New England Journal of Medicine Publishes New Data for Genentech’s Gazyva Which Shows Superiority Over Standard Therapy in People With Active Lupus Nephritis
Genentech announced significant results from its Phase III REGENCY trial of Gazyva (obinutuzumab) for active lupus nephritis, published in the New England Journal of Medicine. The study showed that 46.4% of patients treated with Gazyva plus standard therapy achieved complete renal response (CRR) at 76 weeks, compared to 33.1% with standard therapy alone.
The trial demonstrated consistent benefits across patient subgroups, with improvements in complement levels and reductions in disease activity markers. Key secondary endpoints revealed that patients receiving Gazyva were more likely to achieve CRR with successful corticosteroid reduction and showed improved proteinuric response versus standard therapy alone.
Gazyva is the only anti-CD20 monoclonal antibody to demonstrate CRR benefit in a Phase III lupus nephritis study. The drug's safety profile remained consistent with its known profile in hematology-oncology indications.
Genentech ha annunciato risultati significativi dal suo studio di Fase III REGENCY su Gazyva (obinutuzumab) per il nefrite lupica attiva, pubblicati sul New England Journal of Medicine. Lo studio ha dimostrato che 46,4% dei pazienti trattati con Gazyva e terapia standard ha mostrato una risposta renale completa (CRR) a 76 settimane, rispetto al 33,1% con solo terapia standard.
Il trial ha dimostrato benefici costanti tra i sottogruppi di pazienti, con miglioramenti nei livelli di complemento e riduzioni nei marcatori di attività della malattia. Gli endpoint secondari chiave hanno rivelato che i pazienti che ricevevano Gazyva avevano maggiori probabilità di raggiungere la CRR con una riduzione riuscita dei corticosteroidi e hanno mostrato una risposta proteica migliorata rispetto alla sola terapia standard.
Gazyva è l'unico anticorpo monoclonale anti-CD20 che ha dimostrato un beneficio CRR in uno studio di Fase III sulla nefrite lupica. Il profilo di sicurezza del farmaco è rimasto coerente con il suo profilo noto nelle indicazioni di ematologia-oncologia.
Genentech anunció resultados significativos de su ensayo Fase III REGENCY de Gazyva (obinutuzumab) para la nefritis lúpica activa, publicado en el New England Journal of Medicine. El estudio mostró que 46.4% de los pacientes tratados con Gazyva más terapia estándar alcanzaron respuesta renal completa (CRR) a las 76 semanas, en comparación con el 33.1% que recibió solo terapia estándar.
El ensayo demostró beneficios consistentes en los subgrupos de pacientes, con mejoras en los niveles de complemento y reducciones en los marcadores de actividad de la enfermedad. Los puntos finales secundarios clave revelaron que los pacientes que recibieron Gazyva tenían más probabilidades de alcanzar CRR con una reducción exitosa de corticosteroides y mostraron una mejor respuesta proteinúrica en comparación con la terapia estándar sola.
Gazyva es el único anticuerpo monoclonal anti-CD20 que ha demostrado un beneficio de CRR en un estudio de Fase III de nefritis lúpica. El perfil de seguridad del fármaco se mantuvo consistente con su perfil conocido en indicaciones de hematología-oncología.
제넨텍은 가자바 (오비누투주맙)의 활성 루푸스 신염에 대한 III상 REGENCY 시험의 중요한 결과를 발표했으며, 이 결과는 뉴잉글랜드 의학 저널에 게재되었습니다. 연구 결과, 가자바와 표준 요법으로 치료받은 환자의 46.4%가 76주 후 완전 신장 반응(CRR)을 달성한 반면, 표준 요법 단독으로 치료받은 환자는 33.1%였습니다.
이번 시험은 환자 하위 그룹에서 일관된 이점을 보여주었으며, 보완 수준이 개선되고 질병 활동성 마커가 감소하였습니다. 주요 2차 평가 지표는 가자바를 받은 환자들이 성공적인 코르티코스테로이드 감소로 CRR에 도달할 가능성이 더 높았고, 표준 요법 단독에 비해 단백뇨 반응도 개선되었음을 보여주었습니다.
가자바는 III상 루푸스 신염 연구에서 CRR 이점을 입증한 유일한 항-CD20 단클론 항체입니다. 이 약물의 안전성 프로파일은 혈액학-종양학 적응증에서 알려진 프로파일과 일관성을 유지했습니다.
