2020. gada decembris: 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.
Šie atklājumi tika prezentēti Amerikas Hematoloģijas biedrības virtuālajā 2020. gada sanāksmē.
Traditionally, around half of patients with high-risk LBCL, a subgroup of the disease in which patients have double- or triple-hit limfoma 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 šūnu terapija 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 šūnu terapija, if successful, may make it a one-time infusion with treatment completed in one month.
Pamatojoties uz galveno pētījumu ZUMA-1, Axi-cel pašlaik ir licencēts tādu cilvēku ārstēšanai ar recidivējošu vai refraktāru LBCL, kuriem jau ir bijušas divas vai vairākas sistēmiskas ārstēšanas līnijas. ZUMA-12 pētījums ir 2. fāzes atklāts, vienas grupas, daudzcentru pētījums, kas balstās uz ZUMA-1 pētījuma rezultātiem, lai novērtētu axi-cel lietošanu kā pirmās izvēles terapiju pacientiem ar augsta riska LBCL. .
Saskaņā ar ZUMA-12 starpposma pētījumu, 85 procentiem pacientu, kuri tika ārstēti ar axi-cel, bija vispārēja atbildes reakcija, un 74% bija pilnīga atbildes reakcija. Pēc vidēji 9.3 mēnešu novērošanas 70% darbā pieņemto pacientu uzrādīja nepārtrauktu atbildes reakciju datu robežās.
White blood cell count reduction, encephalopathy, anaemia, and citokīnu atbrīvošanās sindroms 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 šūnu terapija.
"Šo T šūnu piemērotību varētu saistīt ar lielāku terapeitisko efektivitāti, kā rezultātā pacientam ir labāki rezultāti," piebilda Neelapu.
Pēc lieliskajiem ZUMA-12 starpposma rezultātiem pētnieki plāno turpināt sekot līdzi pacientiem, lai nodrošinātu, ka viņu reakcija uz zālēm ir ilgstoša.
“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-šūna limfoma.
