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

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: Jan 2027 ➔ Jul 2027 | Trial primary completion date: Jan 2026 ➔ Jul 2026

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

ALTAIR: A Platform Study in Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) - P1/2 | N=182 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

DESTINY-Endometrial01 Phase 3 Trial of ENHERTU Initiated as First-Line Therapy in Patients with HER2 Expressing Primary Advanced or Recurrent Endometrial Cancer (Daiichi Sankyo Press Release) - "The first patient has been dosed in the DESTINYEndometrial01 phase 3 trial evaluating ENHERTU (trastuzumab deruxtecan) in combination with rilvegostomig or pembrolizumab versus platinum-based chemotherapy (carboplatin and paclitaxel) in combination with pembrolizumab as a first-line therapy in patients with HER2 expressing (IHC 3+/ 2+), mismatch repair proficient (pMMR) primary advanced or recurrent endometrial cancer."

pMMR • Trial status • Endometrial Cancer

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 | "Approximately 840 participants (pts) will be randomized to Arm A: rilvegostomig + T-DXd + investigator's (INV) choice of capecitabine or 5-fluorouracil (5-FU); Arm B: pembrolizumab + trastuzumab + INV choice of 5-FU and cisplatin (FP) or capecitabine and oxaliplatin (CAPOX); Arm C: rilvegostomig + trastuzumab + INV choice of FP or CAPOX. Secondary endpoints include safety/tolerability, objective response rate, and duration of response. Enrollment is planned across ~25 countries in Asia, Australia, Europe, and North and South America."

Clinical • IO biomarker • Metastases • P3 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HER-2 • TIGIT

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 | "GEMINI-Hepatobiliary (NCT05775159) is a phase 2 study evaluating rilve or volrustomig alone or in combination regimens in patients (pts) with advanced hepatocellular carcinoma (substudy 1) or BTC (substudy 2)... Pts aged ≥18 years with previously untreated unresectable/metastatic BTC and an ECOG performance status 0–1 received rilve every 3 weeks (Q3W) for up to 2 years plus gemcitabine 1000 mg/m2 and cisplatin 25 mg/m2 on days 1 and 8 Q3W for up to 8 cycles... Rilve plus CTx demonstrated promising efficacy with a manageable safety profile and sustained target engagement. Longer follow-up for data maturity is warranted. Phase 3 studies with rilve in BTC (ARTEMIDE-Biliary 01; DESTINY-BTC01) are ongoing."

Clinical • IO biomarker • Metastases • Biliary Cancer • Biliary Tract Cancer • Hepatocellular Cancer • Oncology • Solid Tumor • PD-L1 • TIGIT

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 | "The safety profile for the combination of Dato-DXd + rilvegostomig was consistent with the expected toxicities of each agent and without new safety findings. Dato-DXd + rilvegostomig had encouraging activity as 1L treatment for pts with a/mNSCLC without AGAs, with responses seen in both histologies and across all PD-L1 levels."

Clinical • Metastases • Alopecia • Cardiovascular • Dental Disorders • Fatigue • Gastrointestinal Disorder • Immunology • Infectious Disease • Interstitial Lung Disease • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pneumonia • Pulmonary Disease • Respiratory Diseases • Septic Shock • Solid Tumor • Stomatitis • TIGIT

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 | " Approximately 878 pts will be randomized 1:1 to either Arm A: rilvegostomig + PBC (pemetrexed + cisplatin or carboplatin) intravenous (IV) every three weeks (Q3W) for 4 cycles followed by rilvegostomig + pemetrexed maintenance treatment IV Q3W, or Arm B: pembrolizumab + chemotherapy IV Q3W for 4 cycles followed by pembrolizumab + pemetrexed maintenance IV Q3W. Safety/tolerability and biomarkers will also be assessed. The study will be conducted across approximately 350 sites in 25−30 countries."

Clinical • Combination therapy • IO biomarker • Metastases • P3 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • PD-L1 • ROS1 • TIGIT

Rilvegostomig: “GEMINI-HBP in advanced biliary tract cancer: Encouraging efficacy for rilvegostomig + CTx in Phase II trial”; Biliary tract cancer (AstraZeneca) - ASCO 2025

P2 data • Biliary Tract Cancer • Gastrointestinal Cancer • Oncology

ALTAIR: A Platform Study in Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) - P1/2 | N=143 | Not yet recruiting | Sponsor: AstraZeneca

New P1/2 trial • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

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 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

Enrollment open • IO biomarker • Hepatocellular Cancer • Oncology • Solid Tumor • PD-L1

DE-01: DESTINY-Endometrial01: A Phase III Study of Trastuzumab Deruxtecan Plus Rilvegostomig or Pembrolizumab as First-Line Treatment of HER2-Expressing (IHC 3+/2+), Mismatch Repair Proficient (pMMR) Endometrial Cancer (clinicaltrials.gov) - P3 | N=600 | Recruiting | Sponsor: AstraZeneca

Mismatch repair • New P3 trial • pMMR • Endometrial Cancer • Oncology • Solid Tumor

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 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

Enrollment open • Monotherapy • Lung 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