LBCL is an aggressive (fast-growing) type of non-Hodgkin lymphoma (NHL) and is one of the most prevalent types of blood cancer among adults in the U.S.1 The FDA is expected to make a decision on approval of this novel cancer immunotherapy by
Unfortunately, people with relapsed or refractory large B-cell lymphoma have a poor prognosis and desperately need additional therapies that are immediately available at the time of relapse,' said
The BLA is based on positive data from the pivotal phase I/II NP30179 study, which included patients who had previously received multiple courses of therapy, with 85.1% of patients refractory to their most recent therapy and about one-third (33.1%) having received prior CAR T-cell therapy. Results showed that 40.0% of patients (n=62/155) achieved a complete response (CR; a disappearance of all signs of cancer), and 51.6% (n=80/155) achieved an objective response (OR; the combination of CR and partial response, a decrease in the amount of cancer in their body). The median follow-up time was 13.4 months. Among those who achieved a CR, 73.1% continued to experience a response at 12 months, while the median duration of CR was not reached. The median duration of response was 18.4 months.
An earlier cut-off of data from the phase I/II study showed that glofitamab given as a fixed-duration treatment resulted in early and durable complete remissions. In this analysis, presented at the 64th
The most common adverse event was cytokine release syndrome (CRS), which was generally low grade (48.1% of patients had Grade 1 and 12.3% had Grade 2). Most CRS events were associated with initial administration of glofitamab (in cycle 1). The incidence of Grade 3 or higher CRS was 3.9%, with no Grade 5 events. Only one patient (n=1/155) discontinued glofitamab due to CRS.
The FDA will review the glofitamab BLA under the granted Fast Track Designation. Data from the phase I/II NP30179 study of glofitamab were submitted for review to the
Glofitamab is part of
A robust clinical development programme for glofitamab is ongoing, including the phase III STARGLO trial, evaluating glofitamab in combination with gemcitabine and oxaliplatin (GemOx) versus rituximab in combination with GemOx in patients with second line plus diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant. Additional studies are ongoing to investigate the molecule as a monotherapy and in combination with other medicines for the treatment of patients with B-cell NHLs, including DLBCL, mantle cell lymphoma and other blood cancers.
About the NP30179 study
The NP30179 study [NCT03075696] is a phase I/II, multicentre, open-label, dose-escalation and expansion study evaluating the safety, efficacy and pharmacokinetics of glofitamab in people with relapsed or refractory diffuse large B-cell lymphoma. Outcome measures include complete response rate by an independent review committee (primary endpoint), overall response rate, duration of response, progression-free survival, safety, and tolerability (secondary endpoints).
About Large B-Cell Lymphoma
Large B-cell lymphoma (LBCL) is an aggressive (fast-growing) blood cancer and is one of the most prevalent blood cancers among adults.1 Diffuse large B-cell lymphoma (DLBCL), a subtype of LBCL, is the most common form of non-Hodgkin lymphoma (NHL) and accounts for almost a third of NHL diagnoses.4 While many patients are responsive to initial treatment, four out of ten are not cured with the current standard of care, and the majority of patients who require subsequent lines of therapy have poor outcomes.5,6
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 programme 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 lymphomas, including diffuse large B-cell lymphoma and other blood cancers.
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