{"id":60439,"date":"2024-12-05T07:02:50","date_gmt":"2024-12-05T06:02:50","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/fda-accepts-supplemental-biologics-license-application-for-genentechs-columvi-combination-for-people-with-relapsed-or-refractory-diffuse-large-b-cell-lymphoma\/"},"modified":"2024-12-05T07:02:50","modified_gmt":"2024-12-05T06:02:50","slug":"fda-accepts-supplemental-biologics-license-application-for-genentechs-columvi-combination-for-people-with-relapsed-or-refractory-diffuse-large-b-cell-lymphoma","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/fda-accepts-supplemental-biologics-license-application-for-genentechs-columvi-combination-for-people-with-relapsed-or-refractory-diffuse-large-b-cell-lymphoma\/","title":{"rendered":"FDA Accepts Supplemental Biologics License Application for Genentech\u2019s Columvi Combination for People With Relapsed or Refractory Diffuse Large B-Cell Lymphoma"},"content":{"rendered":"
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\n\u2013 Application is based on data from the Phase III STARGLO study where Columvi plus chemotherapy showed a statistically significant and clinically meaningful improvement in overall survival \u2013<\/i><\/p>\n

\n\u2013 This regimen could provide an off-the-shelf, fixed-duration treatment option for patients to start soon after diagnosis, which is important for those who are at high-risk of disease progression \u2013<\/i><\/p>\n

\n\u2013 Improving survival outcomes is needed for people with an aggressive disease like relapsed or refractory DLBCL, especially those who aren\u2019t eligible for transplant \u2013<\/i><\/p>\n

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted the company\u2019s supplemental Biologics License Application (sBLA) for Columvi\u00ae<\/sup> (glofitamab-gxbm) in combination with gemcitabine and oxaliplatin (GemOx) for the treatment of people with relapsed or refractory (R\/R) diffuse large B-cell lymphoma (DLBCL) who have received at least one prior line of therapy and are not candidates for autologous stem cell transplant. The FDA is expected to make a decision on approval by July 20, 2025.<\/p>\n

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\nThe standard second-line therapy for R\/R DLBCL patients has historically been high-dose chemotherapy followed by stem-cell transplant, however, not all patients are a candidate due to age or coexisting medical conditions. While newer therapies are becoming available, barriers remain for many and alternative treatment options are needed for these patients to improve survival outcomes.<\/p>\n

\n\u201cFor people with aggressive lymphomas like DLBCL, timely intervention with effective therapies can be crucial to reduce the risk of disease progression and improve long-term outcomes,\u201d said Levi Garraway, M.D., Ph.D., Genentech\u2019s chief medical officer and head of Global Product Development. \u201cWe are encouraged by the overall survival benefit seen with this Columvi combination and hope it can become an important treatment option for those who are in need of alternative therapies.\u201d<\/p>\n

\nThe sBLA is based on results from the Phase III STARGLO study, which were presented at the European Hematology Association Congress earlier this year and recently published in The Lancet<\/i>. Data showed Columvi in combination with GemOx demonstrated a statistically significant and clinically meaningful overall survival (OS) improvement versus Rituxan\u00ae<\/sup> (rituximab) and GemOx (R-GemOx), making it the first CD20xCD3 bispecific antibody to show a survival benefit in DLBCL in a randomized Phase III trial. Safety of the combination appeared consistent with the known safety profiles of the individual medicines.<\/p>\n

\nData from the STARGLO study have been submitted to other health authorities around the world for approval consideration, including the European Medicines Agency.<\/p>\n

\nColumvi is part of Genentech\u2019s industry-leading CD20xCD3 bispecific antibody program, which has seen more than 3,000 patients treated in clinical trials and more than 2,600 treated in clinical practice to date. Columvi was the first fixed-duration bispecific antibody to receive accelerated approval by the U.S. FDA and conditional marketing authorization in the EU as a monotherapy to treat people with R\/R DLBCL after two or more lines of systemic therapy and is currently approved in more than 50 countries around the world.<\/p>\n

\nAs part of Genentech\u2019s efforts to elevate treatment standards in the earlier stages of DLBCL, where there is the best opportunity to improve long-term outcomes and prevent relapse, Columvi is also being investigated in combination with Polivy\u00ae<\/sup> (polatuzumab vedotin-piiq), Rituxan, cyclophosphamide, doxorubicin and prednisone (R-CHP) in previously untreated DLBCL in the Phase III SKYGLO study.<\/p>\n

