• Columvi (glofitamab) is the first bispecific CD20xCD3 T-cell-recruiting antibody for the treatment of the most common form of aggressive lymphoma, diffuse large B-cell lymphoma (DLBCL).¹
• The approval is based on the results of the phase I/II NP30179 trial, which showed a durable response with an overall response rate of 55.3% and a complete response of 40.4% in patients who had received prior CAR T-cell treatment.¹
• Columvi is administered over a limited period of maximum 8.5 months and thus offers patients the possibility of a treatment-free period after the end of therapy.¹
  
  

Basel, 15 November 2023 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the Swiss Agency for Therapeutic Products (Swissmedic) has approved Columvi® (glofitamab) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) following two or more lines of treatment*. This indication has been temporarily granted by Swissmedic as part of an accelerated approval procedure (the Orbis procedure) based on the convincing response rates and duration of response in the phase I/II study NP30179.

DLBCL is an aggressive disease that is difficult to treat. It is the most common form of non-Hodgkin's lymphoma (NHL) in Switzerland.² While many people with DLBCL respond to first-line therapy, the majority of those who experience relapse or are refractory to treatment have a poor prognosis.^3,4 It is estimated that around 160,000 people worldwide are diagnosed with DLBCL every year.⁵

Columvi is the first CD20xCD3 T-cell-activating bispecific antibody for the treatment of R/R DLBCL that is administered over a fixed period of time. This is in contrast to approaches where treatment continues until the disease progresses or until therapy can no longer be tolerated. Therapy with Columvi is designed in such a way that treatment is completed after a maximum of 8.5 months, and thus offers patients the possibility of a treatment-free period after the end of therapy. In addition, Columvi is a chemotherapy-free treatment option that is ready for infusion immediately (“off-the-shelf”).

“People with diffuse large-cell B-cell lymphoma who have already undergone several lines of therapy urgently need additional treatment options,” explains Dr Jean-Marc Häusler, Country Medical Director, Roche Pharmaceuticals Switzerland. “Data from the pivotal study show that Columvi gives these patients a chance of complete remission and that remission can be maintained even after the end of treatment. I am also pleased that Columvi is already the second bispecific antibody after Lunsumio® that Roche is able to bring to market for the treatment of non-Hodgkin's lymphoma. We are proud to be able to offer patients a promising therapy option thanks to this innovative and effective approach.”

About Columvi® (glofitamab)
Columvi is a CD20xCD3 T-cell-activating bispecific antibody that binds in a unique 2:1 structure to the CD20 on the surface of B-cells and the CD3 on the surface of T-cells. Through this simultaneous binding, Columvi brings the malignant B-cell into contact with the T-cell, which kills the B-cell in response. A broad clinical development programme is currently underway in which Columvi is being studied both as a monotherapy and in combination with other medicinal products for the treatment of patients with different non-Hodgkin's lymphomas, including diffuse large-cell B-cell lymphoma.

About the NP30179 study
The NP30179 study [NCT03075696] is a phase I/II, multicentre, open-label, dose-escalation and expansion study to evaluate the safety, efficacy, and pharmacokinetics of Columvi (glofitamab) in patients with relapsed or refractory diffuse large-cell B-cell lymphoma. Study end points include complete response rate by an independent review committee (primary endpoint), overall response rate, duration of response, progression-free survival, safety and tolerability (secondary end point). The data from the NP30179 study were recently published in the New England Journal of Medicine.⁶

Overall, 86% of patients were refractory to their last therapy, 90% were refractory to a previous line of therapy, and about one-third (33%) had previously received CAR T-cell therapy.⁶ The results showed that a total of 52% (95% CI: 44–60) of patients responded to the therapy (ORR —overall response rate; the combination of CR (CR — complete response; disappearance of all signs of cancer) and partial response, i.e. a decrease in the amount of cancer in the body), with 40% (95% CI: 32–48) of patients achieving a complete response.⁷ The median duration of the complete response was 26.9 months (95% CI:18.4; NE). ⁷ Complete response was generally rapid, median after 42 days (95% CI: 42–44)⁶. The most common adverse events were cytokine release syndrome (CRS; 63%), neutropenia (reduction in white blood cells [38%]), anaemia (31%) and thrombocytopenia (reduction in platelets [25%]).⁶ CRS was generally low in severity (grade 1: 47%; grade 2: 12%).⁶

