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January 14, 2022 / eMedClub News/--Recently, Legend Bio introduced its B-cell maturation antigen (BCMA) CAR-T cell therapy at the 40th JPM Conference on the afternoon of January 13, EST The latest news on cilta-cel
.
According to a published JPM report, Legend Bio entered into a partnership with Johnson & Johnson subsidiary Janssen Pharmaceuticals in 2017 and has so far received $350 million in upfront payments and $200 million in milestone payments, and if all goes well, the collaboration could be Generated $1.
15 billion in potential milestone payments and over 50% global profit share for Legend Biotech
.
At present, cilta-cel has submitted marketing applications in the United States, the European Union and Japan for the treatment of relapsed and/or refractory multiple myeloma (r/r MM) in adults, and has obtained FDA priority review qualification and EMA accelerated Review eligibility
.
Multiple myeloma (MM) is a malignant disease of abnormal proliferation of clonal plasma cells and the second most common hematological malignancy after non-Hodgkin lymphoma
.
BCMA is one of the important markers on the surface of mature B cells.
It is highly expressed on all multiple myeloma (MM) cells and is almost not expressed in other normal tissues.
Therefore, BCMA has always been an important research and development target for hematological tumor cell therapy worldwide.
At this point, the research and development in CAR-T has attracted much attention
.
Data from a phase 1 clinical trial called LEGEND-2 in China showed that cilta-cel has a long-term deep response and high response rate in patients with RR MM, with an overall response rate (ORR) as high as 88%, and mPFS of 18%.
more than a month
.
Another phase 1b/2 trial called CARTITUDE-1 showed that at a median follow-up of 12.
4 months, the median progression-free survival (mPFS) was not reached, and the 12-month PFS rate and OS rate were were 76.
6% and 88.
5%
.
▲ LEGEND-2 study data (Image source: Legend Bio JPM speech PPT) After a median long-term follow-up of 24 months, the primary endpoint ORR reached 97.
9%, and the very good partial response (VGPR) was 94.
9%, of which 82.
5% of patients achieved strict complete remission (sCR)
.
60.
5% of patients were alive after 2 years without disease progression
.
Of the 61 patients evaluable for MRD (molecular residual disease), 92% achieved 10-5 MRD negativity
.
BCMA-targeted CAR-T becomes a new trend Since the world's first two CAR-T products in 2017, the global CAR-T market has been expanding rapidly
.
Based on the potential of CAR-T cell therapy in the treatment of hematological malignancies, the global CAR-T market has grown from USD 100 million in 2017 to USD 700 million in 2019 and is expected to increase to USD 6.
6 billion in 2024, 2019 The CAGR to 2024 is 55.
0%
.
In 2030, the global CAR-T market is expected to reach $21.
8 billion
.
In 2020, CAR-T therapy targeting BCMA has begun to enter the market process.
Although the subsequent approval process has experienced bumps, it is undoubtedly an important supplement to the CAR-T market that currently only targets CD19
.
cilta-cel Important Node Events In December 2017, Legend Bio entered into an exclusive global license and collaboration agreement with Janssen Biotech, a Johnson & Johnson company, to develop and commercialize cilta-cel
.
In 2018, Chidaki Orenza therapy obtained the first CAR-T clinical trial application (IND) approval from the China National Medical Products Administration and the IND approval from the US FDA
.
In 2019, Cedarquiorenza was granted the Priority Medicine Designation (PRIME) qualification by the European Medicines Agency and the Breakthrough Therapy Designation granted by the US FDA
.
In December 2020, Janssen Biotech submitted the raw Sidakis Orenza BLA to the U.
S.
FDA
.
In May 2021, Cidaki Orenza was granted priority review by the FDA
.
In November 2021, the FDA delayed the Cedar Keorenza PDUFA target date
.
It is worth mentioning that a month ago the U.
S.
Food and Drug Administration (FDA) extended the Prescription Drug User Fee Act (PDUFA) target action date for cilta-cel from November 29, 2021 to February 28, 2022
.
However, according to the press release issued by Legend Bio, although the FDA extended the review time this time, it did not require the company to submit new clinical data, possibly considering that CAR-T cell therapy, as the most cutting-edge and new technology at present, has different Due to the complexity of traditional medicines, the review and supervision need to be more meticulous and cautious
.
At present, seven CAR-T therapeutic products have been launched in the world, namely Novartis Kymriah, Yescarta and Tecartus of Kite, a subsidiary of Gilead, Breyanzi of Bristol-Myers Squibb, Abecma of Celgene, and Fosun Kite, which has been approved for listing in China.
The Achilles injection of WuXi Junuo and the Ruiki Aurenx Injection of WuXi Junuo
.
In March 2021, Abecma brought by BMS and Bluebird Bio was approved by the FDA, making it the world's first CAR-T cell therapy targeting BCMA
.
If cilta-cel is finally approved by the FDA, it is expected to become the second CAR-T cell therapy targeting BCMA in the world, which will bring new options for the treatment of r/r MM
.