\nAbout the STARGLO Study<\/b><\/p>\n

\nThe STARGLO study [GO41944; NCT04408638<\/a>] is a Phase III, multicenter, open-label, randomized study evaluating the efficacy and safety of Columvi\u00ae<\/sup> (glofitamab-gxbm) in combination with gemcitabine plus oxaliplatin (GemOx) versus Rituxan\u00ae<\/sup> (rituximab) in combination with GemOx in patients with relapsed or refractory 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, or who have received two or more prior lines of therapy. Preclinical research indicated an increased antitumor effect when combining Columvi with GemOx over GemOx alone, so the STARGLO study was initiated to further explore the potential complementary effects of the treatment combination. Outcome measures include overall survival (OS; primary endpoint), progression-free survival, complete response rate, objective response rate, duration of objective response (secondary endpoints), and safety and tolerability.<\/p>\n

\nIn the primary analysis (conducted after a median follow-up of 11.3 months) patients treated with Columvi plus GemOx lived significantly longer, with a 41% reduction in the risk of death (hazard ratio [HR]=0.59, 95% CI: 0.40-0.89, p=0.011) versus R-GemOx. Median OS was not reached with the Columvi regimen versus nine months for R-GemOx. Safety of the combination appeared consistent with the known safety profiles of the individual medicines. Adverse event (AE) rates were higher with the Columvi combination versus R-GemOx, noting higher median number of cycles received with the Columvi combination (11 versus 4). One of the most common AEs was cytokine release syndrome, which was generally low grade (Any Grade: 44.2%, Grade 1: 31.4%, Grade 2: 10.5%, Grade 3: 2.3%) and occurred primarily in Cycle 1.<\/p>\n

\nSTARGLO is intended as a confirmatory study to convert the accelerated approval of Columvi in the U.S. and conditional marketing authorization in the EU to full approvals for people with R\/R DLBCL after two or more lines of systemic therapy based on the pivotal Phase I\/II NP30179 study [NCT03075696<\/a>].<\/p>\n

\nAbout Columvi\u00ae<\/sup> (glofitamab-gxbm)<\/b><\/p>\n

\nColumvi 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 Genentech\u2019s broad and industry-leading CD20xCD3 T-cell-engaging bispecific antibody clinical development program that also includes Lunsumio\u00ae<\/sup> (mosunetuzumab), which aims to provide tailored treatment options that suit the diverse needs, preferences, and experiences of people with blood cancers and healthcare systems. Genentech 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.<\/p>\n

\nAbout Diffuse Large B-Cell Lymphoma<\/b><\/p>\n

\nDiffuse large B-cell lymphoma (DLBCL) is an aggressive (fast-growing) blood cancer and is the most common form of non-Hodgkin\u2019s lymphoma (NHL) in the U.S. While many people with DLBCL are responsive to treatment, the majority of those who relapse or are refractory to subsequent treatments have poor outcomes. DLBCL not otherwise specified is the most common category of large B-cell lymphoma (LBCL) and accounts for about 80% or more of cases. It applies to cases that do not fall into any specific disease subgroups of LBCL.<\/p>\n

\nColumvi U.S. Indication<\/b><\/p>\n

\nColumvi (glofitamab-gxbm) is a prescription medicine to treat adults with certain types of diffuse large B-cell lymphoma (DLBCL) or large B-cell lymphoma (LBCL) that has come back (relapsed) or that did not respond to previous treatment (refractory), and who have received 2 or more prior treatments for their cancer.<\/p>\n

\nIt is not known if Columvi is safe and effective in children.<\/p>\n

\nThe conditional approval of Columvi is based on response rate and durability of response. There are ongoing studies to establish how well the drug works.<\/p>\n

\nWhat is the most important information I should know about Columvi?<\/b><\/p>\n

\nColumvi can cause Cytokine Release Syndrome (CRS),<\/b> a serious side effect that is common during treatment with Columvi, and can also be serious and lead to death.<\/p>\n

\nCall your healthcare provider or get emergency medical help right away if you develop any signs or symptoms of CRS, including:<\/b><\/p>\n