ທັນວາ 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.
ການຄົ້ນພົບເຫຼົ່ານີ້ໄດ້ຖືກນໍາສະເຫນີຢູ່ໃນກອງປະຊຸມປະຈໍາປີ 2020 virtual ຂອງສະມາຄົມ Hematology ອາເມລິກາ.
Traditionally, around half of patients with high-risk LBCL, a subgroup of the disease in which patients have double- or triple-hit ເນື້ອງອກ 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 ການປິ່ນປົວດ້ວຍຈຸລັງ T T 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. ການປິ່ນປົວດ້ວຍຈຸລັງ T T, if successful, may make it a one-time infusion with treatment completed in one month.
ອີງຕາມການຄົ້ນຄວ້າທີ່ສໍາຄັນ ZUMA-1, Axi-cel ປະຈຸບັນໄດ້ຮັບອະນຸຍາດສໍາລັບການປິ່ນປົວຜູ້ທີ່ມີ LBCL relapsed ຫຼື refractory ຜູ້ທີ່ມີແລ້ວສອງຫຼືຫຼາຍສາຍຂອງການປິ່ນປົວລະບົບ. ການທົດລອງ ZUMA-12 ແມ່ນໄລຍະ 2 ເປີດປ້າຍຊື່, ແຂນດຽວ, multicenter ການທົດລອງທີ່ສ້າງຂຶ້ນຈາກການຄົ້ນພົບຂອງການທົດລອງ ZUMA-1 ເພື່ອປະເມີນການນໍາໃຊ້ axi-cel ເປັນການປິ່ນປົວເສັ້ນທໍາອິດສໍາລັບຄົນເຈັບທີ່ມີ LBCL ຄວາມສ່ຽງສູງ. .
ອີງຕາມການສຶກສາຊົ່ວຄາວຂອງ ZUMA-12, 85 ເປີເຊັນຂອງຄົນເຈັບທີ່ໄດ້ຮັບການປິ່ນປົວດ້ວຍ axi-cel ມີການຕອບສະຫນອງໂດຍລວມ, ແລະ 74% ມີການຕອບສະຫນອງຢ່າງສົມບູນ. ຫຼັງຈາກການຕິດຕາມສະເລ່ຍຂອງ 9.3 ເດືອນ, 70% ຂອງຄົນເຈັບທີ່ໄດ້ຮັບການທົດແທນໄດ້ສະແດງໃຫ້ເຫັນການຕອບສະຫນອງຢ່າງຕໍ່ເນື່ອງຢູ່ທີ່ການຕັດຂໍ້ມູນ.
White blood cell count reduction, encephalopathy, anaemia, and ໂຣກການປ່ອຍ 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 ການປິ່ນປົວດ້ວຍຈຸລັງ T T.
Neelapu ກ່າວຕື່ມວ່າ "ການສອດຄ່ອງຂອງຈຸລັງ T ນີ້ສາມາດເຊື່ອມໂຍງກັບປະສິດທິພາບການປິ່ນປົວຫຼາຍກວ່າເກົ່າ, ເຮັດໃຫ້ຜົນໄດ້ຮັບຂອງຄົນເຈັບດີຂຶ້ນ," Neelapu ກ່າວຕື່ມວ່າ.
ປະຕິບັດຕາມຜົນໄດ້ຮັບຊົ່ວຄາວທີ່ດີເລີດຂອງ ZUMA-12, ນັກຄົ້ນຄວ້າວາງແຜນທີ່ຈະສືບຕໍ່ຕິດຕາມຄົນເຈັບເພື່ອຮັບປະກັນວ່າປະຕິກິລິຍາຂອງພວກເຂົາຕໍ່ຢາແມ່ນຍາວນານ.
“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-cell ເນື້ອງອກ.
