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

Updated Efficacy Results of Rilvegostomig for Checkpoint Inhibitor (CPI)-NaïVe Metastatic Non-Small-Cell Lung Cancer (Mnsclc) (IASLC-WCLC 2026) - P1/2, P3 | "The observed pharmacodynamic immune response corresponded with clinical outcomes, consistent with the mechanism of action of rilvegostomig. These data support ongoing phase 3 studies, including ARTEMIDE-Lung02 (NCT06692738), ARTEMIDE-Lung03 (NCT06627647), and ARTEMIDE-Lung04 (NCT06868277)."

Checkpoint inhibition • Clinical • IO biomarker • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • GZMB • ICOS • IFNG • TIGIT

Session II: Immune Cell Engagers and Bispecifics: From Bench to Bispecific: The Rilvegostomig Program at a Glance (SITC 2026) - No abstract available

Bispecific • Immune cell • Oncology

ALTAIR substudy 2: A Phase 1b/2 platform study evaluating rilvegostomig in combination with chemotherapy (CT), with or without ramucirumab, in patients (pts) with advanced or metastatic NSCLC (ESMO 2026) - No abstract available

Clinical • Combination therapy • Metastases • P1/2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

CLARITY-Gastric 02: a randomised Phase 3 study of sonesitatug vedotin (Sone-Ve) and capecitabine with or without rilvegostomig in Claudin18.2 positive (CLDN18.2+) advanced or metastatic gastric, gastroesophageal junction, or oesophageal adenocarcinoma (GC / GEJC / EAC) (ESMO 2026) - No abstract available

Clinical • Metastases • P3 data • Gastric Cancer • Oncology • Solid Tumor • CLDN18

H-FROG: Perioperative Retlirafusp Alfa(Anti-PD-L1/TGF-β Bifunctional Fusion Protein) Plus Famitinib and GEMOX-Based Hepatic Arterial Infusion Chemotherapy for Locally Advanced Intrahepatic Cholangiocarcinoma: A Multicenter, Single-Arm, Exploratory Phase II Trial (clinicaltrials.gov) - P2 | N=81 | Recruiting | Sponsor: The First Affiliated Hospital with Nanjing Medical University

New P2 trial • Biliary Cancer • Cholangiocarcinoma • Oncology • Solid Tumor

LIBRA: A Phase 2, Open-Label Platform Study Evaluating Novel Agent-Based Combinations in Locally Advanced or Metastatic NSCLC (IASLC-WCLC 2026) - P2 | "Approaches targeting angiogenesis and the PD-1/PD-L1 axis have demonstrated benefit in previously treated AGA-positive (the ORIENT-31 and HARMONi-A studies) and AGA-negative (the Lung-MAP S1800A study of ramucirumab [anti-VEGFR2 monoclonal antibody] plus pembrolizumab) advanced NSCLC...Dato-DXd plus ramucirumab and rilvegostomig may further improve efficacy over Dato-DXd monotherapy in patients with EGFR m NSCLC that has progressed on prior EGFR TKIs...Response and progression will be assessed by investigators per RECIST v1.1. Exploratory objectives include assessment of molecular responses based on ctDNA, pharmacodynamic and predictive biomarkers, and multiomics."

Clinical • IO biomarker • Metastases • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • TIGIT

D9750C00001: Study of AZD5863 in Adult Participants With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=392 | Recruiting | Sponsor: AstraZeneca | N=280 ➔ 392 | Trial completion date: Jul 2027 ➔ Mar 2029 | Trial primary completion date: Jul 2027 ➔ Mar 2029

Enrollment change • Trial completion date • Trial primary completion date • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18

WIRE - Novel Treatments in Renal Cell Cancer (clinicaltrials.gov) - P2 | N=134 | Recruiting | Sponsor: CCTU- Cancer Theme | N=60 ➔ 134 | Trial completion date: Nov 2025 ➔ Dec 2027 | Trial primary completion date: Nov 2025 ➔ Dec 2027

Enrollment change • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • IL2 • TIGIT

