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     181  0 Kommentare [Ad hoc announcement pursuant to Art. 53 LR] Roche’s Columvi meets primary endpoint of overall survival in people with relapsed or refractory diffuse large B-cell lymphoma in Phase III STARGLO study - Seite 2

    About the STARGLO study
    The STARGLO study [GO41944; NCT04408638] is a Phase III, multicentre, open-label, randomised study evaluating the efficacy and safety of Columvi (glofitamab) in combination with gemcitabine plus oxaliplatin (GemOx) versus MabThera/Rituxan (rituximab) in combination with GemOx in patients with diffuse large B-cell lymphoma who have received at least one prior line of therapy and who are not candidates for autologous stem cell transplant.1 Outcome measures include overall survival (primary endpoint), progression-free survival, complete response rate, objective response rate, duration of objective response (secondary endpoints), and safety and tolerability.1

    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. Columvi is part of Roche’s broad and industry-leading CD20xCD3 T-cell-engaging bispecific antibody clinical development programme that also includes Lunsumio (mosunetuzumab), which aims to provide tailored treatment options that suit the diverse needs, preferences, and experiences of people with blood cancers and healthcare systems. Roche is investigating Columvi as a monotherapy and in combination with other medicines, including Polivy (polatuzumab vedotin), in earlier lines of treatment for people with B-cell non-Hodgkin lymphomas, including diffuse large B-cell lymphoma and other blood cancers.

    About diffuse large B-cell lymphoma (DLBCL)
    DLBCL is the most common form of non-Hodgkin lymphoma (NHL), accounting for about one in three cases of NHL.2 DLBCL is an aggressive (fast-growing) type of NHL.2 While it is generally responsive to treatment in the frontline, as many as 40% of people will relapse or have refractory disease, at which time salvage therapy options are limited and survival is short.3 Improving treatments earlier in the course of the disease and providing much needed alternative options could help to improve long-term outcomes. Approximately 160,000 people worldwide are diagnosed with DLBCL each year.2, 4

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    [Ad hoc announcement pursuant to Art. 53 LR] Roche’s Columvi meets primary endpoint of overall survival in people with relapsed or refractory diffuse large B-cell lymphoma in Phase III STARGLO study - Seite 2 Columvi, in combination with chemotherapy, demonstrated a statistically significant improvement in overall survival for people with relapsed or refractory diffuse large B-cell lymphoma Data from the STARGLO study will be submitted to health …

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