On October 9, 2024 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer, reported four accepted abstracts at the 2024 EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics being held October 23-25, 2024, in Barcelona, Spain (Press release, Arcus Biosciences, OCT 9, 2024, View Source [SID1234647121]). The data being presented include a growing body of evidence supporting the potential of casdatifan as a best-in-class HIF-2a inhibitor for the treatment of ccRCC.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The oral presentation will highlight data from the approximately 30 patients in the 100mg daily monotherapy expansion cohort of ARC-20, a Phase 1/1b study evaluating casdatifan in late-line ccRCC. It will include data on safety and efficacy, including objective response rate and rate of primary progression, as well as other data to assess the depth and duration of responses. The presentation will also highlight data from the 50mg monotherapy expansion cohort of approximately 30 patients in the same setting.

"We are thrilled to be presenting the first clinical efficacy data from the ARC-20 study for our HIF-2a inhibitor, casdatifan, in an oral plenary session, as well as two additional posters that further highlight the differentiation of casdatifan in ccRCC and the therapeutic opportunities in other tumor types," said Terry Rosen, Ph.D., chief executive officer of Arcus. "These data support a potential best-in-class profile, and we are rapidly advancing a differentiated development program for casdatifan, including the planned initiation of our first Phase 3 study in the first half of 2025."

Arcus is pursuing a broad development program in both the first-line and post-anti-PD-1 settings with differentiated combinations to maximize the opportunity for casdatifan in ccRCC. In addition to the monotherapy cohorts of ARC-20, the study is also enrolling a cohort to evaluate casdatifan in combination with cabozantinib, a VEGFR tyrosine kinase inhibitor, which is intended to support the initiation of Arcus’s first Phase 3 study, PEAK-1, evaluating casdatifan in combination with cabozantinib versus cabozantinib monotherapy in patients with metastatic ccRCC who have previously received anti-PD-1 therapy. The primary endpoint will be progression-free survival with a key secondary endpoint of overall survival. Arcus also recently announced a clinical collaboration as part of its first-line strategy in advanced first-line ccRCC to evaluate casdatifan in combination with volrustomig, an investigational PD-1/CTLA-4 bispecific antibody.

Investors may dial in to the conference call at +1 (404) 975-4839 (local) or +1 (833) 470-1428 (toll-free), using Conference ID: 595409 on Thursday, October 24, 2024, at 5:00 AM PT / 8:00 AM ET. 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.

Four Accepted Abstracts Will Be Presented

Study

Title

Abstract Number

Session Type & Title

Session Date & Time

Casdatifan (HIF-2a Inhibitor)

ARC-20

Casdatifan in Patients (pts) with Previously Treated Clear Cell Renal Cell Cancer (ccRCC) and Other Solid Tumors; Preliminary Results From ARC-20: A Phase 1, Open-Label Dose Escalation and Expansion Study

4

Proffered Papers: Advancing patient care through novel clinical trials – Oral Plenary Session 3

10/24/2024, 10:54 AM – 11:06 AM CEST

AB521 (Casdatifan) Potently and Selectively Inhibits Hypoxia-Inducible Factor 2 Alpha (HIF-2α) Dependent Pro-Tumorigenic Activity

91

Molecular Targeted Agents

10/23/2024, 12:00 PM – 7:00 PM CEST

ARC-20

Clinical Pharmacokinetic/Pharmacodynamic (PK/PD) Relationship for Casdatifan (AB521), a Small Molecule Inhibitor of HIF-2α, Confirms Best-in-class Potential in Treatment of Renal Cell Carcinoma

51

Molecular Targeted Agents

10/23/2024, 12:00 PM – 7:00 PM CEST

AB801 (AXL Inhibitor)

ARC-26

AB801, a Potent and Highly Selective Clinical Stage AXL Inhibitor, Sensitizes Tumors to Standard of Care Therapies

119

New Drugs

10/23/2024, 12:00 PM – 7:00 PM CEST