A Master Protocol of a Phase II, Open-label, Multicenter, Global Platform Study to Evaluate the Safety and Efficacy of Immunotherapy With or Without Other Anticancer Drugs in Participants with Unresectable Stage III Non-small Cell Lung Cancer Planning to Undergo Concurrent Chemoradiotherapy (AQUARIUS)

Start Date29 Jan 2027

Sponsor / Collaborator

AstraZeneca AB

NCT07720284

/ RecruitingPhase 3

A Phase III, Open-Label, Randomised, Multicentre, Global Study of Adjuvant Datopotamab Deruxtecan in Combination With Rilvegostomig in Participants With High-risk Muscle Invasive Urothelial Carcinoma

Purpose: to assess efficacy and safety of Dato-DXd + rilvegostomig as adjuvant therapy versus SoC in MIUC participants with high-risk residual disease after radical resection.
Study details:
Duration:
78 months (6.5 years) from FSI to last subject visit Treatment length: up to
12 months, depending on randomized arm Visit frequency: every 3 weeks in Arms 1 and 2; every 2-4 weeks per SoC in Arm 3

Start Date16 Jul 2026

Sponsor / Collaborator

AstraZeneca PLC

[+1]

CTIS2026-525620-23-00

/ Not yet recruitingPhase 2IIT

Local and systemic immune modulation by Rilvegostomig (AZD2936) in the treatment of advanced gastric cancer (RILVE Project)

Start Date01 Jun 2026

Sponsor / Collaborator-

100 Clinical Results associated with Rilvegostomig

100 Translational Medicine associated with Rilvegostomig

100 Patents (Medical) associated with Rilvegostomig

Literatures (Medical) associated with Rilvegostomig

01 Jan 2026·JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY

TROPION-Lung12: A phase 3 study of adjuvant datopotamab deruxtecan and rilvegostomig in ctDNA-positive or high-risk pathology stage I non–small cell lung cancer

Article

Author: Lim, Eric ; Forcina, Alessandra ; Opitz, Isabelle ; Yanagawa, Jane ; Batig, Anastasiya ; Harpole, David ; Felip, Enriqueta ; Tsutani, Yasuhiro ; Lyfar, Pavlo ; Jones, David R ; Bodla, Shankar ; Dacic, Sanja ; Ganti, Apar Kishor ; Tan, Daniel S W

BACKGROUND:

Five-year disease recurrence rates for patients with stage I non-small cell lung cancer (NSCLC) postsurgery are variable (15%-40%). There is an urgent need for novel biomarker strategies to identify high-risk patients who may benefit from adjuvant treatment. High-risk pathologic features, including high-grade histology and lymphovascular or visceral pleural invasion, serve as independent risk factors for worse outcomes. Preoperative circulating tumor DNA (ctDNA) detection is also correlated with poorer outcomes in stage I NSCLC. Datopotamab deruxtecan (Dato-DXd), an antibody-drug conjugate composed of a humanized anti-TROP2 antibody conjugated to a potent topoisomerase I inhibitor via a plasma-stable linker, and rilvegostomig, an Fc-reduced monovalent bispecific humanized IgG1 antibody targeting both PD-1 and TIGIT receptors, have shown promise in NSCLC studies. Combining Dato-DXd with rilvegostomig may improve treatment outcomes in selected patients with stage I NSCLC.

METHODS:

TROPION-Lung12 (NCT06564844) is a phase 3 randomized study enrolling approximately 660 patients with stage I adenocarcinoma without actionable genomic alterations who have undergone complete surgical resection. Eligible patients must have preoperative ctDNA-positive status or 1 or more high-risk pathologic features. Patients will be randomized 2:1:2 to receive Dato-DXd (6 mg/kg intravenously [IV] every 3 weeks) plus rilvegostomig (750 mg IV every 3 weeks) for 4 cycles, followed by rilvegostomig (up to 12 months/18 cycles total), rilvegostomig alone (up to 12 months/18 cycles total), or standard of care (SoC) for up to 12 months. The primary endpoint is disease-free survival, assessed using blinded independent central review according to RECIST v1.1, with key secondary endpoints including overall survival, for the Dato-DXd plus rilvegostomig arm versus the SoC arm.