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=25 | Active, not recruiting | Sponsor: AstraZeneca | Trial completion date: Jun 2027 ➔ Mar 2027 | Trial primary completion date: Jun 2027 ➔ Jul 2026

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

A phase 3, randomized study of adjuvant rilvegostomig plus chemotherapy in resected biliary tract cancer: ARTEMIDE-Biliary01. (ASCO 2024) - P3 | " ARTEMIDE-Biliary01 (NCT06109779) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, global study to assess the efficacy and tolerability of rilvegostomig IV every three weeks versus placebo in combination with investigator's choice of chemotherapy (capecitabine, S-1 [tegafur/gimeracil/oteracil] or gemcitabine/cisplatin) as adjuvant treatment in patients with BTC after curative intent resection. Additional endpoints include progression-free survival following recurrence, patient-reported tolerability, and safety. Enrollment has begun, and approximately 200 sites will be recruiting globally across Asia, Australia, Europe, North America, and South America."

Clinical • P3 data • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Gastrointestinal Disorder • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • TIGIT

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 | Trial primary completion date: Mar 2029 ➔ Mar 2030

IO biomarker • Trial primary completion date • Hepatocellular Cancer • Oncology • Solid Tumor • PD-L1

CLARITY-Gastric 02: Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma Expressing Claudin18.2 (clinicaltrials.gov) - P3 | N=2130 | Recruiting | Sponsor: AstraZeneca

Trial initiation date • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • CLDN18 • PD-L1

Safety, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of AZD2936, a bispecific antibody targeting PD-1 and TIGIT, in checkpoint inhibitor (CPI)-experienced advanced/metastatic non-small-cell lung cancer (NSCLC): First report of ARTEMIDE-01. (ASCO 2023) - P1/2 | "In this interim analysis, AZD2936 showed an acceptable safety profile and preliminary antitumor activity in pts with advanced/metastatic NSCLC previously treated with standard therapy including CPIs. Further exploration of AZD2936 in CPI-naïve NSCLC pts, including a randomized dose optimization cohort is ongoing. Clinical trial information: NCT04995523."

Checkpoint inhibition • Clinical • IO biomarker • Metastases • PK/PD data • Dermatology • Fatigue • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pruritus • Solid Tumor • Squamous Cell Carcinoma • PD-L1 • TIGIT

Efficacy and safety of rilvegostomig, an anti-PD-1/TIGIT bispecific antibody, for checkpoint inhibitor (CPI)-naïve metastatic non-small cell lung cancer (mNSCLC): ARTEMIDE-01 (ESMO 2025) - P1/2, P3 | "Data supports ongoing Ph3 studies in mNSCLC including ARTEMIDE-Lung02 (NCT06692738), -Lung03 (NCT06627647) and -Lung04 (NCT06868277). Table: 1853MO PD-L1 TPS (local) 1–49% ≥50% Rilvegostomig 750 mg CPI-naive (n=31) CPI + CT-naïve (n=18) CPI-naïve (n=34) CPI + CT-naïve (n=31) Response, n (%) ORR 9 (29.0) 8 (44.4) 21 (61.8) 21 (67.7) Complete response 0 0 1 (2.9) 1 (3.2) Partial response 9 (29.0) 8 (44.4) 20 (58.8) 20 (64.5) Stable disease 11 (35.5) 5 (27.8) 9 (26.5) 7 (22.6) Progression 9 (29.0) 5 (27.8) 4 (11.8) 3 (9.7) Not evaluable 2 (6.5) 0 0 0 Median (95% CI) DoR, months 9.9 (4.1, 14.6) 8.5 (4.1, NC) NC (10.3, NC) NC (10.3, NC) PFS Events, n (%) 27 (87.1) 15 (83.3) 18 (52.9) 15 (48.4) Median (95% CI) PFS, months 6.1 (2.7, 8.3) 7.8 (1.9, 12.5) 12.3 (8.4, NC) 21.2 (10.2, NC) PFS-12, % (95% CI) 27.2 (12.9, 43.6) 30.1 (11.1, 52.0) 55.5 (37.3, 70.3) 60.8 (41.4, 75.6)"

Checkpoint inhibition • Clinical • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-1 • TIGIT

WIRE: Window of Opportunity Clinical Trials Platform for Evaluation of Novel Treatments Strategies in Renal Cell Cancer (KCRS 2024) - P2 | "Cediranib + Olaparib (a PARP inhibitor), 3...Volrustomig (anti PD-1/CTLA4 bispecific) and 5. Rilvegostomig (anti PD-1/TIGIT bispecific)...WIRE may identify novel biomarkers of response and toxicity, to inform treatment selection for patients. The data generated will be a foundation for further trials of these IMPs in advanced disease."

