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2021 latest analysis of global CAR-T drugs and future development.
In recent years, chimeric antigen receptor T (CAR-T) cell therapy has made breakthroughs in the treatment of acute B lymphocytic leukemia and large B-cell lymphoma, and has gradually become the focus of research in the field of hematological tumor therapy worldwide And hot spots.
In fact, CAR-T therapy is chimeric antigen receptor T cell immunotherapy, which is a new type of precision targeted therapy for tumor treatment. It uses leukocyte separation to collect patient’s T cells, and then activates and transduce T cells in vitro. CAR virus vector, CAR-T cell expansion and infusion into the patient’s body.
CAR is composed of antibody-derived fragments that can recognize, bind and promote T cell expansion costimulatory molecules coupled to tumor antigens.
In recent years, this therapy has achieved good results in clinical tumor treatment through optimization and improvement. It is a very promising new tumor immunotherapy method that can be accurate, fast, efficient, and may cure cancer.
At the same time, according to Frost & Sullivan’s data, the global CAR-T cell therapy market has grown from US$10 million in 2017 to US$700 million in 2019 and US$1.1 billion in 2020.
It is expected to accelerate growth in the next few years. 2024 It will expand to 6.6 billion U.S. dollars in the year, with a compound annual growth rate of 55.0% from 2019 to 2024.
The market is expected to further grow to 21.8 billion U.S. dollars in 2030, with a compound annual growth rate of 22.1% from 2024 to 2030.
The following will summarize the information and market of CAR-T drugs listed on the global level:
1. Kymriah ( Novartis )
On July 12, 2017, the FDA expert panel unanimously approved Kymriah’s application for a biologics license for the treatment of children and young adult patients with advanced leukemia. ALL is a type of cancer that starts in lymphocytes.
Abnormal cells in patients with ALL will proliferate in the bone marrow, affecting the production of red blood cells, white blood cells, platelets and other normal blood cells. Therefore, ALL patients will have symptoms such as anemia, bruising, and easy bleeding. It is also the most common cancer in children younger than 15 years old in the United States.
Although there have been significant advances in the treatment of B-cell ALL in children and young people in recent years, effective treatment options are still extremely limited for those patients who are refractory or have relapsed. Kymriah was approved, a breakthrough therapy that brought good news to these patient groups.
2. Yescarta ( Kite Pharmaceuticals )
In October 2017, the US FDA approved Kite Pharmaceuticals Yescarta (axicabtagene ciloleucel, KTE-C10)-cell gene therapy.
Yescarta is the first gene therapy approved for the treatment of specific types of non-Hodgkin’s lymphoma for treatment B-cell precursor acute lymphoblastic leukemia (ALL) patients under 25 years of age, refractory or two or more relapses, including diffuse large B-cell lymphoma, transforming follicular lymphoma, and primary mediastinal B-cells Lymphoma is not suitable for the treatment of patients with primary central nervous system lymphoma.
At the same time, according to the Yaorongyun database , in August 2018, the European Union approved Yescarta for the treatment of two or more adult systems for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal enlargement. Patients with B-cell lymphoma (PMBCL).
In the same year, Gilead purchased Kite for US$12 billion. With this acquisition, Gilead acquired Yescarta’s heavyweight product and became the leader in the CAR-T field overnight. Yescarta’s net sales in 2019 were US$456 million, an increase of 50% year-on-year.
3. Tecartus ( Gilead Science )
In 2020, the FDA approved Gilead Sciences’ new CAR-T treatment product Tecartus listing application for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). Prior to this, Tecartus has been given “priority”. Approval” and “Breakthrough Therapy” titles.
At this stage, the main clinical use of chemotherapy and other drugs in the treatment of MCL. For young patients who relapse after early treatment, stem cell transplantation can also be performed. However, once the disease develops resistance to existing therapies, clinical treatment will be greatly limited.
In addition, most MCL patients are already in the advanced stage when they are diagnosed. They are highly invasive, often difficult to cure, and have a low five-year survival rate. Therefore, patients with MCL urgently need a new treatment option.
Tecartus is an autologous CAR-T cell therapy targeting CD19. It collects the patient’s peripheral blood and extracts T cells, transforms the patient’s immune T cells in vitro through biotechnology, so that it has the ability to recognize tumor cell surface antigens, and then transfers these modified T cells back to the patient to achieve precision The therapeutic effect of identifying and killing tumor cells, while avoiding damage to normal tissues.
4. Breyanzi ( Bristol-Myers Squibb )
On February 5, 2021, the US FDA announced the approval of Breyanzi developed by Juno Therapeutics, a subsidiary of Bristol-Myers Squibb, for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (R/R LBCL), including diffuse large B-cell lymphoma (DLBCL), these patients did not respond to at least 2 other systemic treatments, or relapsed after treatment.
Breyanzi is the third CD19-directed CAR-T cell therapy approved by the US FDA and the fourth CAR-T cell therapy approved by the agency.
Breyanzi is an autologous, CD19-directed, chimeric antigen receptor (CAR) T cell therapy with a clear composition and 4-1BB costimulatory domain.
It will play an important role in clinical practice for patients with relapsed or refractory Patients with large B-cell lymphoma provide an opportunity for lasting remission and provide personalized treatment experience.
On March 26, 2021, the CAR-T cell therapy product Abecma jointly developed by BMS and Bluebird was officially approved for marketing by the FDA.
The drug is a chimeric antigen receptor (CAR) oriented to the B-cell maturation antigen (anti-BCMA) T cell therapy is used to treat adult patients with relapsed/refractory multiple myeloma (R/R MM), specifically: having received 4 or more therapies in the past (including immunomodulators, proteasome inhibitors, Anti-CD38 antibody) R/R MM adult patients.
The approval of Abecma is not only the first CAR-T therapy targeting BCMA that has been approved by the FDA for marketing, it will also provide a new, effective, and personalized treatment plan for such patients in the future, which can be quickly achieved with only one infusion. , Deep and lasting relief.
Under the craze, research on CAR-T cell therapy continues to increase. According to incomplete statistics , there are nearly 40 CAR-T therapies under development.
Statistics found that the targets of these drugs were mainly distributed on CD19, followed by BCMA. In addition, the dual-target CAR-T therapy under the new trend has also become a “golden track” sought after by enterprises.
(source:internet, reference only)