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    Home > Medical News > Latest Medical News > BCMA CAR-T cell therapy! Johnson/Nanjing Legend JNJ-4528 Treatment RRMM Efficacy Strong

    BCMA CAR-T cell therapy! Johnson/Nanjing Legend JNJ-4528 Treatment RRMM Efficacy Strong

    • Last Update: 2020-05-30
    • Source: Internet
    • Author: User
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    The study, an ongoing Ib/II, open label, multicenter study, is evaluating the efficacy and safety of JNJ-4528 in treating adult patients with recurrent or refractory multiple myeloma (RRMM)Of the patients in the study group, 97 percent were ineffective and 86 percent were triple-difficult to treat, meaning that their cancer did not or no longer respond to immunomodulators (IMiD), protease inhibitors (PiPs) and anti-CD38 antibodiesThe main purpose of the Ib phase section is to determine the safety and dosage of JNJ-4528Phase II will evaluate the efficacy of JNJ-4528, with the primary endpoint being the Total Mitigation Rate (ORR)the update dismembered results from the Ib period (n-29) long-term follow-up results: show edified treatment responses to JNJ-4528, i.e100% total remission rate (ORR), and the response was profound and persistent, with 86% of patients achieving severe total remission (sCR) at 11.5 months of median follow-up, and 86% of patients surviving and not deteriorating at 9 months100% orR, including: 97% of patients achieved very good or better partial remission (-VGPR), and 3% of patients achieved partial remission (PR)In 29 patients with over-pre-treatment (hardly pre-treated), the therapeutic response was observed when low-dose CAR-T cells (median dose dose 0.72x10-6 CAR plus live T cells/kg) were givenThe median number of patients assessed who had been treated prior to treatment was 5 (range 3-18), 86% of patients were triple difficult to treat and 28% were treated with a triple difficultyThe median time for the first response was 1 month (range 1-3 months), and 81% of assessable patients (n-16) achieved a minimum residual disease (MRD) negative state (1/100000 or 1/1000000) at the first suspected full responseThe most common adverse events observed in's ADULTA-1 study were neutroperatic granulocytic cell reduction (100%) and cytokine release syndrome (CRS, 93%)The most common cases of patients experiencing level 3 AE were neutrophil reduction (100%), platelet reduction (69%) and white blood cell reduction (66%)The median duration of THE onset of CRS was 7 days after infusion (range 2-12), with 1-2 levels of CRS in most patients and 3 or above CRS in 2 patientsNeurotoxicity consistent with immuno-effect cell-related neurotoxic syndrome (ICANS) was observed in 3 patients (10%), of which 1 patient (3%) had a level 3 or higher toxicityThree deaths were reported in the Ib phase study: one from CRS, one from acute myeloid leukemia (not related to treatment), and one from progressive disease"The latest data from the CARTITUDE-1 study show that JNJ-4528 has long-lasting efficacy and tolerable safety," said DrSen Zhuang, Vice President of Oncology Clinical Development atJansenWe are continuing to advance this new CAR-T cell therapy study, which aims to provide differentiated immunotherapy for patients with multiple myeloma, many of who have exhausted all possible prior treatment options"The latest findings from the CART-1 study show that JNJ-4528 has a long-term therapeutic effect for patients with severe pretreatment who face a poor prognosis," said DrJesus G Berdeja, M.D., lead investigator of thestudy and director of myeloma research at the Sarah Cannon InstituteWe are encouraged not only by the relatively high rate of rigorous total remission, but also by the progression less likely to survive these patientsBCMA as the target of MM immunotherapy (source literature - PMID: 3127554)JNJ-4528 (LCAR-B38M) is a research chimeric antigen receptor T cell (CAR-T) therapy for the treatment of recurrent or refractory multiple myeloma (RRMM)The therapy is designed to include a structurally differentiated CAR-T and two BCMA targeted single-domain antibodiesCAR-T cells are an innovative way to destroy cancer cells by harnessing the power of the patient's own immune systemBCMA is a protein that is highly expressed on myeloma cellsIn December 2017, Janssen signed an exclusive global licensing and cooperation agreement with Legendary Biotech to develop and commercialize JNJ-4528 (LCAR-B38M)In May 2018, based on the LEGEND-2 study, Jansen launched an Ib/II trial (NCT03548207) to assess the efficacy and safety of JNJ-4528 for treating recurrent or refractory multiple myeloma in adultsin the United States, the FDA granted JNJ-4528 breakthrough drug eligibility in December 2019 and orphan drug in February 2019In the EU, the European Commission granted JNJ-4528 orphan drug eligibility in February 2020 and priority drug eligibility (PRIME) in April 2019 original origin: Janssen's BCMA CAR-T The JNrapyJ-4528 Showed Multiple, Deep and Dover Responses in Heavily Pretreated Patients With Myeloma
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