About diffuse large-cell B-cell lymphoma (DLBCL)
DLBCL is the most common form of non-Hodgkin's lymphoma and accounts for about one in three NHL cases.⁸ DLBCL is an aggressive form of NHL, i.e. it progresses rapidly.⁸ Although patients generally respond well to initial treatment, up to 40% suffer a relapse or are refractory to therapy. Patients who do not respond to first-line therapy still have a poor prognosis. ^3,4 It is estimated that around 160,000 people worldwide are diagnosed with DLBCL every year.⁵

About Roche in haematology
Roche has been developing medicines for people with malignant and benign blood disorders for over 20 years; our experience and knowledge in this therapeutic area runs deep. Today, Roche is investing more than ever in activities to bring innovative treatment options to patients across a wide range of blood disorders. Our approved medicines include MabThera® (rituximab), Gazyvaro® (obinutuzumab), Polivy® (Polatuzumab vedotin), Hemlibra® (emicizumab), Lunsumio® (mosunetuzumab) and Columvi® (glofitamab). Our haematological investigational medicinal product pipeline includes the T-cell-activating bispecific antibody cevostamab, which targets both FcRH5 and CD3; Tecentriq® (atezolizumab), a monoclonal antibody that binds to PD-L1; and crovalimab, an anti-C5 antibody designed to optimize complement inhibition. Roche's scientific expertise, combined with the breadth of its portfolio and pipeline, also provides an opportunity to develop combination treatments 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 endeavour 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.

* Including a CD20-targeted antibody and an anthracycline. In addition, patients must have progression to, or be ineligible for, prior anti-CD19 directed CAR-T cell therapy.
 

References
[1] Fachinformation von Columvi® unter www.swissmedicinfo.ch
[2] https://www.lymphome.ch/lymphome/krankheitsbilder/diffus-grosszelliges-b-zell-lymphom-dblcl/
[3] Maurer MJ et al. Event-free survival at 24 months is a robust end point for disease-related outcome in diffuse large B-cell lymphoma treated with immunochemotherapy. J Clin Oncol. 2014;32:1066-73.
[4] Sehn LH, Gascoyne RD. Diffuse large B-cell lymphoma: optimizing outcome in the context of clinical and biologic heterogeneity. Blood. 2015;125(1):22-32.
[5] Calculation for Worldwide incidence: World Health Organization. GLOBOCAN 2020, Cancer Incidence and Mortality: IARC CancerBase No. 11 [Internet; cited June 2023]. Available from: https://gco.iarc.fr/today/online-analysis-table?v=2020&mode=cancer&mode_population=continents&population=900&populations=908&key=asr&sex=0&cancer=39&type=0&statistic=5&prevalence=0&population_group=0&ages_group%5B%5D=0&ages_group%5B%5D=17&group_cancer=1&include_nmsc=1&include_nmsc_other=1#collapse-group-1-4-0
[6] Dickinson MJ et al. Glofitamab for Relapsed or Refractory Diffuse Large B-Cell-Lympho-ma. NEJM 2022;387(24):2220-2231 und Supplementary Appendix
[7] Falchi L et al. Glofitamab monotherapy in patients with relapsed/refractory (R/R)large B-cell lymphoma (LBCL): extended follow-up and landmark analyses from a pivotal Phase II study. ASCO 2023 oral presentation (Abstract P7550)
[8] Cancer.Net. Lymphoma - Non-Hodgkin: Subtypes. [Internet; cited June 2023]. Available from:
https://www.cancer.net/cancer-types/lymphoma-non-hodgkin/subtypes

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