rilvegostomig (AZD2936) / AstraZeneca, Compugen, Xoma - LARVOL DELTA

ARTEMIDE-Gastric01: A phase 3 randomized study of rilvegostomig with fluoropyrimidine and trastuzumab deruxtecan (T-DXd) as first-line (1L) treatment for locally advanced or metastatic HER2-positive gastric or gastroesophageal junction cancer (GC/GEJC). (ASCO 2025) - P3 | "Clinical Trial Registration Number: NCT06764875 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • Metastases • P3 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • HER-2

First-line rilvegostomig (rilve) plus chemotherapy (CTx) in advanced biliary tract cancer (BTC): Primary analysis of GEMINI-Hepatobiliary substudy 2 Cohort A. (ASCO 2025) - P2 | "Clinical Trial Registration Number: NCT05775159 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • Metastases • Biliary Cancer • Biliary Tract Cancer • Oncology • Solid Tumor

First-line (1L) datopotamab deruxtecan (Dato-DXd) + rilvegostomig in advanced or metastatic non-small cell lung cancer (a/mNSCLC): Results from TROPION-Lung04 (cohort 5). (ASCO 2025) - P1 | "Clinical Trial Registration Number: NCT04612751 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

ARTEMIDE-Lung03: A phase 3, randomized, double-blind, multicenter, global study of rilvegostomig or pembrolizumab in combination with platinum-based chemotherapy as first-line treatment for patients with metastatic non-squamous non-small-cell lung cancer whose tumors express PD-L1. (ASCO 2025) - P3 | "Clinical Trial Registration Number: NCT06627647 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • Combination therapy • Metastases • P3 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Rilvegostomig: Data from P3 ARTEMIDE-Gastric01 trial (NCT06764875) for HER2-positive locally advanced or metastatic gastric or GEJ adenocarcinoma post 2026 (AstraZeneca) - Q1 2025 Results

P3 data • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology

Rilvegostomig: Data from P2b GEMINI-Gastric trial (NCT05702229) for gastric cancer in 2026 (AstraZeneca) - Q1 2025 Results: Data from P2b GEMINI-Hepatobiliary trial (NCT05775159) for HCC and biliary tract cancer in H2 2025

P2b data • Biliary Tract Cancer • Gastric Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology

Rilvegostomig: Data from P3 ARTEMIDE-Lung04 trial (NCT06868277) for 1L PD-L1 NSCLC post 2026 (AstraZeneca) - Q1 2025 Results: Data from P1/2 ARTEMIDE-Lung01 trial (NCT04995523) for 1L non-squamous NSCLC in 2026

P1/2 data • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology

Volrustomig/Rilvegostomig related "triple M"-myasthenia gravis and overlap syndrome. (PubMed, Postgrad Med J) - No abstract available

Journal • CNS Disorders • Myasthenia Gravis

ARTEMIDE-HCC01: Phase III Study of Rilvegostomig in Combination With Bevacizumab With or Without Tremelimumab as First-line Treatment of Hepatocellular Carcinoma (clinicaltrials.gov) - P3 | N=1220 | Not yet recruiting | Sponsor: AstraZeneca

IO biomarker • New P3 trial • Hepatocellular Cancer • Oncology • Solid Tumor • PD-L1

ARTEMIDE-Gastric01: A Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treatment for HER2-positive Gastric Cancer (clinicaltrials.gov) - P3 | N=840 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

Enrollment open • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • PD-L1

Phase Ib open-label study of trastuzumab deruxtecan (T-DXd) + rilvegostomig ± carboplatin as first-line (1L) treatment (Tx) for metastatic HER2-overexpressing (HER2-OE) non-small cell lung cancer (NSCLC): DESTINY-Lung03 (DL-03) part 4 (ELCC 2025) - P1, P1/2 | "Primary endpoints include adverse events (AEs; including serious AEs), AEs of special interest, and dose-limiting toxicities. Secondary endpoints include confirmed ORR, duration of response, disease control rate, and PFS by investigator per RECIST 1.1; and OS."

Clinical • IO biomarker • Metastases • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HER-2 • TIGIT

TROPION-Lung10: Phase III study of datopotamab deruxtecan (Dato-DXd) + rilvegostomig in non-squamous (NSQ) advanced/metastatic (a/m) non-small cell lung cancer (NSCLC) with high PD-L1 expression and without actionable genomic alterations (AGAs) (ELCC 2025) - P3 | "Funding: This trial is sponsored by AstraZeneca. The first pt was enrolled in April 2024; enrolment is ongoing.Table 122TiPcDato-DXd + rilvegostomig vs rilvegostomig. BICR, blinded independent central review; OS, overall survival; PFS, progression-free survival; PFS2, second progression-free survival; TROP2, trophoblast cell surface antigen 2.aDato-DXd + rilvegostomig vs pembrolizumab.bRilvegostomig vs pembrolizumab."

IO biomarker • Metastases • P3 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1 • TACSTD2 • TIGIT

ARTEMIDELung04: A Global Phase III Study of Rilvegostomig or Pembrolizumab Monotherapy for First-Line Treatment of PD-L1-high Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov) - P3 | N=830 | Not yet recruiting | Sponsor: AstraZeneca

Monotherapy • New P3 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Compugen Reports Fourth Quarter and Full Year 2024 Results (PRNewswire) - "Next Planned Milestones: Q2 2025 – initiation of a randomized adaptive platform trial comparing COM701 maintenance therapy to placebo in total of 60 patients with relapsed platinum sensitive ovarian cancer; 2025 – Compugen's partner, AstraZeneca, plans to share early data for rilvegostomig in combination with their ADCs; H2 2026 – data from projected interim analysis of single agent COM701 sub-trial 1 as maintenance therapy in relapsed platinum sensitive ovarian cancer."