Clinical • IO biomarker • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • CD8 • TIGIT

Datopotamab deruxtecan (Dato-DXd) + rilvegostomig (rilve) in patients (pts) with locally advanced or metastatic urothelial cancer (a/mUC): Results from the phase II TROPION-PanTumor03 study (ESMO 2025) - P2 | "We present results from pts with a/mUC who received Dato-DXd + rilve, an Fc reduced anti–PD-1/TIGIT bispecific antibody (anti–TIGIT component derived from COM902 [Compugen]). Methods Pts with histologically documented unresectable a/mUC were enrolled in two eligible populations: 1L population, no prior systemic therapy in the a/mUC setting (progression >12 months after platinum-based neoadjuvant or adjuvant therapy permitted), and ineligible for cisplatin-based chemotherapy (CT); 2L population, had received previous platinum-based CT in the a/mUC setting or progressed <12 months after platinum-based neoadjuvant or adjuvant therapy...Conclusions Dato-DXd in combination with rilve showed encouraging efficacy and a manageable safety profile in pts with a/mUC. Table: 3072MO Incidence of AEs, n (%) Dato-DXd + rilve 1L (n=22) 2L (n=18) TRAEs 21 (95.5) 17 (94.4) Grade ≥3 TRAEs 4 (18.2) 7 (38.9) Any TRAE leading to: Dose reduction of any study treatment 12 (54.5) 4..."

Clinical • Metastases • P2 data • Pan tumor • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • TIGIT

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. (ASCO 2026) - P2 | "Pts in arm D received T-DXd 6.4 mg/kg + pembrolizumab (pembro) + fluoropyrimidine (FP; 5-fluorouracil or capecitabine), and pts in arm F received T-DXd 5.4 mg/kg + pembro + FP. In Part 4, pts with previously untreated advanced HER2-expressing (IHC 3+, IHC 2+/ISH+, IHC 2+/ISH−, or IHC 1+) GC/GEJA/EA were enrolled and received T-DXd 5.4 mg/kg + rilvegostomig (rilve; a monovalent, Fc-reduced, bispecific IgG1 antibody against PD-1 and TIGIT receptors) + FP... Results with T-DXd (5.4 mg/kg)–based regimens were generally consistent with the known safety profiles of each agent; no new signals were observed. Safety data support use of pembro/rilve as combination partners for T-DXd (5.4 mg/kg) in advanced HER2-expressing GCs. *Assessed by the investigator as possibly related to any investigational product (IP); †ILD/pneumonitis (n=2), respiratory failure due to pneumonitis/pneumocytis jirovecii infection (n=1), febrile neutropenia (n=1); ‡pneumonia."

Clinical • Metastases • Esophageal Adenocarcinoma • Febrile Neutropenia • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Infectious Disease • Interstitial Lung Disease • Neutropenia • Oncology • Pneumonia • Pulmonary Disease • Respiratory Diseases • Solid Tumor • HER-2 • TIGIT

Efficacy and Safety of Rilvegostomig, an Anti-PD-1/TIGIT Bispecific, for CPI-naïve Metastatic NSCLC with PD-L1 1-49% or ≥50% (IASLC-WCLC 2024) - P1/2 | "Conclusions : In CPI-naïve patients, rilvegostomig showed a favourable safety profile and encouraging preliminary efficacy in those with PD-L1 TPS 1‒49% and PD-L1 TPS ≥50%. Data support 750 mg Q3W as the pivotal dose for registrational studies."