POSTGRADUATE MEDICAL JOURNAL

Retraction of: Volrustomig/Rilvegostomig related “triple M”—myasthenia gravis and overlap syndrome

Article

Frontiers in Oncology

Correction: TROPION-Lung10: a phase 3 study of datopotamab deruxtecan and rilvegostomig in patients with treatment-naïve locally advanced or metastatic nonsquamous non-small cell lung cancer with high PD-L1 expression and without actionable genomic alterations

[This corrects the article DOI: 10.3389/fonc.2025.1721624.].

158

News (Medical) associated with Rilvegostomig

03 Aug 2026

·www.prnewswire.com

Compugen Reports Second Quarter 2026 Results

COM701 MAIA-ovarian trial progressing as planned with median progression-free survival data from the interim analysis expected by Q1 2027 Trial-in-progress poster on MAIA-ovarian presented at the ESMO Gynaecological Cancers Congress 2026, reinforcing the biological and clinical rationale for evaluating COM701 in platinum-sensitive ovarian cancer Partner AstraZeneca presented new data at ASCO 2026, including the first overall survival readout from the GEMINI-Hepatobiliary study in first-line biliary tract cancer Gilead-partnered GS-0321 Phase 1 trial continues to progress as planned Solid financial position with cash runway expected to fund operations into 2029 HOLON, Israel, Aug. 3, 2026 /PRNewswire/ -- Compugen Ltd. (NASDAQ: CGEN) (TASE: CGEN), a clinical-stage cancer immunotherapy company and a pioneer in computational drug target discovery powered by AI/ML, today reported financial results for the second quarter of 2026 and provided a corporate update. "Q2 2026 reflects continued execution across the business," said Eran Ophir, Ph.D., President and CEO of Compugen. "Our MAIA-ovarian trial in platinum-sensitive ovarian cancer remains on track for the interim analysis with median progression-free survival data expected by the first quarter of 2027, which would mark a potential inflection point for COM701 in a patient population with a significant unmet need. Our partnered programs also advanced during the quarter, with AstraZeneca initiating an additional Phase 3 trial with rilvegostomig and presenting new rilvegostomig data at ASCO 2026, and the Gilead-partnered GS-0321 Phase 1 trial progressing as planned. With cash runway expected into 2029, we believe we are well positioned to advance our immuno-oncology pipeline." COM701 Compugen continues to advance MAIA-ovarian, its sponsored, randomized, placebo-controlled adaptive platform trial evaluating COM701, a potential first-in-class anti-PVRIG antibody, as maintenance monotherapy in patients with second- and third-line relapsed platinum-sensitive ovarian cancer, a setting with no approved treatment option. The Company anticipates the interim analysis with median progression-free survival data by the first quarter of 2027. During the quarter, Compugen presented a trial-in-progress poster on MAIA-ovarian at the ESMO Gynaecological Cancers Congress in Copenhagen. The poster underscored the strong biological and clinical rationale for evaluating COM701 in this population, including the differentiated biology of the PVRIG pathway versus other checkpoints such as PD-1 and TIGIT, its high expression in ovarian cancer, and the durable responses previously observed with COM701 as mono- and combination therapy in heavily pre-treated platinum-resistant patients. The Company believes that clear prolongation of PFS in these patients versus placebo could inform a registration path for COM701 and establish it as a potential backbone for drug combinations. Clinically meaningful success could also enable a broader clinical development plan across earlier and later lines of ovarian cancer and other indications where clinical signals were previously observed. Rilvegostomig Rilvegostomig is a PD-1/TIGIT bispecific antibody being advanced by Compugen's partner AstraZeneca, the TIGIT component of which is derived from Compugen's fully owned COM902 program. At the 2026 ASCO Annual Meeting, AstraZeneca presented an updated analysis from the GEMINI-Hepatobiliary study of rilvegostomig in combination with chemotherapy in the first-line setting. This was the first overall survival readout for rilvegostomig, with median overall survival of 16.8 months, versus less than 13 months in historical first-line biliary tract cancer trials. The data showed encouraging efficacy together with a manageable safety profile in a setting of high unmet need, while longer follow-up and randomized data from the ongoing Phase 3 trial will ultimately be needed to validate these findings. AstraZeneca continues to advance rilvegostomig across its broad late-stage program in 12 ongoing Phase 3 trials, including the recently initiated trial of rilvegostomig in combination with Datroway in urothelial carcinoma. GS-0321 GS-0321, formerly known as COM503, is a potential first-in-class anti-IL-18 binding protein antibody licensed to Gilead that represents a novel antibody approach to harness cytokine biology for the treatment of cancer, potentially overcoming the limitations of direct cytokine administration. The ongoing Phase 1 dose-escalation trial continues to progress as planned. Early Pipeline Compugen continues to leverage Unigen™, its AI/ML-powered computational discovery platform, to identify novel drug targets and biological pathways grounded in human disease biology. Unigen has already discovered the targets of COM701, COM902, and GS-0321 and we remain committed to identifying and advancing the next generation of immuno-oncology innovation. Second Quarter 2026 Financial Highlights Cash: As of June 30, 2026, Compugen had approximately $125.3 million in cash, cash equivalents, short-term bank deposits, and investment in marketable securities. Compugen expects that its cash and cash-related balances will be sufficient to fund its operating plans into 2029. This does not include any additional cash inflows. The Company has no debt. Revenues for the second quarter of 2026 were approximately $2.6 million, compared to approximately $1.3 million for the comparable period in 2025. Revenues in the second quarters of 2026 and 2025 