The largest pivotal study of patients with relapsed or refractory large B-cell lymphoma who have experienced at least two previous therapies has paid off. The subject of the experiment was a therapy based on cells engineered to recognize diseased cells and attack them. CAR-T cell therapy is called lisocabtagene maraleucel and has been shown to induce rapid and lasting complete responses in patients with a manageable safety profile. Based on these data, the European Commission has therefore granted Marketing Authorization for this cellular immunotherapy consisting of human T cells expressing an anti? CD19 chimeric antigen receptor (CAR), for the treatment of adult patients with lymphoma. relapsed or refractory (R / R) diffuse large B-cell (DLBCL), primary B-cell large-cell mediastinal lymphoma (PMBCL), and grade 3B follicular lymphoma (FL3B), after at least two lines of systemic therapy. Lisocabtagene maraleucel is administered as a personalized treatment in a single infusion.
Everything you ever wanted to know about CAR-T
by Anna Lisa Bonfranceschi
A response to the needs of patients
Diffuse large B-cell lymphoma (DLBCL) is an aggressive form of blood disease that accounts for one in three diagnoses of non-Hodgkin’s lymphoma (NHL), making it the most common form of NHL. More than two-thirds of patients with DLBCL achieve no response or relapse after two lines of treatment and, historically, response rates for these patients are low, with complete response rates ranging from 2% to 15% .2 Despite recent therapeutic advances, new options are needed that offer long-term clinical benefits. “In diffuse large B-cell lymphoma, the goal of treatment is to provide patients with lasting remission. However, for patients who relapse or who do not get a response with initial therapies, the treatment options that are able to control the disease in the long term are limited, ”said Ulrich Jäger, MD, hematologist at the Medical University of Vienna / Vienna General. Hospital and investigator of the TRANSCEND WORLD study. “Liso-cel is an attractive new option for patients with relapsed or refractory large B cell lymphoma in Europe, offering potentially curative treatment to patients with historically poor prognosis, and the results of the TRANSCEND NHL 001 and TRANSCEND WORLD studies confirm lyso- cel as an effective treatment for a wide range of patients with diffuse large B cell lymphoma, after at least two previous therapies ”.
CAR-T, seven authorized centers in Lombardy
by Barbara Orrico
Studies
The Marketing Authorization is based on the results of the TRANSCEND NHL 001 study, which evaluated lisocabtagene maraleucel in adult patients with relapsed or refractory diffuse large B-cell lymphoma, primary B-cell large mediastinal lymphoma and grade 3B follicular lymphoma, including patients with a wide range of histologies and high-risk disease. Of the 216 patients treated with lisocabtagene maraleucel and evaluable for efficacy, 73% achieved a response, of which 53% had minimal residual disease or lymphoma no longer detectable after treatment.
“Lisocabtagene maraleucel addresses a current unmet need of patients in Europe who have relapsed or refractory large B-cell lymphoma and who have limited treatment options that can offer long-term remission,” says Samit Hirawat, MD, chief medical officer, Bristol Myers Squibb. “The approval of lisocabtagene maraleucel is a significant step forward in making an innovative and personalized therapy such as CAR T cells available to the largest number of patients worldwide.”
Large cell lymphoma B
Diffuse large B-cell lymphoma (DLBCL) is a rapidly evolving aggressive disease and is the most common form of non-Hodgkin’s lymphoma (NHL), accounting for one in three diagnoses. More than two-thirds of patients with DLBCL achieve no response or relapse after the second line of treatment. For patients with relapse or no response after initial therapies, conventional treatment options that can ensure lasting remission are limited and the median life expectancy is approximately six months, thus confirming the fundamental need for new therapies.
Follicular lymphoma (FL) is the most common form of indolent lymphoma, accounting for approximately 20% of non-Hodgkin’s lymphoma (NHL) cases. Although most patients respond to initial treatments, follicular lymphoma typically recurs and becomes more difficult to treat after each relapse. In some cases, follicular lymphoma can be aggressive – known as FL3B – or evolve into diffuse large B-cell lymphoma (DLBCL). Primary large B-cell mediastinal lymphoma (PMBCL) is a rare subtype of NHL that occurs increasingly in adolescents and young adults, with poor outcomes for patients with relapsed or refractory disease.