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    Home > Active Ingredient News > Antitumor Therapy > Heavy! Mercado Keytruda approved by the U.S. FDA for the second "unlimited cancer" indications: high tumor mutation burden (TMB-H) solid tumor!

    Heavy! Mercado Keytruda approved by the U.S. FDA for the second "unlimited cancer" indications: high tumor mutation burden (TMB-H) solid tumor!

    • Last Update: 2020-07-20
    • Source: Internet
    • Author: User
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    , June 18, 2020 /PRNewswire/

    -- Merck and Co has announced that the U.S

    Food and Drug Administration (

    ) has approved Keytruda (Corrida, generic name: pembrolizumab, Pabo) lizumab as a monodrug therapy for the treatment of patients with physical tumors and adults with progressive conditions after previous treatment, unsatisfactory alternative treatment options, non-removability or metastatic high tumor mutation burden (TMB-H: 10 mutations/muplyns.) Depending on the tumor remission rate and the duration of the mitigation, the indication is approved under the accelerated approval process

    Continued approval of the indications may depend on the validation and description of clinical benefits in validation trials

    The safety and efficacy of


    in children treated by Keytruda in the treatment of tMB-H has not been confirmed

    in addition,

    The FDA

    also approved FoundationOne® CDx (F1CDx), a

    in vitro diagnostic
    sissic product of Roche's cancer treatment company Foundation Medicine, as an accompanying


    product for identifying TMB-H (s10 mutations/megabase) solid tumor patients who may benefit from Keytruda monodrug therapy

    note, Keytruda is the first checkpoint inhibitor approved for use in patients with TMB-H solid tumors

    The approval also marks Keytruda's second "unlimited cancer" indication, which is based on a biomarker and is independent of the site of the tumor in the body

    Previously, in May 2017, Keytruda was approved by the U.S


    to become the first anticancer drug based on microsatellite instability (MSI-H)/dMMR


    , to treat patients with MSI-H or dMMR solid tumors, regardless of

    type of tumor

    this accelerated approval is based on a forward-looking program review analysis of patients with previously treated non-removable or metastatic TMB-H solid tumors in the STUDY of 10 queues (A-J) of THE KEYNOTE-158 (NCT02628067)

    The trial was a multicenter, non-random, open-label study that evaluated the efficacy and safety of Keytruda (200mg, once every 3 weeks)

    The trial excluded patients who had previously received anti-PD-1 therapy or other immunomodulatory monoclonal antibodies,


    diseases, and required immunosuppressive therapy

    trial, The TMB status was evaluated with F1CDx analysis and pre-specified thresholds of .10 and s13mut/Mb, and the clinical outcome was detected to be blinded



    response was assessed every 9 weeks for the first 12 months, followed by every 12 weeks

    Objective remission rate (ORR) and duration of reliever (DOR) were evaluated in patients receiving at least one dose of Keytruda (DOR) using the Blind Independent Center Review (BICR) to evaluate up to 10 target lesions and up to 5 target lesions per organ, based on the criteria for evaluation of the efficacy criteria (RECIST v1.1)

    the study, 1,050 patients were included in the outcome analysis population

    According to the testing requirements set out in the agreement, 790 patients with sufficient tissue were tested for TMB analysis

    Of the 790 patients, 102 (13%) were identified as TMB-H, defined as TMB-10 mut/Mb

    The 102 patients were characterized by a median age of 61 years (27-80 years), 34% age, 34% male, 81% white, 41% of the Oriental


    Cooperative Group (PS) with 0,58% ECOG PS 1

    Fifty-six percent of patients had previously received at least two treatments

    in 102 patients with TMB-H


    , Keytruda had an ORR of 29% (95% CI:21-39), a total remission rate (CR) of 4% and a partial remission rate (PR) of 25%

    After 11.1 months of median follow-up time, the median DOR has not been reached (range: 2.2 to 34.8 plus months)

    In 30 patients with remission, 57% continued to remission for 12 months and 50% of patients for a sustained remission of 24 months

    in a pre-specified analysis of patients with TMB?13mut/Mb (n?70), Keytruda showed an ORR of 37% (95% CI:26-50), a total mitigation rate (CR) of 3%, and a partial mitigation rate (PR) of 34%

    After 11.1 months of median follow-up time, the median DOR has not been reached (range: 2.2 to 34.8 plus months)

    In 26 patients with remission, 58% continued to remission for 12 months and 50% continued to remission for 24 months

    The orterion analysis of 32 cases of cancer with TMB,10 mut/Mb and 13 mut/Mb was 13% (95% CI: 4-29), including 2 cases of complete remission and 2 partial remission

    the median duration of

    Keytruda treatment was 4.9 months (range: 0.03 to 35.2 months)

    Keytruda's most common adverse


    (reported in 20% of patients) are fatigue, musculoskeletal pain, decreased appetite, itching, diarrhea, nausea, rash, fever, cough, dyspnea, constipation, pain and abdominal pain

    "This is the second time that Keytruda single drug has been approved based on a


    , rather than

    originated in the body," said Dr

    Scott Ebbinghaus, vice president of clinical research at the

    's Mercado Research Laboratory

    TMB-H, defined as 10 or more mutations per megabase, can help identify patients most likely to benefit from Keytruda

    We are pleased that our collaborative efforts to advance biomarker research enable us to provide a new treatment option that addresses the high medical needs that these cancer patients cannot meet

    "As doctors, we are always looking for new options for patients, especially in second- or more-line treatment environments," said Dr

    Roy S

    Herbst, a professor at Yale University School of Medicine,

    I am pleased to see innovative biomarkers combined with the use of immunotherapy, and now we have a new option for treating patients
    with tMB-H

    tumors across cancer types, including rare cancers

    "These approvals stem from years of research into how TMB levels affect patients' responses to immunotherapy," said Dr

    Brian Alexander, chief medical officer at

    Foundation Medicine

    It is critical that healthcare professionals have access to proven genomic testing to measure TMB in clinical


    assessments and identify those who are more likely to respond

    We are proud to work with Mercayon to help the right patients receive this important treatment

    original origin:



    Roves Second Biomarker-Based Oat S

    Merck's keytruda ® (pembrolizumab), Regard of The Tumor Type

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