reflect the recognition of portions of both the upfront payment and the IND milestone payment from the license agreement with Gilead. R&D expenses for the second quarter of 2026 were approximately $6.3 million, compared to approximately $5.6 million in the second quarter of 2025. G&A expenses for the second quarter of 2026 were approximately $2.3 million, compared to approximately $2.2 million in the second quarter of 2025. Net loss for the second quarter of 2026 was approximately $7.0 million, or $0.07 per basic and diluted share, compared to a net loss of approximately $7.3 million, or $0.08 per basic and diluted share, in the second quarter of 2025. Full financial tables are included below. Conference Call and Webcast Information The Company will hold a conference call today, August 3, 2026, at 8:30 AM ET to review its second quarter 2026 results. To access the conference call by telephone, please dial 1-866-744-5399 from the United States, or +972-3-918-0644 internationally. The call will also be available via live webcast through Compugen's website, located at the following link. Following the live audio webcast, a replay will be available on the Company's website. About Compugen Compugen is a clinical-stage therapeutic discovery and development company utilizing Unigen™, its AI/ML powered computational discovery platform, to identify novel drug targets and to develop therapeutics in the field of cancer immunotherapies. Compugen's innovative immuno-oncology pipeline consists of COM701, rilvegostomig and GS-0321 (previously COM503). COM701, a potential first-in-class anti-PVRIG antibody, is currently being evaluated in a blinded randomized ovarian cancer adaptive platform trial as a single agent in maintenance therapy in relapsed platinum sensitive ovarian cancer (named MAIA-ovarian trial). Rilvegostomig, a PD-1/TIGIT bispecific antibody with a TIGIT component that is derived from COM902, Compugen's anti-TIGIT antibody, is being developed by AstraZeneca pursuant to an exclusive license agreement between Compugen and AstraZeneca and is being evaluated in multiple Phase 3, Phase 2 and Phase 1 clinical trials. GS-0321 (previously COM503), Compugen's potential first-in-class high affinity antibody, which blocks the interaction between IL-18 binding protein and IL-18, is licensed to Gilead and is being evaluated in a Phase 1 clinical trial that Compugen is conducting. In addition, Compugen has an early-stage immuno-oncology pipeline that consists of research programs aiming to address various mechanisms to enhance anti-cancer immunity. Compugen's shares are listed on Nasdaq and the Tel Aviv Stock Exchange under the ticker symbol CGEN. Forward-Looking Statement This press release contains "forward-looking statements" within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended, and the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are based on the current beliefs, expectations, and assumptions of Compugen. Forward-looking statements can be identified using terminology such as "will," "may," "expects," "anticipates," "believes," "potential," "plan," "goal," "estimate," "likely," "should," "confident," and "intends," and similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements include, but are not limited to, statements regarding our expectations for COM701 MAIA-ovarian to have median progression-free survival data at the interim analysis by Q1 2027; statements regarding the biological and clinical rationale for evaluating COM701 in platinum-sensitive ovarian cancer and the potential of clear prolongation of PFS in these patients versus placebo to inform a registration path, serve as a backbone for combinations; statements regarding the potential clinical meaningful success of the MAIA-Ovarian trial to enable a broader clinical development across ovarian cancer and other indications; statements regarding AstraZeneca's advancement of its rilvegostomig program; statements regarding the advancement of Phase 1 trial for Gilead-partnered GS-0321; statements to the effect that our cash and cash-related balances will be sufficient to fund our operating plans into 2029. These forward-looking statements involve known and unknown risks and uncertainties that may cause the actual results, performance, or achievements of Compugen to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Among these risks: the clinical trials of any product candidates that Compugen, or any current or future collaborators, may develop may fail to satisfactorily demonstrate safety and efficacy to the FDA, and Compugen, or any collaborators, may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of these product candidates; Compugen's business model is substantially dependent on entering into collaboration agreements with third parties and Compugen may not be successful in generating adequate revenues or commercializing aspects of its business model; Compugen's approach to the discovery of therapeutic products is based on its proprietary computational target discovery infrastructure, which is unproven clinically; general market, political and economic conditions in the countries in which Compugen operates, including Israel; the effect of the evolving nature of the recent war in Israel; and Compugen does not know whether it will be able to discover and develop additional potential product candidates or products of commercial value. These risks and other risks are more fully discussed in the "Risk Factors" section of Compugen's most recent Annual Report on Form 20-F as filed with the Securities and Exchange Commission (SEC) as well as other documents that may be subsequently filed by Compugen from time to time with the SEC. In addition, any forward-looking statements represent Compugen's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. Compugen does not assume any obligation to update any forward-looking statements unless required by law. Company contact: Lindsey Trickett Head of Investor Relations and Corporate Communications Email: [email protected] Tel: +1 (628) 241-0071 SOURCE Compugen Ltd. 21% more press release views with Request a Demo

