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    Home > Active Ingredient News > Drugs Articles > ASH |。 Three years on, what is the progress of Kymriah, the first approved CAR-T therapy in history?

    ASH |。 Three years on, what is the progress of Kymriah, the first approved CAR-T therapy in history?

    • Last Update: 2020-12-18
    • Source: Internet
    • Author: User
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    On August 31, 2017, the FDA's official website announced that Novarma's CAR-T therapy Kymriah (tisagenlecleucel) has been approved for the treatment of patients under 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) with difficulty treating or relapsing twice or more, the first CAR-T therapy approved in human history and the first gene therapy approved by the FDA in the United States! In 2020, at the oncoming ASH conference, Novart has announced the progress of Kymriah's clinical performance.
    interim analysis of phase II clinical ELARA II. phase clinical ELARA studies showed that 65% of patients treated with Kymriah had full remission (CR) in patients with relapsed or refracticable (r/ r) folytic lymphoma (FL) and 83% of patients with total remission (ORR) after at least three months of follow-up.
    Kymriah injections, these patients received multiple therapies, but the ongoing recurrence of the disease was difficult to treat.
    patients with folytic lymphoma, they often relapse after receiving multiple therapies, or do not respond at all to treatment options, " he said.
    , however, for every new treatment they had, the response to the treatment was significantly reduced.
    "That's why we're very excited about the interim results of the ELARA trial, because we're in great need of these potential options and alternatives to stem cell transplantation in clinical trials," said Dr. Nathan H. Fowler of the Lymphoma and Myeloma Department at the Desen Cancer Center.
    expect Kymriah to bring more benefits to patients in the future.
    ", in an interim analysis of the ELARA clinical trial, the researchers evaluated the efficacy of 52 patients.
    follow-up time was 9.9 months.
    results show that most patients can respond after receiving Kymriah injections.
    after at least three months of follow-up, 65% (99.5% CI, 45.1-82.4) of patients were fully relieved, reaching the main clinical endpoint of the trial.
    response rate was 83% (95% CI, 69.7-91.8).
    patients who received a full response, the vast majority (90%) of treatment responses lasted six months or more.
    , Novaral also announced safety data for Kymriah therapy in the ELARA trial.
    ELARA safety results showed that in 97 patients who could be assessed for safety, there were no new safety alerts due to injection of Kymriah.
    patients did not experience crS levels 3 and 4, and 49% of patients experienced other levels of CRS (29% for level 1; 20% for level 2).
    in order to treat CRS that occurs, 15% of patients need to use tocilizumab and 3% need to use steroids.
    neurological disorders and CRS events can be addressed through appropriate interventions.
    in addition, three patients in the trial died of the disease, but the study was not related to treatment.
    phase II clinical JULIET clinical trial called JULIET, this phase II clinical trial has a mid-phase follow-up period of 40 months.
    clinical report showed a 33% chance of two-year progressive survival (PFS) in patients with r/r diffuse large B-cell lymphoma (DLBCL).
    is an important finding because these patients have limited treatment options in the past, and traditional treatments often have unsustainable responses in their companies, ultimately leading to patient death.
    response in the JULIET trial showed Kymriah's safety for these patients with clear characteristics.
    juliet trial, the researchers showed a sustained response in patients treated with Kymriah r/r DLBCL in a 40-month-medium follow-up analysis.
    60 percent of the 61 patients who responded to the treatment did not relapse at 24 and 36 months.
    survival rate was 33 per cent for two years and 40 per cent and 36 per cent for 24 and 36 months after treatment, respectively.
    important conclusion in this experiment: after more than three years of long follow-up observation, no new safety issues were found.
    "Before Kymriah went on sale, there were very few treatment options on the market that could be long-term for patients with relapsed or incurable DLBCL."
    "These results presented in the JULIET trial, including an analysis of biomarkers to better define the subgroups of patients who may benefit most from CAR-T cell therapy, demonstrate that Kymriah may have a definitive selectivity for some patients," said Ulrich Jaeger of the Medical University of Vienna, Austria.
    addition, as new safety issues have not been observed during long-term follow-up visits, doctors can continue to confidently refer their patients to authorized treatment centres for Kymriah treatment.
    report, the researchers also assessed the relationship between biomarkers such as baseline Myc over-expression and tumor micro-environment (TME) characteristics in tumors) and reactions to Kymriah.
    patients who expressed negative were treated better than those who over-expressed Myc.
    and Myc expression negative has a negative effect on immunosuppressive TME, which is limited in T cells.
    these results are consistent with the patient's Myc expression history.
    researchers are analyzing the results to further identify biomarkers that respond to CAR-T cell therapy, and look forward to using these methods in the future to predict patients' responses to CAR-T therapy in advance.
    more than three years, Kymriah, the first CAR-T therapy in history, has consistently shown good results in terms of efficacy and safety, benefiting a wide range of hematoma and lymphoma patients.
    at this ASH conference, many pharmaceutical companies and biotechnology companies reported on their own CAR-T pipeline process, the pharmaceutical era will continue to track for you to report!
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