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On November 13th, The Drug Ming Juno announced that the results of a Phase 2 clinical trial for patients with recurring/recurring large B-cell lymphoma (LBCL) will be displayed as posters during the 62nd Annual Meeting of the American Society of Hematology (ASH).
the study, the patient's optimal total remission rate reached 75.9 percent and the total remission rate was 51.7 percent.
Relma-cel is an anti-CD19 CAR-T therapy developed by Pharmaceuticals, which is intended to be developed for the treatment of various types of B-cell malignancies, and is a core candidate for Pharmaceuticals.
June 2020, relma-cel's third-line application for recurring/recurring large B-cell lymphoma was accepted by the State Drug Administration of China (NMPA) and included in the priority review in September this year.
According to the ASH summary, the current demonstration is a forward-looking, one-arm, multi-center, critical study (RELIANCE trial) conducted by reelma-cel in China, which is also supported by reelma-cel's application for recurring/reassotic large B-cell lymphoma adaptation to be accepted by NMPA.
the main endpoint of the study was the 3-month Objective Mitigation Rate (ORR).
secondary endpoints include optimal total mitigation rate (BOR), mitigation duration (DOR), progress-free lifetime (PFS), total lifetime (OS), frequency/severity of adverse events, and so on.
between May 2018 and December 2019, 59 patients with relapsed/incurable large B-cell lymphoma were treated with reelma-cel.
study data show that in 58 patients with assessable efficacy, the ORR for three months was 58.6%; 7%; the medium follow-up time was 8.9 months, the medium OS was not achieved, 6 months DOR, PFS and OS were 60.0%, 54.2% and 90.8%, respectively; and the high-dose group did not observe an improvement in efficacy.
Screenshot Source: Resources: In terms of adverse events, in 59 patients treated, more than 5% of patients with level 3 and above adverse events were cytokine release syndrome (CRS), febrative neutral granulocyte reduction, and lung infection.
addition, patients experienced a decrease in the number of neophilic white blood cells, a decrease in the number of white blood cells, a decrease in white blood cells, and a decrease in nexual granulocytes.
as of the data cut-off, there were no cases of severe blood cell reduction or serious infection after 30 days of infusion.
study noted that the results of relma-cel show similar initial remission rates and pharmacodynamic properties, while providing potential for improved toxicity in treated patients with relapsed/difficult-to-treat DLBCL. in addition to relapsed/refractic large B-cell lymphoma, the company plans to develop relma-cel for the treatment of a variety of other blood-adaptive disorders, including foty lymphoma (FL), clover lymphoma (MCL), chronic lymphoblastic leukemia (CLL), second-line DLBCL, and acute lymphoblastic leukemia (ALL), according to public information from
.
, relma-cel's application for treatment of recurring or refractic folytic lymphoma was approved by the NMPA in September 2020 as a breakthrough treatment.
there is no CAR-T therapy approved for market in China, looking forward to the smooth progress of the research on relma-cel of the drug Ming Juno, to bring new treatment options to patients at an early date.