Phase 1Clinical ResultLicense out/inPhase 3Immunotherapy

27 Jul 2026

·www.businesswire.com

Sonesitatug vedotin demonstrated a statistically significant and highly clinically meaningful improvement in overall survival in 2nd and later-line CLDN18.2-positive advanced gastric/GEJ cancers

WILMINGTON, Del.--(BUSINESS WIRE)--Positive high-level results from the CLARITY-Gastric01 global Phase III trial showed that sonesitatug vedotin (Sone-Ve) demonstrated a statistically significant and highly clinically meaningful improvement in overall survival (OS) in 2nd and later-line Claudin 18.2-positive advanced gastric cancers versus investigator’s choice of therapy. The trial included patients with locally advanced or metastatic gastric cancer, gastroesophageal junction (GEJ) cancer, or esophageal adenocarcinoma (EAC) with Claudin 18.2 (CLDN18.2) expression on at least 25% of tumor cells at any staining intensity. The trial had dual primary endpoints of OS in 3rd and later-line treatment and progression-free survival (PFS) in the overall trial population. The trial met the dual primary endpoint of OS in 3rd and later-line treatment, and a key secondary endpoint of OS in the overall trial population of patients treated in the 2nd and later-line setting, demonstrating a statistically significant and highly clinically meaningful improvement. For the other dual primary endpoint of PFS as assessed by blinded independent central review (BICR), results showed a trend toward improved PFS in patients treated in the 2nd and later-line setting but did not reach statistical significance. The majority of patients with gastric/GEJ cancers are diagnosed at an advanced or metastatic stage, where the prognosis is especially poor and treatment options are limited, with less than 20% surviving more than one year.1,2 CLDN18.2 has emerged as an important therapeutic target for these patients, with an estimated 60% of gastric/GEJ cancers expressing CLDN18.2 in 25% or more of tumor cells.3 Each year, there are roughly 183,500 patients in the US, EU, China and Japan treated in the 2nd and later-line setting for advanced or metastatic CLDN18.2-positive, non-HER2-positive gastric/GEJ cancers.4 Rui-Hua Xu, M.D., Ph.D., Professor in the Department of Medical Oncology, Sun Yat-Sen University Cancer Center, Guangzhou, China, and principal investigator of the trial said: “Metastatic gastric cancer is an aggressive disease with very limited options once patients progress after first-line treatment. Sone-Ve is the first CLDN18.2-targeted antibody drug conjugate to demonstrate an overall survival benefit in this setting and has the potential to establish a new precision treatment for a broader population of patients with CLDN18.2 expression.” Susan Galbraith, Executive Vice President, Oncology Haematology R&D, said: “Sone-Ve has the potential to reshape the treatment of gastric cancer by replacing classic chemotherapy with this novel targeted antibody drug conjugate to improve outcomes for patients. These transformative results from the first Phase III readout for Sone-Ve, together with our broad development program, highlight the potential for Sone-Ve to become an important new medicine in CLDN18.2-positive cancers.” Sone-Ve was well tolerated, and its profile was consistent with the known safety profile of Sone-Ve with no new safety signals identified. Sone-Ve is a potential global first-in-class CLDN18.2-targeting antibody drug conjugate (ADC) with a monomethyl auristatin E (MMAE) payload. These data will be presented at a forthcoming medical meeting and shared with global regulatory authorities. Sone-Ve has received Orphan Drug Designation from the US Food and Drug Administration and the European Commission for the treatment of gastric and GEJ cancers. It has also received Breakthrough Designation in China for the 2nd-line treatment of gastric cancer. Notes Gastric and GEJ cancers Gastric (stomach) cancer is the fifth most common cancer worldwide and the fifth-leading cause of cancer-related