ዲሴ 2020 የቴክሳስ ዩኒቨርሲቲ ኤምዲ አንደርሰን የካንሰር ማእከል ተመራማሪዎች አክሲ-ሴል፣ ራስ-ሰር ፀረ-CD19 ቺሜሪክ አንቲጂን ተቀባይ (CAR) ቲ ሴል ቴራፒ ደህንነቱ የተጠበቀ እና ውጤታማ የሆነ ትልቅ ቢ-ሴል ሊምፎማ ላለባቸው ታካሚዎች የመጀመሪያ መስመር ሕክምና እንደሆነ ደርሰውበታል። (LBCL)፣ ተስፋ የቆረጠ አዲስ እና ውጤታማ ህክምና የሚያስፈልገው ቡድን።
እነዚህ ግኝቶች በአሜሪካ የሂማቶሎጂ ማህበረሰብ ምናባዊ 2020 አመታዊ ስብሰባ ላይ ቀርበዋል።
Traditionally, around half of patients with high-risk LBCL, a subgroup of the disease in which patients have double- or triple-hit ሊምፎማ 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 የሕዋስ ሕክምና 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 የሕዋስ ሕክምና, if successful, may make it a one-time infusion with treatment completed in one month.
በ ZUMA-1 ቁልፍ ምርምር ላይ በመመስረት፣ Axi-cel በአሁኑ ጊዜ ሁለት ወይም ከዚያ በላይ የስርዓታዊ ህክምና መስመሮች ላጋጠማቸው ወይም ለማገገም LBCL ላለባቸው ሰዎች ህክምና ፈቃድ ተሰጥቶታል። የZUMA-12 ሙከራ በZUMA-2 ሙከራ ግኝቶች ላይ የሚገነባ የደረጃ 1 ክፍት መለያ፣ ባለአንድ ክንድ፣ ባለብዙ ማእከላዊ ሙከራ ከፍተኛ ተጋላጭነት ላለባቸው ታካሚዎች axi-celን እንደ የመጀመሪያ መስመር ህክምና መጠቀሙን ለመገምገም ነው። .
በZUMA-12 ጊዜያዊ ጥናት መሠረት 85 በመቶ የሚሆኑት በአክሲ-ሴል የታከሙ ታካሚዎች አጠቃላይ ምላሽ ነበራቸው, እና 74% የሚሆኑት የተሟላ ምላሽ አግኝተዋል. ከ9.3 ወራት አማካኝ ክትትል በኋላ፣ ከተቀጠሩት ታካሚዎች መካከል 70% በመረጃ ማቋረጡ ቀጣይነት ያለው ምላሽ አሳይተዋል።
White blood cell count reduction, encephalopathy, anaemia, and ሳይቶኪን መልቀቂያ ሲንድሮም 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 የሕዋስ ሕክምና.
ኔላፑ አክለውም "ይህ የቲ ሴል ብቃት ከበለጠ የሕክምና ውጤታማነት ጋር ሊገናኝ ይችላል, ይህም የተሻለ የታካሚ ውጤቶችን ያስከትላል."
የ ZUMA-12 ጥሩ ጊዜያዊ ውጤቶችን ተከትሎ ተመራማሪዎቹ በሽተኞቹን ለመድሀኒት የሚሰጡት ምላሽ ለረጅም ጊዜ የሚቆይ መሆኑን ለማረጋገጥ ክትትልን ለመቀጠል አቅደዋል።
“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 ቢ-ሴል ሊምፎማ.
