On February 10, 2025 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for patients with cancer, reported that data from the ARC-20 study will be presented in a rapid oral session at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary (GU) Cancers Symposium taking place February 13 – 15, 2025, in San Francisco, CA (Press release, Arcus Biosciences, FEB 10, 2025, View Source [SID1234650148]).

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The oral presentation will highlight safety and efficacy data from three cohorts of ARC-20, which evaluated casdatifan monotherapy in patients that had received both prior TKI and anti-PD-1 therapy. The presentation will include initial data for the 100mg QD tablet cohort, our selected dose and formulation for Arcus’s Phase 3 studies, as well as updated data for the 50mg BID and 50mg QD expansion cohorts of ARC-20.

"We look forward to presenting new data from our ARC-20 study evaluating our HIF-2a inhibitor, casdatifan, in an oral presentation at ASCO (Free ASCO Whitepaper) GU," said Terry Rosen, Ph.D., chief executive officer of Arcus. "The data to be shared support the differentiation of casdatifan, across all key efficacy measures, relative to published data from studies with HIF-2a inhibitors. We are continuing to rapidly advance an extensive and robust development program for casdatifan, including the planned initiation of our first Phase 3 study (PEAK-1) in the first half of this year, a clinical collaboration with AstraZeneca to evaluate casdatifan in combination with volrustomig and the addition of new cohorts to ARC-20 to evaluate casdatifan in the first-line setting. We also look forward to presenting additional data from ARC-20 throughout the year."

Study

Title

Abstract
Number

Session Type &
Title

Session Date
& Time

Casdatifan (HIF-2a Inhibitor)

ARC-20

Casdatifan (Cas) Monotherapy in Patients (pts) with Previously Treated Clear Cell Renal Cell Carcinoma (ccRCC): Safety, Efficacy and Subgroup Analysis Across Multiple Doses from ARC-20, a Phase 1 Open-Label Study

441

Rapid Oral Abstract Session C: Renal Cell Cancer and Penile Cancer

2/15/2025
12:45 PM –
12:50 PM PT

Investors may dial in to the conference call at +1 404 975 4839 (local) or +1 833 470 1428 (toll-free) using Conference ID: 331780 on Tuesday, February 18, 2025, at 5:00 AM PT / 8:00 AM ET. Participants may also register for the call online using the following link: View Source To access the live webcast and accompanying slide presentation, please visit the "Investors & Media" section of the Arcus Biosciences website at www.arcusbio.com. A replay will be available following the live event.

About Casdatifan (AB521)

Casdatifan is a small-molecule inhibitor of HIF-2a, a transcription factor responsible for activating multiple tumor growth pathways in hypoxic and pseudo-hypoxic tumor environments. By selectively binding HIF-2a, casdatifan is designed to shut down hypoxic oncogenesis, which blocks tumor growth and key oncogenic pathways, leading to cancer cell death. Clear cell RCC (ccRCC) is almost universally associated with HIF-2a dysregulation. Casdatifan is currently being evaluated in ARC-20, a Phase 1/1b study in renal cell carcinoma and other cancers.

Casdatifan is an investigational molecule. Approval from any regulatory authority for its use has not been received, and its safety and efficacy have not been established.

About RCC

According to the American Cancer Society, kidney cancer is among the top 10 most commonly diagnosed forms of cancer among both men and women in the U.S., and an estimated 81,600 Americans will be diagnosed with kidney cancer in 2024. Clear cell RCC is the most common type of kidney cancer in adults. If detected in its early stages, the five-year survival rate for RCC is high; for patients with advanced or late-stage metastatic RCC, however, the five-year survival rate is only 15%. In 2022, approximately 32,200 patients with advanced kidney cancer required systemic therapy in the U.S., with over 20,000 patients receiving first-line treatment.