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    Home > Medical News > Latest Medical News > Data on the efficacy of 7 types of tumors were first published by Theoshi/Mershadon K drug combined with lenvatini.

    Data on the efficacy of 7 types of tumors were first published by Theoshi/Mershadon K drug combined with lenvatini.

    • Last Update: 2020-10-28
    • Source: Internet
    • Author: User
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    Recently, Weishi and Mercadon released clinical trial data for two LEAP trials (LEAP-004 and LEAP-004), both of which are in clinical phase II.
    of these, LEAP-004 targets melanoma, while LEAP-004 is mainly in the group of patients with tricystic breast cancer, ovarian cancer, stomach cancer, colorectal cancer (non-microsatellite high instability (non-MSI-H)/mismatch repair gene normal (pMMR), polygonal glioblastoma and bile duct cancer.
    data are also the first to be published in both studies.
    both studies were conducted with multi-target tyrosine kinase inhibitor lenphatinib combined with PD-1 monoantitor Pabli bead monoantigen.
    , Lenvatinib is a multi-target kinase inhibitor developed by Japan's Equifax that targets a range of regulatory factors, including VEGFR1-3, FGFR 1-4, PDGFR alpha, KIT, RET, and Pembrolizumab, which is developed by Mercado.
    combination therapy of the two is the immuno combination target therapy which is hot in tumor therapy research, and the combination of immuno combination target therapy has achieved good results in clinical trials of several different tumors.
    LEAP-004: ADVANCED melanoma LEAP-004 (NCT03776136) for progress after treatment of PD-1 or PD-L1 monoantigen is an II Phase, single-arm, open clinical trials designed to assess the efficacy and safety of patients with non-removable or advanced melanoma who have progressed after PD-1 or PD-L1 monoantigen therapy.
    the study was included in patients with non-removable or advanced melanoma who had been treated with PD-1 or PD-L1 monoantigens, or who had progressed with other immuno-checkpoint inhibitors.
    during the study period, patients were given intravenously 200 mg of Pabliju monotherapy every three weeks, for a total of no more than 35 cycles (approximately two years);
    study ends are objective mitigation rates (ORRs), which include progress-free lifetime (PFS) and mitigation duration (DOR), total lifetime (OS), and security.
    at the data cut-off date (2020/6/10), a total of 103 patients were admitted and treated, with a medium follow-up time of 12 months (range: 8.7-15.6) and an ORR of 21.4% (n s 22) (95% CI: 13.9-30.5), CR (full mitigation rate) is 1.9% (n s 2), PR (partial mitigation rate) is 19.4% (n s 20).
    in all study populations, the medium DOR was 6.3 months (range: 2.1 plus to 11.1 plus).
    PFS was 4.2 months (95%CI:3.5-6.3), of which 73.8% had disease progression or death, while the 9-month PFS rate was 26.2% (95% CI: 17.4-35.9).
    OS was 13.9 months (95% CI:10.8-NR), of which 44.7% died, while the nine-month OS rate was 65.4% (95% CI: 55.2-73.8).
    exploratory analysis showed that in 29 patients who received progression of the disease after PD-1 or PD-L1 monoantial and anti-CTLA-4 therapy, the ORR was 31% (95% CI:15.3-50.8), CR was 3.4% (n-1) and PR was 27.6% (n-8).
    62.1% (95% CI: 42.3-79.3) of these patients.
    the total study population, DCR was 65% (95% CI: 55.0-74.2).
    safety analysis, TRAE (treatment-related adverse events) resulted in 7.8% of patients deactivated with lenfortinib and/or pabori bead monoanti.
    44.7% of patients had level 3-4 TRAE (level 3: 39.8%; level 4: 3.9%; level 5: 1.0%), and 18.4% had severe TRAE.
    30 percent of patients had the most common TRAE at any level, including hypertension (56.3%), diarrhea (35.9%), nausea (34.0%), hypothyroidation (33.0%) and decreased appetite (31.1%).
    Figure 2. LEAP-004 and LEAP-005 Trial Source: ClinicalTrials LEAP-004: For past treatments for TNBC, ovarian cancer, stomach cancer, colorectal cancer (non-MSI-H/pMMR), GBM and BTC patients -005 (NCT03797326) Phase II, Single-Arm, Open Clinical Trials, designed to assess the efficacy and safety of patients with tricystic breast cancer, ovarian cancer, stomach cancer, colorectal cancer (non-MSI-H/pMMR), polygonal glioblastoma (GBM) and bile tube cancer (BTC) who have previously received failed treatment.
    during the study period, patients were given intravenously 200 mg of Pabliju monotherapy every three weeks, for a total of no more than 35 cycles (approximately two years);
    main research endpoints are Objective Mitigation Rate (ORR) (TNBC, Ovarian Cancer, Gastric Cancer, Colorectal Cancer (non-MSI-H/pMMR), and BTC based on RECIST v1.1 evaluation, GBM by Neuro-oncology Response Evaluation (response assessment in neuro-oncology, RANO) standard assessment, the same next) and safety, secondary endpoints include DCR, DORS, PFS and OS.
    the data deadline (2020/4/10), a total of 187 patients were admitted to the group and treated.
    analyzed data from six different types of tumor patients after a medium follow-up time of 8.6 months (range: 1.9-13.1).
    , TNBC patients had ORR of 29%, ovarian cancer orR of 32.3%, stomach cancer of 9.7%, colorectal cancer of ORR of 21.9%, bile tube cancer of ORR of 9.7%, orR of polymorphic glioblastoma of 16.1%.
    Table 1. LEAP-005 trial data At least 20% of the total study population had the most common TRAEs of any level, high blood pressure (39.0%), fatigue (29.4%), diarrhea (26.7%), decreased appetite (25.1%), hypothyroidation (27.8%) and nausea (21.9%).
    based on the preliminary results above, the trial will then be expanded to include approximately 100 patients in each queue.
    Conclusion In March 2018, Wesfarmers and Mercaton reached a global co-development and common commercialization strategy for Lenvatini, under which the two companies will jointly develop and commercialize lenfortinib, making it possible to use it as both a monotherapy and a The study of LEAP-004 and LEAP-005 introduced in this paper is the result of the above-mentioned cooperation, and is also the exploration of the tumor species by Wessau and Mercadon for this combination therapy.
    Currently, in addition to the ongoing combination therapy for several different types of tumors, the two companies have jointly initiated new clinical studies through the LEAP (LEnvatinib and Pembrolizumab) clinical programs and are evaluating 13 different tumor types (uterus) A total of 19 clinical trials were conducted on endometrial cancer, hepatocellular carcinoma, melanoma, non-small cell lung cancer, renal cell carcinoma, head and neck squamous cell carcinoma, urinary pathway cancer, bile tract cancer, colorectal cancer, stomach cancer, glioblastoma, ovarian cancer and triple-negative breast cancer.
    look forward to positive results from the relevant studies.
    Source: Eisai and Merck Present First-Time Data From Two Studies Evaluating KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) in Seven Different Tumor Types at ESMOMo First-Time Congress Virtual 2020 ClinicalTrials.gov.
    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

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