By these two functions, you are able to activate the immune system against the tumor. That is the idea behind this molecule. Responses were confirmed by repeat assessment after 6 weeks of follow-up. We previously treated patients with stage IV non—small-cell lung cancer with at least one platinum-based chemotherapy, and the design for this cohort was a randomized design. The main endpoints were to see the activity at these two different doses in non—small-cell lung cancer, [and] to describe the toxicity profile of the drug in this patient setting. Patients received M at a dose of 0. The duration of objective response was defined as the time from the initial response to the time of disease progression or death. The primary objective is to determine the safety and maximum tolerated dose MTD ; secondary objectives include pharmacokinetics, immunogenicity, and best overall response.
One peculiar effect was skin lesions. E Primary tumor growth curves left panel and tumor volumes of individual animals right panel, inset: Data represent 3 independent experiments. Tumor volumes were measured and survival was tracked. First, can you describe M, the agent that was tested in this phase I trial? Clinical activity On-treatment patients underwent tumor assessment scans or physical examination with photography every 6 weeks unless clinical symptoms warranted earlier imaging or until confirmed disease progression. Bifunctional antibodies represent an emerging and exciting new therapeutic strategy, whereby two molecular targets are simultaneously inhibited by a single agent containing two distinct functional domains. Researchers believe the effectiveness of treatments targeting PD-L1 — a protein used by cancer cells to evade immune attack when bound to PD-1 in T-cells — could be improved with the simultaneous inhibition of the TGF-beta pathway. See all images 6 Free text Figure 1. So, those could be the two settings where the priorities are for [patients with] non—small-cell lung cancer. As of the data analysis cutoff on Oct. For safety and efficacy analyses, all patients who received M were included. Patients with a history of autoimmune disease were ineligible, except for those with type 1 diabetes mellitus, vitiligo, alopecia, psoriasis, or hypothyroid or hyperthyroid disease not requiring immunosuppressive treatment. B Survival curves inset: One grade 5 event total 5 doses received was considered possibly treatment related, but suspected rupture of preexisting thoracic aortic aneurysm was cited as other probable cause by the investigator. No treatment-related grade 4 AEs occurred. These preliminary data show that M resulted in a manageable safety profile in heavily pretreated Asian patients with gastric cancer. The study was conducted in accordance with all applicable regulatory requirements, and the protocol was approved by the Institutional Review Board of the Center for Cancer Research at the National Cancer Institute. In synthesis, the overall response rate was Stable disease SD was defined as a change in the sum of target and new lesions not meeting the above definitions for CR, PR, or progressive disease. This strategy aims to boost the anti-cancer activity of the immune system by targeting the two immunosuppressive pathways and controlling tumor growth. You presented results of an expansion cohort part of a phase I trial. Outcomes The primary objective of this study was to determine the safety, tolerability, and maximum tolerated dose MTD of M; secondary objectives included pharmacokinetics, immunogenicity, and best overall response. This is an ongoing study; updated data will be presented. Twenty-four hours after the last treatment, intratumoral analysis of surface PD-L1 expression left and presence of biologic agents Mmut or M right on CD45 negative cells was performed by flow cytometry.
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