A Phase Ib/III Randomized, Multicenter, Global Study of Volrustomig Plus Casdatifan or Volrustomig Monotherapy Versus Nivolumab Plus Ipilimumab as First-line Treatment for Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)

This is a Phase Ib/III, randomized, multicenter, global study evaluating the efficacy and safety of volrustomig in combination with casdatifan for the first-line (1L) treatment of participants with advanced clear cell renal cell carcinoma (ccRCC).
The Phase III part of the study will no longer be conducted.

Start Date28 Jul 2025

Sponsor / Collaborator

AstraZeneca PLC

[+1]

NCT06943833

/ Active, not recruitingPhase 2

A Phase II Single-arm Multi-centre Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer Who Have Not Progressed Following Platinum Based, Concurrent Chemoradiation Therapy

This is a phase II single-arm open-label study to investigate the efficacy and safety of volrustomig in women with FIGO 2018 stage IIIA to IVA cervical cancer who have not progressed following platinum-based concurrent chemoradiation therapy (CCRT).

Start Date31 Mar 2025

Sponsor / Collaborator

AstraZeneca PLC

100 Clinical Results associated with Volrustomig

100 Translational Medicine associated with Volrustomig

100 Patents (Medical) associated with Volrustomig

Literatures (Medical) associated with Volrustomig

01 Dec 2025·Cancer Medicine

The Landscape of Bispecific Antibodies in Solid Tumor Oncology: Trends, Challenges, and Opportunities

Article

Author: Mark Gramling ; Judith Pérez-Granado ; Aakash Desai ; Rafik ElBeblawy ; Chinmay Jani

ABSTRACT:

Background:

Bispecific Antibodies (BsAbs) represent a novel class of immunoglobulins that can target and bind to two distinct antigens simultaneously. The global BsAbs market, valued at approximately USD 8.65 billion in 2023, reflects tremendous promise and substantial growth. Here, we present a comprehensive analysis of the current BsAbs research pipeline in solid tumors.

Methods:

Data were extracted from LARVOL CLIN, an outcomes database storing over 130,000 trials, to analyze the number of BsAbs including the number of trials per company, the timeline of trial initiation, phases, specific molecules, targets, and associated biomarkers. LARVOL CLIN leverages regular expression‐based text mining to extract data from major trial registries, including ClinicalTrials.gov , EudraCT, the Australian registry ANZCTR and the Asian Registries ChiCTR and UMIN.

Results:

Our analysis identified 681 registered clinical trials in ClinicalTrials.gov , a number that has doubled since 2019, each with a known target and phase, evaluating a total of 183 BsAbs. Solid tumors, particularly gastrointestinal, lung, gynecological and breast cancer, have emerged as primary focuses. A significant trend is the strong focus on immune checkpoint bispecific targets, particularly PD1‐CTLA4 ( n = 216 trials, 31.7%, 4 BsAbs), PD1‐VEGF ( n = 56 trials, 8.2%, 3 BsAbs), followed by oncogene targets like EGFR‐MET ( n = 34 trials, 5%, 3 BsAbs). The distribution of clinical molecules also reflects such focus, with dual PD1‐CTLA4 inhibitors (Cadonilimab, Volrustomig, Danviostomig) leading the highest number of trials ( n = 208, 30.5%). Other promising molecules include Ivonescimab ( n = 51, 7.5%), targeting PD1‐VEGF, and Amivantamab‐vmjw ( n = 29, 4.3%), targeting EGFR‐MET. Clinical trials investigating PD1‐CTLA4 BsAbs showed improved overall survival (OS) and progression‐free survival (PFS) with tolerable adverse effects when combined with standard chemotherapy. Only 38% of trials, n = 258, specified a biomarker inclusion. Among oncogene‐targeted BsAbs, EGFR is the most prevalent ( n = 80, 31%), followed by HER2 ( n = 77, 29.8%), and ALK ( n = 41, 15.8%). Gene‐specific alterations were also represented; HER2 ‐positive alterations garnered the most attention in n = 35 trials. BsAbs development is primarily driven by biotechnology companies (Akesobio, Alphamab, Biokin Pharma, etc.) compared to large pharmaceutical companies (J&J, AstraZeneca, and Boehringer Ingelheim). Geographically, the United States, China and the European Union have the highest number of trials available.

Conclusion:

Since the first BsAb approval in 2014, the field has rapidly expanded, with solid tumor oncology advancing dynamically. The major focus has been on combining BsAbs with immunotherapy strategies, followed by targeting known oncogenic pathways. The shift toward biotechnology‐led innovation underscores the growing therapeutic and financial interest in this field. Optimizing the efficacy and safety of these molecules is key to paving the way for the next era of immune and precision oncology.

02 Jun 2022·Cancer discoveryQ1 · MEDICINE

MEDI5752 Suppresses Two Immune Checkpoints

Q1 · MEDICINE

Article

Abstract:

Preliminary data from a phase I trial of MEDI5752, a bispecific antibody targeting both PD-1 and CTLA4, indicate the drug is well tolerated and active, with durable responses seen across diverse tumor types.

01 May 2021·Cancer discoveryQ1 · MEDICINE

Bispecific Antibodies to PD-1 and CTLA4: Doubling Down on T Cells to Decouple Efficacy from Toxicity

Q1 · MEDICINE

Article

Author: Tawbi, Hussein A. ; Burton, Elizabeth M.

Abstract:

Summary::

Although combination anti–PD-1 and anti-CTLA4 mAbs have revolutionized outcomes for many cancers, their utility has been limited due to significant immune-related toxicities and the emergence of resistance. In this issue of Cancer Discovery, Dovedi and colleagues describe the development and preclinical testing of MEDI5752, a bispecific anti–PD-1/CTLA4 antibody designed to optimize therapeutic response by maximizing CTLA4 blockade on antigen-experienced T cells, thereby increasing efficacy and potentially minimizing toxicity.See related article by Dovedi et al., p. 1100.

News (Medical) associated with Volrustomig

22 May 2026

·www.biospace.com

AstraZeneca to showcase Phase III data in liver, breast and bladder cancers and potential first-in-class rare disease therapy at ASCO 2026

