2020 de dezembro: The University of Texas MD Anderson Cancer Center researchers discovered that axi-cel, an autologous anti-CD19 chimeric antigen receptor (CAR) T cell therapy, is a safe and effective first-line therapy for patients with high-risk large B-cell lymphoma (LBCL), a group in desperate need of new and effective treatments.
Essas descobertas foram apresentadas na Reunião Anual virtual de 2020 da Sociedade Americana de Hematologia.
Traditionally, around half of patients with high-risk LBCL, a subgroup of the disease in which patients have double- or triple-hit linfoma or additional clinical risk factors identified by the International Prognostic Index (IPI), have not achieved long-term disease remission with standard treatment approaches such as chemoimmunotherapy.
This trial represents a step toward making Terapia de células T CAR a first-line treatment option for patients with aggressive B-cell lymphoma,” said Sattva S. Neelapu, M.D., professor of Lymphoma and Myeloma. “At the moment, patients with newly diagnosed aggressive B-cell lymphoma get chemotherapy for about six months. Terapia de células T CAR, if successful, may make it a one-time infusion with treatment completed in one month.
Com base na pesquisa-chave ZUMA-1, o Axi-cel está atualmente licenciado para o tratamento de pessoas com LBCL recidivante ou refratária que já tiveram duas ou mais linhas de tratamentos sistêmicos. O estudo ZUMA-12 é um estudo multicêntrico de fase 2 aberto, de braço único, que se baseia nas descobertas do estudo ZUMA-1 para avaliar o uso de axi-cel como terapia de primeira linha para pacientes com LBCL de alto risco .
De acordo com o estudo provisório ZUMA-12, 85% dos pacientes tratados com axi-cel tiveram uma resposta geral e 74% tiveram uma resposta completa. Após um acompanhamento médio de 9.3 meses, 70% dos pacientes recrutados apresentaram uma resposta contínua no corte de dados.
White blood cell count reduction, encephalopathy, anaemia, and síndrome de liberação de citocinas were the most common side effects linked with axi-cel treatment. By the time the data was analysed, all adverse events had been resolved.
Furthermore, when compared to when the immunotherapy products were generated from patients who had already received several lines of chemotherapy, the peak level of CAR T cells present in the blood, as well as the median CAR T cell expansion, were higher in this trial of first-line Terapia de células T CAR.
“Essa aptidão das células T pode estar ligada a uma maior eficácia terapêutica, resultando em melhores resultados para os pacientes”, acrescentou Neelapu.
Após os excelentes resultados provisórios do ZUMA-12, os pesquisadores planejam continuar acompanhando os pacientes para garantir que suas reações ao medicamento sejam duradouras.
“A randomised clinical trial would be required to definitely demonstrate that CAR T cell therapy is superior to existing standard of care with chemoimmunotherapy in these high-risk patients if the responses are persistent after prolonged follow-up,” Neelapu said. It also begs the question of whether CAR T cell treatment should be tested in intermediate-risk patients with big célula B linfoma.