Genentech a annoncé des résultats significatifs de son essai de Phase III REGENCY sur Gazyva (obinutuzumab) pour la néphrite lupique active, publiés dans le New England Journal of Medicine. L'étude a montré que 46,4% des patients traités par Gazyva en plus du traitement standard ont atteint une réponse rénale complète (CRR) à 76 semaines, contre 33,1% avec le traitement standard seul.
L'essai a démontré des avantages constants à travers les sous-groupes de patients, avec des améliorations des niveaux de complément et des réductions des marqueurs d'activité de la maladie. Les principaux endpoints secondaires ont révélé que les patients recevant Gazyva avaient plus de chances d'atteindre la CRR avec une réduction réussie des corticostéroïdes et montraient une réponse protéinurique améliorée par rapport au traitement standard seul.
Gazyva est le seul anticorps monoclonal anti-CD20 à démontrer un bénéfice CRR dans une étude de Phase III sur la néphrite lupique. Le profil de sécurité du médicament est resté cohérent avec son profil connu dans les indications d'hématologie-oncologie.
Genentech hat bedeutende Ergebnisse aus seiner Phase-III-Studie REGENCY zu Gazyva (Obinutuzumab) bei aktiver Lupusnephritis angekündigt, die im New England Journal of Medicine veröffentlicht wurden. Die Studie zeigte, dass 46,4% der mit Gazyva und Standardtherapie behandelten Patienten nach 76 Wochen eine vollständige renale Reaktion (CRR) erreichten, im Vergleich zu 33,1% mit nur Standardtherapie.
Die Studie zeigte konsistente Vorteile über die Patientensubgruppen hinweg, mit Verbesserungen der Komplementspiegel und Reduzierungen der Krankheitsaktivitätsmarker. Wichtige sekundäre Endpunkte zeigten, dass Patienten, die Gazyva erhielten, mit einer erfolgreichen Reduzierung von Kortikosteroiden wahrscheinlicher CRR erreichten und eine verbesserte proteinurische Reaktion im Vergleich zur alleinigen Standardtherapie zeigten.
Gazyva ist der einzige anti-CD20-Monoklonalen Antikörper, der in einer Phase-III-Studie zur Lupusnephritis den CRR-Vorteil gezeigt hat. Das Sicherheitsprofil des Medikaments blieb mit dem bekannten Profil bei hämatologisch-onkologischen Indikationen konsistent.
- 46.4% CRR achievement rate with Gazyva vs 33.1% for standard therapy (13.4% improvement)
- Statistically significant improvement in proteinuric response (55.5% vs 41.9%)
- Significant reduction in death or renal-related events (18.9% vs 35.6%)
- FDA Breakthrough Therapy Designation received in 2019
- Some secondary endpoints did not meet statistical significance (eGFR change, ORR at Week 50, FACIT-F change)
– Nearly half of patients on Gazyva plus standard therapy achieved a complete renal response (CRR), with a statistically significant and clinically meaningful improvement, compared to standard treatment alone –
– Analysis showed consistent CRR benefit across patient subgroups highlighting potential to treat a broad patient population with high unmet need –
– Gazyva is the only anti-CD20 monoclonal antibody in a phase III study to demonstrate CRR benefit, which is associated with preservation of kidney function and delay or prevention of end-stage kidney disease –
Data were presented at the World Congress of Nephrology (WCN) 2025 and are being shared with health authorities, including the
“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 compared to standard treatment alone,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “Lupus nephritis disproportionately affects younger women, mostly women of color, 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, benefited 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. “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’s safety profile was consistent with the well-characterized profile observed in its hematology-oncology indications. Key secondary endpoints showed that at week 76, patients who received Gazyva plus standard therapy were more likely to achieve CRR, with a successful reduction of corticosteroid use than standard therapy alone. In addition, a higher proportion of patients also showed improvement in proteinuric response when treated with Gazyva plus standard therapy versus standard therapy alone. 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 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.
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 % ( |
Placebo (n=136)
Response % ( |
Treatment Difference
( |
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, 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, 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 met |
Lupus nephritis is a potentially life-threatening manifestation of an autoimmune disease that affects approximately 1.7 million people worldwide, predominantly women, mostly of color and childbearing age. 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.
Gazyva is the only anti-CD20 monoclonal antibody to demonstrate a CRR benefit in a randomized phase III study in lupus nephritis. Based on data from the Phase II NOBILITY study, Gazyva was granted Breakthrough Therapy Designation by the
About Gazyva in Kidney Diseases
Gazyva® (obinutuzumab) is a Type II engineered humanized monoclonal antibody designed to attach to CD20, a protein found on certain types of B cells. In lupus nephritis, disease-causing B cells drive persistent inflammation that damages the kidneys. We can target an underlying cause of lupus nephritis to help gain better control of the disease by depleting disease-causing B cells with Gazyva, aiming to protect the kidneys from further damage and potentially prevent or delay progression to end-stage kidney disease.
