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) (DKK 2026) - No abstract available

Clinical • Metastases • P3 data • Gastric Cancer • Oncology • Solid Tumor • HER-2

Randomized Phase 3 study of first-line trastuzumab deruxtecan with rilvegostomig or pembrolizumab in patients with human epidermal growth factor receptor 2-expressing, mismatch repair-proficient, primary advanced or recurrent endometrial cancer: DESTINY-Endometrial01/GOG-3098/ENGOT-EN24 (ESGO 2026) - P3 | "Approximately 600 patients will be randomized (1:1:1) to 3 arms: T-DXd with rilvegostomig, T-DXd with pembrolizumab, or carboplatin/paclitaxel with pembrolizumab. Previously presented at ESMO 2025, Final Publication Number: 1223TiP, Brian Slomovitz et al. Reused with permission.Results N/AConclusion N/A"

Clinical • IO biomarker • Metastases • Mismatch repair • P3 data • pMMR • Endometrial Cancer • Oncology • Solid Tumor • HER-2

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

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. (PubMed, Front Oncol) - P3 | "TROPION-Lung10 (NCT06357533) is a phase 3, open-label, multicenter, randomized study evaluating the efficacy and safety of first-line Dato-DXd plus rilvegostomig versus standard-of-care pembrolizumab in patients with advanced/metastatic nonsquamous NSCLC with PD-L1 TC expression ≥50% and without AGAs. TROPION-Lung10 will assess first-line Dato-DXd plus rilvegostomig in patients with advanced/metastatic NSCLC with high PD-L1 expression and without AGAs. ClinicalTrials.gov, identifier NCT06357533."

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

First-line rilvegostomig (rilve) plus chemotherapy (CTx) in advanced biliary tract cancer (BTC): Primary analysis of GEMINI-Hepatobiliary substudy 2 Cohort A (DKK 2026) - No abstract available

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

In Q4 2025, AstraZeneca paid Compugen Ltd. (Compugen) $65m, expensed in Cost of sales, and agreed a potential additional $25m upon the next milestone payment on BLA acceptance, for a portion of Compugen’s existing royalty interest in rilvegostomig. (AstraZeneca Press Release) - "AstraZeneca will pay tiered royalties of up to mid-single digits on future sales."

Commercial • Bladder Cancer • Breast Cancer • Cholangiocarcinoma • Esophageal Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Hepatocellular Cancer • Lung Non-Small Cell Squamous Cancer • Ovarian Cancer • Squamous Cell Carcinoma of Head and Neck • Thoracic Cancer • Urothelial Cancer • Uterine Cancer

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

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

LIBRA: A Study of Novel Combinations in Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) - P2 | N=278 | Recruiting | Sponsor: AstraZeneca | Trial primary completion date: Mar 2027 ➔ Apr 2029

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

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=24 | Active, not recruiting | Sponsor: AstraZeneca | N=660 ➔ 24 | Trial completion date: Jan 2035 ➔ Jun 2027 | Trial primary completion date: May 2033 ➔ Jun 2027 | Recruiting ➔ Active, not recruiting

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

Randomized phase III study of first-line (1L) trastuzumab deruxtecan (T-DXd) with rilvegostomig or pembrolizumab in patients with HER2-expressing, mismatch repair-proficient (pMMR), primary advanced or recurrent endometrial cancer (SGO 2026) - No abstract available

Clinical • Metastases • Mismatch repair • P3 data • pMMR • Endometrial Cancer • Oncology • Solid Tumor • HER-2

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

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

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

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

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

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

ARTEMIDE-HCC01: A phase 3, randomized, open-label, sponsor-blinded, multicentre, global study of rilvegostomig in combination with bevacizumab with or without tremelimumab as first-line (1L) treatment for unresectable hepatocellular carcinoma (uHCC). (ASCO-GI 2026) - P3 | "In the randomization period, ~1200 patients will be randomized 1:1:1 to receive tremelimumab, rilvegostomig and bevacizumab (arm A), rilvegostomig and bevacizumab (arm B), or atezolizumab and bevacizumab (arm C) until progression/unacceptable toxicity. Other endpoints include OS (arm B vs arm C), ORR, duration of response, progression-free survival, safety, and quality of life. Enrollment began in May 2025 and is ongoing."

