CHMP recommends EU approval of Roche’s subcutaneous formulation of Lunsumio for people with relapsed or refractory follicular lymphoma
Roche (OTCQX: RHHBY) has received a CHMP recommendation for EU approval of a subcutaneous formulation of Lunsumio for treating adult patients with relapsed or refractory follicular lymphoma. The new formulation significantly reduces administration time to approximately one minute compared to 2-4 hours for IV infusion.
The recommendation is based on the phase II GO29781 study, which demonstrated pharmacokinetic non-inferiority to IV administration. Key safety data showed a low rate of cytokine release syndrome (29.8%), with mostly low-grade events. The treatment offers a fixed duration of 6-12 months and can be administered in outpatient settings.
Notably, Lunsumio has shown high and long-lasting response rates, with about two-thirds of patients maintaining complete response remission after four years.
Roche (OTCQX: RHHBY) ha ricevuto una raccomandazione CHMP per l'approvazione UE di una formulazione sottocutanea di Lunsumio per trattare adulti con linfoma follicolare recidivante o refrattario. La nuova formulazione riduce significativamente il tempo di somministrazione a circa un minuto rispetto alle 2-4 ore per l'infusione IV.
La raccomandazione si basa sullo studio di fase II GO29781, che ha dimostrato non inferiorità farmacocinetica rispetto all'IV. I dati chiave di sicurezza hanno mostrato un basso tasso di sindrome da rilascio di citochine (29,8%), con eventi per lo più di gravità lieve. Il trattamento offre una durata fissa di 6-12 mesi e può essere somministrato in setting ambulatoriali.
Da notare che Lunsumio ha mostrato tassi di risposta elevati e duraturi, con circa due terzi dei pazienti che mantengono una remissione completa dopo quattro anni.
Roche (OTCQX: RHHBY) ha recibido una recomendación del CHMP para la aprobación en la UE de una formulación subcutánea de Lunsumio para tratar a pacientes adultos con linfoma folicular recidivado o refractario. La nueva formulación reduce significativamente el tiempo de administración a aproximadamente un minuto frente a las 2-4 horas para la infusión IV.
La recomendación se basa en el estudio de fase II GO29781, que demostró no inferioridad farmacocinética respecto a la administración IV. Los datos clave de seguridad mostraron una baja tasa de síndrome de liberación de citocinas (29,8%), con eventos mayoritariamente de bajo grado. El tratamiento ofrece una duración fija de 6-12 meses y puede administrarse en entornos ambulatorios.
Cabe destacar que Lunsumio ha mostrado tasas de respuesta altas y duraderas, con alrededor de dos tercios de los pacientes manteniendo la remisión completa tras cuatro años.
Roche (OTCQX: RHHBY)은 성인 재발 또는 난치성 follicular lymphoma 환자 치료를 위한 Lunsumio의 피하 제형에 대한 EU 승인을 CHMP 권고로 받았습니다. 새로운 제형은 IV 주사에 비해 투여 시간을 약 1분로 크게 단축합니다.
권고는 2상 GO29781 연구를 바탕으로 하며 IV 투여에 비해 약동학적으로 비열등함을 입증했습니다. 주요 안전 데이터는 사이토카인 방출 증후군의 발생률이 낮고(29.8%), 대부분 경증인 것으로 나타났습니다. 이 치료는 6-12개월의 고정 기간 동안 시행 가능하며 외래 진료 환경에서 투여할 수 있습니다.
주목할 점은 Lunsumio가 높은 반응률과 장기간 지속되는 반응을 보였고, 약 환자의 2/3가 4년 후에도 완전 반응 상태를 유지한다는 점입니다.
Roche (OTCQX : RHHBY) a reçu une recommandation du CHMP pour l'approbation par l'UE d'une formulation sous-cutanée de Lunsumio destinée aux patients adultes atteints de lymphome folliculaire en relapse ou réfractaire. La nouvelle formulation réduit significativement le temps d'administration à environ une minute par rapport à 2-4 heures pour l'infusion IV.
La recommandation repose sur l'étude de phase II GO29781, qui a démontré une non-infériorité pharmacocinétique par rapport à l'administration IV. Les données clés de sécurité montrent un faible taux de syndrome de libération des cytokines (29,8 %), les événements étant majoritairement de gravité faible. Le traitement offre une durée fixe de 6-12 mois et peut être administré en milieu ambulatoire.
À noter que Lunsumio a montré des taux de réponse élevés et durables, avec environ les deux tiers des patients conservant une rémission complète après quatre ans.
Roche (OTCQX: RHHBY) hat eine CHMP-Empfehlung für die EU-Zulassung einer subkutanen Formulierung von Lunsumio zur Behandlung erwachsener Patienten mit rezidiviertem oder refraktärem follikulärem Lymphom erhalten. Die neue Formulierung reduziert die Verabreichungszeit erheblich auf ungefähr eine Minute im Vergleich zu 2-4 Stunden bei der intravenösen Infusion.