Gazyva is already approved in 100 countries for various types of lymphoma. In
About the REGENCY Study
REGENCY [NCT04221477] is a Phase III, randomized, double-blind, placebo-controlled, multicenter study investigating the efficacy and safety of Gazyva® (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 randomized 1:1 to receive either biannual intravenous dosing of Gazyva 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 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; death or renal related events through week 76 and overall renal response at 50 weeks. Safety and tolerability were also assessed.
About Lupus Nephritis
Lupus nephritis is a potentially life-threatening manifestation of systemic lupus erythematosus, an autoimmune disease that commonly affects the kidneys. Lupus nephritis affects approximately 1.7 million people worldwide. Lupus nephritis has a profound impact on the lives and outlook of those affected and even with the latest treatments, the damage caused 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. Lupus nephritis predominantly affects women, mostly women of color and usually of childbearing age. Currently, there is no cure.
Gazyva
Gazyva® (obinutuzumab) is a prescription medicine used:
- With the chemotherapy drug, chlorambucil, to treat chronic lymphocytic leukemia (CLL) in adults who have not had previous CLL treatment.
- With the chemotherapy drug, bendamustine, followed by Gazyva alone for follicular lymphoma (FL) in adults who did not respond to a rituximab-containing regimen, or whose FL returned after such treatment.
- In combination with chemotherapy, followed by Gazyva alone in those who responded, to treat stage II bulky, III, or IV FL in adults who have not had previous FL treatment.
Important Safety Information
The most important safety information patients should know about Gazyva
Patients must tell their doctor right away about any side effect they experience. Gazyva can cause side effects that can become serious or life-threatening, including:
- Hepatitis B Virus (HBV): Hepatitis B can cause liver failure and death. If the patient has a history of hepatitis B infection, Gazyva could cause it to return. Patients should not receive Gazyva if they have active hepatitis B liver disease. The patient’s doctor or healthcare team will need to screen them for hepatitis B before, and monitor the patient for hepatitis during and after, their treatment with Gazyva. Sometimes this will require treatment for hepatitis B. Symptoms of hepatitis include: worsening of fatigue and yellow discoloration of skin or eyes.
- Progressive Multifocal Leukoencephalopathy (PML): PML is a rare and serious brain infection caused by a virus. PML can be fatal. The patient’s weakened immune system could put them at risk. The patient’s doctor will watch for symptoms. Symptoms of PML include: confusion, difficulty talking or walking, dizziness or loss of balance, and vision problems.
Who should not receive Gazyva:
Patients should NOT receive Gazyva if they have had an allergic reaction (e.g., anaphylaxis or serum sickness) to Gazyva. Patients must tell their healthcare provider if they have had an allergic reaction to obinutuzumab or any other ingredients in Gazyva in the past.
Additional possible serious side effects of Gazyva:
Patients must tell their doctor right away about any side effect they experience. Gazyva can cause side effects that may become severe or life threatening, including:
- Infusion Reactions: These side effects may occur during or within 24 hours of any Gazyva infusion. Some infusion reactions can be serious, including, but not limited to, severe allergic reactions (anaphylaxis), acute life-threatening breathing problems, or other life-threatening infusion reactions. If the patient has a reaction, the infusion is either slowed or stopped until their symptoms are resolved. Most patients are able to complete infusions and receive medication again. However, if the infusion reaction is life-threatening, the infusion of Gazyva will be permanently stopped. The patient’s healthcare team will take steps to help lessen any side effects the patient may have to the infusion process. The patient may be given medicines to take before each Gazyva treatment. Symptoms of infusion reactions may include: fast heartbeat, tiredness, dizziness, headache, redness of the face, nausea, chills, fever, vomiting, diarrhea, rash, high blood pressure, low blood pressure, difficulty breathing, and chest discomfort.
- Hypersensitivity Reactions Including Serum Sickness: Some patients receiving Gazyva may have severe or life-threatening allergic reactions. This reaction may be severe, may happen during or after an infusion, and may affect many areas of the body. If an allergic reaction occurs, the patient’s doctor will stop the infusion and permanently discontinue Gazyva.
