Tecartus becomes the first CAR T cell therapy to receive FDA approval for adults with ALL
ALL is an aggressive cancer of the lymphoid lineage of blood cells that can also affect the lymph nodes, spleen, liver, central nervous system, and other organs. B-cell precursor ALL accounts for about 75% of cases, and this form is generally associated with lower outcomes compared to other types of ALL. About 1,000 adult patients are treated each year for relapsed or refractory ALL, and survival rates remain very low in this group, with a median overall survival of less than eight months.
Tecartus is an autologous anti-CD19 CAR T-cell therapy. T cells are harvested from the patient and genetically engineered to express CARs targeting CD19, an antigen ubiquitously expressed on B cells. T cells are then multiplied in large numbers before being injected back into the patient. CARs combine the functions of specific antigen binding and T cell activation into a single receptor molecule. When these modified T cells encounter B cells expressing CD19, they proliferate and become cytotoxic, releasing cytokines to produce a coordinated immune response against all CD19 + B cells.
Tecartus has the same design as Yescarta (axicabtagene ciloleucel), Kite’s other anti-CD19 CAR T therapy, except that Tecartus undergoes a white blood cell enrichment step as part of Kite’s XLP manufacturing process. Treatment is also currently under investigation in the European Union and the United Kingdom for the same indication.
In addition to Tecartus’ recent approval for ALL in adults, Kite has received FDA approval for three other indications for Tecartus and Yescarta:
- In October 2017, the FDA approved Yescarta for the treatment of adults with relapsed or refractory large B-cell lymphoma after at least two lines of systemic treatment were attempted.
- In July 2020, the FDA approved Tecartus for relapsed or refractory mantle cell lymphoma.
- In March 2021, the FDA approved Yescarta for relapsed or refractory follicular lymphoma after two or more lines of systemic therapy were tried.
Kite has several other indications and treatments currently in clinical trials:
- Yescarta is in a Phase III clinical trial as a second-line treatment for diffuse large B-cell lymphoma. On September 30, 2021, Kite announced that it had filed its application with the FDA for this indication.
- Yescarta is in a Phase II clinical trial as a first-line treatment for diffuse large B-cell lymphoma.
- Tecartus is in phase II clinical trials for the treatment of ALL in children.
- KITE-439 is an autologous T cell therapy designed by TCR targeting the human papillomavirus 16 (HPV-16 E7) E7 antigen, which is currently in phase I clinical trials for adults with solid tumors positive for human leukocyte antigen (HLA) – A * 02:01.
- KITE-718 is an autologous T cell therapy designed by TCR targeting melanoma-associated antigens 3 and 6 (MAGE-A3 / A6). It is currently in phase I clinical trials for the treatment of adults with solid tumors positive for HPV-16 and HLA-DPB1 * 04:01.
Kite Pharma was founded in 2009 by Dr Arie Belldegrun and Joshua Kazam to develop cancer therapies with a focus on autologous CAR T cells. In 2015, Kite invested heavily in the European market with the acquisition of T-Cell Factory in the Netherlands for 20 million euros. ($ 21 million at the time). The company was acquired by Gilead Sciences for $ 11.9 billion in 2017, when Yescarta became the first CAR T treatment approved to treat adults with R / R large B cell lymphoma.
Following the acquisition of Kite by Gilead, founders Belldegrun and Kazam, along with Kite’s chief medical officer, Dr David Chang, PhD, entered into an agreement with Pfizer to found Allogene Therapeutics and develop allogeneic CAR T therapies (derived of donors).
Do you have a unique perspective on your cell therapy research? Contact the publisher today to find out more.
Copyright © 2021 scienceboard.net