EMERALD-3 late-breaking presentation will showcase benefit of IMFINZI ® (durvalumab) and IMJUDO ® (tremelimumab-actl) in early liver cancer Phase III data from SERENA-6, DESTINY-Breast09 and TROPION-Breast02 span all three major subtypes of metastatic breast cancer CARES Phase III results will demonstrate highly clinically meaningful benefit of anti-fibril therapy, anselamimab, for kappa light chain amyloidosis WILMINGTON, Del.--(BUSINESS WIRE)--AstraZeneca advances its ambition to eliminate cancer as a cause of death and transform outcomes for people living with rare diseases with new data across its diverse, industry-leading portfolio and pipeline at the American Society of Clinical Oncology (ASCO) Annual Meeting, May 29 to June 2, 2026. More than 85 abstracts will feature 10 approved and 13 potential new medicines from the Company, including 25 oral presentations. Highlights include: EMERALD-3: Phase III trial of IMFINZI ® (durvalumab) in combination with IMJUDO ® (tremelimumab-actl), with or without lenvatinib, and transarterial chemoembolization (TACE) in patients with unresectable hepatocellular carcinoma (HCC) eligible for embolization (Oral Abstract #LBA4000). CARES: Phase III clinical program of anselamimab, a potential first-in-class anti-fibril therapy from Alexion, AstraZeneca Rare Disease, in newly diagnosed patients with light chain (AL) amyloidosis receiving standard of care for underlying plasma cell dyscrasia, including results from a prespecified subgroup analysis based on involved kappa (κ) or lambda (λ) free light chain (Oral Abstract #7501). SERENA-6: Final progression-free survival 2 (PFS2) results and circulating tumor DNA (ctDNA) clearance data linked to longer-term efficacy outcomes from the SERENA-6 Phase III trial of camizestrant in combination with widely approved cyclin-dependent kinase (CDK) 4/6 inhibitors in the 1st-line treatment of patients with hormone receptor (HR)-positive, HER2-negative advanced breast cancer whose tumors have an emergent ESR1 mutation (Oral Abstract #LBA1007). BLUESTAR: Updated safety and efficacy results from the BLUESTAR Ph I/IIa trial of the B7-H4-directed ADC puxitatug samrotecan (Puxi-Sam) in patients with relapsed/metastatic B7-H4-positive endometrial and ovarian cancer who progressed on prior standard-of-care therapy (Rapid Oral Abstract #5515). Puxi-Sam was recently granted Breakthrough Therapy Designation by the US Food and Drug Administration (FDA) in this setting. PRIMAVERA: Safety and preliminary efficacy from the first-in-human Phase I PRIMAVERA trial of the protein arginine methyltransferase 5 (PRMT5) inhibitor AZD3470 as monotherapy in relapsed/refractory classic Hodgkin lymphoma (Oral Abstract #7003). Phase I initial results for NT-175 T-cell receptor therapy in TP53 R175H-mutated unresectable, advanced and/or metastatic solid tumors including pancreatic adenocarcinoma (Oral Abstract #2506). TROPION-Breast02: Additional efficacy endpoints from the TROPION-Breast02 Phase III trial of DATROWAY ® (datopotamab deruxtecan-dlnk) as 1st-line treatment for patients with locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitors (Oral Abstract #1002). DESTINY-Breast09: Exploratory analysis of treatment duration and clinical outcomes by complete response, partial response or stable/progressive disease in the DESTINY-Breast09 Phase III trial of ENHERTU ® (fam-trastuzumab deruxtecan-nxki) in combination with pertuzumab for the 1st-line treatment of patients with HER2-positive metastatic breast cancer (Rapid Oral Abstract #1021). POTOMAC: Five-year overall survival and patient-reported outcomes from the Phase III POTOMAC trial of IMFINZI plus Bacillus Calmette-Guérin (BCG) induction and maintenance therapy in patients with high-risk non-muscle-invasive bladder cancer (Rapid Oral Abstract #4624). Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “The data at ASCO for our innovative medicines and next-wave assets further our strategy to redefine patient outcomes by taking novel combinations into earlier stages of disease and advancing new modalities. New data for ENHERTU, DATROWAY and camizestrant reinforce their transformational potential in breast cancer. We’re also excited to share first clinical data for our T-cell receptor therapy, NT-175, and our PRMT5 inhibitor, AZD3470, as well as updated data for our most advanced in-house antibody drug conjugate, Puxi-Sam, which was recently granted Breakthrough Therapy Designation by the FDA. Collectively, these datasets underscore the strength and depth of our oncology pipeline.” Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: “The EMERALD-3 data for IMFINZI and IMJUDO in early liver cancer exemplify our successful strategy to move immunotherapy regimens into earlier stages of cancer where we can further improve outcomes for patients. With more than a dozen different indications approved across five cancer medicines in the last six months alone, we are reaching more patients with our growing portfolio, underscoring both the quality of our innovation and the strength of our business.” Gianluca Pirozzi, Head of Development, Regulatory and Safety, Alexion, said: "Results from the CARES Phase III clinical program highlight the pioneering potential of anselamimab as a first-in-class, anti-fibril therapy for patients with kappa light chain amyloidosis. Its novel mechanism of action is designed to target and deplete amyloid deposits in affected organs, with potential to extend survival and reduce cardiovascular hospitalizations." AstraZeneca is collaborating with Daiichi Sankyo to develop and commercialize ENHERTU and DATROWAY. Key AstraZeneca presentations during ASCO 2026 1 Lead Author Abstract Title Presentation details (CDT) Antibody drug conjugates Loi, S Trastuzumab deruxtecan (T-DXd) + durvalumab (D) in patients (pts) with previously untreated HER2+ unresectable/metastatic breast cancer (mBC): Final analysis from DESTINY-Breast07. Abstract #1012 Clinical Science Symposium May 31, 2026 9:18am Cescon, DW First-line datopotamab deruxtecan (Dato-DXd) vs chemotherapy in patients with locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC) for whom immunotherapy was not an option: Additional efficacy endpoints from the TROPION-Breast02 study. Abstract #1002 Oral Abstract Session June 2, 2026 10:09am Mileshkin, LR Updated safety and efficacy of puxitatug samrotecan (Puxi-Sam, AZD8205) in patients (pts) with endometrial cancer (EC) or ovarian cancer (OC): Phase 1/2a BLUESTAR study. Abstract #5515 Rapid Oral Abstract Session May 30, 2026 9:00am Park, YH A DESTINY-Breast09 analysis of treatment duration and clinical outcomes by best response to trastuzumab deruxtecan (T-DXd) + pertuzumab (P). Abstract #1021 Rapid Oral Abstract Session May 31, 2026 12:42pm Untch, M Secondary safety analysis of trastuzumab deruxtecan (T-DXd) vs trastuzumab emtansine (T-DM1) in DESTINY-Breast05: Clinical and demographic