Daina Graybosch

Yigal Nochomovitz

Jonathan Miller

Peter Lawson

Asthika Goonewardene

Eva Fortea-Verdejo

Jason Zemansky

Li Wang Watsek

Salveen Richter

Emily Bodnar

Karina Rabayeva

Kaveri Pohlman

Li Watsek

Terence Flynn

Umer Raffat

- Arcus Biosciences announced that the anti-TIGIT domvanalimab plus anti-PD-1 zimberelimab and chemotherapy regimen showed a **median overall survival (OS) of 26.7 months** as a first-line treatment for unresectable or advanced gastroesophageal adenocarcinomas in Arm A1 of the Phase 2 EDGE-Gastric study.  **[1724521_f2c6b53e13844695a6cdc3257b4fb69b_0]** 
- **50% of the patients** enrolled in Arm A1 of the EDGE-Gastric study went on to live for **more than two years**.  **[1724521_f2c6b53e13844695a6cdc3257b4fb69b_0]** 
- The regimen demonstrated **sustained efficacy** with a median time on treatment of **49 weeks** and a safety profile consistent with anti-PD-1 plus chemotherapy, with no unexpected safety signals observed.  **[1724521_f2c6b53e13844695a6cdc3257b4fb69b_1]** 
- These results support the ongoing development of domvanalimab plus zimberelimab and chemotherapy in the **Phase 3 STAR-221 study** in the same patient population.  **[1724521_f2c6b53e13844695a6cdc3257b4fb69b_0]**

Arcus Biosciences Announces Positive Phase 2 EDGE-Gastric Study Results

- Arcus Biosciences presented castadafen as a **best-in-class HIF2α inhibitor**, demonstrating superior efficacy compared to belzutifan with a comparable safety profile.  **[1724521_2169322_4]** **[1724521_2169322_6]** **[1724521_2169322_10]**  The pooled data set of 121 patients from the ARC-20 study showed a median Progression-Free Survival (PFS) of **12.2 months** with a median follow-up of **15.2 months**, and a confirmed Objective Response Rate (ORR) of **35%** for the 100 mg tablet.  **[1724521_2169322_5]** **[1724521_2169322_9]** 
- The company is pursuing a multi-billion dollar market opportunity in Renal Cell Carcinoma (RCC) with castadafen, projecting to capture well over **50% share** of the HIF2α inhibitor market.  **[1724521_2169322_31]** **[1724521_2169322_35]**  The RCC market is currently nearly **$10 billion** in major markets and is expected to grow to **$13 billion** in a few years.  **[1724521_2169322_33]** 
- Arcus Biosciences has a robust clinical development plan, with ongoing Phase 3 trials including **PEAK-1** (castadafen plus cabozantinib in IO-experienced RCC) and **Evolve** (frontline clear cell RCC with AstraZeneca).  **[1724521_2169322_2]** **[1724521_2169322_3]** **[1724521_2169322_13]** 
- The company is well-funded with over **$900 million**, which is expected to support initial readouts from late-stage programs and drive value inflections.  **[1724521_2169322_2]**  Investment in other programs like domvanalimab and zimberelimab is expected to decrease by approximately **50%** next year, with the majority of clinical investment shifting to castadafen.  **[1724521_2169322_3]**

Arcus Biosciences Highlights Castadafen as Best-in-Class HIF2α Inhibitor with Multi-Billion Dollar Market Potential

- Arcus Biosciences presented new monotherapy data for its HIF-2a inhibitor **casdatifan** in late-line metastatic kidney cancer, demonstrating better efficacy measures compared to the only marketed HIF-2a inhibitor.  **[1724521_7745601b4465468da8a7a97758b7ef0c_0]** 
- In the **100mg QD cohort (Phase 3 dose)**, casdatifan achieved a **35% confirmed overall response rate (ORR)**, with median progression-free survival (mPFS) not yet reached after a median follow-up of one year.  **[1724521_7745601b4465468da8a7a97758b7ef0c_0]** **[1724521_7745601b4465468da8a7a97758b7ef0c_2]** 
- A pooled analysis of **121 patients** across all four monotherapy cohorts showed a **confirmed ORR of 31%** and a **median PFS of 12.2 months**, with an **18-month landmark PFS of 43%**.  **[1724521_7745601b4465468da8a7a97758b7ef0c_0]** **[1724521_7745601b4465468da8a7a97758b7ef0c_2]** 
- The company also disclosed the expansion of its research into **five new autoimmune and inflammatory disease programs**, with the first clinical study anticipated to begin in **2026**.  **[1724521_7745601b4465468da8a7a97758b7ef0c_0]** **[1724521_7745601b4465468da8a7a97758b7ef0c_3]** 
- Arcus Biosciences retains full rights to casdatifan as Gilead's option rights to the drug have expired.  **[1724521_7745601b4465468da8a7a97758b7ef0c_5]**

Arcus Biosciences Presents New Casdatifan Data and Discloses New Inflammation Programs

- Arcus Biosciences is in a **transformational period** with **four molecules** in late-stage (Phase 3) programs, including **Casdatafan**, **DomZim**, and **Quemly**, targeting major markets.  **[1724521_tx_377881_1]** **[1724521_tx_377881_2]** 
- For **Casdatafan**, an investor event is scheduled for **October 6** to share updated monotherapy data, including the first look at **progression-free survival (PFS)** data.  **[1724521_tx_377881_1]**  The company has initiated two Phase 3 studies: Peak One (Casdatafan plus cabo) and a collaboration with AstraZeneca (Casdatafan plus Volru), with Peak One expected to enroll in less than **18 months**.  **[1724521_tx_377881_1]** **[1724521_tx_377881_5]** 
- The Phase 3 study for **DomZim** (Start 221 in upper GI cancers) is expected to read out in **2026**  **[1724521_tx_377881_1]** , having been fully enrolled in **June 2024**.  **[1724521_tx_377881_10]**  Data from its Phase 2 correlate, Edge Gastric, including **overall survival (OS)**, will be presented at ESMO.  **[1724521_tx_377881_1]** 
- The Phase 3 study for **Quemly** in pancreatic cancer is fully enrolled as of **September 2025**, having completed enrollment in approximately **nine months**, significantly ahead of schedule, with a readout anticipated in the next **12 to 18 months**.  **[1724521_tx_377881_1]** **[1724521_tx_377881_11]**

Arcus Biosciences Provides Updates on Late-Stage Clinical Programs and Upcoming Data Readouts

Arcus Biosciences (RCUS)