCD3 T-cell engaging bispecific antibody being investigated in SLE, RG6382, a CD19xCD3 T-cell engaging bispecific antibody being investigated in SLE, and P-CD19CD20-ALLO1, an allogeneic dual CAR-T therapy being investigated in SLE. 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 All trademarks used or mentioned in this release are protected by [1] Furie RA, et al. Efficacy and safety of obinutuzumab in active lupus nephritis. NEJM. [Internet; cited February 2025]. Available at: [2] Hocaoglu et al. Incidence, prevalence, and mortality of lupus nephritis: a population-based study over four decades—The Lupus Midwest Network (LUMEN). Arthritis Rheumatol. 202;75(4):567–73.[3] Tian J, et al. Global epidemiology of systemic lupus erythematosus: a comprehensive systematic analysis and modelling study. Ann Rheum Dis. 2023;82:351-56.[4] Hoi A, et al. Systemic lupus erythematosus. The Lancet. 2024;403(10441):2326-38.[5] Anders HJ, et al. Lupus nephritis. Nat Rev Dis Primers. 2020;6(1):7. doi: 10.1038/s41572-019-0141-9.[6] Mok C, et al. Treatment of lupus nephritis: consensus evidence and perspectives. Nat Rev Rheumatol. 2023;19:227-38.[7] Roche. FDA grants Breakthrough Therapy Designation for Roche's Gazyva (obinutuzumab) in Lupus Nephritis. 2019. [Internet, cited February 2025]. Available from: A study to evaluate the efficacy, safety, and pharmacokinetics of obinutuzumab in adolescents with active class III or IV lupus nephritis and the safety and PK of obinutuzumab in pediatric participants (POSTERITY). [Internet; cited February 2025]. Available from: A study evaluating the efficacy and safety of obinutuzumab in participants with primary membranous nephropathy (MAJESTY). [Internet; cited February 2025]. Available from: Clinical A study to evaluate the efficacy and safety of obinutuzumab versus MMF in participants with childhood onset idiopathic nephrotic syndrome (INShore). [Internet; cited February 2025]. Available from: A study to evaluate the efficacy and safety of obinutuzumab in participants with systemic lupus erythematosus (ALLEGORY). [Internet; cited February 2025]. Available from: Herter S, et al. Preclinical activity of the type II CD20 antibody GA101 (obinutuzumab) compared with rituximab and ofatumumab in vitro and in xenograft models. Mol Cancer Ther. 2013;12(10):2031-42.[13] Atisha-Fregoso Y, et al. Meant to B: B cells as a therapeutic target in systemic lupus erythematosus. J Clin Invest. 2021;131(12):e149095.[14] Furie RA, et al. B-cell depletion with obinutuzumab for the treatment of proliferative lupus nephritis: a randomised, double-blind, placebo-controlled trial. Ann Rheum Dis. 2022;81(1):100-7. 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