death.5 Nearly one million new patients were diagnosed with gastric cancer in 2024, with approximately 650,000 deaths reported globally. In many regions, its incidence has been increasing in patients younger than 50 years old, along with other gastrointestinal (GI) malignancies.5 GEJ cancer is a type of gastric cancer that arises from and spans the area where the esophagus connects to the stomach.6 Most advanced gastric cancer patients will eventually experience disease progression after standard 1st-line therapies, and subsequent lines yield poor outcomes, with median survival of 5-9 months for patients receiving 2nd and later-line systemic treatments.7-9 CLARITY-Gastric01 CLARITY-Gastric01 is a randomized, open-label, sponsor-blinded, multicenter, global Phase III trial evaluating Sone-Ve as a 2nd and later-line therapy for patients with advanced or metastatic gastric cancer, GEJ cancer, or EAC with CLDN18.2 expression in 25% or more of tumor cells, with IHC+ of any intensity. In the trial, patients were randomized 1:1:1 in Stage 1 (dose selection) to Sone-Ve monotherapy 2.2 mg/kg or 1.8 mg/kg every three weeks, or investigator’s choice of therapy, the comparator arm. In Stage 2, the trial continued with Sone-Ve 2.2 mg/kg as the recommended Phase III dose. The efficacy analyses from this study will also provide the basis to evaluate the clinical performance of the Ventana SP455 assay for the identification of patients with advanced or metastatic gastric, GEJ or EAC cancers expressing CLDN18.2 who may benefit from Sone-Ve. The trial is being conducted in 175 centers across 19 countries, including in North America, Europe, South America and Asia. Its dual primary endpoints are PFS as assessed by BICR in the 2nd and later-line setting and OS in the 3rd and later-line setting. A key secondary endpoint is OS in the 2nd and later-line setting. Sonesitatug Vedotin (Sone-Ve) Sone-Ve is a novel ADC targeting CLDN18.2, a protein found in the stomach lining and a validated therapeutic target in oncology, particularly for GI cancers. Sone-Ve consists of an anti-CLDN18.2 monoclonal antibody, a protease-degradable linker and a cytotoxic small molecule MMAE payload. AstraZeneca entered into a global exclusive license agreement with KYM Biosciences to develop and commercialize Sone-Ve in March 2023. In addition to CLARITY-Gastric01, Sone-Ve is being evaluated in the CLARITY-Gastric02 Phase III trial in combination with capecitabine, with or without rilvegostomig, as a 1st-line treatment for advanced or metastatic gastric cancer, GEJ cancer and EAC. In Phase II development, Sone-Ve is being evaluated in patients with advanced solid tumors in multiple combinations across settings, including in CLDN18.2-positive pancreatic and biliary tract cancers (BTC). AstraZeneca in GI cancers AstraZeneca has a broad development program for the treatment of GI cancers across several medicines and a variety of tumor types and stages of disease. In 2024, GI cancers collectively represented approximately 5 million new cancer cases leading to approximately 3.3 million deaths.10 Within this program, the Company is committed to improving outcomes in gastric, liver, biliary tract, esophageal, pancreatic and colorectal cancers. Durvalumab, an anti-PDL1 antibody, is approved in the US, China, EU, Japan and other countries in combination with chemotherapy in locally advanced or metastatic BTC, in combination with tremelimumab-actl in unresectable hepatocellular carcinoma (HCC) and in combination with FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin, and docetaxel) in early-stage and locally advanced gastric and GEJ cancers. Durvalumab is also approved as a monotherapy in unresectable HCC in Japan, China and the EU. Fam-trastuzumab deruxtecan-nxki, a HER2-directed ADC is approved in the US, China, EU, Japan and several other countries for HER2-positive advanced gastric cancer. Fam-trastuzumab deruxtecan-nxki is jointly developed and commercialized by AstraZeneca and Daiichi Sankyo. Olaparib, a