New and updated data for Roche's fixed-duration Columvi and Lunsumio at ASH 2024 reinforce their potential to improve outcomes for people with lymphoma
Roche presented new data for its CD20xCD3 bispecific antibodies Columvi and Lunsumio at ASH 2024, demonstrating durable remissions with fixed-duration treatment. Three-year follow-up showed Columvi achieved 40% complete response in large B-cell lymphoma, while Lunsumio showed 64% of follicular lymphoma patients remained progression-free at 45 months.
A new subcutaneous formulation of Lunsumio demonstrated non-inferiority to intravenous treatment, with 76.6% overall response rate and 61.7% complete response rate. Real-world data indicated reduced treatment-related travel burden due to less frequent dosing with these therapies.
The combination of Lunsumio with Polivy showed improved efficacy versus MabThera/Rituxan with Polivy in relapsed/refractory large B-cell lymphoma, achieving 77.5% overall response rate versus 50%.
Roche ha presentato nuovi dati sui suoi anticorpi bispecifici CD20xCD3 Columvi e Lunsumio all'ASH 2024, dimostrando remissioni durature con trattamenti a durata fissa. Il follow-up di tre anni ha mostrato che Columvi ha raggiunto il 40% di risposta completa nel linfoma diffuso a grandi cellule B, mentre Lunsumio ha mostrato che il 64% dei pazienti con linfoma follicolare è rimasto senza progressione a 45 mesi.
Una nuova formulazione sottocutanea di Lunsumio ha dimostrato non inferiorità rispetto al trattamento endovenoso, con un tasso di risposta globale del 76,6% e un tasso di risposta completa del 61,7%. Dati del mondo reale hanno indicato una riduzione del carico di viaggio legato al trattamento grazie a una somministrazione meno frequente di queste terapie.
La combinazione di Lunsumio con Polivy ha mostrato un'efficacia migliorata rispetto a MabThera/Rituxan con Polivy nel linfoma diffuso a grandi cellule B in recidiva/refrattario, raggiungendo un tasso di risposta globale del 77,5% contro il 50%.
Roche presentó nuevos datos sobre sus anticuerpos bispecíficos CD20xCD3 Columvi y Lunsumio en ASH 2024, demostrando remisiones duraderas con tratamientos de duración fija. El seguimiento a tres años mostró que Columvi logró un 40% de respuesta completa en linfoma difuso de células B, mientras que Lunsumio demostró que el 64% de los pacientes con linfoma folicular permanecieron sin progresión a los 45 meses.
Una nueva formulación subcutánea de Lunsumio mostró no inferioridad en comparación con el tratamiento intravenoso, con una tasa de respuesta general del 76,6% y una tasa de respuesta completa del 61,7%. Los datos del mundo real indicaron una reducción de la carga de viajes relacionada con el tratamiento debido a la menor frecuencia de dosificación de estas terapias.
La combinación de Lunsumio con Polivy mostró una eficacia mejorada en comparación con MabThera/Rituxan con Polivy en linfoma difuso de células B en recaída/refractario, logrando una tasa de respuesta general del 77,5% frente al 50%.
로슈는 ASH 2024에서 새로운 CD20xCD3 이중항체 콜룸비 및 룬숨리오에 대한 데이터를 발표하고 고정된 치료 기간 동안 지속적인 Remission을 입증했습니다. 3년 추적 조사에서 콜룸비는 대 B세포 림프종에서 40%의 완전 반응률을 달성한 반면, 룬숨리오는 여포 림프종 환자의 64%가 45개월 동안 진행 없이 유지됨을 보여주었습니다.
룬숨리오의 새로운 피하 제형은 정맥 치료와 비교하여 열등하지 않음을 입증했으며, 76.6%의 전체 반응률과 61.7%의 완전 반응률을 기록했습니다. 실제 데이터에 따르면 이러한 치료법으로 인해 치료 관련 여행 부담이 줄어들었다고 합니다.
룬숨리오와 폴리비의 조합은 재발/내성 대 B세포 림프종에서 MabThera/Rituxan과의 조합에 비해 개선된 효능을 보여주었으며, 전체 반응률이 77.5%로 50%를 초과했습니다.
Roche a présenté de nouvelles données concernant ses anticorps bispécifiques CD20xCD3 Columvi et Lunsumio lors de l'ASH 2024, démontrant des remissions durables avec un traitement à durée fixe. Le suivi de trois ans a montré que Columvi avait atteint un taux de réponse complète de 40 % dans le lymphome à grandes cellules B, tandis que Lunsumio montrait que 64 % des patients atteints de lymphome folliculaire restaient sans progression à 45 mois.
Une nouvelle formulation sous-cutanée de Lunsumio a montré une non-infériorité par rapport au traitement intraveineux, avec un taux de réponse global de 76,6 % et un taux de réponse complète de 61,7 %. Des données du monde réel ont indiqué une réduction de la charge de voyage liée au traitement grâce à une administration moins fréquente de ces thérapies.
