Lymphoma Targets Immunotherapy! Roche CD79b target drug Polivy Japan applies for listing for diffuse large B-cell lymphoma (DLBCL)

, July 04, 2020 /
BioguBIOON/ -- Chugai, a Japanese pharmaceutical company controlled by Roche, has recently submitted a new drug application (NDA) to the Ministry of Health, Labour and Welfare (MHLW) for the treatment of recurrent or refractive diffuse large B-cell lymphoma (DLBL)In Japan, MHLW awarded Polivy Orphan Medicine in November 2019Polivy, a pioneering antibody drug conjugate (ADC) targeting CD79b, was awarded the U.Sin June 2019 FDAaccelerated approval of the combination of phenyartin and rituximatol (BR therapy) for treatment of patients with R/R DLBCL who have previously received at least two treatment
s; In the United States and the European Union, Polivy has been granted the Treatment of DLBCL orphan drug and the Breakthrough Drug (BTD) and priority drug (PRIME) respectivelynote, Polivy is the first chemical immunotherapy approved for R/R DLBCL, and the combination BR program significantly improves clinical outcomes compared to common treatment options (BR)DLBCL is an invasive blood cancer that usually becomes more difficult to treat with each recurrenceApproximately 40% of untreated DLBCL patients relapse after standard treatment, and follow-up treatment options are limited, and Polivy will provide an important treatment option for such patientsthe Japanese application, based on the results of a multi-center, one-arm Japan Phase II study (JO40762/P-DRIVE study) and a multi-center global Ib/II study (GO29365)The previous study assessed the efficacy and safety of Patients with Polyvy Combined BR Therapy for Relapsed or Incurable DLBCL, and the latter compared the efficacy and safety of Polivy Combined BR Therapy and BR Therapy For R/R DLBCL patientsThere is also a double-blind, placebo-controlled Global Phase III study (GO39942/POLARIX study), which is being conducted in patients with previously untreated DLBCL and is evaluating the efficacy of the Polivy-litoxaxaxaxaxamcine-R-CHP (cyclophosine, amycine, penisonronol) combination drug regimen, R-CHOP (cyclophosphamide, amycinion, changchunine, penipinesDLBCL is a heliological subtype of non-Hodgkin's lymphoma (NHL) and is classified as an invasive diseaseDLBCL is the most common NHL, accounting for 30-40% of the NHLDLBCL is common lying in middle-aged and older people, mainly in people over 60 years of ageThe median age of thediagnosedwas reported to be 64rituximab combined chemotherapy is the standard first-line treatment of DLBCL; Although thetransplantation ofstem cells (ASCT) was recommended for patients with recurrent or refractive DLBCL, about half of the patients were unable to perform ASCT due to the failure of pre-ASCT-saving chemotherapyIn addition, there is no standard treatment plan for patients who do not qualify for ASCT due to age or complicationsTherefore, for relapsed or refractive DLBCL, there is an urgent need for new treatment options for bitesPolivy was developed by Roche's Genetek using the SeattleGeneticsCompany's ADC, a pioneering (first-in-class) ADC specifically targeted at CD79b, which is a humanized anti-CD79b antibody paired with the anti-splifying agent MMAE (monomethyl statin E) and is currently being developed to treat several types of non-Hodgkin lymphoma (NHL)CD79b is highly specifically expressed in most types of B-cell NHL, making it a promising target for the development of new therapiesPolatuzumab vedotin targets binding CD79b and destroys these B cells, minimizing the impact on normal cells while maximizing the damage to cancer cellsglobal Ib/II study GO29365 was conducted in patients with R/R DLBCL who were not suitable for hematopoietic stem cell transplantation and had previously received multiple therapies (median: 2)The data showed that the total mitigation rate increased significantly (CR: 40% vs 18%), the total lifetime was more than doubled (median OS: 12.4 months vs 4.7 months), and the duration of the mitigation was significantly longer (median DOR: 10.3 months vs 4.1 months; HR?0.44)safety, the most common adverse events in the Polivy-BR and BR groups include: anemia , platelet reduction, neutrophil reduction, fatigue, diarrhea, nausea and fever (BioValleyBioon.com) original source: Chugai Files a New Drug Application for Polatuzumab Vedotin for the Treatment of the Reed or Orory Diffuse Diffuse Large B-cell Lymphoma