risk factors of interstitial lung disease (ILD) and radiation pneumonitis (RP). Abstract #516 Rapid Oral Abstract Session June 1, 2026 10:57am Shitara, K Sonesitatug vedotin (Sone-Ve) monotherapy in patients (pts) with claudin 18.2–positive (CLDN18.2+) advanced or metastatic gastric or gastroesophageal junction (GEJ) cancers: Data from CLARITY-PanTumor01. Abstract #4023 Poster Session May 30, 2026 9:00am Janjigian, Y First-line (1L) trastuzumab deruxtecan (T-DXd)–based regimens in advanced HER2-expressing gastric cancer (GC), gastroesophageal junction adenocarcinoma (GEJA), or esophageal adenocarcinoma (EA): Safety results from DESTINY-Gastric03 (DG-03) Part 2 arms D and F, and Part 4. Abstract #4022 Poster Session May 30, 2026 9:00am Zhang, Y Trastuzumab deruxtecan (T-DXd) for pretreated patients in China with HER2 IHC 3+ solid tumors: DESTINY-PanTumor03 Part 1 primary analysis. Abstract #3026 Poster Session May 30, 2026 1:30pm Immuno-oncology Abou-Alfa, GK Efficacy and safety results from EMERALD-3: A phase 3, randomized study of tremelimumab plus durvalumab with or without lenvatinib combined with transarterial chemoembolization (TACE) in participants (pts) with unresectable embolization-eligible hepatocellular carcinoma (eeHCC). Abstract #LBA4000 Oral Abstract Session June 1, 2026 9:45am Skoulidis, F Tremelimumab (T) + durvalumab (D) + chemotherapy (CT) vs pembrolizumab (P) + CT in 1L non-squamous (NSQ) metastatic NSCLC (mNSCLC) with STK11 , KEAP1 , and/or KRAS mutations (mut): Interim analysis (IA) of the phase 2b TRITON study. Abstract #8515 Rapid Oral Abstract Session May 30, 2026 1:45pm Heymach, JV Impact of neoadjuvant durvalumab (D) on tumor microenvironment (TME) features and their association with event-free survival (EFS) in patients with resectable NSCLC (R-NSCLC) from the phase 3 AEGEAN trial. Abstract #8015 Rapid Oral Abstract Session May 31, 2026 5:30pm De Santis, M Durvalumab (D) in combination with BCG induction and maintenance (I + M) therapy for BCG-naive, high-risk non–muscle-invasive bladder cancer (NMIBC): 5-year overall survival (OS) analysis and patient-reported outcomes (PROs) from POTOMAC. Abstract #4624 Rapid Oral Abstract Session June 1, 2026 8:12am IO Bispecifics O’Sullivan, CC Neoadjuvant rilvegostomig (R) + trastuzumab deruxtecan (T-DXd) in high-risk HER2-negative breast cancer: Results from the I-SPY 2.2 trial. Abstract #LBA514 Rapid Oral Abstract Session June 1, 2026 10:45am Zhou, J First-line rilvegostomig (R) + chemotherapy (CTx) in advanced biliary tract cancer (BTC): Updated analysis of GEMINI-Hepatobiliary substudy 2 cohort A. Abstract #88 Poster Session May 30, 2026 9:00am Guo, Y Volrustomig monotherapy for recurrent/metastatic HNSCC: Substudy 2 of the eVOLVE-02 phase 2 study. Abstract #482 Poster Session May 30, 2026 1:30pm Tumor drivers and resistance Wang, Z Osimertinib with/without chemotherapy in patients with persistent ctDNA EGFR mutant (EGFRm) NSCLC at 3 weeks after 1L osimertinib: A randomized phase II study (FLAME study). Abstract #LBA101 Clinical Science Symposium May 30, 2026 8:40am Bidard, FC First-line (1L) camizestrant (CAMI) for emergent ESR1 mutations ( ESR1 m) in advanced breast cancer (ABC): Final progression-free survival 2 (PFS2) from the phase III SERENA-6 trial. Abstract #LBA1007 Oral Abstract Session June 2, 2026 11:57am Peng, Z A phase 2 pivotal study of savolitinib in patients with MET -amplified gastric cancer or gastroesophageal junction adenocarcinomas. Abstract #4011 Rapid Oral Abstract Session June 1, 2026 1:27pm Cell Therapy Surana, R Initial phase 1 study results of NT-175 engineered T-cell therapy in TP53 R175H–mutated unresectable advanced solid tumors. Abstract #2506 Oral Abstract Session May 31, 2026 10:00am Epigenetics Derenzini, E A phase 1 study of the PRMT5 inhibitor AZD3470 in patients with relapsed/refractory classic Hodgkin lymphoma (PRIMAVERA). Abstract #7003 Oral Abstract Session May 30, 2026 4:00pm Rare Disease Wechalekar, AD Phase 3 randomized trial to evaluate the impact of anselamimab on all-cause mortality in κ light chain amyloidosis. Abstract #7501 Oral Abstract Session May 29, 2026 2:57pm Chen, AP Final analysis of KOMET (NCT04924608), a phase 3 study of selumetinib in adults with NF1-PN. Abstract #3110 Poster Session May 30, 2026 1:30pm 1 More than 85 abstracts at ASCO 2026 will feature AstraZeneca medicines and pipeline molecules IMPORTANT SAFETY INFORMATION FOR IMFINZI ® (durvalumab) There are no contraindications for IMFINZI ® (durvalumab) or IMJUDO ® (tremelimumab-actl). Severe and Fatal Immune-Mediated Adverse Reactions Important immune-mediated adverse reactions listed under Warnings and Precautions may not include all possible severe and fatal immune-mediated reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. Immune-mediated adverse reactions can occur at any time after starting treatment or after discontinuation. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and before each dose. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue IMFINZI and IMJUDO depending on severity. See USPI Dosing and Administration for specific details. In general, if IMFINZI and IMJUDO requires interruption or discontinuation, administer systemic corticosteroid therapy (1 mg to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. Immune-Mediated Pneumonitis IMFINZI and IMJUDO can cause immune-mediated pneumonitis, which may be fatal. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation. IMFINZI as a Single Agent In patients who did not receive recent prior radiation, the incidence of immune-mediated pneumonitis was 2.4% (34/1414), including fatal (<0.1%), and Grade 3-4 (0.4%) adverse reactions. In patients who received recent prior radiation, the incidence of pneumonitis (including radiation pneumonitis) in patients with unresectable Stage III NSCLC following definitive chemoradiation within 42 days prior to initiation of IMFINZI in PACIFIC was 18.3% (87/475) in patients receiving IMFINZI and 12.8% (30/234) in patients receiving placebo. Of the patients who received IMFINZI (475), 1.1% were fatal and 2.7% were Grade 3 adverse reactions. The incidence of pneumonitis (including radiation pneumonitis) in patients with LS-SCLC following chemoradiation within 42 days prior to initiation of IMFINZI in ADRIATIC was 14% (37/262) in patients receiving IMFINZI and 6% (16/265) in patients receiving placebo. Of the patients who received IMFINZI (262), 0.4% had a fatal adverse reaction and 2.7% had Grade 3 adverse reactions. The frequency and severity of immune-mediated pneumonitis in patients who did not receive definitive chemoradiation prior to IMFINZI were similar in patients who received IMFINZI as a single agent or with ES-SCLC or BTC when given in combination with chemotherapy. IMFINZI with IMJUDO Immune‑mediated pneumonitis occurred in 1.3% (5/388) of patients receiving IMFINZI and IMJUDO, including fatal (0.3%) and Grade 3 (0.2%) adverse reactions. IMFINZI with IMJUDO and Platinum-Based Chemotherapy Immune-mediated pneumonitis occurred in 3.5% (21/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including fatal (0.5%), and Grade 3 (1%) adverse reactions. Immune-Mediated Colitis IMFINZI with IMJUDO and platinum-based chemotherapy can cause immune-mediated colitis, which may be fatal. IMFINZI and IMJUDO can cause immune-mediated colitis that is frequently associated with diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. IMFINZI as a Single Agent Immune-mediated colitis occurred in 2% (37/1889) of patients receiving IMFINZI, including Grade 4 (<0.1%) and Grade 3 (0.4%) adverse reactions. IMFINZI with IMJUDO Immune‑mediated colitis or diarrhea occurred in 6% (23/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (3.6%) adverse reactions. Intestinal perforation has been observed in other studies of IMFINZI and IMJUDO. IMFINZI with IMJUDO and Platinum-Based Chemotherapy Immune-mediated colitis occurred in 6.5% (39/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy including fatal (0.2%) and Grade 3 (2.5%) adverse reactions. Intestinal perforation and large intestine perforation were reported in 0.1% of patients. Immune-Mediated Hepatitis IMFINZI and IMJUDO can cause immune-mediated hepatitis, which may be fatal. IMFINZI as a Single Agent Immune-mediated hepatitis occurred in 2.8% (52/1889) of patients receiving IMFINZI, including fatal (0.2%), Grade 4 (0.3%) and Grade 3 (1.4%) adverse reactions. IMFINZI with IMJUDO Immune‑mediated hepatitis occurred in 7.5% (29/388) of patients receiving IMFINZI and IMJUDO, including fatal (0.8%), Grade 4 (0.3%) and Grade 3 (4.1%) adverse reactions. IMFINZI with IMJUDO and Platinum-Based Chemotherapy Immune-mediated hepatitis occurred in 3.9% (23/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including fatal (0.3%), Grade 4 (0.5%), and Grade 3 (2%) adverse reactions. Immune-Mediated Endocrinopathies Adrenal Insufficiency : IMFINZI and IMJUDO can cause primary or secondary adrenal insufficiency. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. IMFINZI as a Single Agent Immune-mediated adrenal insufficiency occurred in 0.5% (9/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions. IMFINZI with IMJUDO Immune-mediated adrenal insufficiency occurred in 1.5% (6/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.3%) adverse reactions. IMFINZI with IMJUDO and Platinum-Based Chemotherapy Immune-mediated adrenal insufficiency occurred in 2.2% (13/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.8%) adverse reactions. Hypophysitis : IMFINZI and IMJUDO can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field cuts. Hypophysitis can cause hypopituitarism. Initiate symptomatic treatment including hormone replacement as clinically indicated. IMFINZI as a Single Agent Grade 3 hypophysitis/hypopituitarism occurred in <0.1% (1/1889) of patients who received IMFINZI. IMFINZI with IMJUDO Immune-mediated hypophysitis/hypopituitarism occurred in 1% (4/388) of patients receiving IMFINZI and IMJUDO. IMFINZI with IMJUDO and Platinum-Based Chemotherapy Immune-mediated hypophysitis occurred in 1.3% (8/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.5%) adverse reactions. Thyroid Disorders (Thyroiditis, Hyperthyroidism, and Hypothyroidism) : IMFINZI and IMJUDO can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement therapy for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated. IMFINZI as a Single Agent Immune-mediated thyroiditis occurred in 0.5% (9/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions. Immune-mediated hyperthyroidism occurred in 2.1% (39/1889) of patients receiving IMFINZI. Immune-mediated hypothyroidism occurred in 8.3% (156/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions. IMFINZI with IMJUDO Immune-mediated thyroiditis occurred in 1.5% (6/388) of patients receiving IMFINZI and IMJUDO. Immune-mediated hyperthyroidism occurred in 4.6% (18/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.3%) adverse reactions. Immune-mediated hypothyroidism occurred in 11% (42/388) of patients receiving IMFINZI and IMJUDO. IMFINZI with IMJUDO and Platinum-Based Chemotherapy Immune-mediated thyroiditis occurred in 1.2% (7/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy. Immune-mediated hyperthyroidism occurred in 5% (30/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.2%) adverse reactions. Immune-mediated hypothyroidism occurred in 8.6% (51/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.5%) adverse reactions. IMFINZI with Carboplatin and Paclitaxel Immune-mediated hypothyroidism occurred in 14% (34/235) of patients receiving IMFINZI in combination with carboplatin and paclitaxel. Type 1 Diabetes Mellitus, which can present with diabetic ketoacidosis : Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. IMFINZI as a Single Agent Grade 3 immune-mediated Type 1 diabetes mellitus occurred in <0.1% (1/1889) of patients receiving IMFINZI. IMFINZI with IMJUDO Two patients (0.5%, 2/388) had events of hyperglycemia requiring insulin therapy that had not resolved at last follow-up. IMFINZI with IMJUDO and Platinum-Based Chemotherapy Immune-mediated Type 1 diabetes mellitus occurred in 0.5% (3/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy including Grade 3 (0.3%) adverse reactions. Immune-Mediated Nephritis with Renal Dysfunction IMFINZI and IMJUDO can cause immune-mediated nephritis. IMFINZI as a Single Agent Immune-mediated nephritis occurred in 0.5% (10/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions. IMFINZI with IMJUDO Immune-mediated nephritis occurred in 1% (4/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.5%) adverse reactions. IMFINZI with IMJUDO and Platinum-Based Chemotherapy Immune-mediated nephritis occurred in 0.7% (4/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.2%) adverse reactions. Immune-Mediated Dermatology Reactions IMFINZI and IMJUDO can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson Syndrome (SJS), drug rash with eosinophilia and systemic symptoms (DRESS), and toxic epidermal necrolysis (TEN), has occurred with PD-1/L-1 and CTLA-4 blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes. IMFINZI as a Single Agent Immune-mediated rash or dermatitis occurred in 1.8% (34/1889) of patients receiving IMFINZI, including Grade 3 (0.4%) adverse reactions. IMFINZI with IMJUDO Immune-mediated rash or dermatitis occurred in 4.9% (19/388) of patients receiving IMFINZI and IMJUDO, including Grade 4 (0.3%) and Grade 3 (1.5%) adverse reactions. IMFINZI with IMJUDO and Platinum-Based Chemotherapy Immune-mediated rash or dermatitis occurred in 7.2% (43/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0. Contacts Media Inquiries Fiona Cookson +1 212 814 3923 Lauren-Jei McCarthy +1 347 918 7001 US Media Mailbox: usmediateam@astrazeneca.com Read full story here

