Vyloy (zolbetuximab-clzb) / Astellas - LARVOL DELTA

Impact of enhanced antiemetic prophylaxis including atypical antipsychotics in zolbetuximab-containing chemotherapy: A retrospective study (ESMO Asia 2025) - "Additionally, 14 pts received prophylactic olanzapine on the evening of day -1, 1 on the morning of day 1, and 2 received asenapine on day -1. The addition of atypical antipsychotics may help relieve zolbetuximab-induced nausea, with a notably low incidence of grade 3 events and good tolerability. However, as nausea still occurred in a substantial proportion of patients, particularly those at higher risk, further preventive strategies should be considered."

Retrospective data • Gastric Cancer • Oncology • Solid Tumor

Comprehensive biomarker study of zolbetuximab plus CapeOX or SOX to identify predictors of efficacy and resistance mechanisms in patients with HER2-negative, CLDN18.2-positive gastric or gastro-oesophageal junction cancer (JACCRO GC-12AR) (ESMO Asia 2025) - P=N/A | "The findings are expected to provide valuable insights for optimizing treatment strategies with ZOL. Table: 472TiP Main measured variables ∗If available"

Biomarker • Clinical • IO biomarker • Esophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • CLDN18 • HER-2

Multi-centre experience of tolerability of Zolbetuximab (Zolb) in combination with chemo for advanced gastroesophageal adenocarcinoma (GEA) in Singapore (SGP) (ESMO Asia 2025) - "Chemo backbones: SOX/CAPOX (36%), mFOLFOX6 (36%), FP + i.p Paclitaxel (14%), mFOLFIRI (9%) and mFOLFOX6 + Nivolumab (5%)...From cycle 2, 10/18 pts (59%) had infusion rates lengthened; 5/18 pts (28%) received extra antiemetics (4 olanzapine, 1 lorazepam)... IRRs with Zolb were manageable and lower than phase III studies due to triplet antiemetic prophylaxis in cycle 1. Adjusting Zolb infusion rate and antiemetics further reduced IRRs. Zolb plus chemo had manageable AEs, supporting its use in SGP."

Clinical • Combination therapy • Metastases • Esophageal Adenocarcinoma • Esophageal Cancer • Oncology • Solid Tumor

Feasibility of claudin18.2 testing in biopsy specimens of pancreatic cancer for zolbetuximab patient selection (ESMO Asia 2025) - "CLDN18.2 was positive in about 30% of PDAC cases on small-volume biopsy specimens, a prevalence comparable to that previously reported in surgical cohorts. Evaluation using metastatic site samples also appeared feasible, with high concordance with primary tumors. These findings support the clinical utility of biopsy-based CLDN18.2 testing; however, specimen adequacy and staining quality must be carefully considered to ensure accurate patient selection."

Biopsy • Clinical • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CLDN18

Zolbetuximab plus mFOLFOX6/CAPOX as first-line (1L) treatment in patients with claudin 18 isoform 2 positive (CLDN18.2+) metastatic gastric or gastroesophageal junction (mG/GEJ) adenocarcinoma with peritoneal metastases: A post hoc analysis of SPOTLIGHT and GLOW (ESMO Asia 2025) - P3 | "The phase 3 SPOTLIGHT (NCT03504397) and GLOW (NCT03653507) trials showed survival benefits of 1L zolbetuximab plus modified fluorouracil, leucovorin, and oxaliplatin regimen (mFOLFOX6)/capecitabine and oxaliplatin (CAPOX) vs placebo (PBO) plus mFOLFOX6/CAPOX in patients with CLDN18.2+, human epidermal growth factor receptor 2 (HER2)−, locally advanced (LA) unresectable or mG/GEJ adenocarcinoma. This post hoc analysis showed numeric PFS and OS improvements with 1L zolbetuximab plus chemotherapy vs PBO plus chemotherapy in patients with CLDN18.2+, HER2−, LA unresectable or mG/GEJ adenocarcinoma with baseline peritoneal metastases. Safety events were similar compared to patients in the pooled intent-to-treat population."

Clinical • Metastases • Retrospective data • Gastroesophageal Junction Adenocarcinoma • Oncology • CLDN18 • HER-2

Clinical case insights on zolbetuximab: Experience from Korea (ESMO Asia 2025) - "Sponsored By Astellas"

Clinical • Gastric Cancer • Gastroesophageal Cancer • Oncology

Clinical case insights on zolbetuximab: Experience from Japan (ESMO Asia 2025) - "Sponsored By Astellas"

Clinical • Gastric Cancer • Gastroesophageal Cancer • Oncology

Zolbetuximab at the forefront: Evaluating efficacy, safety, and evolving guidelines (ESMO Asia 2025) - "Sponsored By Astellas"