first-in-class PARP inhibitor, is approved in the US and several other countries for the treatment of BRCA-mutated metastatic pancreatic cancer. Olaparib is developed and commercialized in collaboration with Merck & Co., Inc., known as MSD outside the US and Canada. Savolitinib, an oral, potent, and highly selective MET tyrosine kinase inhibitor (TKI), has received conditional approval in China for the treatment of patients with locally advanced or metastatic gastric cancer or GEJ adenocarcinoma harboring MET amplification who have progressed on at least two prior lines of systemic therapy. Savolitinib is being jointly developed and commercialized by AstraZeneca and HUTCHMED. The Company is also assessing rilvegostomig, a PD-1/TIGIT bispecific antibody, in combination with chemotherapy as an adjuvant therapy in BTC, and in combination with fam-trastuzumab deruxtecan-nxki in previously untreated, HER2-expressing, locally advanced or metastatic BTC. Rilvegostomig is also being evaluated in combination with bevacizumab with or without tremelimumab-actl as a 1st-line treatment in patients with advanced HCC, and as a 1st-line combination treatment in patients with HER2-positive, or CLDN18.2-positive and HER2-negative, locally advanced unresectable or metastatic gastric and GEJ cancers. In addition to Sone-Ve, AstraZeneca is also advancing AZD5863, a novel CLDN18.2/CD3 T-cell engager bispecific antibody licensed from Harbour Biomed in Phase I development. In early development, AstraZeneca is developing AZD7003, a Glypican 3 armored CAR T, in HCC. The Company is also advancing a pan-KRAS inhibitor program licensed from Jacobio Pharma, which is being evaluated in Phase I trials in advanced solid tumors with KRAS alterations, including in pancreatic ductal adenocarcinoma. AstraZeneca in oncology AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients. The Company's focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyze changes in the practice of medicine and transform the patient experience. AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death. AstraZeneca AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca-us.com and follow the Company on social media @AstraZeneca. References Davis JA, et al. Treatment heterogeneity and overall survival in patients with advanced/metastatic gastric or gastroesophageal junction adenocarcinoma in the United States. J Gastrointest Oncol . 2022 Jun;13(3):949-957. Cancer Research UK. Survival for stomach cancer. https://www.cancerresearchuk.org/about-cancer/stomach-cancer/survival . Accessed July 2026. Poniewierska-Baran A, et al. Claudin18.2 as a Promising Therapeutic Target in Gastric Cancer. Cells. 2025;14(16):1285. AstraZeneca PLC. Investor Relations Epidemiology Spreadsheet. Top 8 Countries. Available at: https://www.astrazeneca.com/investor-relations.html . Accessed July 2026. World Health Organization. International Agency for Research on Cancer. Stomach Fact Sheet. Available at: https://gco.iarc.who.int/today/en/fact-sheets-cancers/7/stomach . Accessed July 2026. National Cancer Institute. Gastroesophageal junction. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/gastroesophageal-junction . Accessed July 2026. Abderhalden LA, et al. Clinical Outcomes for Previously Treated Patients with Advanced Gastric or Gastroesophageal Junction Cancer: A Systematic Literature Review and Meta-Analysis. J Gastrointest Cancer. 2023;54(4):1031-1045. Ford HE, et al. Docetaxel versus active symptom control for refractory oesophagogastric adenocarcinoma (COUGAR-02): an open-label, phase 3 randomised controlled trial. ⁠ The Lancet Oncology , 2014;15(1), 78-86. Wilke H, et al. Ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (RAINBOW): a randomised, multicentre, double-blind, phase 3 trial. ⁠ The Lancet Oncology , 2014;15(11), 1224-1235. World Health Organization. World Cancer Fact Sheet. Available at https://gco.iarc.who.int/today/en/fact-sheets-populations/900/world . Accessed July 2026. US- 114581 Last Updated 7/26