Phase 3Clinical ResultPhase 2ASCOPhase 1

25 Feb 2026

·investors.arcusbio.com

Arcus Biosciences Reports Fourth-Quarter and Full-Year 2025 Financial Results and Provides a Pipeline Update

Updated data for casdatifan in late-line kidney cancer demonstrated median progression-free survival (PFS) of 15.1 months and a confirmed overall response rate (cORR) of 45% for the 100mg once-daily (QD) cohort At least two additional data presentations for casdatifan are expected in 2026: updated data for casdatifan plus cabozantinib and initial data in early-line kidney cancer In addition to the ongoing Phase 3 PEAK-1 study, Arcus plans to initiate a Phase 3 study in the first-line (1L) metastatic setting evaluating casdatifan in a tyrosine kinase inhibitor (TKI)-free combination by the end of 2026 With $1.0 billion in cash, cash equivalents and marketable securities at year-end, Arcus is well positioned to advance casdatifan with cash runway until at least the second half of 2028 HAYWARD, Calif.--(BUSINESS WIRE)-- Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for patients with cancer and inflammatory and autoimmune diseases, today reported financial results for the year and quarter ended December 31, 2025, and provided a pipeline update on its clinical-stage investigational molecules and discovery programs. “This week’s updated data at ASCO GU continue to validate casdatifan’s profile as the best-in-class HIF-2a inhibitor and new potential standard-of-care therapy for ccRCC,” said Terry Rosen, Ph.D., chief executive officer of Arcus. “We are focused on rapidly enrolling PEAK-1, our Phase 3 study evaluating casdatifan plus cabozantinib in IO-experienced patients, as well as determining the optimal TKI-free casdatifan-based regimen for a registrational trial in the 1L setting by the end of the year. Together, the IO-experienced and first line settings represent an over $5 billion peak sales opportunity for casdatifan. We remain extremely well-positioned to execute on our casdatifan program and our emerging inflammation portfolio, with cash runway until at least the second half of 2028.” Casdatifan (HIF-2a inhibitor) Recent Data Update: Earlier this week, Arcus shared updated ORR and PFS data from the cohorts of the Phase 1/1b ARC-20 study evaluating casdatifan monotherapy in late-line ccRCC. These data will be presented by Dr. Toni Choueiri of the Dana-Farber Cancer Institute at ASCO GU on February 28, 2026. In the 100mg QD cohort, with 17.9 months of median follow up, cORR increased to 45.2% with an mPFS of 15.1 months as of the data cut-off (DCO) date of January 30, 2026. In the pooled analysis (n=121), with 20.8 months of median follow up, cORR increased to 34.7% and mPFS was stable at 12.2 months as of the DCO. New biomarker data demonstrated a strong correlation between the magnitude and durability of erythropoietin suppression by casdatifan and clinical benefit, including rate of primary progression, cORR and PFS. The safety profile of casdatifan remained consistent with prior analyses. In the 100mg QD cohort, with 17.9 months of median follow up, cORR increased to 45.2% with an mPFS of 15.1 months as of the data cut-off (DCO) date of January 30, 2026. In the pooled analysis (n=121), with 20.8 months of median follow up, cORR increased to 34.7% and mPFS was stable at 12.2 months as of the DCO. New biomarker data demonstrated a strong correlation between the magnitude and durability of erythropoietin suppression by casdatifan and clinical benefit, including rate of primary progression, cORR and PFS. The safety profile of casdatifan remained consistent with prior analyses. Casdatifan Development Program: IO-experienced ccRCC: PEAK-1, a Phase 3 study evaluating casdatifan + cabozantinib versus cabozantinib in immunotherapy (IO)-experienced metastatic ccRCC, started enrollment in 3Q25 and is now enrolling globally. Similar Phase 3 trials in this setting have completed enrollment in 18 months or less, and Arcus’s goal is to achieve a similar timeline. 1L ccRCC: Arcus is focused on TKI-free regimens, which are enabled by the consistently low rate of primary progression observed with casdatifan across all cohorts and settings evaluated to date. Emerging data from the following cohorts are designed to determine the optimal 1L registrational strategy with the goal of initiating a Phase 3 study by the end of 2026: Casdatifan plus zimberelimab (Arcus’s anti-PD-1 antibody) and ipilimumab: Arcus is now enrolling a cohort evaluating this combination as part of ARC-20. Casdatifan plus zimberelimab: The cohort evaluating this combination in ARC-20 has completed enrollment. Arcus plans to present data from this cohort in the second half of 2026. Arcus expects this to be the backbone of its front-line strategy. Casdatifan plus volrustomig (AstraZeneca’s anti-PD-1/CTLA-4 bispecific antibody): This combination is being evaluated in the eVOLVE-RCC02 study (which is being operationalized by AstraZeneca). Additional combinations in ccRCC and tumor types: This year, Arcus plans to evaluate the potential of casdatifan in at least one additional combination in 1L ccRCC and in another tumor type. Casdatifan plus zimberelimab (Arcus’s anti-PD-1 antibody) and ipilimumab: Arcus is now enrolling a cohort evaluating this combination as part of ARC-20. Casdatifan plus zimberelimab: The cohort evaluating this combination in ARC-20 has completed enrollment. Arcus plans to present data from this cohort in the second half of 2026. Arcus expects this to be the backbone of its front-line strategy. Casdatifan plus volrustomig (AstraZeneca’s anti-PD-1/CTLA-4 bispecific antibody): This combination is being evaluated in the eVOLVE-RCC02 study (which is being operationalized by AstraZeneca). Planned Data Readouts: Arcus expects to have at least two data readouts for casdatifan in 2026: More mature ORR data and initial PFS data for approximately 45 patients treated in the ARC-20 cohort evaluating casdatifan plus cabozantinib in the IO-experienced setting will be presented at an investor event or at a medical conference. All patients will have had at least 12 months of follow-up. Initial data from the ARC-20 cohorts evaluating casdatifan in early-line settings, including the cohort evaluating casdatifan plus zimberelimab in 1L ccRCC. Quemliclustat (small-molecule CD73 inhibitor) Enrollment was completed for PRISM-1, a Phase 3 trial of quemliclustat combined with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel in 1L metastatic pancreatic ductal adenocarcinoma, in September 2025. Results from this study are expected in the first half of 2027. Emerging I&I Portfolio Arcus expects to advance its first inflammation program, a potential best-in-class oral MRGPRX2 antagonist for atopic dermatitis and chronic spontaneous urticaria, into clinical development in 2026. The molecule was designed to have exquisite potency, enabling the ability to elicit maximal pharmacology at substantially lower exposure relative to the most advanced MRGPRX2 antagonist in clinical development, thereby avoiding potential exposure-limiting toxicities. Clinical development will begin with a first-in-human healthy volunteer study followed quickly by a proof-of-concept study, with potential for data within a year from entry into the clinic. Arcus also expects to advance an oral small-molecule TNF inhibitor, a potential treatment for rheumatoid arthritis, psoriasis and inflammatory bowel disease, into the clinic in late 2026 or early 2027. The molecules are being designed to selectively block TNFR1 signaling in order to achieve better safety and efficacy than approved anti-TNF antibodies. The molecule was designed to have exquisite potency, enabling the ability to elicit maximal pharmacology at substantially lower exposure relative to the most advanced MRGPRX2 antagonist in clinical development, thereby avoiding potential exposure-limiting toxicities. Clinical development will begin with a first-in-human healthy volunteer study followed quickly by a proof-of-concept study, with potential for data within a year from entry into the clinic. The molecules are being designed to selectively block TNFR1 signaling in order to achieve better safety and efficacy than approved anti-TNF antibodies. Domvanalimab (Fc-silent anti-TIGIT antibody) plus Zimberelimab (anti-PD-1 antibody) Status Update: Arcus and Gilead