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Recent popular reports from Yimaike ★ Iterative update of antibody drugs, how to improve drug characterization and quality controlMedical Class ★ The U.
S.
FDA grants Janssen BCMA/CD dual-antibody breakthrough therapy designation Yimai Meng broke the news on June 8, 2021 / Yimaike News eMedClub News/--Recently, Gilead's Kite announced the results of the Phase II study of ZUMA-3 in the oral report of ACSO Hematological Malignancies—Leukemia, MDS and Transplantation (Abstract No.
7002), suggesting the treatment of Tecartus (KTE-X19) Adult relapsed or refractory B-cell precursor acute lymphoblastic leukemia (R/R B-ALL) has a significant effect
.
KTE-X19 is an autologous, anti-CD19, CAR-T cell therapy that uses the XLP manufacturing process, including T cell selection and lymphocyte enrichment
.
For some B-cell malignancies with evidence of circulating lymphoblasts, lymphocyte enrichment is a necessary step
.
Currently, Tecartus being developed for the treatment of mantle cell lymphoma (MCL), acute lymphocytic leukemia (ALL), chronic lymphocytic leukemia (CLL) and the like
.
In July 2020, KTE-X19 received accelerated approval from the US FDA for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (R/R MCL)
.
Data from the key ZUMA-2 clinical trial showed that the overall response rate (ORR) of a single infusion of Tecartus in MCL patients was as high as 93%, and the complete response rate (CR) was 67%
.
This is the first indication that Tecartus has been approved
.
At the same time, Kite began to actively study the application of KTE-X19 to other R/R hematological malignancies in order to obtain a new scope of application
.
At the ASCO 2021 meeting, Gilead/Kite announced the latest data of the clinical study ZUMA-3, the next target indication for KTE-X19, R/R B-ALL.
The data shows that KTE-X19 has a good treatment of R/R B-ALL.
Effectiveness and safety
.
The results showed that the overall complete remission (CR/CRi) rate was 71% (95% CI, 57-82; 56% CR, 15% CRi); 31% of the respondents maintained a sustained response
.
The median duration of response (DOR), recurrence-free survival (RFS) and overall survival (OS) were 12.
8 months, 11.
6 months, and 18.
2 months, respectively
.
The MRD rate of CR/CRi patients is 97%
.
Among the 25 patients previously treated with belintouximab, the CR/CRi rate was 60%
.
Ten patients (18%) received follow-up allo-SCT at a median of 98 days after KTE-X19 infusion
.
In the absence of allo-SCT, the median DOR remained unchanged
.
It is worth mentioning that Gilead/Kite has submitted a supplementary biologics license application to the US FDA for the treatment of adult patients with relapsed or refractory acute lymphoblastic leukemia (ALL)
.
On May 28, the FDA conducted a priority review of the application and set the PDUFA date as October 1
.
Recommended reading: The second indication for this CAR-T has been declared for less than one year! Gilead/Kite is about to announce Tecartus clinical data for ALL.
Yimai Meng revealed that the market for CAR-T cell therapy continues to expand.
Nearly 3 years after Novartis and Gilead/Kite have led the way, the global market has ushered in new faces.
The domestic market is also gaining momentum
.
In the global cancer cell therapy field, the number of cell therapy developments in China is gradually approaching the dominant United States
.
However, the rapid increase in the number of CAR-T research and development also means fierce market competition
.
In addition, several CAR-T candidates that are currently on the market and under review are all aimed at a single target.
The CD19 track is even in a competitive situation that tends to be saturated, with BCMA following CD19 in second place
.
Therefore, if you want to catch up with the leader of CAR-T, a differentiated layout is particularly important, and the layout of indications is a key part
.
Scan the QR code and read the detailed data reference materials of this article: 1.
https://endpts.
com/asco21-a-week-after-nabbing-priority-review-kite-unveils-the-pivotal-data-it-hopes- will-lead-to-a-new-car-t-approval/ Yimaike has always been committed to original news reports such as cutting-edge technology, industry trends, industry insights, etc.
of bio-innovative drugs.
The full-media high-end matrix users have reached 160,000+, among which industrial Users accounted for more than 50%, about 30% of scientific research and clinical users, and more than 5% of users of investment institutions
.
