Roche Presents Promising Data on Bispecific Antibodies at ASH 2024, Highlighting Advancements in Lymphoma Treatment

Roche Presents Promising Data on Bispecific Antibodies at ASH 2024, Highlighting Advancements in Lymphoma Treatment

(IN BRIEF) Roche presented new data at the ASH 2024 meeting highlighting the effectiveness of its bispecific antibodies, Columvi and Lunsumio, in treating lymphomas. Long-term studies show durable remissions and immune system recovery with fixed-duration therapies, while real-world data emphasize reduced treatment burdens due to less frequent dosing. Subcutaneous Lunsumio demonstrated comparable efficacy to intravenous delivery with faster administration, offering a convenient outpatient option. Additionally, innovative combinations like Columvi with Polivy showed strong response rates, even in patients previously treated with CAR T-cell therapy. These findings reinforce Roche’s commitment to advancing lymphoma care with patient-centered, flexible treatment options.

(PRESS RELEASE) BASEL, 10-Dec-2024 — /EuropaWire/ — Roche has unveiled compelling new data from its CD20xCD3 T-cell-engaging bispecific antibody program at the 66th American Society of Hematology (ASH) Annual Meeting & Exposition. These findings reinforce the potential of Columvi® (glofitamab) and Lunsumio® (mosunetuzumab) in addressing the diverse needs of lymphoma patients through durable remissions, innovative treatment options, and patient-centered care approaches.

Durable Remissions and Patient-Centered Benefits
Long-term follow-up data from pivotal studies underscore the effectiveness of fixed-duration therapies. The NP30179 study on Columvi in relapsed or refractory large B-cell lymphoma (LBCL) showed that 40% of patients achieved complete remission, with a median duration of 29.8 months, while safety remained consistent. Similarly, four-year data from the GO29781 study of Lunsumio in follicular lymphoma (FL) demonstrated sustained remissions, with 64% of complete responders remaining disease-free at 45 months. Importantly, both treatments showed signs of B-cell recovery, essential for immune system health.

A real-world study highlighted the reduced travel burden for patients receiving fixed-duration therapies like Columvi and Lunsumio, thanks to less frequent dosing. This finding underscores the importance of addressing logistical and emotional aspects of cancer treatment beyond clinical outcomes.

Exploring Subcutaneous Administration
In a landmark development, subcutaneous administration of Lunsumio demonstrated non-inferior efficacy compared to intravenous delivery in a phase II study. This approach achieved an overall response rate (ORR) of 76.6% and a complete response (CR) rate of 61.7%, with a favorable safety profile. The subcutaneous route offers a faster administration time, enhancing convenience for outpatient settings.

In a randomized phase II study, combining subcutaneous Lunsumio with Polivy® (polatuzumab vedotin) improved response rates in relapsed or refractory LBCL compared to MabThera®/Rituxan® with Polivy. This investigational regimen delivered an ORR of 77.5%, suggesting potential for expanded treatment options.

Pioneering New Frontiers in Lymphoma Care
Roche continues to explore innovative combinations to elevate treatment standards. Phase I/Ib data revealed robust outcomes for Columvi paired with Polivy in patients with relapsed or refractory LBCL, including those previously treated with CAR T-cell therapy. This combination achieved an ORR of 80.6% and a CR rate of 62%, further supporting its development in advanced trials.

Roche’s Chief Medical Officer, Levi Garraway, highlighted the significance of these findings, stating, “These data demonstrate our commitment to transforming lymphoma care through innovative therapies tailored to patient needs, offering hope for improved outcomes.”

Looking Ahead
Roche’s advancements in bispecific antibodies aim to address clinical and logistical challenges faced by lymphoma patients. The company’s pursuit of innovative administration methods and fixed-duration treatments underscores its dedication to patient-centric care and expanding therapeutic possibilities.

For more details, the complete findings are available in the ASH 2024 abstracts.

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.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

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.

Media Contacts:

Roche Global Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Roche Investor Relations

Investor Relations North America

SOURCE: Roche