are in the process of rapidly winding down activities related to the Phase 3 STAR-221 and Phase 2 EDGE-Gastric studies. A futility analysis of STAR-121, a Phase 3 study evaluating domvanalimab plus zimberelimab and chemotherapy in 1L non-small cell lung cancer, will be conducted in the next couple of months to determine next steps for the program. Financial Results for Fourth Quarter and Full Year 2025: Cash, Cash Equivalents and Marketable Securities were $1.0 billion as of December 31, 2025, compared to $992 million as of December 31, 2024. The increase is primarily due to $429 million in net proceeds from issuances of our common stock, the additional $50 million drawdown under our term loan facility, and $37 million from Taiho for development milestones and option payments, partially offset by cash used in research and development activities. Arcus expects its cash and investments will be sufficient to provide funding until at least the second half of 2028. Revenues were $33 million for the fourth quarter 2025, compared to $36 million for the same period in 2024. Fourth quarter 2025 revenues included (i) $23 million related to programs under the Gilead collaboration, (ii) $7 million related to Taiho's exercise of its option to casdatifan, and (iii) $3 million related to Gilead’s ongoing rights to access Arcus’s research and development pipeline. GAAP revenue for the full year 2026 is expected to be between $45 to $55 million. Research and Development (R&D) Expenses were $121 million for the fourth quarter 2025, compared to $111 million for the same period in 2024. The net increase of $10 million was primarily attributable to higher late-stage development costs, driven by increased enrollment and clinical activities in our Phase 3 studies for casdatifan and quemliclustat, partially offset by lower early-stage development costs, as earlier study activities for domvanalimab and etrumadenant approached completion. For the fourth quarter 2025 and 2024, Arcus recognized gross reimbursements of $28 million and $41 million, respectively, for shared collaboration expenses, primarily from Gilead. Gross reimbursements were $127 million for the full year 2025, compared to $165 million for 2024. Our partnership reimbursements decreased compared to the prior year, primarily due to Gilead-led activities representing a larger share of total joint development costs and an increase in programs fully funded by us. R&D expenses are expected to decrease meaningfully for the full year 2026 relative to 2025; the magnitude of the decrease will be determined in part by the results of the futility analysis of STAR-121. Non-cash stock-based compensation expense was $8 million for each of the fourth quarter 2025 and 2024. General and Administrative (G&A) Expenses were $26 million for the fourth quarter 2025, compared to $28 million for the same period in 2024. Non-cash stock-based compensation expense was $7 million for the fourth quarter 2025, compared to $9 million for the same period in 2024. Net Loss was $106 million for the fourth quarter 2025, compared to $94 million for the same period in 2024. Conference Call Information: Arcus will host a conference call and webcast today, February 25, 2026, at 1:30 PM PT/4:30 PM ET to discuss its fourth-quarter and full-year 2025 financial results and pipeline updates. To access the call, please dial +1 (646) 844-6383 (local) or +1 (833) 470-1428 (toll-free), using Access Code: 190500. Participants may also register for the call online using the following link: https://events.q4inc.com/attendee/640976415. 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 of the webcast will be available following the live event. About Arcus Biosciences Arcus Biosciences is a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules for the treatment of cancer and inflammatory and autoimmune diseases. In partnership with industry collaborators, patients and physicians around the world, Arcus is expediting the development of its late-stage portfolio of first- and/or best-in-class medicines against well-characterized biological targets and pathways and studying novel, biology-driven combinations that have the potential to help people with cancer live longer. Founded in 2015, the company has advanced multiple investigational medicines into registrational clinical trials including casdatifan, a HIF-2a inhibitor for clear cell renal cell carcinoma, and quemliclustat, a small-molecule CD73 inhibitor for pancreatic cancer. For more information about Arcus Biosciences’ clinical and preclinical programs, please visit www.arcusbio.com. Forward-Looking Statements This press release contains forward-looking statements. All statements regarding events or results to occur in the future contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, the timing of milestones, including future data presentations, initiation of new cohorts and clinical studies and completion of enrollment for ongoing studies; potential for casdatifan to become a standard-of-care therapy; and advantages of Arcus’s inflammation and immunology programs. All forward-looking statements involve known and unknown risks and uncertainties and other important factors that may cause Arcus’s actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, risks associated with: interim data not being guarantees of future data or replicated in other studies evaluating casdatifan, including the Phase 3 PEAK-1 study; the unexpected emergence of adverse events or other undesirable side effects with casdatifan; risks associated with manufacturing or supplying product for clinical trials evaluating casdatifan; adverse data from toxicology studies that affect Arcus’s ability to advance development candidates from its immunology and inflammation programs, uncertainties in timelines associated with the conduct of clinical studies and with respect to the regulatory approval process; changes in the competitive landscape for Arcus’s programs; and the inherent uncertainty associated with pharmaceutical product development and clinical trials. Risks and uncertainties facing Arcus are described more fully in the “Risk Factors” section of Arcus’s most recent periodic report filed with the U.S. Securities and Exchange Commission (SEC) and in other filings that Arcus makes with the SEC from time to time, which are available at www.sec.gov. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Arcus disclaims any obligation or undertaking to update, supplement or revise any forward-looking statements contained in this press release, except to the extent required by law. The Arcus name and logo are trademarks of Arcus Biosciences, Inc. All other trademarks belong to their respective owners. ARCUS BIOSCIENCES, INC. Consolidated Statements of Operations (unaudited) (In millions, except per share amounts) Three Months Ended December 31, Years Ended December 31, 2025 2024 2025 2024 Revenues: License and development service $ 29 $ 28 $ 221 $ 222 Other collaboration 4 8 26 36 Total revenues 33 36 247 258 Operating expenses: Research and development 121 111 523 448 General and administrative 26 28 110 120 Impairment of long-lived assets — — — 20 Total operating expenses 147 139 633 588 Loss from operations (114 ) (103 ) (386 ) (330 ) Non-operating income (expense): Interest and other income, net 10 12 41 52 Interest expense (2 ) (2 ) (8 ) (4 ) Total non-operating income, net 8 10 33 48 Loss before income taxes (106 ) (93 ) (353 ) (282 ) Income tax expense — (1 ) — (1 ) Net loss $ (106 ) $ (94 ) $ (353 ) $ (283 ) Net loss per share: Basic and diluted $ (0.89 ) $ (1.03 ) $ (3.29 ) $ (3.14 ) Shares used to compute net loss per share: Basic and diluted 118.5 91.7 107.4 90.1 Selected Consolidated Balance Sheet Data (unaudited) (In millions) December 31, 2025 December 31, 2024 Cash, cash equivalents and marketable securities $ 1,010 $ 992 Total assets 1,139 1,150 Total liabilities 508 665 Total stockholders’ equity 631 485 Derived from the audited financial statements included in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 25, 2026. Investor Inquiries: Pia Eaves VP of Investor Relations & Strategy (617) 459-2006 peaves@arcusbio.com Media Inquiries: Holli Kolkey VP of Corporate Affairs (650) 922-1269 hkolkey@arcusbio.com Maryam Bassiri AD, Corporate Communications (510) 406-8520 mbassiri@arcusbio.com

