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    Home > Medical News > Latest Medical News > Roche announces the latest results of multiple bispecific antibodies and ADC therapies

    Roche announces the latest results of multiple bispecific antibodies and ADC therapies

    • Last Update: 2022-01-14
    • Source: Internet
    • Author: User
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    Today, Roche announced that it will announce the clinical results of a series of innovative treatments for different blood diseases at this year's American Society of Hematology (ASH) annual meeting
    .
    The press release pointed out that these innovative therapies are expected to redefine the standard treatment for a variety of blood diseases

    .
    Today, WuXi AppTec's content team will share with readers the latest developments in Roche's many bispecific antibodies and antibody-conjugated drugs (ADC)

    .

    The feature of bispecific antibodies is that they can target two different antigens at the same time.
    At present, the most common application is to bring two different cells closer together by binding to specific antigens on the surface of different cells to promote mutual interaction between them.
    Role

    .
    Roche's mosunetuzumab is such a bispecific antibody

    .
    One end of it binds to the CD20 antigen on the surface of B cells, and the other end binds to the CD3 receptor on the surface of T cells.
    It recruits T cells to the vicinity of B cells, activates T cells to kill B cells, and treats many types of cancers caused by B cells.
    Blood cancer

    .

    At the ASH annual meeting, Roche will announce the key clinical trial results of mosunetuzumab in the treatment of patients with relapsed/refractory follicular lymphoma
    .
    These patients have received at least two pre-treatments, and 78.
    9% of them have developed resistance to anti-CD20 antibody therapy

    .

    The results described in the ASH summary showed that mosunetuzumab monotherapy showed anticancer activity in most patients
    .
    The objective response rate (ORR) reached 78.
    9%, and the complete response rate (CR) reached 57.
    8%

    .
    The median progression-free survival (PFS) was 17.
    9 months

    .
    In different pre-set patient subgroups, mosunetuzumab also showed consistent anti-cancer activity

    .

    In terms of safety, cytokine release syndrome (CRS) is the most common adverse event, occurring in 44% of patients, most of which are grade 1 or 2
    .
    No patient died due to CRS

    .
    4.
    4% of patients stopped the trial due to adverse events

    .

    At the R&D Day event held a few days ago, Roche pointed out that based on these positive data, the company will submit a regulatory application for mosunetuzumab before the end of 2021
    .

    In addition to Mosunetuzumab, another CD20-targeting bispecific antibody glofitamab developed by the company has a unique 2:1 structure
    .
    It contains two protein domains that bind to CD20 and one protein domain that binds to CD3 receptors

    .
    Roche’s research found that having two protein domains that bind to CD20 enhances the activity of glofitamab, and that it can achieve better results when combined with an approved anti-CD20 monoclonal antibody

    .

    The clinical trial data described in the ASH summary showed that glofitamab, as a single-agent therapy, achieved 81% ORR (n=43) and 70% complete metabolic remission in early clinical trials for the treatment of patients with relapsed/refractory follicular lymphoma Rate (CMR)
    .
    If combined with an approved anti-CD20 antibody, the ORR is 100% (n=19) and the CMR is 73.
    7%

    .

    In terms of safety, CRS appeared in 66% of monotherapy patients and 79% of combination therapy patients, most of which were grade 1 or 2
    .

    Roche believes that these two bispecific therapies have the potential to become "first-in-class" and "best-in-class" therapies for the treatment of follicular lymphoma and diffuse large B-cell lymphoma
    .
    They have different characteristics.
    Mosunetuzumab is more suitable for use in non-hospital patients, while glofitamab has the potential to bring higher complete relief, allowing doctors and patients to choose according to different needs

    .

    In addition, cevostamab is a bispecific antibody that targets the FcRH5 receptor
    .
    FcRH5 receptor is expressed in all myeloma cells, and the expression level in myeloma cells and normal plasma cells is higher than that in normal B cells

    .
    Cevostamab binds to the CD3 receptor on the surface of T cells to recruit T cells around multiple myeloma cells, activating them to kill myeloma cells

    .

