Arcus Biosciences (RCUS) used the 12th Annual Cantor Fitzgerald Global Healthcare Conference on September 10 to present updated clinical data and commercial projections for its lead oncology asset, casdatifan, an HIF-2α inhibitor being developed for metastatic clear-cell renal cell carcinoma.
CFO Bob stated the company views casdatifan as having potential for broad utilization across every line of treatment for the disease. The commercial opportunity in second-line metastatic RCC is estimated at $1.5 billion to $2 billion, while the frontline opportunity exceeds $4 billion, he said.
In late-line monotherapy, casdatifan showed a median progression-free survival of 12 to 15 months against a median follow-up of 28 months. That compares with a 5.6-month PFS benchmark from Merck's belzutifan LITESPARK-005 study, which reported an overall survival of 21.4 months. "We're cautiously optimistic on the OS front for casdatifan there," Bob said.
On potency, he noted: "We believe we're hitting the target essentially five times harder. With belzutifan, you see a loss of pharmacodynamic effect relatively quickly."
In second-line combination therapy, casdatifan paired with cabozantinib showed a median follow-up of 20 months. Data were compared against Merck's LITESPARK-011 program evaluating belzutifan plus lenvatinib versus cabozantinib, which carried a hazard ratio of 0.7 and a non-significant overall survival hazard ratio of 0.85.
For frontline doublet therapy, casdatifan combined with an anti-PD-1 agent showed a 7% primary progression rate at a median follow-up of 11 months, versus 18% for the CheckMate 214 ipilimumab-nivolumab regimen. CheckMate 214's median PFS was 12 months; KEYNOTE-427 anti-PD-1 monotherapy reported a median PFS of 7 months.
A frontline triplet regimen of casdatifan plus ipilimumab and nivolumab has been studied in about 20 patients with 12 weeks of follow-up, or four cycles of ipilimumab.
Arcus also outlined upcoming milestones: an October 20 data event in New York is expected to feature datasets covering late-line monotherapy, second-line combination therapy, and frontline regimens. A CD73 inhibitor in frontline pancreatic cancer is expected to report interim analysis in the fourth quarter of 2024, and the ARC-20 frontline triplet Phase III trial is anticipated to initiate by end of 2024, with a second frontline Phase III trial potentially beginning in 2025.
Casdatifan accounts for approximately 80% of Arcus's portfolio spending. The company holds a market capitalization of roughly $3.5 billion. Shares delivered a 143% return over the prior year but pulled back 5.4% in the week ahead of the conference, trading at $29.66.
Analysts maintain a consensus Buy rating on RCUS with price targets ranging from $23 to $47.
