Company Announcements

• Data showcase the potential of glofitamab and Lunsumio to address diverse patient needs
• Data presented at ASH 2022 and simultaneously published in the New England Journal of Medicine showed that glofitamab, given as a fixed course, induced early and durable responses in people with heavily pre-treated large B-cell lymphoma^1,2

• 27-month follow-up data showed Lunsumio continued to induce high and durable responses in people with relapsed or refractory follicular lymphoma, with 60% experiencing a complete response³
  
  

Basel, 12 December 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that updated clinical data for its CD20xCD3 T-cell engaging bispecific antibodies, including five oral presentations, were presented at the 64th American Society of Hematology (ASH) Annual Meeting & Exposition, 10-13 December 2022. Updated results for investigational bispecific glofitamab in people with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) suggest glofitamab has the potential to be the first, off-the-shelf CD20xCD3 T-cell engaging bispecific antibody that can be given for a fixed period of time to people with heavily pre-treated aggressive lymphoma.¹ These data will be presented at the meeting, and simultaneously published online in the New England Journal of Medicine (NEJM).² Additionally, updated data for Lunsumio® (mosunetuzumab) continued to demonstrate clinically meaningful outcomes in people with heavily pre-treated follicular lymphoma (FL).³ Lunsumio is a fixed-duration treatment that can be administered in the outpatient setting, which could allow people the possibility of experiencing a lasting remission with a treatment-free period.³

“We pioneered the development of T-cell engaging bispecific antibodies for lymphoma with the aim of expanding treatment options for people with difficult-to-treat blood cancers,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “New glofitamab and Lunsumio data continue to demonstrate durable and impressive patient responses, including complete remissions, when given for a fixed period of time. We believe these medicines could potentially transform treatment and offer new hope for people with lymphomas.” 

Pivotal phase II glofitamab data presented at ASH 2022 and published in NEJM
Updated data from the pivotal phase II NP30179 study in people with R/R LBCL showed glofitamab given as a fixed course induced early and durable responses that were maintained beyond the end of treatment. Most patients who had achieved a complete response (CR; a disappearance of all signs of cancer) at the end of treatment experienced durable responses, with a median CR follow-up from end of treatment of 11.5 months (95% confidence interval [CI]: 10.5-16.4). Twelve months after the end of treatment with glofitamab, 61% of patients (n=37/61) maintained a CR, 92.6% remained progression-free and only one patient (n=1/44) experienced disease progression.¹

Simultaneously, an earlier data cut from the phase II NP30179 study in R/R diffuse large B-cell lymphoma (DLBCL) was published online in NEJM.²

Data from this pivotal phase II study have been submitted for review to the European Medicines Agency, and submissions to additional health authorities worldwide, including the U.S. Food and Drug Administration (FDA), are ongoing.

Updated pivotal phase II Lunsumio data presented at ASH 2022
An updated analysis from the pivotal phase II GO29781 study of Lunsumio in people with R/R FL who had received two or more prior therapies showed 60.0% (n=54/90; 95% CI: 49.1–70.2) achieved a CR and 77.8% (95% CI: 67.8–85.9) achieved an objective response (a CR or a partial response, a decrease in the amount of cancer in their body) at a median follow-up of 28.3 months. After 24 months of achieving a CR, 62.7% of patients remained in remission (95% CI: 37.7–87.7). Overall, 48.3% of patients remained progression-free (95% CI: 36.2-60.3). The median duration of response, median duration of CR, and median progression-free survival were not reached. Safety was consistent with the previous analysis of study data, with no new cytokine release syndrome (CRS) events or Grade 3 or higher adverse events (AEs) reported. CRS events were experienced by 44% of patients, and were predominately low grade and during cycle one.³

The European Commission granted conditional marketing authorisation for Lunsumio for the treatment of people with R/R FL who have received at least two prior systemic therapies in June 2022, making it the first and only fixed-duration bispecific antibody to be approved in Europe for lymphoma. Lunsumio is under Priority Review with the FDA, with a decision expected by 29 December 2022.

Additional Lunsumio and glofitamab data presented at ASH 2022
Roche continues to evaluate Lunsumio and glofitamab as part of its commitment to providing off-the-shelf therapies for people with lymphomas that can meet their diverse needs, including fixed-duration treatment options. Additional data presented at ASH 2022 include the following:

• A subcutaneous (SC) formulation of Lunsumio (administered as an injection given under the skin) demonstrated comparable efficacy with the intravenous formulation and a manageable safety profile in people with R/R non-Hodgkin lymphoma (NHL). The most common AEs were injection site reactions (60.9%; n=53/87) and CRS events (27.6%; n=24/87), which were all Grade 1 or 2. These findings suggest that a SC formulation of Lunsumio may offer patients a treatment option that could reduce their time spent in treatment centres.⁴
  
