2020 Nollaig: 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.
Cuireadh na torthaí seo i láthair ag Cruinniú Bliantúil fíorúil 2020 Chumann Haemaiteolaíochta Mheiriceá.
Traditionally, around half of patients with high-risk LBCL, a subgroup of the disease in which patients have double- or triple-hit liomfóma 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.
Is ionann an triail seo agus céim i dtreo a dhéanamh Teiripe cille CAR T. rogha cóireála céadlíne d'othair a bhfuil liomfóma ionsaitheach B-chealla orthu,” a dúirt Sattva S. Neelapu, MD, ollamh le Liomfóma agus Myeloma. “I láthair na huaire, faigheann othair a bhfuil linfoma ionsaitheach B-chealla diagnóisithe acu le déanaí ceimiteiripe ar feadh thart ar shé mhí. Teiripe cille CAR T., má éiríonn leis, féadfaidh sé insileadh aonuaire é a dhéanamh agus cóireáil críochnaithe i mí amháin.
Bunaithe ar an bpríomhthaighde ZUMA-1, tá Axi-cel ceadúnaithe faoi láthair chun cóireáil a dhéanamh ar dhaoine a bhfuil LBCL athiompaithe nó teasfhulangacha acu a bhfuil dhá líne nó níos mó de chóireálacha sistéamacha acu cheana féin. Is éard atá sa triail ZUMA-12 ná triail lipéad oscailte Céim 2, aon lámh, multicenter a thógann ar thorthaí na trialach ZUMA-1 chun measúnú a dhéanamh ar úsáid axi-cel mar theiripe céadlíne d'othair a bhfuil ard-riosca LBCL orthu. .
De réir staidéar eatramhach ZUMA-12, bhí freagra iomlán ag 85 faoin gcéad de na hothair a ndearnadh cóireáil orthu le axi-cel, agus bhí freagra iomlán ag 74%. Tar éis meán leantach de 9.3 mí, léirigh 70% de na hothair a earcaíodh freagra leanúnach ag an scoite sonraí.
White blood cell count reduction, encephalopathy, anaemia, and siondróm scaoileadh cytokine 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 Teiripe cille CAR T..
“D’fhéadfaí an folláine T cille seo a nascadh le héifeachtacht theiripeach níos fearr, rud a fhágann go mbeadh torthaí othar níos fearr ann,” a dúirt Neelapu leis.
Tar éis torthaí eatramhacha den scoth ZUMA-12, tá sé beartaithe ag na taighdeoirí leanúint ar aghaidh leis na hothair chun a chinntiú go mbeidh a n-imoibrithe ar an gcógas fada buan.
“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-chill liomfóma.
