BUSINESS WIRE<\/a>)–
\nArcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer, today announced new monotherapy data for casdatifan, a HIF-2a inhibitor with best-in-class potential, in late-line metastatic clear cell renal cell carcinoma (ccRCC). At an investor event hosted later today, 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.<\/p>\nNew Casdatifan Data<\/b><\/p>\n
\n\u201cIn the 100mg tablet cohort, our Phase 3 dose and formulation, casdatifan showed a 35% confirmed ORR, with two additional responses pending confirmation, and mPFS had not been reached, even with a median follow-up of one year,\u201d said Richard Markus, M.D., Ph.D., chief medical officer at Arcus Biosciences. \u201cEven when we analyzed pooled data for the 121 patients treated with casdatifan monotherapy, casdatifan showed a confirmed ORR of 31% and a median PFS of 12.2 months, which is meaningfully longer than published data from studies with the only marketed HIF-2a inhibitor and for TKIs alone in a similar patient population and setting.\u201d<\/p>\n
\nARC-20 is a Phase 1\/1b dose-escalation and expansion study with four monotherapy cohorts (n=121): 50mg twice daily (BID), 50mg once daily (QD), 100mg QD (tablet) 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 (TKI). The patient population was heavily pretreated; in the pooled analysis, more than half (55%) of patients received at least three prior lines of therapy, and more than one quarter (29%) had received at least four prior lines of therapy. Most patients (71%) had an International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk factor of intermediate or poor.<\/p>\n
\nAt the time of data cut-off (DCO, August 15, 2025), most patients (81%) had experienced disease control, with either a partial response or stable disease. Seventy-four percent (28 of the 38) of confirmed responders across all four cohorts remained on treatment.<\/p>\n
\nNo 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 (3%) discontinued due to hypoxia. Summaries of the efficacy and safety data are below.<\/p>\n