Desember 2020: 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.
Hierdie bevindings is by die Amerikaanse Vereniging van Hematologie se virtuele 2020-jaarvergadering aangebied.
Traditionally, around half of patients with high-risk LBCL, a subgroup of the disease in which patients have double- or triple-hit limfoom 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 CAR T-selterapie 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. CAR T-selterapie, if successful, may make it a one-time infusion with treatment completed in one month.
Gebaseer op die sleutelnavorsing ZUMA-1, is Axi-cel tans gelisensieer vir die behandeling van mense met terugval of refraktêre LBCL wat reeds twee of meer reëls sistemiese behandelings gehad het. Die ZUMA-12 proef is 'n Fase 2 oop-etiket, enkelarm, multisentrum proef wat voortbou op die bevindinge van die ZUMA-1 proef om die gebruik van axi-cel as eerstelyn terapie vir pasiënte met hoërisiko LBCL te assesseer .
Volgens die ZUMA-12 tussentydse studie het 85 persent van pasiënte wat met axi-cel behandel is 'n algehele reaksie gehad, en 74% het 'n volledige reaksie gehad. Na 'n mediaan opvolg van 9.3 maande, het 70% van die pasiënte wat gewerf is, 'n voortdurende reaksie by die data-afsnypunt getoon.
White blood cell count reduction, encephalopathy, anaemia, and sitokienvrystellingsindroom 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 CAR T-selterapie.
"Hierdie T-sel fiksheid kan gekoppel word aan groter terapeutiese doeltreffendheid, wat lei tot beter pasiënt uitkomste," het Neelapu bygevoeg.
Na aanleiding van die uitstekende tussentydse resultate van ZUMA-12, beplan die navorsers om voort te gaan om die pasiënte op te volg om te verseker dat hul reaksies op die medikasie langdurig is.
“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 B-sel limfoom.