- Tumor Lysis Syndrome (TLS): Tumor lysis syndrome, including fatal cases, has been reported in patients receiving Gazyva. Gazyva works to break down cancer cells quickly. As cancer cells break apart, their contents are released into the blood. These contents may cause damage to organs and the heart, and may lead to kidney failure requiring the need for dialysis treatment. The patient’s doctor may prescribe medication to help prevent TLS. The patient’s doctor will also conduct regular blood tests to check for TLS. Symptoms of TLS may include nausea, vomiting, diarrhea, and tiredness.
- Infections: While the patient is taking Gazyva, they may develop infections. Some of these infections may be fatal and severe, so the patient should be sure to talk to their doctor if they think they have an infection. Patients administered Gazyva in combination with chemotherapy, followed by Gazyva alone are at a high risk of infections during and after treatment. Patients with a history of recurring or chronic infections may be at an increased risk of infection. Patients with an active infection should not be treated with Gazyva. Patients taking Gazyva plus bendamustine may be at higher risk for fatal or severe infections compared to patients taking Gazyva plus CHOP or CVP.
- Low White Blood Cell Count: When the patient has an abnormally low count of infection-fighting white blood cells, it is called neutropenia. While the patient is taking Gazyva, their doctor will do blood work to check their white blood cell count. Severe and life-threatening neutropenia can develop during or after treatment with Gazyva. Some cases of neutropenia can last for more than one month. If the patient’s white blood cell count is low, their doctor may prescribe medication to help prevent infections.
- Low Platelet Count: Platelets help stop bleeding or blood loss. Gazyva may reduce the number of platelets the patient has in their blood; having low platelet count is called thrombocytopenia. This may affect the clotting process. While the patient is taking Gazyva, their doctor will do blood work to check their platelet count. Severe and life-threatening thrombocytopenia can develop during treatment with Gazyva. Fatal bleeding events have occurred in patients treated with Gazyva. If the patient’s platelet count gets too low, their treatment may be delayed or reduced.
- Disseminated Intravascular Coagulation (DIC): Fatal and severe DIC has been reported in people receiving GAZYVA. DIC is a rare and serious abnormal blood clotting condition that should be monitored and managed by your doctor as it can lead to uncontrollable bleeding
The most common side effects of Gazyva in CLL were infusion-related reactions and low white blood cell counts.
The most common side effects seen with GAZYVA in a study that included relapsed or refractory NHL, including FL patients were infusion-related reactions, fatigue, low white blood cell counts, cough, upper respiratory tract infection, and joint or muscle pain.
The most common side effects seen with GAZYVA in a study that included previously untreated FL patients were infusion-related reactions, low white blood cell count, upper respiratory tract infections, cough, constipation and diarrhea.
Before receiving Gazyva, patients should talk to their doctor about:
- Immunizations: Before receiving Gazyva therapy, the patient should tell their healthcare provider if they have recently received or are scheduled to receive a vaccine. Patients who are treated with Gazyva should not receive live vaccines.
- Pregnancy: The patient should tell their doctor if they are pregnant, think that they might be pregnant, or plan to become pregnant. Gazyva may harm their unborn baby. The patient should speak to their doctor about using Gazyva while they are pregnant. The patient should talk to their doctor or their child’s doctor about the safety and timing of live virus vaccinations to their infant if they received Gazyva during pregnancy. Patients of childbearing potential should use effective contraception while taking Gazyva and for 6 months after your Gazyva treatment.
- Breastfeeding: Because of the potential risk of serious side reactions in breastfed children, patient should not breastfeed while taking Gazyva and for 6 months after your last dose.
Patients should tell their doctor about any side effects.
These are not all of the possible side effects of Gazyva. For more information, patients should ask their doctor or pharmacist.
Gazyva is available by prescription only.
Report side effects to the FDA at (800) FDA-1088, or http://www.fda.gov/medwatch. Report side effects to Genentech at (888) 835-2555.
Please visit https://www.Gazyva.com for the Gazyva full Prescribing Information, including BOXED WARNINGS, for additional Important Safety Information.
About Genentech in Kidney Diseases
For 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, atypical hemolytic uremic syndrome, childhood-onset idiopathic nephrotic syndrome and systemic lupus erythematosus, an autoimmune disease that can lead to lupus nephritis.
About Genentech
Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in
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FAQ
What were the main results of Genentech's Phase III REGENCY trial for RHHBY's Gazyva?
How did Gazyva (RHHBY) perform in reducing death or renal-related events in lupus nephritis patients?
What was the proteinuric response rate for Gazyva (RHHBY) in the REGENCY trial?
When did Gazyva (RHHBY) receive FDA Breakthrough Therapy Designation for lupus nephritis?
What patient population is most affected by lupus nephritis according to RHHBY's research?
