Arcus Biosciences announces new data for casdatifan

Arcus Biosciences (RCUS) announced new monotherapy data for casdatifan, a HIF-2a inhibitor with in late-line metastatic clear cell renal cell carcinoma. At an investor event hosted later, the company will share more detail on these data and preview the expansion of its research efforts into autoimmune and inflammatory diseases. Featured presenters will include members of the Arcus management team and key opinion leaders with expertise in HIF-2a biology and treatment of ccRCC. ARC-20 is a Phase 1/1b dose-escalation and expansion study with four monotherapy cohorts: 50mg twice daily, 50mg once daily, 100mg QD and 150mg QD, all of which evaluated casdatifan in patients with metastatic ccRCC, most of whom had progressed on at least two prior lines of therapy, including both an anti-PD-1 and a VEGFR tyrosine kinase inhibitor. The patient population was heavily pretreated; in the pooled analysis, more than half of patients received at least three prior lines of therapy, and more than one quarter had received at least four prior lines of therapy. Most patients had an International Metastatic Renal Cell Carcinoma Database Consortium risk factor of intermediate or poor. At the time of data cut-off, most patients had experienced disease control, with either a partial response or stable disease. Seventy-four percent of confirmed responders across all four cohorts remained on treatment. No unexpected safety signals were observed at the time of DCO, and casdatifan had an acceptable and manageable safety profile across all doses. Across all four cohorts, one patient discontinued treatment due to anemia, and four patients discontinued due to hypoxia. Summaries of the efficacy and safety data are below.