Phase 3Clinical ResultFinancial StatementPhase 2

07 Jan 2026

·investors.arcusbio.com

Arcus Outlines 2026 Plans for Casdatifan, its Potential Best-in-Class HIF-2a Inhibitor, and its Inflammation Programs

Arcus’s highest priority is to execute on its ongoing Phase 3 trial and overall development plan aimed at establishing casdatifan as the standard-of-care and backbone therapy for clear cell renal cell carcinoma (ccRCC), including the initiation of a Phase 3 trial in the first-line (1L) setting At least three data presentations are planned for casdatifan in 2026, including updated data from the four late-line monotherapy cohorts of the Phase 1/1b ARC-20 study, which will be presented at a medical conference in February 2026 Arcus’s first development candidate for inflammatory and autoimmune diseases, an oral MRGPRX2 antagonist for chronic spontaneous urticaria, is expected to enter the clinic in 2026 With approximately $1 billion of cash and investmentsi, Arcus expects to be able to fund its planned operations until at least the second half of 2028 Arcus will present at the 44th Annual J.P. Morgan Healthcare Conference on Wednesday, January 14, 2026 HAYWARD, Calif.--(BUSINESS WIRE)-- Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules for patients with cancer and inflammatory and autoimmune diseases, today outlined its 2026 priorities for casdatifan and its emerging inflammation and immunology (I&I) programs. “As we enter 2026, the highest priorities for Arcus will be the rapid enrollment of PEAK-1, our Phase 3 study evaluating casdatifan in immunotherapy (IO)-experienced ccRCC patients, and the initiation of a 1L Phase 3 study evaluating casdatifan informed by data from multiple ongoing and soon-to-be initiated Phase 1 combination studies,” said Terry Rosen, Ph.D., chief executive officer of Arcus. “This year, we also expect to advance our first small molecule for inflammatory disease into the clinic.” Casdatifan (HIF-2a inhibitor for ccRCC) Upcoming Data Presentations: Arcus expects to have at least three data readouts for casdatifan, its potential best-in-class HIF-2a inhibitor, during 2026: In February 2026, Arcus plans to present updated data from the four cohorts of the Phase 1/1b ARC-20 study evaluating casdatifan monotherapy in late-line ccRCC at a medical conference. These data will include updated progression-free survival (PFS) data for the 100mg once-daily (QD) cohort of casdatifan and for all four monotherapy cohorts combined (n=121), as well as updated biomarker data correlating erythropoietin suppression with clinical outcomes. Mid-year, Arcus expects to present updated data for approximately 45 patients treated in ARC-20 with casdatifan plus cabozantinib in IO-experienced ccRCC; this cohort evaluates the same combination in the same setting as PEAK-1, an ongoing Phase 3 study, which represents Arcus’s “fast-to-market” strategy in ccRCC. In the second half of the year, Arcus expects to present data from multiple ARC-20 cohorts evaluating casdatifan in early-line metastatic settings, including data from the cohort evaluating casdatifan plus the anti-PD-1 antibody, zimberelimab, in 1L ccRCC. This will be the first presentation of data for a tyrosine kinase inhibitor (TKI)-sparing HIF-2a inhibitor-based regimen in the 1L setting. Data from this cohort are expected to show an acceptable safety profile and early efficacy, including a low rate of primary progression, which is essential in this setting. The cohort is designed to de-risk Arcus’s strategy to displace TKIs as an early-line treatment. This will be the first presentation of data for a tyrosine kinase inhibitor (TKI)-sparing HIF-2a inhibitor-based regimen in the 1L setting. Data from this cohort are expected to show an acceptable safety profile and early efficacy, including a low rate of primary progression, which is essential in this setting. The cohort is designed to de-risk Arcus’s strategy to displace TKIs as an early-line treatment. Development Strategy: Arcus’s development plan is designed to establish casdatifan as a foundational standard of care across multiple settings of ccRCC, which represents a potential global market opportunity of $5 billion or more. Arcus’s ongoing Phase 3 study for casdatifan in IO-experienced ccRCC, PEAK-1, is evaluating casdatifan plus cabozantinib, the most widely used TKI in this setting. Similar Phase 3 trials in this setting have completed enrollment in 18 months or less, and Arcus’s goal is to achieve a similar timeline. Arcus’s strategy in 1L ccRCC is focused on TKI-free regimens, which are enabled by the consistently low rate of primary progression observed with casdatifan across all cohorts and settings evaluated to date. This strategy has the potential to bring about a highly desirable paradigm shift with a first-in-class regimen that delays treatment with TKIs and their associated toxicities to later lines of therapy. The following cohorts are designed to efficiently determine the optimal 1L registrational strategy for casdatifan: Casdatifan plus zimberelimab (Arcus’s anti-PD-1 antibody): This combination is currently being evaluated in ARC-20, and this cohort has completed enrollment. Arcus plans to present data from this cohort in the second half of 2026. Casdatifan plus anti-PD-1-containing regimens: Arcus is planning to initiate new cohorts to evaluate two other TKI-free casdatifan plus anti-PD-1-containing regimens in the 1L setting. Casdatifan plus volrustomig (AstraZeneca’s anti-PD-1/CTLA-4 bispecific antibody): This combination is being evaluated in the eVOLVE-RCC02 study (which is being operationalized by AstraZeneca). Data from these cohorts will inform and enable the initiation of a Phase 3 study for a casdatifan-containing, TKI-free regimen in the 1L setting. Arcus is targeting initiation of this study by year-end 2026. Small-Molecule Inflammation & Immunology Programs Arcus’s I&I strategy leverages the company’s demonstrated capabilities in small-molecule drug discovery, focusing on indications currently dominated by blockbuster injectable biologics and on highly validated targets. Arcus’s I&I portfolio currently includes several oral small molecules, including an MRGPRX2 antagonist and inhibitors of TNF, CCR6 and CD40L. The company is also developing an anti-CD89 antibody that has potential in patients with a type of rheumatoid arthritis that is currently difficult to treat. Arcus expects to advance its lead inflammation program, a potential best-in-class oral MRGPRX2 antagonist for atopic dermatitis and chronic spontaneous urticaria, into clinical development in 2026. The molecule was designed to have exquisite potency, enabling substantially lower-dose target coverage relative to the most advanced MRGPRX2 antagonist in clinical development, thereby avoiding potential exposure-limiting toxicities. Arcus also expects to advance an oral small-molecule TNF inhibitor, a potential treatment for rheumatoid arthritis, psoriasis and inflammatory bowel disease (such as ulcerative colitis), into the clinic in late 2026 or early 2027. Quemliclustat (CD73 inhibitor for pancreatic cancer) Arcus's oncology portfolio also includes quemliclustat, a small-molecule CD73 inhibitor, which is being evaluated in PRISM-1, a registrational Phase 3 study in 1L pancreatic cancer that completed enrollment in September 2025. Results from this study are expected in the first half of 2027. Runway Guidance Arcus has approximately $1 billion of cash and investmentsi and expects to be able to fund its planned operations until at least the second half of 2028. This guidance includes a rapid wind down of the Phase 3 STAR-221 and Phase 2 EDGE-GASTRIC studies. In the first quarter of 2026, Arcus and Gilead expect to conduct an analysis of STAR-121, a Phase 3 study evaluating domvanalimab plus zimberelimab and chemotherapy in 1L non-small cell lung cancer. Depending on the outcome of this analysis, Arcus could realize additional cost savings. Presentation at 44th Annual J.P. Morgan Healthcare Conference Arcus will present at the 44th Annual J.P. Morgan Healthcare Conference at 3:00 pm PT on Wednesday, January 14, 2026. A live webcast of the presentation will be available on the “Investors & Media” section of the Arcus Biosciences website at www.arcusbio.com. A replay will be available following the live event. Domvanalimab, zimberelimab and quemliclustat are investigational molecules, and neither Arcus nor Gilead has received approval from any regulatory authority for any use globally, and their safety and efficacy have not been established. Casdatifan is also an investigational molecule, and Arcus has not received approval from any regulatory authority for any use globally, 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 80,980 Americans will be diagnosed with kidney cancer in 2025. 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 18%. 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. About Casdatifan (AB521) Casdatifan is a small-molecule inhibitor of HIF-2a, a master switch that turns on hundreds of genes in response to low oxygen levels. In a majority of people with the most common form of kidney cancer (clear cell renal cell carcinoma), genetic anomalies result in the dysregulation of this master switch and transformation of normal kidney cells into cancerous ones. Casdatifan was designed to provide deep and durable inhibition of the HIF-2a pathway. Early clinical studies have shown high response rates and a low primary progression rate relative to clinical benchmarks, warranting further investigation in late-stage studies. Casdatifan, which is administered in pill form once daily, has a safety profile that allows it to be investigated in combination with other treatments. About Zimberelimab Zimberelimab is an anti-programmed cell death protein-1 (PD-1) monoclonal antibody that binds PD-1, with the goal of restoring the antitumor activity of T cells. Zimberelimab has demonstrated high affinity, selectivity and potency in various tumor types. Zimberelimab is being evaluated in the U.S. and globally as a foundational anti-PD-1 treatment option in multiple ongoing clinical studies in combination with other immunotherapies. Guangzhou Gloria Biosciences Co. Ltd., which holds commercialization rights for zimberelimab in greater China, has obtained approval for zimberelimab for the treatment of recurrent or metastatic cervical cancer and for relapsed or refractory classical Hodgkin’s lymphoma. Zimberelimab is not approved for any use in the U.S. or other regions outside of China. Gloria conducts its development and commercialization activities independent of Arcus and Gilead. About Arcus Biosciences Arcus Biosciences is a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules for the treatment of cancer and inflammatory and autoimmune diseases. In partnership with industry collaborators, patients and physicians around the world, Arcus is expediting the development of its late-stage portfolio of first- and/or best-in-class medicines against well-characterized biological targets and pathways and studying novel, biology-driven combinations that have the potential to help people with cancer live longer. Founded in 2015, the company has advanced multiple investigational medicines into registrational clinical trials including casdatifan, a HIF-2a inhibitor for clear cell renal cell carcinoma, and quemliclustat, a small-molecule CD73 inhibitor for pancreatic cancer. For more information about Arcus Biosciences’ clinical and preclinical programs, please visit www.arcusbio.com. Forward Looking Statement This press release contains forward-looking statements. All statements regarding events or results to occur in the future contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Arcus’s goals and strategy for its casdatifan and inflammation and immunology programs; the potential for casdatifan to become a standard‑of‑care or “backbone” therapy or to be best‑in‑class; planned, expected or potential timing, occurrence and content of clinical data readouts, presentations and publications (including those from ARC‑20, eVOLVE‑RCC02, PEAK‑1 and PRISM‑1); the design, initiation, enrollment, conduct and timelines of ongoing or planned clinical trials (including the potential initiation of a 1L Phase 3 study by year‑end 2026 and enrollment goals for PEAK‑1); the anticipated clinical profile of Arcus’s product candidates, including safety, tolerability and activity, and expectations regarding TKI‑sparing regimens; the advancement and therapeutic potential of Arcus’s I&I candidates (including MRGPRX2 antagonist and TNF inhibitor) and the timing of their entry into the clinic; the scope and timing of program wind‑downs; market opportunity estimates; collaboration activities and expectations (including with AstraZeneca and Gilead); and Arcus’s cash runway and other financial or operational expectations. All forward-looking statements involve known and unknown risks and uncertainties and other important factors that may cause Arcus’s actual results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: the outcomes of anticipated analyses from ongoing Phase 3 studies with domvanalimab, including STAR-121 and PACIFIC-8; delays in the wind-down of STAR-221 and EDGE-Gastric; the unexpected emergence of adverse events or other undesirable side effects in Arcus’s investigational products, including casdatifan; risks associated with preliminary and interim data not being guarantees that future data will be similar; difficulties or delays in initiating or conducting clinical trials due to difficulties or delays in the regulatory process, enrolling subjects or manufacturing or supplying product for such clinical trials; further changes to Arcus’s strategy and operating plans; changes in the competitive landscape for Arcus’s programs; reliance on collaborators and third parties (including AstraZeneca and Gilead) and related dependencies; regulatory feedback that may alter design or timing; and assumptions underlying cash‑runway guidance and program wind‑downs and the inherent uncertainty associated with pharmaceutical product development and clinical trials. Risks and uncertainties facing Arcus are described more fully in the “Risk Factors” section of Arcus’s most recent periodic report filed with the U.S. Securities and Exchange Commission. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this press release. Arcus disclaims any obligation or undertaking to update, supplement or revise any forward-looking statements contained in this press release except to the extent required by law. i Based on cash, cash equivalents and marketable securities balance of $841 million as of September 30, 2025, and net proceeds of approximately $270 million from Arcus’s November 2025 financing. Investor Inquiries: Pia Eaves VP of Investor Relations & Strategy (617) 459-2006 peaves@arcusbio.com Media Inquiries: Holli Kolkey VP of Corporate Affairs (650) 922-1269 hkolkey@arcusbio.com Maryam Bassiri AD, Corporate Communications (510) 406-8520 mbassiri@arcusbio.com

