The Phase 1 HAMMER study introduced a new method that combines MoA biomarkers, response, and toxicity to set the best Phase 2 dose for SAR’245. Early oncology studies used joint modeling with non-invasive biomarkers and safety data to guide dose-response and RP2D choices. This advanced model influenced clinical designs, and ongoing studies continue […]...
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Background Immune-related adverse events (irAEs) are major barriers of clinical management and further development of immune checkpoint inhibitors (ICIs) for cancer therapy. Therefore, biomarkers associated with the onset of severe irAEs are needed. In this study, …
Background Adoptive cell transfer (ACT) shows promise as an immunotherapy for melanoma and other cancers. However, there are several challenges associated with ACT such as the logistical complexity and inconsistency when using patient-derived antigen-presenting cells for …
Background Immune checkpoint inhibitors (ICIs) are standard therapy for advanced hepatocellular carcinoma (HCC). However, the efficacy of combining nivolumab and ipilimumab in Anti-PD(L)-1 Naïve and Experienced HCC patients remains unclear. Methods We retrospectively reviewed 23 patients with advanced …
Background Novel early-line therapies for advanced (unresectable or metastatic) melanoma are needed to improve the rate of deep and durable responses and increase the proportion of patients with long-term benefit. TILVANCE-301 will evaluate the efficacy and …
