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Chuangsheng Group, an international biopharmaceutical company with the ability to integrate the entire process of biopharmaceutical R&D, clinical and production, announced the release of its pH-dependent PD-L1 antibody MSB2311 in summary form at the 2021 American Society of Clinical Oncology (ASCO) annual meeting Update on safety and efficacy data of the Phase I clinical study (NCT04272944) in patients with advanced solid tumors and hematological malignancies in China (Abstract number: #e14547, May 19, 2021, 5:00 PM, Eastern Time)
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The research announced at the 2021 ASCO annual meeting was carried out by a research team led by Professor Shen Lin, the vice president of Peking University Cancer Hospital.
It is a project designed to evaluate the unique pH-dependent antigen-binding properties of the PD-L1 antibody MSB2311.
Phase I study in patients with advanced solid tumors and hematological malignancies in China
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The main goal of the study is to evaluate the safety and tolerability of the drug, determine the maximum tolerated dose (MTD) and the recommended dose for the phase II study (RP2D)
The study is divided into a dose escalation phase and a dose expansion phase
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In the dose escalation phase, the dose levels of MSB2311 were set to 3mg/kg, 10mg/kg and 20mg/kg, intravenously every 3 weeks
As of August 31, 2020, 33 Chinese patients have been treated, including 27 patients with solid tumors who have undergone multi-line treatment and 6 patients with lymphoma
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No dose-limiting toxicity was observed, and the maximum tolerated dose (MTD) was not reached
Among the 17 solid tumor patients with biomarker expression and evaluable efficacy, 6 patients achieved confirmed partial remission (PR), with an objective remission rate (ORR) of 35%; among them, 4 patients in the 20mg/kg Q3W dose group In the case of PR patients, the ORR reached 44% (4/9); in addition, there were 2 PR patients in the 10 mg/kg Q2W dose group, and the ORR was 25% (2/8)
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In addition, according to iRECIST, 1 patient had iPR
The lead investigator of this research, Professor Lin Shen, deputy dean of Peking University Cancer Hospital, said: "In recent years, tumor immunotherapy has gradually become a research hotspot in the field of tumor treatment, and it has played a huge role in the comprehensive treatment of tumors.
We have also been Efforts have been made in this area
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Most of the patients enrolled in this study are patients with metastatic solid tumors or selected lymphomas who have failed previous treatments.
Dr.
Ming Shi, Executive Vice President and Chief Medical Officer of Global R&D of Chuangsheng Group, said: “MSB2311 has shown controllable safety and expected anti-tumor activity in patients with advanced solid tumors and lymphomas.
It is great to see Our self-developed drugs can benefit patients, and we will continue to move forward and insist on benefiting patients around the world with differentiated and affordable biological drugs
.
"