Clinical data • New trial • Ovarian Cancer

Efficacy and Safety of Rilvegostomig (Anti-PD-1/TIGIT Bispecific) for CPI-naïve Metastatic NSCLC with PD-L1 1-49%/>=50% (JSMO 2025) - No abstract available

Clinical • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1 • TIGIT

BLUESTAR: A Phase I/IIa Study of AZD8205 Given Alone or in Combination With Anticancer Drugs, in Participants With Advanced or Metastatic Solid Malignancies (clinicaltrials.gov) - P1/2 | N=370 | Recruiting | Sponsor: AstraZeneca | Trial completion date: Jun 2026 ➔ May 2027 | Trial primary completion date: Jun 2026 ➔ May 2027

Monotherapy • Trial completion date • Trial primary completion date • Biliary Cancer • Biliary Tract Cancer • Breast Cancer • Endometrial Cancer • Hepatology • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor

TROPION-Lung12: A Phase III, Randomised Study of Adjuvant Dato-DXd in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma NSCLC Who Are ctDNA-positive or Have High-risk Pathological Features (clinicaltrials.gov) - P3 | N=660 | Recruiting | Sponsor: AstraZeneca | Trial primary completion date: Oct 2031 ➔ May 2033

Circulating tumor DNA • Monotherapy • Trial primary completion date • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Rilvegostomig: Data from P3 ARTEMIDE-Lung03 trial (NCT06627647) for 1L non-squamous NSCLC post 2026 (AstraZeneca) - Q4 & FY2024 Results: Data from P3 ARTEMIDE-Lung02 trial (NCT06692738) for 1L squamous NSCLC post 2026

P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology

Rilvegostomig: Data from P1/2 ARTEMIDE-Lung01 trial (NCT04995523) for 1L non-squamous NSCLC post 2026 (AstraZeneca) - Q4 & FY2024 Results: Data from P2b GEMINI-Gastric trial (NCT05702229) for gastric cancer in 2026

P1/2 data • Gastric Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology

Rilvegostomig: Data from P2b GEMINI-Hepatobiliary trial (NCT05775159) for HCC and biliary tract cancer in 2026 (AstraZeneca) - Q4 & FY2024 Results: Data from P3 ARTEMIDE-Biliary01 trial (NCT06109779) for biliary tract cancer post 2026

P2 data • P3 data • Biliary Tract Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology

ARTEMIDE-01: A Study of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants With Advanced or Metastatic NSCLC (clinicaltrials.gov) - P1/2 | N=199 | Recruiting | Sponsor: AstraZeneca | Trial primary completion date: Mar 2028 ➔ Aug 2026

Trial primary completion date • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

TROPION-Lung12 Phase 3 Trial Initiated Evaluating DATROWAY as Part of Adjuvant Regimen for Patients with Early-Stage Non-Small Cell Lung Cancer at High Risk of Relapse (Businesswire) - "The first patient has been dosed in the TROPION-Lung12 phase 3 trial evaluating the efficacy and safety of adjuvant DATROWAY (datopotamab deruxtecan) plus rilvegostomig or rilvegostomig monotherapy versus standard of care in patients with stage 1 adenocarcinoma non-small cell lung cancer (NSCLC) after complete surgical resection who are ctDNA-positive or have other high risk pathological features."

Trial status • Non Small Cell Lung Cancer

GEMINI-Gastric: Novel Combinations in Participants With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov) - P2 | N=240 | Recruiting | Sponsor: AstraZeneca | Trial completion date: Mar 2026 ➔ Jan 2027 | Trial primary completion date: Sep 2025 ➔ Jan 2026

Trial completion date • Trial primary completion date • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • CLDN18

Randomized, open-label, multicenter, phase III study of trastuzumab deruxtecan (T-DXd) with rilvegostomig vs standard of care (SOC) in first-line, human epidermal growth factor receptor 2 (HER2)-expressing, locally advanced or metastatic (LA/m) biliary tract cancer (BTC): DESTINY-BTC01 (ESMO Asia 2024) - P3 | "A safety run-in will evaluate the safety and tolerability of T-DXd with rilvegostomig, prior to randomization of patients to 3 arms: T-DXd with rilvegostomig; T-DXd alone; or gemcitabine, cisplatin, and durvalumab. Safety and tolerability will also be assessed. Enrollment is ongoing, with a recruitment target of 620 patients."

Clinical • Metastases • P3 data • Biliary Cancer • Biliary Tract Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • HER-2

A phase Ib/II open-label study evaluating trastuzumab deruxtecan (T-DXd) in combination with rilvegostomig and chemotherapy in patients with HER2-positive (HER2+) and HER2-low gastric or gastroesophageal junction adenocarcinoma (GEJA): DESTINY-Gastric03 Part 4 (ESMO Asia 2024) - P2 | "Initially, T-DXd 5.4 mg/kg intravenous (IV) infusion Q3W, rilvegostomig 750 mg IV Q3W, and an FP (5-fluorouracil or capecitabine) will be evaluated in a safety cohort of ≥6 pts with HER2+ (IHC 3+ or IHC 2+/ISH-positive) or HER2-low (IHC 2+/ISH-negative or IHC 1+) esophageal/gastric/GEJA. Safety and tolerability will be assessed. Enrollment is ongoing."

Clinical • Combination therapy • P1/2 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • HER-2 • PD-1 • PD-L1 • TIGIT