Clinical • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-1 • PD-L1 • TIGIT

ARTEMIDE-Lung02: A Phase 3 Global Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for 1L Metastatic Squamous NSCLC (IASLC-WCLC 2025) - P3 | "Methods : Approximately 880 pts will be randomised 1:1 to either Arm A: rilvegostomig + chemotherapy (carboplatin + paclitaxel or nab-paclitaxel) intravenous (IV) every three weeks (Q3W) for 4 cycles followed by rilvegostomig IV Q3W, or Arm B: pembrolizumab + chemotherapy IV Q3W for 4 cycles followed by pembrolizumab IV Q3W. Additional endpoints include safety/tolerability and biomarkers. Enrolment is planned across approximately 350 sites in 25-30 countries."

Clinical • IO biomarker • Metastases • P3 data • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Solid Tumor • TIGIT

Neoadjuvant rilvegostomig (R) + trastuzumab deruxtecan (T-DXd) in high-risk HER2-negative breast cancer: Results from the I-SPY 2.2 trial. (ASCO 2026) - P2 | "All HER2-negative subtypes were eligible for R + T-DXd in Block A. Predicted responders at the end of Block A or B could undergo surgery; otherwise, they continued to Block B +/- C. Block B pts received paclitaxel +/- carboplatin +/- pembrolizumab and Block C pts doxorubicin + cyclophosphamide (AC) +/- pembrolizumab, HR+ immune+ received IO in Blocks B/C. When considering the full treatment strategy including block B and C regimens, experimental strategies had similar EpCR rates vs. controls in immune+ subtypes but block A rates exceeded pre-defined goal thresholds. This infers that treatment beginning with R + T-DXd has equivalent efficacy to standard of care for immune+ pts, but 64% pts with pCR skip chemotherapy (Block B) and 97% avoid AC (Block C)."

Clinical • IO biomarker • Late-breaking abstract • Alopecia • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Immunology • Interstitial Lung Disease • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • HER-2 • PROCR • 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

First-line rilvegostomig (R) + chemotherapy (CTx) in advanced biliary tract cancer (BTC): Updated analysis of GEMINI-Hepatobiliary substudy 2 cohort A. (ASCO 2026) - P2 | " Pts ≥18 years with previously untreated unresectable/metastatic BTC and ECOG PS 0/1 received intravenous R every 3 weeks (Q3W; ≤2 years) + gemcitabine 1000 mg/m2 + cisplatin 25 mg/m2 on days 1 and 8 Q3W (≤8 cycles). R + CTx demonstrated promising efficacy and a manageable safety profile. This study and phase 3 studies of R in BTC (ARTEMIDE-Biliary01, ARTEMIDE-Biliary02, DESTINY-BTC01) are ongoing. *N=29 for responses."

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

MODULE 4: Other Novel Agents and Strategies Under Evaluation for Advanced Gastroesophageal Cancers (ASCO-GI 2026) - "This event is organized and accredited by Research To Practice and supported by educational grants from Astellas, BeOne, Gilead Sciences Inc, and Jazz Pharmaceuticals Inc. Potential immunotherapy targets beyond PD-1/PD-L1 and CTLA-4 in gastroesophageal cancers; proposed rationale for targeting TIGIT Updated efficacy findings, including overall survival outcomes, documented with the combination of the anti-TIGIT monoclonal antibody domvanalimab, the anti-PD-1 antibody zimberelimab and chemotherapy as first-line therapy for advanced gastroesophageal adenocarcinoma in arm A1 of the EDGE-Gastric study Emerging outcomes from the Phase III STAR-221 trial comparing domvanalimab/zimberelimab/chemotherapy to nivolumab/chemotherapy for previously untreated advanced gastric, GEJ and esophageal adenocarcinoma Mechanism of action of and early findings with the PD-1/TIGIT bispecific antibody rilvegostomig for advanced gastroesophageal cancers Ongoing Phase III ARTEMIDE-Gastric01 study..."

Metastases • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • CLDN18 • HER-2 • TIGIT

Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03) (clinicaltrials.gov) - P2 | N=452 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting

Enrollment closed • Monotherapy • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Oncology • Solid Tumor • HER-2

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