Phase 3ImmunotherapyDrug ApprovalPhase 2

100 Deals associated with Volrustomig

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Locally Advanced Head and Neck Squamous Cell Carcinoma	Phase 3	United States	AstraZeneca PLC	14 Dec 2023
Locally Advanced Head and Neck Squamous Cell Carcinoma	Phase 3	China	AstraZeneca PLC	14 Dec 2023
Locally Advanced Head and Neck Squamous Cell Carcinoma	Phase 3	Japan	AstraZeneca PLC	14 Dec 2023
Locally Advanced Head and Neck Squamous Cell Carcinoma	Phase 3	Austria	AstraZeneca PLC	14 Dec 2023
Locally Advanced Head and Neck Squamous Cell Carcinoma	Phase 3	Belgium	AstraZeneca PLC	14 Dec 2023
Locally Advanced Head and Neck Squamous Cell Carcinoma	Phase 3	Brazil	AstraZeneca PLC	14 Dec 2023
Locally Advanced Head and Neck Squamous Cell Carcinoma	Phase 3	Canada	AstraZeneca PLC	14 Dec 2023
Locally Advanced Head and Neck Squamous Cell Carcinoma	Phase 3	France	AstraZeneca PLC	14 Dec 2023
Locally Advanced Head and Neck Squamous Cell Carcinoma	Phase 3	Germany	AstraZeneca PLC	14 Dec 2023
Locally Advanced Head and Neck Squamous Cell Carcinoma	Phase 3	Hungary	AstraZeneca PLC	14 Dec 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06535607 (eVOLVE-02, ESMO_ELCC2026)	Phase 2	Unresectable Pleural Malignant Mesothelioma First line	75	Volrustomig (Pleural Mesothelioma)	bfgnmemerf(yewfcwsusk) = aeklxprwcw crolavgrjo (ypynhhnfez )	Positive	25 Mar 2026
NCT04379596 (DESTINY-Gastric03 (DG-03), ASCO_GI2026)	Phase 1/2	Adenocarcinoma of Esophagus \| HER2-Low Gastric Cancer \| Gastroesophageal junction adenocarcinoma First line HER2-low	30	trastuzumab deruxtecan+volrustomig+fluoropyrimidine	dcxtprxpyd(wibfiyaoco) = qcbmnjyxqc weaxxnipqj (gggkgnhsky, 8.1 - NE)	Positive	08 Jan 2026
NCT03530397 (ESMO2022) Manual	Phase 1/2	Non-squamous non-small cell lung cancer First line PD-L1	91	MEDI5752+chemotherapy (R cohort)	xkxclzuwhh(iqxziyajfy) = clzmspfzgr ylrgzszegb (ntoykpuqqc, 27.2 - 72.8) View more	Positive	11 Sep 2022
NCT03530397 (ESMO2022) Manual	Phase 1/2	Non-squamous non-small cell lung cancer First line PD-L1	91	Pembrolizumab+chemotherapy (R cohort)	xkxclzuwhh(iqxziyajfy) = jprqumkywd ylrgzszegb (ntoykpuqqc, 25.7 - 70.2) View more	Positive	11 Sep 2022
NCT03530397 (AACR2022)	Phase 1	HR-positive/HER2-low Solid Tumors	86	MEDI5752	ugljndofgk(calgxutxtw) = hydgbytkmb laruzfeleg (bzbopiegpq ) View more	-	15 Jun 2022
NCT03530397 (ASCO2022) Manual	Phase 1	Advanced Renal Cell Carcinoma First line	46	MEDI 5752 (escalation)	pvrhnaddbm(taxvcnnmej) = rzhsnmyppk crvwpticnk (plsxcixsqo, 16.3 - 61.6) View more	Positive	02 Jun 2022
NCT03530397 (ASCO2022) Manual	Phase 1	Advanced Renal Cell Carcinoma First line	46	MEDI 5752 (expansion total)	pvrhnaddbm(taxvcnnmej) = qtqaoartyl crvwpticnk (plsxcixsqo, 20.2 - 59.4) View more	Positive	02 Jun 2022

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Hiro LS Researcher

The AI Search Engine Built to Accelerate Biopharma Decisions

Search across billion-scale life sciences data to uncover signals, validate evidence, and act with confidence.

Ask any biopharma research question→

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, Patsnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Discover Synapse Data Servers

Synapse data is now integrated into the PatSnap LS Model Context Protocol (MCP) service. Customize your LLM agent now using our MCP server!

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis