prosinac 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.
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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 Terapija CAR T stanicama 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. Terapija CAR T stanicama, if successful, may make it a one-time infusion with treatment completed in one month.
Na temelju ključnog istraživanja ZUMA-1, Axi-cel je trenutno licenciran za liječenje osoba s relapsiranim ili refraktornim LBCL-om koji su već imali dvije ili više linija sistemskog liječenja. Ispitivanje ZUMA-12 je otvoreno, jednostruko, multicentrično ispitivanje faze 2 koje se temelji na nalazima ispitivanja ZUMA-1 za procjenu upotrebe axi-cela kao terapije prve linije za pacijente s visokorizičnim LBCL-om. .
Prema ZUMA-12 privremenoj studiji, 85 posto pacijenata liječenih axi-celom imalo je ukupan odgovor, a 74% je imalo potpuni odgovor. Nakon srednjeg praćenja od 9.3 mjeseca, 70% regrutiranih pacijenata pokazalo je kontinuirani odgovor na graničnoj vrijednosti podataka.
White blood cell count reduction, encephalopathy, anaemia, and sindrom oslobađanja citokina 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 Terapija CAR T stanicama.
"Ova sposobnost T stanica mogla bi se povezati s većom terapijskom učinkovitošću, što rezultira boljim ishodima pacijenata", dodao je Neelapu.
Nakon izvrsnih privremenih rezultata ZUMA-12, znanstvenici planiraju nastaviti pratiti pacijente kako bi osigurali da njihove reakcije na lijek budu dugotrajne.
“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-stanice limfoma.