Clinical • Gastric Cancer • Gastroesophageal Cancer • Oncology

Zolbetuximab Plus Chemotherapy as First-Line Treatment in Patients with Claudin 18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma: Korean Population Subgroup-Combined Efficacy and Safety Analysis from SPOTLIGHT and GLOW. (PubMed, Cancer Res Treat) - "Patients were randomized 1:1 to receive zolbetuximab plus chemotherapy or placebo plus chemotherapy (mFOLFOX6 [modified folinic acid, 5-fluorouracil, and oxaliplatin] or CAPOX [capecitabine and oxaliplatin]). Zolbetuximab plus chemotherapy demonstrated favorable PFS and OS versus placebo plus chemotherapy in the Korean subgroup, with numerically greater efficacy compared with the overall pooled population. This may be potentially attributable to low rates of zolbetuximab discontinuation and toxicity management."

Journal • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • CLDN18 • HER-2

Safety run-in results from C-SOLVE (JACCRO GC-12): A randomized, non-comparative phase II trial of CapeOX or SOX plus zolbetuximab in patients with HER2-negative, CLDN18.2-positive unresectable advanced gastric or GEJ cancer. (ASCO-GI 2026) - "Funded by Astellas Clinical Trial Registration Number: 031240510 The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

Clinical • Metastases • P2 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • CLDN18 • HER-2

Assessment of the impact of proton pump inhibitor (PPI) exposure on survival outcomes in patients with gastric or gastroesophageal junction adenocarcinoma treated with zolbetuximab plus chemotherapy. (ASCO-GI 2026) - P2 | "Funded by Astellas Pharma, Inc. Clinical Trial Registration Number: NCT01630083 The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

Clinical • Esophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

Safety and efficacy of zolbetuximab plus chemotherapy for CLDN18.2-positive gastric cancer: A single-center retrospective study. (ASCO-GI 2026) - "The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

Retrospective data • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CLDN18

Zolbetuximab + pembrolizumab and chemotherapy as first-line treatment for patients with CLDN18.2-positive, HER2-negative, PD-L1-positive locally advanced unresectable or metastatic G/GEJ adenocarcinoma: Phase 3, double-blind, randomized trial (LUCERNA). (ASCO-GI 2026) - P3 | "Funded by Astellas Pharma Inc. Clinical Trial Registration Number: NCT06901531 The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

Clinical • Metastases • P3 data • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • CLDN18 • HER-2 • PD-L1

Randomized phase II trial evaluating the efficacy of zolbetuximab in the second-line for claudin18.2 positive advanced gastric/EGJ cancer patients previously treated with zolbetuximab and platinum-based chemotherapy (ZELDA trial). (ASCO-GI 2026) - "Funded by Astellas Pharma Inc Clinical Trial Registration Number: 071250038 The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

Clinical • Metastases • P2 data • Gastric Cancer • Gastrointestinal Cancer • Oncology • CLDN18

Phase 2 ILUSTRO trial of 1L zolbetuximab plus mFOLFOX6 and nivolumab in patients with CLDN18.2+ locally advanced (LA) unresectable or metastatic gastric or gastroesophageal junction (mG/GEJ) adenocarcinoma. (ASCO-GI 2026) - P2 | "Funded by Astellas Pharma Inc. Clinical Trial Registration Number: NCT03505320 The full, final text of this abstract will be available on Jan 08 at 10:00 AM EST."

Clinical • Late-breaking abstract • Metastases • P2 data • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • CLDN18

CLDN18.2-Targeted Therapy in Gastrointestinal Cancers. (PubMed, Cancers (Basel)) - "Finally, we identify current limitations in the field, including inconsistent CLDN18.2 testing criteria, and outline prioritized future directions to optimize integration of CLDN18.2-directed therapies across gastrointestinal cancers. By looking beyond zolbetuximab and incorporating cross-platform comparison, immuno-oncology considerations, and multi-tumor context, this review provides a broad and forward-looking framework to guide clinical application and next-generation research in CLDN18.2-targeted therapy."

IO biomarker • Journal • Review • Biliary Cancer • Biliary Tract Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18 • PD-L1

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.Legal entity responsible for the study AstraZeneca."

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

Spatial discordance of claudin18.2 in gastric cancer: clinical implications for patient selection in Zolbetuximab therapy. (PubMed, Surg Today) - No abstract available

Journal • Gastric Cancer • Oncology • Solid Tumor • CLDN18

Synergistic Approach in Metastatic Esophageal Carcinoma: FOLFOX, Pembrolizumab, and Zolbetuximab Yield Remarkable Response in PD-L1 and Claudin-1 Positive Patients [WITHDRAWN] (ESMO Asia 2025) - No abstract available

Clinical • Metastases • Esophageal Cancer • Oncology • CLDN1 • PD-L1

Astellas to Present New Clinical Data Across Its Gastrointestinal Cancers Portfolio at 2026 ASCO GI Cancers Symposium (PRNewswire) - "Highlights include a late-breaking oral presentation of cohort results from the Phase 2 ILUSTRO study of first-line zolbetuximab in combination with chemotherapy and immunotherapy in claudin 18.2-positive, HER2-negative, locally advanced or metastatic G/GEJ cancer, as well as new Phase 1 data from ASP3082 (setidegrasib), an investigational KRAS G12D targeted protein degrader, in pancreatic cancer."

