The first triple-negative breast cancer ADC drug! Sacituzumab govitecan validation Phase III study has significant efficacy, early termination!

08 April 2020 /
Biovalley BIOON/-- Immunomedic is a clinical biopharmaceutical company focused on developing monoclonal antibody-based therapies for targeted treatments for cancer and other serious diseases Recently, the company announced that the verified Phase III ASCENT study would be discontinued due to compelling evidence of efficacy The decision is based on the unanimous recommendations of the Independent Data Security Monitoring Committee (DSMC) in its recent routine review of THE ASCENT study ASCENT is a Phase III validation study designed to verify the very promising safety and efficacy data observed in patients with the antibody drug conjugal (ADC) acituzumab govitecan (research code: IMMU-132) in patients with over-pretreatment (pre-pretreatmented) metastatic triple-negative breast cancer (mTNBC
) The main endpoints of the ASCENT study were progression-free lifetime (PFS), and secondary endpoints included total lifetime (OS) and objective mitigation rate (ORR) in its last update in December, Immunomedic reported Phase II study data for 108 over-treatment of mTNBC patients, with the acituzumab govitecan-induced objective remission rate (ORR) at 34% and median remission duration (DOR) at 9 months , as assessed by the Independent Review Committee , the agency's resubmitted acituzumab govitecan license application (BLA) is under review by the U.S Food and Drug Administration (FDA), with the Target Date of the Prescription Drug User Charge Sfa (PDUFA) dated June 2, 2020 The BLA seeks accelerated approval of acituzumab govitecan for patients with metastatic triple-negative breast cancer (mTNBC) who have previously received at least two treatments for metastatic diseases Previously, the FDA has granted acituzumab govitecan breakthrough drug eligibility (BTD) industry analysts had previously argued that is a significant improvement over standard care based on the available Phase II clinical data, and that if approved, the drug would be the first and only antibody drug to treat mTNBC," with sales peaking expected to reach more than $1 billion "I am honored to be the independent DSMC Chair for this important study," said Julie R Gralow, M.D., a professor of breast cancer at the University of Washington School of Medicine and a member of the Fred Hutchinson Cancer Research Center Triple-negative breast cancer (TNBC) is a disease that has a very limited treatment regimen in addition to traditional chemotherapy The remarkable results we observed at multiple endpoints in the ASCENT study confirm edifythe severity of the trial and indicate potentially significant advances in the treatment of this devastating disease Currently, the disease affects young women and African-American women at a higher rate I look forward to a comprehensive and final analysis of these research data as they become publicly available "
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 acituzumab govitecan is a new and first-of-its-kind antibody drug conjugated (ADC) drug, made up of a humanized IgG1 antibody targeting TROP-2 antigen, and a metabolic ally product, SN-38, of the chemotherapy drug Ihomogenetht I inhibitor TROP-2 is a cell surface glycoprotein expressed in more than 90% of TNBC , Immunomedic is currently evaluating acituzumab govitecan for treatment of a variety of types of cancer, including mTNBC, urinary skin cancer, non-small cell lung cancer, and so on 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 ASCENT Study to be Stopped for Lacourt Efficacy