Recommended reading: Heavy! The first BCMA CAR-T was approved for listing today! Yimai Meng broke the news reference materials: 1.
https://
.
According to a published JPM report, Legend Bio entered into a partnership with Johnson & Johnson subsidiary Janssen Pharmaceuticals in 2017 and has so far received $350 million in upfront payments and $200 million in milestone payments, and if all goes well, the collaboration could be Generated $1.
15 billion in potential milestone payments and over 50% global profit share for Legend Biotech
.
At present, cilta-cel has submitted marketing applications in the United States, the European Union and Japan for the treatment of relapsed and/or refractory multiple myeloma (r/r MM) in adults, and has obtained FDA priority review qualification and EMA accelerated Review eligibility
.
Multiple myeloma (MM) is a malignant disease of abnormal proliferation of clonal plasma cells and the second most common hematological malignancy after non-Hodgkin lymphoma
.
BCMA is one of the important markers on the surface of mature B cells.
It is highly expressed on all multiple myeloma (MM) cells and is almost not expressed in other normal tissues.
Therefore, BCMA has always been an important research and development target for hematological tumor cell therapy worldwide.
At this point, the research and development in CAR-T has attracted much attention
.
Data from a phase 1 clinical trial called LEGEND-2 in China showed that cilta-cel has a long-term deep response and high response rate in patients with RR MM, with an overall response rate (ORR) as high as 88%, and mPFS of 18%.
more than a month
.
Another phase 1b/2 trial called CARTITUDE-1 showed that at a median follow-up of 12.
4 months, the median progression-free survival (mPFS) was not reached, and the 12-month PFS rate and OS rate were were 76.
6% and 88.
5%
.
▲ LEGEND-2 study data (Image source: Legend Bio JPM speech PPT) After a median long-term follow-up of 24 months, the primary endpoint ORR reached 97.
9%, and the very good partial response (VGPR) was 94.
9%, of which 82.
5% of patients achieved strict complete remission (sCR)
.
60.
5% of patients were alive after 2 years without disease progression
.
Of the 61 patients evaluable for MRD (molecular residual disease), 92% achieved 10-5 MRD negativity
.
BCMA-targeted CAR-T becomes a new trend Since the world's first two CAR-T products in 2017, the global CAR-T market has been expanding rapidly
.
Based on the potential of CAR-T cell therapy in the treatment of hematological malignancies, the global CAR-T market has grown from USD 100 million in 2017 to USD 700 million in 2019 and is expected to increase to USD 6.
6 billion in 2024, 2019 The CAGR to 2024 is 55.
0%
.
In 2030, the global CAR-T market is expected to reach $21.
8 billion
.
In 2020, CAR-T therapy targeting BCMA has begun to enter the market process.
Although the subsequent approval process has experienced bumps, it is undoubtedly an important supplement to the CAR-T market that currently only targets CD19
.
cilta-cel Important Node Events In December 2017, Legend Bio entered into an exclusive global license and collaboration agreement with Janssen Biotech, a Johnson & Johnson company, to develop and commercialize cilta-cel
.
In 2018, Chidaki Orenza therapy obtained the first CAR-T clinical trial application (IND) approval from the China National Medical Products Administration and the IND approval from the US FDA
.
In 2019, Cedarquiorenza was granted the Priority Medicine Designation (PRIME) qualification by the European Medicines Agency and the Breakthrough Therapy Designation granted by the US FDA
.
In December 2020, Janssen Biotech submitted the raw Sidakis Orenza BLA to the U.
S.
FDA
.
In May 2021, Cidaki Orenza was granted priority review by the FDA
.
In November 2021, the FDA delayed the Cedar Keorenza PDUFA target date
.
It is worth mentioning that a month ago the U.
S.
Food and Drug Administration (FDA) extended the Prescription Drug User Fee Act (PDUFA) target action date for cilta-cel from November 29, 2021 to February 28, 2022
.
However, according to the press release issued by Legend Bio, although the FDA extended the review time this time, it did not require the company to submit new clinical data, possibly considering that CAR-T cell therapy, as the most cutting-edge and new technology at present, has different Due to the complexity of traditional medicines, the review and supervision need to be more meticulous and cautious
.
At present, seven CAR-T therapeutic products have been launched in the world, namely Novartis Kymriah, Yescarta and Tecartus of Kite, a subsidiary of Gilead, Breyanzi of Bristol-Myers Squibb, Abecma of Celgene, and Fosun Kite, which has been approved for listing in China.
The Achilles injection of WuXi Junuo and the Ruiki Aurenx Injection of WuXi Junuo
.
In March 2021, Abecma brought by BMS and Bluebird Bio was approved by the FDA, making it the world's first CAR-T cell therapy targeting BCMA
.
If cilta-cel is finally approved by the FDA, it is expected to become the second CAR-T cell therapy targeting BCMA in the world, which will bring new options for the treatment of r/r MM
.
Recommended reading: Heavy! The first BCMA CAR-T was approved for listing today! Yimai Meng broke the news reference materials: 1.
https://
