2020 decembrie: 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.
Aceste constatări au fost prezentate la reuniunea anuală virtuală din 2020 a Societății Americane de Hematologie.
Traditionally, around half of patients with high-risk LBCL, a subgroup of the disease in which patients have double- or triple-hit limfom 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 cu celule 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 cu celule T CAR, if successful, may make it a one-time infusion with treatment completed in one month.
Pe baza cercetării cheie ZUMA-1, Axi-cel este în prezent autorizat pentru tratamentul persoanelor cu LBCL recidivat sau refractar care au avut deja două sau mai multe linii de tratamente sistemice. Studiul ZUMA-12 este un studiu de fază 2, deschis, cu un singur braț, multicentric, care se bazează pe rezultatele studiului ZUMA-1 pentru a evalua utilizarea axi-cel ca terapie de primă linie pentru pacienții cu LBCL cu risc ridicat. .
Potrivit studiului interimar ZUMA-12, 85% dintre pacienții tratați cu axi-cel au avut un răspuns global, iar 74% au avut un răspuns complet. După o urmărire mediană de 9.3 luni, 70% dintre pacienții recrutați au prezentat un răspuns continuu la limita de date.
White blood cell count reduction, encephalopathy, anaemia, and sindromul de eliberare de citokine 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 cu celule T CAR.
„Această fitness a celulelor T ar putea fi legată de o eficiență terapeutică mai mare, rezultând rezultate mai bune pentru pacient”, a adăugat Neelapu.
În urma rezultatelor intermediare excelente ale ZUMA-12, cercetătorii intenționează să continue urmărirea pacienților pentru a se asigura că reacțiile lor la medicament sunt de lungă durată.
“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 Celula B limfom.