La combinaison de Lunsumio avec Polivy a montré une efficacité améliorée par rapport à MabThera/Rituxan avec Polivy dans le lymphome à grandes cellules B en rechute/réfractaire, atteignant un taux de réponse global de 77,5 % contre 50 %.
Roche präsentierte auf der ASH 2024 neue Daten zu seinen bispezifischen Antikörpern CD20xCD3 Columvi und Lunsumio, die nachhaltige Remissionen bei Behandlungen mit fester Dauer zeigen. Die dreijährige Nachverfolgung ergab, dass Columvi eine vollständige Ansprechrate von 40% bei großzelligem B-Zell-Lymphom erreichte, während Lunsumio zeigte, dass 64% der Patienten mit follikulärem Lymphom 45 Monate lang progressionsfrei blieben.
Eine neue subkutane Formulierung von Lunsumio zeigte eine Nichtunterlegenheit gegenüber der intravenösen Behandlung, mit einer Gesamtansprechrate von 76,6% und einer vollständigen Ansprechrate von 61,7%. Daten aus der realen Welt deuteten auf eine verringerte Reisebelastung im Zusammenhang mit der Behandlung hin, da diese Therapien weniger häufig verabreicht werden mussten.
Die Kombination von Lunsumio mit Polivy zeigte eine verbesserte Wirksamkeit gegenüber MabThera/Rituxan mit Polivy beim rezidivierten/refraktären großzelligen B-Zell-Lymphom und erreichte eine Gesamtansprechrate von 77,5% im Vergleich zu 50%.
- Three-year data shows 40% complete response rate for Columvi in LBCL
- Lunsumio demonstrates 64% progression-free survival at 45 months in FL
- New subcutaneous Lunsumio shows 76.6% overall response rate
- Lunsumio-Polivy combination achieves 77.5% response rate vs 50% for standard therapy
- Both drugs show immune system recovery post-treatment
- None.
- Long-term data confirm fixed-duration Columvi and Lunsumio achieve durable remissions beyond the end of treatment, with real-world data suggesting reduced treatment-related travel burden due to less frequent dosing1,2,3
- First presentation of Lunsumio given subcutaneously showed non-inferiority to intravenous treatment with a consistent safety profile, potentially providing an additional outpatient option with a shorter administration time4
- Positive results for Roche's two bispecifics antibodies validate the company's efforts to provide multiple treatment options that suit the diverse needs of lymphoma patients and healthcare providers5,6
Basel, 10 December 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that new and updated data from its industry-leading CD20xCD3 T-cell-engaging bispecific antibody programme were presented at the 66th American Society of Hematology (ASH) Annual Meeting & Exposition, 7-10 December 2024. With more than 20 bispecific antibody abstracts accepted for presentation, data showcase the benefits of fixed-duration Columvi® (glofitamab) and Lunsumio® (mosunetuzumab) across different types of aggressive and indolent lymphomas. This research supports Roche’s efforts to continue innovating for patients by advancing treatment standards at earlier stages of disease while exploring additional forms of administration that could further improve the patient experience.
“The data being presented at ASH offer further evidence that Columvi and Lunsumio can provide lasting remissions for people with advanced lymphoma,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “The results underscore our ambition to transform the treatment of B-cell malignancies with a range of innovative therapeutic options.”
“Lymphoma patients face challenges that extend well beyond the clinical manifestations of their disease, including the physical and emotional strain of frequent appointments and treatments,” said Elizabeth Budde, M.D., Ph.D., City of Hope’s executive medical director of its Enterprise Immune Effector Cell Program and associate professor in its Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation. “While Lunsumio’s fixed duration intravenous formulation has already offered a valuable treatment option, the introduction of a subcutaneous route could provide a shorter administration time. With both routes available, we can better tailor therapy to each patient’s needs, supporting a flexible and patient-centered approach to follicular lymphoma care.”
Follow-up data reinforce benefits of fixed-duration therapies beyond the end of treatment
Three-year follow-up from the pivotal phase II NP30179 study of Columvi in people with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) showed
Long-term data at four years from the pivotal phase II GO29781 study of Lunsumio in patients with R/R follicular lymphoma (FL) showed long-lasting remissions, with nearly two-thirds (
Both studies also showed restoration of B-cell levels, starting from 12-18 months following Columvi treatment and after a median of 19 months following Lunsumio treatment, indicating immune system recovery and supporting the use of a fixed-duration treatment approach.1,2 Recovery of B cells following treatment for lymphoma is important so that patients can maintain immune system function.
