Triple-negative Breast Cancer (TNBC) Heavy News! The first TROP-2 targeted antibody-drug-conjugate therapy Trodelvy is available in the United States!

05 May 2020 /
Biovalley BIOON/--Immunomedic is a pioneer of next-generation antibody drug conjugate (ADC) technology dedicated to helping cancer patients change their lives At the heart of its proprietary ADC platform is the use of a new type of linkthat that does not require enzymes to release an effective load that delivers active drugs within tumor cells and in microenvironments tumors, resulting in a near-side effect ( bytander effect) recently, the company announced the launch of its first commercialproduct, Trodelvy (acituzumab govitecan-hziy), in the U.S market, which was approved by the U.S FDA in April for adult patients who had previously received at least two treatments for metastatic tri-negative breast cancer (mTNBC) It's worth noting that Trodelvy is the first FDA-approved ADC drug specifically for recurrent or refractory mTNBC, and the first anti-Trop-2 ADC drug approved by the FDA TNBC is an aggressive cancer with poor prognosis and treatment options are extremely limited, except for traditional chemotherapy Trodelvy has the potential to become a standard care drug for TNBC treatment In a clinical trial , Trodelvy showed clinical remission in patients with incurable mTNBC, a drug that will provide clinicians with a new tool to deliver better outcomes for mTNBC patients Industry analysts have previously said that, based on Phase II clinical data, represent a significant improvement over standard care, with sales expected to peak at more than $1 billion after the drug goes on sale Trodelvy's active pharmaceutical ingredient is acituzumab govitecan, a new and first-of-its-kind antibody drug conjugated (ADC) drug, made up of sN-38, an active metabolite product of the humanized IgG1 antibody targeting TROP-2 antigen, and the chemotherapy drug I inhibitor of the topological isotechlascya TROP-2 is a cell surface glycoprotein expressed in more than 90% of TNBC Before , The FDA granted Trodelvy Breakthrough Drug Qualification (BTD) and priority review According to objective mitigation rate (ORR) and mitigation duration (DOR) data observed in the single-arm multicenter PHASE II study, Trodelvy was approved through the accelerated approval process The continued approval of this indication will depend on the validation and description of clinical benefits in the validated Phase III ASCENT study (500 patients in the group of 500 mTNBC patients) Just recently, the ASCENT study was terminated early, based on recommendations from the Independent Data Safety Monitoring Committee (DSMC), because of compelling evidence of efficacy at multiple endpoints, and the data will be published in the middle of this year single-arm multicenter Phase II study enrolled 108 over-pre-treated mTNBC adult patients who had previously received multiple therapies (range: 2-10) to treat metastatic diseases Data show that the objective remission rate (ORR) for Trodelvy treatment was 33.3% (95% CI: 24.6, 43.1) and median mitigation duration (DOR) was 7.7 months (95% CI: 4.9, 10.8) a black-box warning is attached to the Drug Label for Trodelvy, indicating severe neutrophil reduction and severe diarrhea The most common adverse reactions in 25% or more , including nausea, neutrophil reduction, diarrhea, fatigue, anemia
, vomiting, hair loss, constipation, loss of appetite, rash and abdominal pain The most common level 3 or 4 adverse events that occur in more than 5% of patients are neutropenocytic cell reduction, white blood cell reduction, anemia, hypophosphate, diarrhea, fatigue, nausea and vomiting 2% of patients stopped treatment due to adverse events There are no treatment-related deaths and no serious cases of neuropathy or interstitial pulmonary disease breast cancer is the most common type of cancer in women, with more than 2 million cases diagnosed worldwide each year Triple breast cancer (TNBC) accounts for about 15 percent of all breast cancers, and TNBC is more common among women under 50 than other types of breast cancer TNBC specifically refers to estrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor 2 (HER-2) all of all negative expression of breast cancer, rapid progress, poor prognosis, 5 year survival rate of less than 15% TNBC's treatment sparing lying with both hormone therapy and HER2 targeted therapies, such as Roche Herceptin, has very limited clinical options and relies heavily on chemotherapy Trodelvy is a new and first-of-its-kind antibody drug, ADC, made up of a perceptibal active product, SN-38, of a synthetic isoenzyme I inhibitor that targets TROP-2 antigens TROP-2 is a cell surface glycoprotein expressed in more than 90% of TNBC Immunomedic is currently evaluating Trodelvy for treatment of a variety of types of cancer, including mTNBC, urinary skin cancer, non-small cell lung cancer, and more it's worth noting that in TNBC therapy, in March 2019 Roche PD-L1 tumor immunotherapy Tecentriq was approved by the U.S FDA to treat Patients with PD-L1-positive pre-ortroid triple-negative breast cancer (TNBC) with first-line chemotherapy (Abraxane) The approval makes the Tecentriq-Abraxane combination the first cancer immunotherapy treatment for TNBC (BioValleyBioon.com) original origin: ImmunoMedic Comm Commercial Availability of TROYDELV in the United State