The CAR-T immunotherapy which for a few years has been developing the Hospital Clinic of Barcelona against the multiple myeloma (he ARI-0002h) is effective at 70% of the sick a year and a half passed of the treatment. He multiple myeloma is a cancer of plasma cells, which are found in the bone marrow and are an important component of immune system. This therapy, developed entirely by a public hospital, is he first CAR-T developed in Europe for this disease. Although rare, multiple myeloma is he second most common blood cancer behind lymphoma: in Spain it affects more than 16,000 people and every year they are detected 3,000 new cases.
70% of multiple myeloma patients present a total response after 18 months, according to ‘The Lancet Oncology’, and Aemps is evaluating its approval
Two years ago, the Clínic was already showing hopeful results: in December 2021, all the patients improved with this treatment and 75% of them maintained the response at 12 months. But these results are now backed by a study recently published in ‘The Lancet Oncology’, which demonstrates that 70% of the patients (all of them resistant to the usual treatments) present a Complete answer to this CAR-T after 18 months, and the rest present partial answers. In these moments, the Spanish Agency for Medicines and Health Products (Aemps) is evaluating the documentation based on the results of this study for its approval as an advanced therapy drug non-industrial manufacturing.
Five Spanish hospitals (four public and one private) have collaborated in the development of this immunotherapy for multiple myeloma: the Hospital Clínic, the Clínica Universidad de Navarra (the only private center), the Hospital Universitario de Salamanca, the Hospital Virgen de la Arrixaca in Murcia and the Hospital Virgen del Rocío in Seville. However, it has been the Clínic who has made the entire therapy proposal and who has the intellectual property and patent, As explained by the head of the Clínic’s Immunology Service, Manuel Juan. These five centers treated 30 patients with this disease who had relapsed after two or three previous treatments.
What are CAR-Ts?
The immunotherapy, that acts on the immune system of the cancer patient, is today the most revolutionary in the cancer treatment. There are many types of immunotherapy and one of them is car T Cell Therapy, which consists of genetically modifying T lymphocytes (some cells of the immune system), after extracting blood from the patient, so that they act against the Acute lymphoblastic leukemiahe B cell lymphoma and now against him multiple myeloma. Myeloma is the 10% of bone marrow cancers.
Specifically, the CAR-T ARI-0002h against multiple myeloma goes to the BCMA Antigen, found on the surface of myeloma tumor cells. Preliminary studies have already shown that it was highly specific and effective against malignant cells of multiple myeloma. This is the second CAR-T developed by the Clínic: the first, ARI-0001, was aimed at to acute lymphoblastic leukemia in an advanced stage and two years ago it became the first CAR-T immunotherapy of public origin approved by Aemps.
“The difference with respect to the previous CAR-T, in addition to the therapeutic target, which in this case is the BCMA Antigen, is that on this occasion is humanized, which means that amino acids are changed to make them look more like a human antibody. are often used mouse antibodies to CAR-T development and in this case we have humanized it so that it has greater durability in the patient and less probability of rejection”, explains Dr. Juan, who is also head of the Immunogenetics and Immunotherapy group of the autoinflammatory and immune response at Idibaps and responsible for the joint platforms of the Sant Joan de Deu Hospital and the Banc de Sang i Teixits.
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The results of the study published in ‘The Lancet Oncology’ show that, after performing a 18-month follow-up there is a response from all patients to treatment and of these, 67% are complete, 27% are very good partial responses and 7% are partial responses. At three months, in 24 of the 26 patients with bone marrow samples no residual disease was identified. Besides, no neurological toxicity was seen and immunological adverse effects were mild, thanks in part to the schedule of administration.
In addition to the 30 patients participating in this study, another 30 patients have already been included, as well as two other Spanish hospitals, and the treatment has been administered as Compassionate use in another 12 patients. This research has had the support of the Carlos III Health Institute, the La Caixa Foundation and the Bosch Aymerich Foundation.