Phase 3Clinical ResultPhase 1License out/inDrug Approval

21 Jul 2026

·www.prnewswire.com

Compugen to Participate in BTIG Biotechnology Conference 2026

HOLON, Israel, July 21, 2026 /PRNewswire/ -- Compugen Ltd. (NASDAQ: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery powered by AI/ML, today announced that management will present and hold 1x1 meetings at the BTIG Biotechnology Conference 2026 taking place virtually from July 28-29, 2026. Please reach out to your BTIG representative to request a meeting. A replay for this event will not be available. About Compugen Compugen is a clinical-stage therapeutic discovery and development company utilizing Unigen™, its AI/ML powered computational discovery platform, to identify novel drug targets and to develop therapeutics in the field of cancer immunotherapies. Compugen's innovative immuno-oncology pipeline consists of COM701, rilvegostomig and GS-0321 (previously COM503). COM701, a potential first-in-class anti-PVRIG antibody, is currently being evaluated in a blinded randomized ovarian cancer adaptive platform trial as a single agent in maintenance therapy in relapsed platinum sensitive ovarian cancer (named MAIA-ovarian trial). Rilvegostomig, a PD-1/TIGIT bispecific antibody with a TIGIT component that is derived from COM902, Compugen's anti-TIGIT antibody, is being developed by AstraZeneca pursuant to an exclusive license agreement between Compugen and AstraZeneca and is being evaluated in multiple Phase 3, Phase 2 and Phase 1 clinical trials. GS-0321 (previously COM503), Compugen's potential first-in-class high affinity antibody, which blocks the interaction between IL-18 binding protein and IL-18, is licensed to Gilead and is being evaluated in a Phase 1 clinical trial that Compugen is conducting. In addition, Compugen has an early-stage immuno-oncology pipeline that consists of research programs aiming to address various mechanisms to enhance anti-cancer immunity. Compugen's shares are listed on Nasdaq and the Tel Aviv Stock Exchange under the ticker symbol CGEN. Company Contact: Lindsey Trickett Head of Investor Relations and Corporate Communications Email: [email protected] Tel: +1 (628) 241-0071 SOURCE Compugen Ltd. 21% more press release views with Request a Demo

Phase 1License out/inImmunotherapyPhase 2

100 Deals associated with Rilvegostomig

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Muscle Invasive Bladder Urothelial Carcinoma	Phase 3	United States	AstraZeneca PLC	16 Jul 2026
Muscle Invasive Bladder Urothelial Carcinoma	Phase 3	China	AstraZeneca PLC	16 Jul 2026
Muscle Invasive Bladder Urothelial Carcinoma	Phase 3	Japan	AstraZeneca PLC	16 Jul 2026
Muscle Invasive Bladder Urothelial Carcinoma	Phase 3	Australia	AstraZeneca PLC	16 Jul 2026
Muscle Invasive Bladder Urothelial Carcinoma	Phase 3	Brazil	AstraZeneca PLC	16 Jul 2026
Muscle Invasive Bladder Urothelial Carcinoma	Phase 3	Canada	AstraZeneca PLC	16 Jul 2026
Muscle Invasive Bladder Urothelial Carcinoma	Phase 3	France	AstraZeneca PLC	16 Jul 2026
Muscle Invasive Bladder Urothelial Carcinoma	Phase 3	Germany	AstraZeneca PLC	16 Jul 2026
Muscle Invasive Bladder Urothelial Carcinoma	Phase 3	India	AstraZeneca PLC	16 Jul 2026
Muscle Invasive Bladder Urothelial Carcinoma	Phase 3	Italy	AstraZeneca PLC	16 Jul 2026

