THE CAR-T opponent is here! CD19 monoanti-tafasitamab jointly come to nadoamine treatment lymphoma to submit FDA listing application

German biopharmaceutical company MorphoSys recently released the final analysis results of the new humanized Fc domain optimization immunobolaic-enhanced monoclonal antibody tafasitamab (MOR208) Phase II clinical study L-MIND (NCT02399085)In January, MorphoSys signed a $2 billion global partnership and licensing agreement with Incyte to further develop and commercialize tafasitamabUnder the agreement, Incyte will pay an advance of $750 million and invest $150 million in MorphoSys to buy its American Depositary StockMorphoSys will also be eligible for milestone payments of up to $1.1 billion, depending on the achievement of specific development, regulatory, and commercialization milestonesDecember 30, 2019, has filed a patent application for a biologics license (BLA) with the U.SFood and Drug Administration (MOR208) to treat patients with recurrent or refracted diffuse large B-cell lymphoma (r/r DLBCL)Tafasitamab is a new type of human-derived Fc domain optimized immune-enhanced monoclonal antibody, CD19 is a clear biomarker of a variety of B-cell malignanciesMarch 3, 2020, the FDA has accepted its development of tafasitamab in conjunction with thelenalidomideto treat patients with recurrent/refractive diffuse large B cell lymphoma (DLBCL) bioproduct licensing (BLA), and at the same time granted it priority review eligibility, is expected to be returned by August 30 this yearL-MIND is a one-arm, open-label, multicenter study that evaluates the efficacy and safety of tafasitamab in combination with lenalidomide for the treatment of recurrent/refractive diffuse large B-cell lymphoma (R/R DLBCL) adult patients who have previously received at least one but no more than three system treatments and do not qualify for high chemotherapy doses (HDC) and self-implantation CT (AS)the data included 80 patients who received tafasitamab and indomine combination therapy and followed the study program for at least a yearThe updated outcome is based on the mitigation assessed by the Independent Review Board for all patientsresults showed that the study reached the main endpoint of total remission rate (ORR): 60% ORR in the combination therapy group and 43% of the total remission rate (n-34/80)Follow-up was 17.3 months, with a median progression-free survival period of 12.1 months and a median mitigation duration of 21.7 monthsThe detailed figures will be presented at the International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland, in JuneThe data confirm data released at the American Society of Hematology (ASH) annual meeting in December 2018: median follow-up for 8.3 months, with a total remission rate of 49% and a full mitigation rate of 31%"It is particularly gratifying to see such high total remission rates and duration data, which are not common in the R/R DLBCL population," said Lead Researcher Gilles Salles, lead researcher in the L-MIND study and head of the Department of Clinical Hematology at the University of Lyon in FranceIf approved, based on good safety, tafasitamab combined to nadoamine will provide a new treatment for these patients, improving prognosis and quality of life"
Re-MIND Study: An observational, retrospective study of real-world data designed to isolate the contribution of tafasitamab in the combination drug regimen with indocheanamine and demonstrate the effectiveness of combination therapyThe study compared real-world response data in patients with r/r DLBCL patients receiving the treatment of nadoamine monodrug and the efficacy of tafasitamab and r-DLBCL in the L-MIND studyThe study collected data on 490 R/R DLBCL patients who received inenado amine monodrug in the U.Sand Europe, 76 of which matched 76 patients in the L-MIND study with a 1:1 match in key baseline characteristicsanalysis showed that the study reached the main endpoint: the combination of tafasitamab-to-inamine therapy had clinical advantages over the monodrug therapy of incanamineThe specific data are: tafasitamab-indo-domine combination therapy has a statistically significant advantage in the primary endpoint ORR compared to the monodrug therapy of incanadolamine, in all Consistent advantages were also observed at secondary endpoints, including: full mitigation rate (CR:39.5% vs 11.8%, p 0.0001), total lifetime (median OS: vs 9.3 months not reached, p 0.0008)"CAR-T Killer"!CD19 is a very important B-cell biomarker that is widely expressed on B cells to enhance B-cell receptor (BCR) signaling, which is important for B-cell survival, will be challenged to two car-T therapies that have been marketedTherefore, CD19 is an ideal target for the treatment of a variety of B-cell malignanciesAccording to the American Cancer Institute's website, CD19 has overtaken PD-1 as the hottest immuno-oncology target and the hottest target for cell therapy in 2018, according to the American Cancer Institute's websiteTafasitamab is a human-derived Fc-enhanced monoclonal antibody that targets CD19, and its Fc domain is modified (including 2 amino acids to replace S239D and I332E), significantly enhancing antibody-dependent cell-mediated cell toxicity (ADCC) and antibody cell-dependent phagocytosis (ADCP) by improving the key tumor cell-killing mechanism by improving the affinity of the active Fc-RiIIa on the effect cells In preclinical model studies, tafasitamab has been shown to induce direct apoptosis of cancer cells by binding CD19 regulatory aspects, tafasitama has been granted fda treatment R/R DLBCL fast-track and breakthrough drug qualification by the FDA, and has been granted treatment DLBCL and CLL/SLL orphan drugs by the EMA CD19 expression at all stages of B cells and the mechanism of tafasitamab Currently, MorphoSys is conducting a number of combination therapies to assess the potential of tafasitamab to treat a wide range of B-cell malignancies Key II/III study B-MIND is evaluating tafasitamab combined chemotherapy drug phenyamestininto to treat patients with R/R DLBCL who do not qualify for HDC and ASCT Phase II study COSMOS is evaluating tafasitamab in combination with idelalisib or venetoclax to treat R/R CLL/SLL patients who have previously been treated with BTK inhibitors (e.g ibrutinib) based on the final analysis of the L-MIND study in the report, MorphoSys plans to complete the submission to the FDA by the end of this year of the patentasitamab joint application for a bioproduct license (BLA) for the tafasitamather R/R DLBCL, and is actively deploying a marketing team in the U.S market to prepare for the commercialization of tafasitamab When Tafasitamab launches, it will directly challenge two CAR-T therapies on the market for R/R DLBCL - Novartis Kymriah and Gilead Yescarta efficacy, tafasitamab (ORR s 60%, CR s 43%) is comparable to Kymriah (ORR s 50%, CR-32%) and Yescarta (ORR s 72%, CR-51%) In terms of medication, Kymriah and Yescarta are prepared separately for each patient and take a certain amount of time, while tafasitamab is an industrialproduction of ready-to-use monotoms, ready-to-use In terms of treatment costs, Kymriah and Yescarta both cost hundreds of thousands of dollars, while tafasitamab can control very little no wonder some analysts have called tafasitamab a "CAR-T killer" and the drug is bound to hit Kymriah and Yescarta hard when it goes on sale Tafasitamab is a humanized monoclonal antibody that targets CD19 antigens CD19 is a widely expressed antigen in B-cell cancer, which enhances the signaling pathway of B-cell receptor-mediated, supports B-cell survival, and is an important target target for B-cell cancer currently, tafasitamab is being developed for two types of B-cell malignancies, including DLBCL and chronic lymphocytic leukemia (CLL) Globally, DLBCL is the most common type of non-Hodgkin's lymphoma (NHL) in adults, accounting for 40% of all cases; CLL is the most common type of leukemia in adults Regulatoryly, the FDA granted the Tafasitama Breakthrough Drug (BTD) in October 2017, a combination of r/r DLBCL patients who are not suitable for high-dose chemotherapy (HDC) and protostemstem stem cell transplantation (ASCT) In 2014, the FDA granted the fast track (FTD) for tafasitamab treatment r/r DLBCL Also in 2014, the FDA and EMA granted tafasitamab the status of orphan drugs for the treatment of DLBCL and CLL/SLL (small cell lymphoma) MedSci Source: MedSci Original