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Immunization and targeted therapy achieve long-term survival in metastasis melanoma, however, new treatment strategies are needed to improve patient outcomes.
recently, researchers published a paper in the journal Nature Medicine reporting the safe operation of the anti-PD-1 antibody Spartali pearl monoantigen in association with BRAF inhibitors Dabrafini and MEK inhibitor quercermettini (Part 1; N s 9) and biomarker (Part 2; n s 27) the efficacy, safety, and biomarker analysis of the queue for a randomized, placebo-controlled Phase III COMBI-i trial (NCT02967692).
non-removable or metastasis melanoma with an untreated BRAF V600 mutation before the patient (n s 36).
In Part 1, the recommended phase 3 was determined based on the rate of dose-restricted toxicity (DLTs; primary endpoint): 400mg Spartali pearl monoanti plus 150mg dabrafini every 4 weeks, plus 2mg qumentinib twice a day.
2 indicates changes in PD-L1 levels and CD8-plus cells (primary endpoint) after treatment, and analyzes other biomarkers.
evaluation of efficacy and safety is a critical secondary endpoint (medium follow-up, 24.3 months).
the objective response rate (ORR) caused by Spartanju monoanti-Gadabrafinib and qumentinib was 78%, including 44% full reaction (CR).
72% of patients ≥ adverse events (TRAEs) associated with level 3 therapy.
all patients had temporary dose adjustments, and 17 percent permanently deactived all three research drugs because of TRAEs.
early progressive survival (PFS) events were associated with low tumor mutation burden/T-cell inflammatory gene expression characteristics (GES) or high immunosuppressive tumor micro-environment (TME) GES levels at baseline;
, there is hope for the regulation of biomarkers in the efficacy, safety and treatment of Spartanju single anti-Gadabrafinib and qumeitinib.
researchers have also found biomarkers that may predict long-term benefits.
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