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05775159 (GEMINI-Hepatobiliary, ASCO2026)	Phase 2	Advanced biliary tract cancer First line	30	Rilvegostomig + gemcitabine + cisplatin	ajrxldibqt(rzemsypise) = The most common were anemia (53.3%), neutrophil count decreased (50.0%), and platelet count decreased (43.3%). vxrpceukyc (wzltoeeaqi )	Positive	29 May 2026
NCT07221253 (ARTEMIDE-Biliary02, ASCO2026)	Phase 3	Advanced biliary tract cancer First line	1,100	Rilvegostomig + Gemcitabine + Cisplatin	nezympxozy(ouectakbqd) = almgcdavvz ysuvurocvi (mmqbmlosob ) View more	Positive	29 May 2026
				Durvalumab + Gemcitabine + Cisplatin	nezympxozy(ouectakbqd) = jeqxpnsetx ysuvurocvi (mmqbmlosob ) View more
NCT05414032 (MERIDIAN, AACR2026)	Phase 2	Advanced Head and Neck Squamous Cell Carcinoma human papillomavirus (HPV)	46	Rilvegostomig 750mg IV q3w x 6	aylykxztbp(bubujpnckj) = The pt on Rv achieved ctDNA clearance at Part D weeks 2 and 10 and remains recurrence-free with undetectable ctDNA 12 months post-Rv. jvkufjzmmo (sntulwpctj ) View more	Positive	20 Apr 2026
NCT06989112 (DESTINY-Endometrial01, ESGO2026)	Phase 3	Recurrent Endometrial Cancer First line HER2-expressing \| mismatch repair-proficient (pMMR)	600	trastuzumab deruxtecan + rilvegostomig	lmdpmcknoy(gqkjxwxand) = gqnfomcilq jtxwlbonxg (lohvunhjcu, 24.9 - NR) View more	Positive	28 Feb 2026
				trastuzumab deruxtecan + pembrolizumab	nyenwxoisa(gkiroocsjn) = zfugylzqdj uqfvpahpzv (znobdnmtxz, 8.3 - 16.5) View more
NCT06764875 (ARTEMIDE-Gastric01, ASCO_GI2026)	Phase 3	Metastatic HER2 positive gastroesophageal junction cancer First line HER2-positive \| PD-L1 CPS ≥1	840	rilvegostomig + T-DXd + investigator’s choice of capecitabine or 5-fluorouracil (5-FU)	evrllmoofa(msoamklqoz) = xjhledghmk qtmaiqlyvw (kdutgvdsbj, 24.9 - NR)	Positive	08 Jan 2026
				rilvegostomig + trastuzumab + investigator’s choice of FP or CAPOX	ngqheshxhg(ihvurfsniq) = hxlceqrvdm vmpmdqrfoa (taqugwsvry, 17.0 - NR) View more
NCT06921785 (ARTEMIDE-HCC01, ESMO_ASIA2025)	Phase 3	Unresectable Hepatocellular Carcinoma First line	1,220	Rilvegostomig + Bevacizumab + Tremelimumab	wfxibxsunb(ylgcjbebqd) = ybtnxhdina ypdupqimom (amzevgwlpq, 17 - 32) View more	Positive	05 Dec 2025
				Tremelimumab + Rilvegostomig + Bevacizumab	wfxibxsunb(ylgcjbebqd) = qovkxcutge ypdupqimom (amzevgwlpq, 17 - 32) View more
NCT06868277 (ARTEMIDE-Lung04, ESMO2025)	Phase 3	metastatic non-small cell lung cancer First line PD-L1 expression ≥50%	830	Rilvegostomig	irblceanju(emgaqkflqb) = qgiwgrwhbw rfzflumzjc (pigeoffdup ) View more	Positive	17 Oct 2025
				Pembrolizumab	irblceanju(emgaqkflqb) = oqlqpkyzis rfzflumzjc (pigeoffdup ) View more
NCT05775159 (GEMINI-Hepatobiliary substudy 2 Cohort A, ASCO2025)	Phase 2	Advanced biliary tract cancer First line	-	Rilve plus Gemcitabine and Cisplatin	evulssbzfj(canrzevnqw) = lmwdkwtmsb aaltxfycvh (eytlhcmlnx ) View more	Positive	30 May 2025
NCT05702229 (GEMINI-Gastric, ESMO2024) Manual	Phase 2	HER2 negative Gastric Cancer First line HER2-negative	40	Rilvegostomig 750 mg Q3W IV + XELOX (oxaliplatin + capecitabine)	wguwafuheb(xyrwngzifi) = fiixgmltyv gnjkawmplu (csbphtltmj, 50.9 - 81.4) View more	Positive	16 Sep 2024
NCT04995523 (ARTEMIDE-01, WCLC2024) Manual	Phase 1/2	metastatic non-small cell lung cancer Second line \| First line PD-L1	96	Rilvegostomig 750 mg (PD-L1 TPS 1-49%)	ntfpcijmdb(xshhlxouyo) = yluviuncuq xjpwemzbsd (xamtljnmua ) View more	Positive	09 Sep 2024
				Rilvegostomig 750 mg	ntfpcijmdb(xshhlxouyo) = jmmdhcdeco xjpwemzbsd (xamtljnmua ) View more

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