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On July 27, AstraZeneca and First Three Co., Ltd. reached a new global development and commercialization agreement for the drug ADC DS-1062, which targets human nourishing layer cell surface glycoprotein antigen 2 (TROP2) antibodies.
DS-1062 is a potentially heavy new drug that promises to redefine the standard of treatment for lung, breast and many other cancers.
DS-1062 is currently being developed to treat a variety of tumors that express TROP2, which is overextended in most non-small cell lung and breast cancers.
agreement, AstraZeneira will pay a total of $1 billion in installments to First Three, which will take effect on July 27, 2020.
the first three will manufacture and supply DS-1062.
for patients with advanced NSCLC who are resistant to multi-line treatment, the need for new drugs is self-evident.
At the 2019 World Lung Cancer Congress (WCLC19), researchers released the latest data on a new drug called DS-1062 for patients with advanced NSCLCs who are multi-line resistant to drugs, including but not limited to patients with oxitin (EGFR mutation direction), Laura tini (ALK mutation direction), chemotherapy, immuno-checkpoint inhibitors and other multi-line treatment resistance.
results show that DS-1062 has potential therapeutic activity in this part of the patient.
2019 ASCO reported the results of Phase I clinical trials of DS-1062 for the treatment of drug-resistant non-small cell lung cancer, which showed an objective remission rate of DS-1062a of more than 40%, a disease control rate of 80%, and more tolerable adverse reactions.
DS-1062 was first revealed, and the 40 advanced NSCLC patients in the group with excellent efficacy and safety were treated repeatedly, including EGFR, ALK inhibitors, and immunospicide inhibitors, with an average of 3.5 options for all patients.
dose range of 0.27-10.0 mg/kg, divided into 8 different gradients, every 21 days injection.
1 study was designed to explore the safety and tolerance of DS-1062 and determine maximum tolerable dose (MTD) and extended dose (RDE), the main findings of which are as follows.
: The latest results show that 12 people have received partial remission (PR), 10 of whom have been confirmed and 2 cases have yet to be confirmed for further efficacy.
In addition, high TROP2 expression was found in 64% of non-small cell adenocarcinomas and 75% of non-small cell squamous cell carcinomas, while TROP2 high expression had higher partial remission (PR), according to Rebecca S. Heist, an expert on the report.
different colors represent different doses, and the waterfall map shows that most patients' tumors are controlled.
that DS-1062 offers patients a better way to treat it, which undoubtedly gives them more hope.
2 DS-1062 therapeutic effect waterfall map dose and efficacy: the efficacy of different dose groups also varies, the results show that as long as a certain dose can be achieved to be satisfactory. Phase I clinical studies of
DS-1062 showed that doses of 4mg/kg and above DS-1062 had a good effect on drug-resistant non-small cell lung cancer after multi-line treatment, with at least 40% of patients with tumors shrinking by 30% or more, and nearly 80% of patients with good tumor control.
experts currently believe that the maximum tolerable dose and the recommended extended dose of 8.0 mg / kg, this dose is the best compared to other doses.
Figure 3 The change in tumor size at different doses of DS-1062 in addition to plasma DS-1062a levels and total anti-TROP2 antibodies show that DS-1062a is stable in circulation, indicating that DS-1062 exhibits better resistance, which means that the drug is effective for a long time within the prescribed dose range.
Safety: Preliminary data from 52 patients who could assess safety showed that DS-1062 had a mid-treatment exposure time of 10.6 weeks, with the most common adverse reactions consisting mainly of fatigue (36.5%) and nausea (36.5%).
4 DS-1062 Safety DS-1062 is expected to be a new hope for advanced NSCLC multi-line treatment resistance patients DS-1062 as nSCLC potential TROP2 targeted therapy, and further enhance the strength and flexibility of the DXd ADC platform.
in patients who experienced partial reactions, TROP2 expression tended to increase.
DS-1062 is selectively combined with THE2 receptors on the surface of tumor cells, which brings new and more beneficial hope for patients' treatment.
Currently, phase II trials are under way, with more and broader assessment objectives, and the end points of the study include progression-free survival, overall survival, objective remission rates, etc., and further studies of more patients at the recommended extended dose will contribute to further evaluation in DSCL6 2 The potential of targeting DS-1062 to TROP2, DS-162 as the NSCLC's first TROP2 targeted therapy, has a broad prospect and will certainly bring more good news to patients, let's wait and see.
: First-In-Human Phase 1 Study of DS-1062a (TROP2 Antibody-Drug Conjugate) in Patients With Advanced Non-Small Cell Lung Cancer. Rebecca S Heist 2019.09 Tymon-Rosario J, Zeybek B, Santin AD. Novel antibody-drug conjugates: current and future roles in gynecologic oncology. Curr Opin Obstet Gynecol. 2020 Jun 28. Doi: 10.1097/GCO.00000000000000642.Goldenberg DM, Sharkey RM. Sacituzumab govitecan, a novel, third, -generation, antibody-drug conjugate (ADC) for cancer therapy. Expert Opin Biol Ther. 2020 Aug;20 (8):871-885 Source: MedSci !-- End of Content Presentation - !-- Determine If Login Ends.