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    Home > Active Ingredient News > Urinary System > 2022 Evaluation of the efficacy of pembrolizumab in patients with advanced UC in East Asia| ESMO ASIA—post-hoc analysis of KEYNOTE-045/052 study

    2022 Evaluation of the efficacy of pembrolizumab in patients with advanced UC in East Asia| ESMO ASIA—post-hoc analysis of KEYNOTE-045/052 study

    • Last Update: 2023-01-01
    • Source: Internet
    • Author: User
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    Hosted by the European Society of Medical Oncology, ESMO ASIA is the leading platform
    in the Asia-Pacific region to discuss the latest data and breakthroughs in oncology.
    The conference brings together the most experienced international experts to present and discuss the latest academic research and clinical progress, and provides important networking opportunities
    for experts and scholars in the field of oncology.
    ESMO ASIA 2022 was held
    online + offline in Singapore from December 2-4.
    Pembrolizumab has greatly changed the treatment pattern of urothelial cancer, but most of the blockbuster studies have been carried out in Europe and the United States, and some scholars have conducted retrospective analysis to evaluate the efficacy and safety
    of pembrolizumab in patients with East Asian urothelial cancer.
    Let's take a look
    together.


    Research background


    The KEYNOTE-052 (phase II.
    ) and KEYNOTE-045 (phase III) studies explored the efficacy of pembrolizumab as a first-line treatment for advanced urothelial carcinoma (UC) and a second-line treatment for platinum-refractory patients who are not suitable for cisplatin, respectively, and the results showed that pembrolizumab showed durable antitumor activity and a controllable safety profile
    .
    To assess whether the efficacy of pembrolizumab in East Asian populations is consistent
    with that of the general population.


    Study design


    The study included patients
    in East Asia in the KEYNOTE-052 study and the KEYNOTE-045 study.
    Patients in the KEYNOTE-052 study were randomized 1:1 to receive investigator-selected chemotherapy regimens (paclitaxel: 175 mg/m2 IV Q3, docetaxel 75 mg/m2 IV Q3, or vinofonin: 320 mg/m2IV Q3) or pembrolizumab (200 mg, IV, Q3W for 2 years
    ).
    。 All patients in the KEYNOTE-045 study were treated
    with pembrolizumab (200 mg intravenously every 3 weeks for 2 years).
    The investigators reported objective response rate (ORR), overall survival (OS), and safety data
    that were independently reviewed by blinded (RECIST v1.
    1 criteria).
    Data are current to 1 October 2020 (KEYNOTE-045 study) and 26 September 2020 (KEYNOTE-052 study).

    Figure 1 Study design


    Study results


    A total of KEYNOTE-045 studies were included (62 patients in the pembrolizumab group; 51 patients in the chemotherapy group) and 113 patients in the KEYNOTE-052 study (20 patients) were analyzed
    .
    The median follow-up time for patients enrolled in the KEYNOTE-045 study and KEYNOTE-052 study was 62.
    4 (range 59.
    2-68.
    6) months and 57.
    3 (range 51.
    4-65.
    2) months, respectively, with the rest of the baseline data shown in the figure below
    .

    Figure 2 Baseline data of enrolled patients


    The patient's remission after treatment is shown in the figure below
    .

    Fig.
    3 Remission of different groups of patients

    FIG.
    4 OS data of East Asian populations in the KEYNOTE-045 study


    FIG.
    5 OS data of East Asian populations in the KEYNOTE-052 study


    In the KEYNOTE-045 study, the incidence of grade 3-5 treatment-related adverse events (TRAEs) in patients with pembrolizumab and chemotherapy was 16% (n=10) and 73% (n=37), respectively, with 1 patient dying from TRAEs
    in each group.
    In the KEYNOTE-052 study, a total of 2 (10%) patients developed TRAEs, of which 1 (5%) died
    .


    Conclusion of the study


    The results of this post-hoc subgroup analysis showed that pembrolizumab exhibited consistent antitumor activity and safety in the KEYNOTE-045 study population in East Asian populations; Experimental results support pembrolizumab as a second-line regimen for patients with platinum-refractory advanced UC, but the small number of East Asian patients (20/370) in the KEYNOTE-052 study limits the generalizability
    of its results.


    The cover and accompanying pictures are from the official ESMO ASIA conference


    Reference source:

    https://asiacongress.
    esmo.
    org/esmo/asia2022/en-GB/presentation/551759


    Edited by Rudolf Reviewed: Rudolf Executed by Gardenia


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