Die Empfehlung basiert auf der Phase-II-Studie GO29781, die eine pharmakokinetische Nicht-Unterlegenheit gegenüber der IV-Verabreichung zeigte. Wichtige Sicherheitsdaten zeigen eine geringe Rate des Cytokine-Release-Syndroms (29,8%), wobei die Ereignisse überwiegend von geringem Schweregrad sind. Die Behandlung bietet eine feste Dauer von 6-12 Monaten und kann in ambulanten Einrichtungen verabreicht werden.
Bemerkenswert ist, dass Lunsumio hohe und langanhaltende Ansprechraten gezeigt hat, wobei etwa zwei Drittel der Patienten nach vier Jahren eine vollständige Remission beibehalten.
حصلت Roche (OTCQX: RHHBY) على توصية من CHMP للموافقة في الاتحاد الأوروبي على صيغة تحت الجلد من Lunsumio لعلاج البالغين المصابين باللمفوما الفوليكلارية المتكررة أو المقاومة. تقلل الصيغة الجديدة بشكل كبير من وقت الإدارة ليصل إلى حوالي دقيقة واحدة تقريباً مقارنةً بـ 2-4 ساعات للحقن الوريدي.
تعتمد التوصية على دراسة المرحلة الثانية GO29781، والتي أظهرت عدم تفوق من حيث علم الحركة الدوائية مقارنة بالإدارة الوريدية. أظهرت بيانات السلامة الرئيسية معدلًا منخفضًا لسِمْنَة إطلاق السيتوكينات (29.8%)، مع أحداث في الغالب من الدرجة المنخفضة. يقدم العلاج مدة ثابتة من 6-12 شهراً ويمكن إعطاؤه في بيئات العيادات الخارجية.
ومن الجدير بالذكر أن Lunsumio أظهر معدلات استجابة عالية وطويلة الأمد، حيث حوالي ثلثا المرضى يحتفظون بالاستجابة الكلية بعد أربع سنوات.
罗氏（OTCQX: RHHBY）已获得 CHMP 就 Lunsumio 的皮下注射制剂用于治疗成人复发或难治性滤泡性淋巴瘤的欧盟批准推荐。新制剂将给药时间显著缩短至大约 1 分钟，相比静脉输注的 2-4 小时。
该推荐基于 II 期 GO29781 研究，显示药代学上不劣于静脉给药。安全性要点显示细胞因子释放综合征发生率较低（29.8%），多为低等级事件。该治疗的 固定治疗期为 6-12 个月，可在门诊环境中给药。值得注意的是，Lunsumio 展现出高且持久的应答率，大约 三分之二的患者在四年后仍维持完全缓解。
- New subcutaneous formulation reduces treatment time from 2-4 hours to just 1 minute
- High efficacy with two-thirds of patients maintaining complete response after 4 years
- Fixed-duration therapy of 6-12 months offers potential treatment-free periods
- Can be administered in outpatient settings, improving accessibility
- Favorable safety profile with low-grade cytokine release syndrome events
- Cytokine release syndrome occurred in 29.8% of patients, though mostly low-grade
- Treatment limited to patients who have already tried two or more systemic therapies
- Lunsumio provides high and long-lasting response rates, with approximately two-thirds of patients with a complete response in remission after four years1
- Subcutaneous Lunsumio has potential to substantially reduce treatment administration time with an approximately one minute injection, compared with 2-4 hours IV infusion
- If approved, Lunsumio would be the first treatment available for people with follicular lymphoma after two or more lines of systemic therapy, which is both fixed-duration and subcutaneously administered
Basel, 19 September - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of a subcutaneous (SC) formulation of Lunsumio® (mosunetuzumab) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. A final decision is expected from the European Commission in the near future.
"Lunsumio was the first-ever approved CD20xCD3 T-cell engaging bispecific antibody demonstrating high, durable response rates and a favourable safety profile in third-line or later follicular lymphoma," said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. "If approved, the subcutaneous formulation could help to expand the treatment options available, offering people a fixed-duration therapy with a faster treatment administration time."
The CHMP opinion is based on results from a primary analysis of the phase II GO29781 study. Data show subcutaneous Lunsumio had pharmacokinetic non-inferiority compared to intravenous (IV) administration, with no unexpected safety signals. Overall, the rate and severity of cytokine release syndrome was low (
Lunsumio administered subcutaneously has the potential to reduce the treatment administration time with an approximately one minute injection, compared with 2-4 hours for IV infusion, while retaining the same dosing schedule. Lunsumio is designed to be given for a fixed duration of approximately 6-12 months, depending on a patient’s response to treatment, and can be initiated in the outpatient setting. This means people have a target end date for their course of treatment and the possibility of a treatment-free period.
