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!--," September 21, 2020 // -- Merck and Co and partner Eisai recently presented new data on two trials of the LEAP clinical project at the 2020 Virtual Conference of the European Society of Medical Oncology (ESMO).
these two trials are evaluating the combination of The Mercado anti-PD-1 therapy Keytruda (Corida ®, generic name: pembrolizumab, Pabliju monoantigen) and the oral polymember tyrosine kinase inhibitor Lenvima (LeWema®, generic name: lenvatinib, lenvatinib) to treat multiple types of cancer.
results showed that the Keytruda-Lenvima combination therapy showed efficacy in all seven types of tumors: (1) Phase 2 LEAP-004 trial, the combination therapy previously received anti-PD-1/PD-L1 therapy of non-removable or metastasis melanoma patients objective remission rate (ORR) was 21.4%.
(2) Phase 2 LEAP-005 trial, in previously treated triple-negative breast cancer (TNBC), ovarian cancer, stomach cancer, colorectal cancer (non-microsatellite instability high (non-MSI-H)/misalmutation repair normal (pMMR) In patients with polymorphic glioblastoma (GBM) and bile tube cancer (BTC), the ORR of keytruda-Lenvima combination therapy was 9.7-32.3% (95% CI: 2.0-51.4%).
, the Keytruda-Lenvima combination has been studied in 13 different types of tumors and has shown strong results in many types of tumors.
the first data from two clinical trials of the LEAP project released at the conference, further supporting the therapeutic potential of the portfolio.
- Phase 2 LEAP-004 Trial (NCT03776136): In patients with non-extinct or advanced melanoma who had previously been treated with an anti-PD-1/PD-L1 therapy for 12 weeks, a total of 103 patients were admitted and treated as of June 10, 2020.
data show that the objective remission rate (ORR) of keytruda-Lenvima combined therapy was 21.4% (95% CI: 13.9-30.5), the full remission rate (CR) was 1.9% (n-2), and the partial remission rate (PR) was 19.4% (n-20).
in the study population, the medium duration of remission (DOR) was 6.3 months (range: 2.1 plus to 11.1 plus), and 72.6% (95% CI: 46.2-87.6) of the remission lasted for more than 6 months.
PFS was 4.2 months (range: 3.5-6.3), 73.8% of patients experienced disease progression or death, and 9 months PFS was 26.2% (95% CI: 17.4-35.9).
total survival (OS) was 13.9 months (range: 10.8-not achieved) and 44.7% of patients died.
65.4% (95% CI: 55.2-73.8) for the last nine months.
exploratory analysis showed that INR was 31.0% (95% CI: 15.3-50) in 29 patients who had previously received a combination of anti-PD-1/L1 therapy and anti-CTLA-4 therapy. .8), CR is 3.4% (n=1), PR is 27.6% (n=8), and disease control rate (DCR) is 62.1% (95% CI: 55.0-74.2).
treatment-related adverse events (TRAEs) caused 7.8% of patients to discontinue Keytruda and/or Lenvima treatment.
Among at least 30 percent of the study population, the most common TRAEs at any level were hypertension (56.3 percent), diarrhea (35.9 percent), nausea (34.0 percent), hypothyroidation (33.0 percent) and loss of appetite (31.1 percent).
- Phase 2 LEAP-005 Trial (NCT03797326): Assessed the efficacy and safety of the Keytruda-Lenvima combination in patients with a variety of advanced solid tumors previously treated, including: TNBC, ovarian cancer, stomach cancer, colorectal cancer (non-MSI-H/pMMR), GBM, BTC.
as of April 10, 2020, a total of 187 patients were admitted to the group and treated.
follow-up time was 8.6 months (range: 1.9-13.1) in patients with 6 types of tumors.
results are as follows.
Among at least 20 percent of the study population, the most common levels of TRAS were hypertension (39.0%), fatigue (29.4%), diarrhea (26.7%), loss of appetite (25.1%), hypothyroidation (27.8%) and nausea (21.9%).
study is ongoing and will be expanded to about 100 patients per queue.
keytruda-Lenvima combination therapy is part of Mercedon's strategic collaboration with Aedes aureon.
March 2018, the two sides signed a $5.8 billion cooperation agreement to develop Lenvima monodrima and a combination with Keytruda for the treatment of multiple types of tumors.
Lenvima is an oral polycep tyrosine kinase (RTK) inhibitor with novel binding patterns that inhibit other angiogenesphage and cancer-causing signaling pathfectal RTKs (including plate plate plate-derived growth factor (PDGF) binders PDGFR alpha, KIT and In addition to RET, it is also ability to selectively inhibit kinase activity of vascular endostropheric growth factor (VEGFR1, VEGFR2, VEGFR3) and fibroblast growth factor (FGF) subjects (FGFR1, FGFR2, FGFR3, FGFR4).
Keytruda is an anti-PD-1 tumor immunotherapy that helps detect and fight tumor cells by improving the body's immune system.
Keytruda is an anthogeneic monoclonal antibody that blocks the interaction between PD-1 and its mediators PD-L1 and PD-L2, activating T lymphocytes that may affect tumor cells and healthy cells.
() !--/ewebeditor:page--!--ewebeditor:page title"--original source: Merck and Eisai Present First-Time Data From Two Studies Evaluating KEYTRU DA ® (pembrolizumab) Plus LENVIMA ® (lenvatinib) in Seven Different Tumor at ESMO Virtual Congress 2020 !--/ewebeditor:page--