Clinical • Combination therapy • IO biomarker • P3 data • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor • AFP • CTLA4 • PD-L1 • TIGIT

GEMINI-Perioperative (PeriOp) Gastric: A phase 2 study of novel agent-based combinations as PeriOp therapy for previously untreated, locally advanced resectable gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma. (ASCO-GI 2026) - P2 | "Background: The standard-of-care treatment for resectable gastric cancer with a high risk of relapse is PeriOp FLOT (5-fluorouracil [5-FU] + leucovorin [isovorin in Japan] + oxaliplatin + docetaxel) and radical surgery. In the MATTERHORN trial, durvalumab + FLOT improved event-free survival versus FLOT alone, establishing a role for immunotherapy + chemotherapy in this setting (Janjigian YY, et al...In substudy 1, CLDN18.2-positive/HER2-negative patients will receive intravenous (IV) sonesitatug vedotin (AZD0901, a CLDN18.2-targeted antibody-drug conjugate) + IV rilvegostomig + 5-FU or capecitabine; in substudy 2, HER2-positive patients will receive IV trastuzumab deruxtecan + IV rilvegostomig + 5-FU or capecitabine; in substudy 3, patients will receive IV rilvegostomig + FLOT...Secondary objectives include the feasibility of surgery, complete resection rate, tumor downstaging, objective response rate, event-free, disease-free, and overall survival, and the..."

Metastases • P2 data • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CLDN18 • HER-2 • PD-L1 • TIGIT

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-GI 2026) - 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 ongoing across 28 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 • Gastrointestinal Cancer • Oncology • Solid Tumor • HER-2 • TIGIT

AB02: A Study of Rilvegostomig or Durvalumab Plus Chemotherapy for First-Line Treatment of Biliary Tract Cancer (ARTEMIDE-Biliary02) (clinicaltrials.gov) - P3 | N=1100 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

Enrollment open • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gallbladder Cancer • Oncology • Solid Tumor • PD-L1

ARTEMIDE-HCC01: A phase III, randomised, open-label, sponsor-blinded, multicentre, global study of rilvegostomig in combination with bevacizumab with or without tremelimumab as first-line (1L) treatment for unresectable hepatocellular carcinoma (uHCC) (ESMO Asia 2025) - P3 | "In the randomisation period, ∼1200 patients will be randomised 1:1:1 to receive tremelimumab, rilvegostomig and bevacizumab (arm A), rilvegostomig and bevacizumab (arm B) or atezolizumab and bevacizumab (arm C) until progression/unacceptable toxicity. Other endpoints include OS (arm B vs arm C), ORR, duration of response, progression-free survival, safety and quality of life. Enrolment began May 2025 and is ongoing."

Clinical • Combination therapy • IO biomarker • P3 data • Hepatocellular Cancer • Oncology • Solid Tumor • AFP • CTLA4 • PD-L1 • TIGIT

ARTEMIDE-subQ: A Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Rilvegostomig in Adult Participants With Advanced Solid Tumors Previously Treated With Standard of Care Therapy (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting | Trial completion date: Mar 2028 ➔ Jul 2029 | Trial primary completion date: Aug 2026 ➔ Jul 2027

Enrollment open • Trial completion date • Trial primary completion date • Solid Tumor

ALTAIR: A Platform Study in Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) - P1/2 | N=152 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting | Trial completion date: Oct 2028 ➔ Feb 2029 | Trial primary completion date: Oct 2028 ➔ Feb 2029

Enrollment open • Trial completion date • Trial primary completion date • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Enhancing AZD5863 (CLDN18.2 T cell engager) activity through combination with chemotherapy and rilvegostomig (PD-1 x TIGIT bispecific) (ESMO-IO 2025) - P1/2 | "Recent clinical success with zolbetuximab has validated CLDN18.2 as a therapeutic target in gastric cancer...Combinatorial activity was assessed with 5-FU/oxaliplatin, gemcitabine/paclitaxel, and rilvegostomig across multiple rounds of AZD5863 treatment...In vivo, combination of AZD5863 with 5-FU and oxaliplatin and a murine surrogate of rilvegostomig resulted in superior tumor growth inhibition, compared with monotherapies.Conclusions AZD5863 induces T cell activation, cytokine secretion, and tumor cell cytotoxicity in vitro, and in vivo. These effects are further potentiated in combination with clinically relevant chemotherapies or rilvegostomig."

IO biomarker • Gastric Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18 • PD-1 • TIGIT