A US real-world data study and economic model evaluating R/R non-Hodgkin lymphoma patient treatment-related travel burden across different bispecific antibody therapies highlight the impact of travel distance, time and associated costs, an often-overlooked aspect of the patient experience beyond clinical efficacy and safety. These factors play a crucial role in treatment decision-making, further emphasising the importance of patient-centred treatment options. The study found fixed-duration therapies, such as Columvi and Lunsumio, reduce treatment-related travel burden due to less frequent dosing.3
Studies investigating subcutaneously-administered Lunsumio show positive results
Data from a primary analysis of the phase II GO29781 study of investigational Lunsumio administered subcutaneously in patients with third-line or later FL were presented for the first time. Results show pharmacokinetic non-inferiority compared to intravenous (IV) administration, with fixed-duration Lunsumio achieving high rates of deep and durable remissions, with
New data from a randomised phase II cohort of the investigational GO40516 study showed improved efficacy and manageable safety with outpatient, subcutaneously administered, fixed-duration Lunsumio in combination with Polivy® (polatuzumab vedotin) versus MabThera®/Rituxan® (rituximab) in combination with Polivy, in people with R/R LBCL. In the Lunsumio-Polivy arm, the ORR was
Additional data support Roche’s goal to elevate treatment standards in earlier stages of LBCL
Updated data from the phase I/Ib investigational NP39488 study showed high and durable response rates in people with R/R LBCL treated with Columvi in combination with Polivy, including those with high-grade disease and prior treatment with CAR T-cell therapy. Of the 128 efficacy-evaluable patients, the best ORR was
About Columvi® (glofitamab)
Columvi is a CD20xCD3 T-cell-engaging bispecific antibody designed to target CD3 on the surface of T cells and CD20 on the surface of B cells. Columvi was designed with a novel 2:1 structural format. This T-cell-engaging bispecific antibody is engineered to have one region that binds to CD3, a protein on T cells, a type of immune cell, and two regions that bind to CD20, a protein on B cells, which can be healthy or malignant. This dual-targeting brings the T cell in close proximity to the B cell, activating the release of cancer cell-killing proteins from the T cell. Roche is investigating Columvi as a monotherapy and in combination with other medicines for the treatment of diffuse large B-cell lymphoma and mantle cell lymphoma.
About Lunsumio® (mosunetuzumab)
Lunsumio is a first-in-class CD20xCD3 T-cell-engaging bispecific antibody designed to target CD3 on the surface of T cells and CD20 on the surface of B 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, and other blood cancers.
About Polivy® (polatuzumab vedotin)
Polivy is a first-in-class anti-CD79b antibody-drug conjugate (ADC). The CD79b protein is expressed in the majority of B cells, an immune cell impacted in some types of non-Hodgkin lymphoma (NHL), making it a promising target for the development of new therapies. Polivy binds to cancer cells such as those expressing CD79b and destroys these B cells through the delivery of an anti-cancer agent, which is thought to minimise the effects on normal cells. Polivy is being developed by Roche using Pfizer ADC technology and is currently being investigated for the treatment of several types of NHL.
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 Tecentriq® (atezolizumab). 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.
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References
[1] Dickinson MJ, et al. Fixed-duration Glofitamab Monotherapy Continues to Demonstrate Durable Responses in Patients with Relapsed or Refractory Large B-Cell Lymphoma: 3-year Follow-Up From a Pivotal Phase II Study. Presented at: ASH Annual Meeting and Exposition; 2024 Dec 7-10; San Diego, CA, USA. Abstract #865.
[2] 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.
[3] Huntington SF, et al. Travel Burden and Travel Costs of Bispecific Antibodies in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma and Relapsed/Refractory Follicular Lymphoma. Presented at: ASH Annual Meeting and Exposition; 2024 Dec 7-10; San Diego, CA, USA. Abstract #782.
[4] Bartlett NL, et al. Subcutaneous Mosunetuzumab Leads to High Rates of Durable Responses, Low Rates of Cytokine Release Syndrome, and Non-Inferior Exposure Compared with Intravenous Administration in Patients with Relapsed/Refractory Follicular Lymphoma: Primary Analysis of a Pivotal Phase II. Presented at: ASH Annual Meeting and Exposition; 2024 Dec 7-10; San Diego, CA, USA. Abstract #1645.
[5] Chavez JC, et al. A Randomized Phase II Study of Mosunetuzumab SC Plus Polatuzumab Vedotin Demonstrates Improved Outcomes Versus Rituximab Plus Polatuzumab Vedotin in Patients (Pts) with Relapsed or Refractory (R/R) Large B-Cell Lymphoma (LBCL). Presented at: ASH Annual Meeting and Exposition; 2024 Dec 7-10; San Diego, CA, USA. Abstract #989.
[6] Hutchings M, et al. Glofitamab in Combination with Polatuzumab Vedotin Maintains Durable Responses and a Manageable Safety Profile in Patients with Heavily Pre-treated Relapsed/Refractory (R/R) Large B-Cell Lymphoma (LBCL) Including High-Grade B-Cell Lymphoma (HGBCL): Extended Follow-Up of a Phase Ib/II Study. Presented at: ASH Annual Meeting and Exposition; 2024 Dec 7-10; San Diego, CA, USA. Abstract #988.
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