    The latest clinical trial results in the ASH Abstract show that as of May 18, 2021, 160 patients with relapsed/refractory multiple myeloma who have received multiple previous treatments have received different doses of cevostamab
    .
    These patients had received an average of six kinds of pre-treatment, including therapy CAR-T, an antibody-drug conjugates, and B cell maturation antigen (BCMA) and the like targeted therapies

    .

    The results of the test showed that among the patients who received cevostamab above the target dose, the ORR of the subgroup of patients who had previously received CAR-T therapy was 36.
    7% (4/9), and patients who had received other bispecific therapies The ORR of the subgroup was 33.
    3% (3/9), and the ORR of the subgroup of patients who had received ADC or anti-BCMA therapy was 50.
    0% (7/14) and 36.
    4% (8/22), respectively

    .
    The estimated median duration of remission is 15.
    6 months

    .

    In addition to bispecific antibodies, the targeted CD79b antibody-conjugated drug Polivy (polatuzumab vedotin) is combined with a treatment program called R-CHP, a key phase 3 clinical trial for the first-line treatment of patients with diffuse large B-cell lymphoma The primary endpoint was reached in mid-range, and compared with the standard treatment of R-CHOP, the risk of disease progression or death was reduced by 27% (HR=0.
    73, 95% CI: 0.
    57-0.
    95, p<0.
    02)

    .
    Roche pointed out that this is the first treatment plan that significantly improves the progression-free survival outcome of such patients in 20 years compared with standard treatment

    .

    CD79b protein is specifically expressed in most B cells.
    Polivy specifically binds to CD79b on tumor cells to deliver anti-cancer drugs to kill these B cells and minimize damage to normal cells

    .

    In this clinical trial, 879 patients received Polivy combination therapy or R-CHOP treatment
    .
    When the median follow-up time was 28.
    2 months, the two-year progression-free survival rate of the Polivy combination therapy group was 76.
    7%, and that of the R-CHOP group was 70.
    2%

    .
    In terms of overall survival, there was no significant difference between the Polivy combination therapy and the R-CHOP group

    .

    Reference materials:

    [1] Roche to present new pivotal data at ASH 2021 from broad and comprehensive portfolio, challenging treatment standards for people with blood disorders.
    Retrieved November 23, 2021, from https:// cor-2021-11-23.
    htm

    [2] Mosunetuzumab Monotherapy Is an Effective and Well-Tolerated Treatment Option for Patients with Relapsed/Refractory (R/R) Follicular Lymphoma (FL) Who Have Received ≥2 Prior Lines of Therapy: Pivotal Results from a Phase I/II Study.
    Retrieved November 23, 2021, from https://ash.
    confex.
    com/ash/2021/webprogram/Paper145872.
    html

    [3] Glofitamab Step-up Dosing Induces High Response Rates in Patients (pts) with Relapsed or Refractory (R/R) Mantle Cell Lymphoma (MCL), Most of Whom Had Failed Prior Bruton's Tyrosine Kinase Inhibitor (BTKi) Therapy.
    Retrieved November 23, 2021, from https://ash.
    confex.
    com/ash/2021/webprogram/Paper148949.
    html

    [4] Cevostamab Monotherapy Continues to Show Clinically Meaningful Activity and Manageable Safety in Patients with Heavily Pre-Treated Relapsed/Refractory Multiple Myeloma (RRMM): Updated Results from an Ongoing Phase I Study.
    Retrieved November 23, 2021, from https:// ash.
    confex.
    com/ash/2021/webprogram/Paper147983.
    html

    [5] Glofitamab As Monotherapy and in Combination with Obinutuzumab Induces High Complete Response Rates in Patients (pts) with Multiple Relapsed or Refractory (R/R) Follicular Lymphoma (FL).
    Retrieved November 23, 2021, from https://ash.
    confex.
    com/ash/2021/webprogram/Paper148778.
    html

    [6] The POLARIX Study: Polatuzumab Vedotin with Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (pola-R-CHP) Versus Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP) Large Therapy in Patients with Previously Untreated Diffuse Cell Lymphoma.
    Retrieved November 23, 2021, from https://ash.
    confex.
    com/ash/2021/webprogram/Paper154729.
    html

    (The original text has been deleted)

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