Clinical data • Late-breaking abstract • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Pancreatic Ductal Adenocarcinoma

Efficacy and safety of first-line treatments in HER2-negative advanced gastric and gastroesophageal junction cancer (GC/GEJC): A systematic review and Bayesian network meta-analysis (ESMO-IO 2025) - "Among these regimens, cadonilimab +chemo and SHR-1701 +chemo achieved similar OS improvement, ranking first (HR 0.66; 95% Crl 0.54, 0.81) and second (HR 0.66; 95% Crl 0.53, 0.81) respectively, followed by zolbetuximab + chemo (HR 0.76; 95% Crl 0.65, 0.89), sintilimab + chemo (HR 0.77; 95% Crl 0.63, 0.94) and other regimens...Similar results were observed in patients with PD-L1 CPS ≥ 5. Regarding grade ≥3 TRAEs, compared with chemo alone, sugemalimab + chemo (OR 1.145; 95% Crl 0.804, 1.627), SHR-1701 + chemo (OR 1.165; 95% Crl 0.863, 1.557), and tislelizumab + chemo (OR 1.174; 95% Crl 0.919, 1.51)showed better safety profile than other regimens.Conclusions Considering the balance between efficacy and safety, SHR - 1701 + chemo might be considered the preferred first-line treatment for patients with HER2-negative advanced GC/GEJC, particularly those with PD-L1 CPS ≥1 or CPS ≥5.Legal entity responsible for the study The authors."

Metastases • Retrospective data • Review • Esophageal Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • HER-2 • PD-L1

Zolbetuximab or Immunotherapy as the Initial Targeted Therapy in CLDN18.2-Positive, HER2-Negative Advanced Gastric Cancer: Weighing the Options. (PubMed, Curr Oncol) - "Zolbetuximab is associated with high rates of nausea and vomiting during the initial infusion, whereas ICIs are associated with risk of later-onset immune-related toxicities that can be fatal in rare cases. In considering the available evidence, our opinion is that zolbetuximab is a reasonable option for initial targeted treatment in HER2-/CLDN18.2-positive advanced G/GEJ when PD-L1 CPS score is <10 based on the reliability of biomarker testing, comparable OS, and avoidance of potentially irreversible ICI-induced immune toxicity."

IO biomarker • Journal • Review • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • CLDN18 • HER-2

A Mucosal Change like Hypertrophic Gastritis Following Zolbetuximab-Based Therapy in a Conversion Surgery Case of Advanced Gastric Cancer. (PubMed, Reports (MDPI)) - "Clinicians should monitor albumin levels during treatment and consider nutritional support when indicated. These findings provide important insights for optimizing patient management and ensuring safe conversion surgery planning."

Journal • Gastric Cancer • Gastrointestinal Disorder • Oncology • Solid Tumor • CLDN18

Claudin 18.2 as a Biomarker for Imaging and Radiopharmaceutical Therapy in Gastric and Pancreatic Tumors. (PubMed, J Nucl Med) - "Serial PET imaging with 89Zr-labeled zolbetuximab, an anti-CLDN18.2 monoclonal antibody ([89Zr]Zr-DFO-zolbetuximab), and human IgG ([89Zr]Zr-DFO-IgG) as control (5.5-7.4 MBq) was performed 1, 3, and 6 d after injection, followed by ex vivo analysis of biodistribution... CLDN18.2 could serve as a promising biomarker for precise quantitative imaging and effective treatment of GCa and PDAC. This proof-of-concept study encourages the clinical translation of CLDN18.2 as a radiotheranostic in patients with CLDN18.2-expressing tumors."

Biomarker • Journal • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CLDN18

Case Report: A case of zolbetuximab-based chemotherapy for Claudin 18.2-positive gastric phenotype adenocarcinoma arising in Meckel's diverticulum. (PubMed, Front Oncol) - "Treatment was started with zolbetuximab plus 5-fluorouracil/leucovorin/oxaliplatin (FOLFOX), which is typically used for CLDN18.2-positive gastric cancer, resulting in a partial response. This is the first case of zolbetuximab-based therapy applied to adenocarcinoma from a Meckel's diverticulum with a gastric phenotype due to a biomarker profile of gastric cancer. This case highlights the importance of identifying both the biomarker profile and tissue of origin of the tumor."

Journal • Gastric Cancer • Oncology • Solid Tumor • CDX2 • CLDN18 • HER-2 • MUC2 • MUC5AC • Mucin 6