Data from the phase II GO29781 study have been submitted to other health authorities around the world for approval consideration, including the US Food and Drug Administration.
Lunsumio, along with Columvi® (glofitamab), is part of Roche’s industry-leading CD20xCD3 bispecific antibody portfolio. Continuing to explore new formulations and combinations of these medicines across different disease areas and lines of treatment is part of Roche’s commitment to improve the patient experience and provide more choice, to suit diverse patient and healthcare system needs.
About the GO29781 study
The GO29781 study is a phase I/II, multicentre, open-label, dose-escalation and expansion study evaluating the safety, efficacy and pharmacokinetics of Lunsumio® (mosunetuzumab), administered both as an intravenous (IV) and subcutaneous (SC) treatment, in people with relapsed or refractory B-cell non-Hodgkin lymphoma. The primary objective for the SC cohort was to show pharmacokinetic (PK) non-inferiority of the SC formulation of Lunsumio compared to the IV formulation, based on the study’s co-primary endpoints. Key secondary endpoints include complete response (CR) rate, objective response rate (ORR), duration of response, progression-free survival, safety and tolerability.
This recommendation is based on a primary analysis that explored Lunsumio administered subcutaneously in patients with third-line or later follicular lymphoma. Results showed PK non-inferiority compared to IV administration, and the ORR and CR rates in patients treated with the fixed-duration, subcutaneous formulation of Lunsumio were
About follicular lymphoma
Follicular lymphoma (FL) is the most common slow-growing (indolent) form of non-Hodgkin lymphoma, accounting for about one in five cases.3,4 It typically responds well to treatment but is often characterised by periods of remission and relapse.3 The disease typically becomes harder to treat each time a patient relapses, and early progression can be associated with poor long-term prognosis.4 It is estimated that more than 110,000 people are diagnosed with FL each year worldwide.4,6
About Lunsumio® (mosunetuzumab)
Lunsumio is a first-in-class CD20xCD3 T-cell engaging bispecific antibody designed to target CD20 on the surface of B cells and CD3 on the surface of T cells. This dual targeting activates and redirects a patient’s existing T cells to engage and eliminate target B cells by releasing cytotoxic proteins into the B cells. A robust clinical development programme for Lunsumio is ongoing, investigating the molecule as a monotherapy and in combination with other medicines, for the treatment of people with B-cell non-Hodgkin lymphomas, including follicular lymphoma and diffuse large B-cell lymphoma, other blood cancers and autoimmune disorders.
About Roche in haematology
Roche has been developing medicines for people with malignant and non-malignant blood diseases for more than 25 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera®/Rituxan® (rituximab), Gazyva®/Gazyvaro® (obinutuzumab), Polivy® (polatuzumab vedotin), Venclexta®/Venclyxto® (venetoclax) in collaboration with AbbVie, Hemlibra® (emicizumab), PiaSky® (crovalimab), Lunsumio® (mosunetuzumab) and Columvi® (glofitamab). Our pipeline of investigational haematology medicines includes T-cell-engaging bispecific antibody cevostamab, targeting both FcRH5 and CD3, and off-the-shelf allogeneic CAR-T therapies. Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further.
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.
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References
[1] Shadman M, et al. Mosunetuzumab Continues to Demonstrate Clinically Meaningful Outcomes in Patients with Relapsed and/or Refractory Follicular Lymphoma after ≥2 Prior Therapies Including Those with a History of POD24: 4-Year Follow-up of a Pivotal Phase II Study. Presented at: ASH Annual Meeting and Exposition; 2024 Dec 7-10; San Diego, CA, USA. Abstract #4407.
[2] Roche data on file.
[3] Adult Non-Hodgkin Lymphoma Treatment-Health Professional Version (PDQ®) National Cancer Institute [Internet; cited September 2025]. Available from: https://www.cancer.gov/types/lymphoma/hp/adult-nhl-treatment-pdq#link/_552_toc.
[4] Cancer.Net. Lymphoma - Non-Hodgkin: Subtypes. [Internet; cited September 2025]. Available from: https://www.cancer.net/cancer-types/lymphoma-non-hodgkin/subtypes.
[5] Casulo C et al. Early Relapse of Follicular Lymphoma After Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone Defines Patients at High Risk for Death: An Analysis From the National LymphoCare Study. J Clin Oncol. 2015; 33(23): 2516-2522.
[6] World Health Organization. Numbers derived from GLOBOCAN 2022. Non-Hodgkin Lymphoma Factsheet [Internet; cited September 2025]. Available from: https://gco.iarc.who.int/media/globocan/factsheets/cancers/34-non-hodgkin-lymphoma-fact-sheet.pdf.
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