  
• Updated results from the phase I/II G050554 study of Lunsumio monotherapy in elderly/unfit patients with previously untreated DLBCL and additional analyses from the phase I/II G040516 study of Lunsumio in combination with Polivy® (polatuzumab vedotin) in heavily pre-treated people with DLBCL continued to show promising efficacy and manageable safety, highlighting the potential of Lunsumio in these patient populations.^5,6
• Results from the phase I/II NP30179 study evaluating glofitamab as a monotherapy following pre-treatment with Gazyva®/Gazyvaro® (obinutuzumab) in patients with heavily pre-treated R/R mantle cell lymphoma continued to show early, high and durable response rates in this difficult-to-treat disease. After a median follow-up of eight months, the overall response rate (ORR) was 83.8%, with the majority of patients showing durable complete responses at the data cut off (74.1%; n=20/27). The most common AE was CRS (75.5%; n=28/37), with the majority low grade.⁷
• Data from the safety and expansion cohorts of the phase Ib NP40126 study evaluating glofitamab in combination with MabThera®/Rituxan® (rituximab) plus cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) in patients with previously untreated DLBCL showed, after a median follow-up of 8.5 months, a best ORR of 92.7% (n=51/55) and a complete metabolic response rate of 72.7% (n=40/55). In the safety cohort, CRS events were all low grade (Grade 1 or 2 [10.7%; n=6/56]), and serious AEs were reported in 18 patients (32.1%).⁸

Both Lunsumio and glofitamab are being investigated as SC formulations and in phase III studies that will expand the understanding of their impact in earlier lines of treatment, with the aim of continuing to address the diverse needs and preferences of people with blood cancers. This includes the confirmatory phase III CELESTIMO study investigating Lunsumio plus lenalidomide as a chemotherapy-free option for patients with R/R FL; the phase III SUNMO study investigating Lunsumio plus Polivy versus MabThera/Rituxan in combination with gemcitabine plus oxaliplatin (R-GemOx) in patients with R/R aggressive B-cell NHL who are ineligible for autologous stem cell transplant (ASCT); and the phase III STARGLO study evaluating glofitamab in combination with gemcitabine and oxaliplatin (GemOx) versus MabThera/Rituxan in combination with GemOx in patients with R/R DLBCL who are ineligible for ASCT.

About glofitamab
Glofitamab is an investigational CD20xCD3 T-cell-engaging bispecific antibody designed to target CD3 on the surface of T-cells and CD20 on the surface of B-cells. Glofitamab 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. A robust clinical development program for glofitamab is ongoing, investigating the molecule as a monotherapy and in combination with other medicines for the treatment of people with B-cell non-Hodgkin’s lymphomas, including diffuse large B-cell lymphoma and other blood cancers.

About Lunsumio® (mosunetuzumab)
Lunsumio is a 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, and other blood cancers.

About Roche in haematology
Roche has been developing medicines for people with malignant and non-malignant blood diseases for more than 20 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) and Lunsumio® (mosunetuzumab). Our pipeline of investigational haematology medicines includes T-cell engaging bispecific antibodies glofitamab, targeting both CD20 and CD3, cevostamab, targeting both FcRH5 and CD3, Tecentriq® (atezolizumab), a monoclonal antibody designed to bind with PD-L1, and crovalimab, an anti-C5 antibody engineered to optimise complement inhibition. 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.

In recognising our endeavor to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the thirteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work.

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] Hutchings M, et al. Relapse Is Uncommon in Patients with Large B-Cell Lymphoma Who Are in Complete Remission at the End of Fixed-Course Glofitamab Treatment. Presented at: ASH Annual Meeting and Exposition; 2022 Dec 10-13. Abstract #441.
[2] Dickinson MJ et al. Glofitamab for Relapsed or Refractory Diffuse Large B-Cell Lymphoma. The New England Journal of Medicine. 2022. doi: 10.1056/NEJMoa2206913
[3] Bartlett N, et al. Mosunetuzumab Monotherapy Demonstrates Durable Efficacy with a Manageable Safety Profile in Patients with Relapsed/Refractory Follicular Lymphoma Who Received ≥2 Prior Therapies: Updated Results from a Pivotal Phase II Study. Presented at: ASH Annual Meeting and Exposition; 2022 Dec 10-13. Abstract #610.
[4] Budde E, et al. Subcutaneous Mosunetuzumab Is Active with a Manageable Safety Profile in Patients (pts) with Relapsed/Refractory (R/R) B-Cell Non-Hodgkin Lymphomas (B-NHLs): Updated Results from a Phase I/II Study. Presented at: ASH Annual Meeting and Exposition; 2022 Dec 10-13. Abstract #1628.
[5] Olszewski A, et al. Mosunetuzumab Monotherapy Continues to Demonstrate Promising Efficacy and Durable Complete Responses in Elderly/Unfit Patients with Previously Untreated Diffuse Large B-Cell Lymphoma. Presented at: ASH Annual Meeting and Exposition; 2022 Dec 10-13. Abstract #738.
[6] Olszewski A, et al. Mosunetuzumab with Polatuzumab Vedotin Is Effective and Has a Manageable Safety Profile in Patients Aged <65 and ≥65 Years with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL) and ≥1 Prior Therapy: Subgroup Analysis of a Phase Ib/II Study. Presented at: ASH Annual Meeting and Exposition; 2022 Dec 10-13. Abstract #1630. 
[7] Phillips T, et al. Glofitamab Monotherapy Induces High Complete Response Rates in Patients with Heavily Pretreated Relapsed or Refractory Mantle Cell Lymphoma. Presented at: ASH Annual Meeting and Exposition; 2022 Dec 10-13. Abstract #74.
[8] Topp M, et al. Glofitamab Plus R-CHOP Induces High Response Rates and a Favorable Safety Profile in Patients with Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL): Results from a Phase Ib Study. Presented at: ASH Annual Meeting and Exposition; 2022 Dec 10-13. Abstract #737.

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