In order to promote interactive exchanges in industry segments, we have established a number of professional WeChat groups, welcome to scan the QR code to add groups
.
S.
FDA grants Janssen BCMA/CD dual-antibody breakthrough therapy designation Yimai Meng broke the news on June 8, 2021 / Yimaike News eMedClub News/--Recently, Gilead's Kite announced the results of the Phase II study of ZUMA-3 in the oral report of ACSO Hematological Malignancies—Leukemia, MDS and Transplantation (Abstract No.
7002), suggesting the treatment of Tecartus (KTE-X19) Adult relapsed or refractory B-cell precursor acute lymphoblastic leukemia (R/R B-ALL) has a significant effect
.
KTE-X19 is an autologous, anti-CD19, CAR-T cell therapy that uses the XLP manufacturing process, including T cell selection and lymphocyte enrichment
.
For some B-cell malignancies with evidence of circulating lymphoblasts, lymphocyte enrichment is a necessary step
.
Currently, Tecartus being developed for the treatment of mantle cell lymphoma (MCL), acute lymphocytic leukemia (ALL), chronic lymphocytic leukemia (CLL) and the like
.
In July 2020, KTE-X19 received accelerated approval from the US FDA for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (R/R MCL)
.
Data from the key ZUMA-2 clinical trial showed that the overall response rate (ORR) of a single infusion of Tecartus in MCL patients was as high as 93%, and the complete response rate (CR) was 67%
.
This is the first indication that Tecartus has been approved
.
At the same time, Kite began to actively study the application of KTE-X19 to other R/R hematological malignancies in order to obtain a new scope of application
.
At the ASCO 2021 meeting, Gilead/Kite announced the latest data of the clinical study ZUMA-3, the next target indication for KTE-X19, R/R B-ALL.
The data shows that KTE-X19 has a good treatment of R/R B-ALL.
Effectiveness and safety
.
The results showed that the overall complete remission (CR/CRi) rate was 71% (95% CI, 57-82; 56% CR, 15% CRi); 31% of the respondents maintained a sustained response
.
The median duration of response (DOR), recurrence-free survival (RFS) and overall survival (OS) were 12.
8 months, 11.
6 months, and 18.
2 months, respectively
.
The MRD rate of CR/CRi patients is 97%
.
Among the 25 patients previously treated with belintouximab, the CR/CRi rate was 60%
.
Ten patients (18%) received follow-up allo-SCT at a median of 98 days after KTE-X19 infusion
.
In the absence of allo-SCT, the median DOR remained unchanged
.
It is worth mentioning that Gilead/Kite has submitted a supplementary biologics license application to the US FDA for the treatment of adult patients with relapsed or refractory acute lymphoblastic leukemia (ALL)
.
On May 28, the FDA conducted a priority review of the application and set the PDUFA date as October 1
.
Recommended reading: The second indication for this CAR-T has been declared for less than one year! Gilead/Kite is about to announce Tecartus clinical data for ALL.
Yimai Meng revealed that the market for CAR-T cell therapy continues to expand.
Nearly 3 years after Novartis and Gilead/Kite have led the way, the global market has ushered in new faces.
The domestic market is also gaining momentum
.
In the global cancer cell therapy field, the number of cell therapy developments in China is gradually approaching the dominant United States
.
However, the rapid increase in the number of CAR-T research and development also means fierce market competition
.
In addition, several CAR-T candidates that are currently on the market and under review are all aimed at a single target.
The CD19 track is even in a competitive situation that tends to be saturated, with BCMA following CD19 in second place
.
Therefore, if you want to catch up with the leader of CAR-T, a differentiated layout is particularly important, and the layout of indications is a key part
.
Scan the QR code and read the detailed data reference materials of this article: 1.
https://endpts.
com/asco21-a-week-after-nabbing-priority-review-kite-unveils-the-pivotal-data-it-hopes- will-lead-to-a-new-car-t-approval/ Yimaike has always been committed to original news reports such as cutting-edge technology, industry trends, industry insights, etc.
of bio-innovative drugs.
The full-media high-end matrix users have reached 160,000+, among which industrial Users accounted for more than 50%, about 30% of scientific research and clinical users, and more than 5% of users of investment institutions
.
In order to promote interactive exchanges in industry segments, we have established a number of professional WeChat groups, welcome to scan the QR code to add groups
.
