CLDN18.2 inhibitors(Claudin 18.2 inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects), Complement dependent cytotoxicity (CDC) effects

Therapeutic Areas

NeoplasmsDigestive System DisordersEndocrinology and Metabolic Disease

Active Indication

Advanced Gastroesophageal Junction AdenocarcinomaCLDN18.2 positive Gastroesophageal junction adenocarcinomaCLDN18.2 positive stomach adenocarcinoma+ [9]

Inactive Indication

AdenocarcinomaCLDN18.2 Positive Gastrointestinal NeoplasmsEsophageal Carcinoma+ [1]

Originator Organization

Ganymed Pharmaceuticals AG

Active Organization

Astellas Pharma Global Development, Inc.

Astellas Pharma China, Inc.Astellas Pharma US, Inc.

+ [5]

Inactive Organization

Ganymed Pharmaceuticals AG

License Organization

Shanghai Pharmaceutical Co., Ltd.

Ganymed Pharmaceuticals AG

Astellas Pharma, Inc.

Drug Highest PhaseApproved

First Approval Date

Japan (26 Mar 2024),

CLDN18.2 positive Stomach Cancer

RegulationAccelerated Approval (United States), Orphan Drug (South Korea), Orphan Drug (Australia), Priority Review (United States)

Structure/Sequence

Sequence Code 431594752L

Source: *****

Sequence Code 524309292H

Source: *****

Clinical Trials associated with Zolbetuximab

NCT06396091

/ Active, not recruitingPhase 1

A Phase 1 Open-label Study to Assess the Safety and Tolerability of Zolbetuximab (IMAB362) in Combination With Chemotherapy (mFOLFIRINOX) in Participants With CLDN18.2 Positive Metastatic Pancreatic Adenocarcinoma

Pancreatic cancer is difficult to diagnose early. By the time people have been diagnosed, the cancer has usually spread to other parts of the body (metastatic). The standard treatment is chemotherapy, but other treatments are needed to improve outcomes in people with pancreatic cancer.
In this study, zolbetuximab will be given together with chemotherapy to people with pancreatic cancer. Zolbetuximab attaches to a protein called CLDN18.2 found at high levels on the surface of the cancer tumor. This switches on the immune system to attack the tumor.
Adults 18 years or older with metastatic pancreatic cancer who have not previously had chemotherapy can take part in the study.
There are 2 main aims of this study:
* To check the safety of zolbetuximab, when given with chemotherapy in people with metastatic pancreatic cancer
* To check if people could cope with (tolerate) any medical problems during the study This is an open-label study. This means people in the study and the study doctors will know that people will receive zolbetuximab with chemotherapy. Different small groups will receive lower to higher doses of zolbetuximab with chemotherapy.
Zolbetuximab and chemotherapy will be given through a vein. This is called an infusion. People will receive zolbetuximab on the first day they receive chemotherapy. This will happen every 14 days in a 28-day cycle.
People will receive zolbetuximab and chemotherapy in the study clinic and at home. Also, doctors will check for any medical problems. People will also have a health check including blood tests. On some visits they will also have scans to check for any changes in their cancer.
People will visit the study clinic about 7 days after they stop treatment. They will be asked about any medical problems and will have a health check including blood tests.
After this, people will have several more visits to the study clinic for health checks. The number of visits and checks done at each visit will depend on the health of each person and whether they complete their treatment or not.

Start Date24 Sep 2025

Sponsor / Collaborator

Astellas Pharma Global Development, Inc.

NCT06901531

/ RecruitingPhase 3

A Phase 3, Double-blind, Randomized Study of Zolbetuximab in Combination With Pembrolizumab and Chemotherapy (CAPOX or mFOLFOX6) in First-line Treatment of Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma in Participants Whose Tumors Are HER2-negative, Claudin (CLDN) 18.2-positive and Programmed Death-ligand 1 (PD-L1)-Positive

Zolbetuximab is being studied in people with cancer in and around the stomach or where the food pipe (esophagus) joins the stomach, called gastroesophageal junction (GEJ) cancer. Zolbetuximab with chemotherapy may be used to treat stomach and GEJ cancer when the cancer cells do not have a protein called HER2 (human epidermal growth factor receptor 2) on their surface (HER2-negative) but do have a protein called Claudin 18.2 (Claudin 18.2-positive). Zolbetuximab is thought to work by attaching to the Claudin 18.2 protein in their tumor, which switches on the body's immune system to attack the tumor. Certain stomach and GEJ cancers may be treated with immunotherapy, which helps the body's immune system fight cancer. This study will give more information about how well zolbetuximab works when given with an immunotherapy medicine called pembrolizumab and chemotherapy. In this study, adults with stomach cancer or GEJ cancer will either be given zolbetuximab with pembrolizumab and chemotherapy or a placebo with pembrolizumab and chemotherapy. A placebo looks like zolbetuximab but doesn't have any medicine in it.
The main aim of the study is to check how long people with stomach cancer and GEJ cancer live after treatment with zolbetuximab with pembrolizumab and chemotherapy compared to placebo with pembrolizumab and chemotherapy.
Adults with locally advanced unresectable or metastatic stomach cancer or GEJ cancer can take part. Locally advanced means the cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body. A tumor sample (biopsy) of their cancer will have the Claudin 18.2 protein, PD-L1 protein, and be HER2-negative. They may have been previously treated with certain standard therapies. People cannot take part if they need to take medicines to suppress their immune system, have blockages or bleeding in their gut, have specific uncontrollable cancers such as symptomatic or untreated cancers in the nervous system, or have a specific heart condition, or infections.
The study treatments are either zolbetuximab with pembrolizumab and chemotherapy, or placebo with pembrolizumab and chemotherapy. People who take part will receive just 1 of the study treatments by chance. The people in the study and the study doctors will not know who takes which of the study treatments. Study treatment will be given in 6-week (42-day) cycles. The study treatment is mainly given to people slowly through a tube into a vein. This is called an infusion. People will receive study treatment as follows: Zolbetuximab or placebo: 1 infusion every 2 or 3 weeks (2 or 3 infusions in a cycle) together with: Chemotherapy (1 of the following types of chemotherapy): 1. CAPOX (capecitabine and oxaliplatin): 1 infusion of oxaliplatin every 3 weeks (2 infusions in a cycle). People will also take 1 tablet of capecitabine twice a day for 2 weeks (14 days) at the start of each cycle (Day 1) and again in the middle of each cycle (Day 22). After 8 study treatments people will receive capecitabine only. 2. Modified FOLFOX6 or mFOLFOX6 (5-fluorouracil, folinic acid and oxaliplatin): 1 infusion every 2 weeks (3 infusions in a cycle). After 12 study treatments people will receive folinic acid and fluorouracil only, instead of mFOLFOX6. Pembrolizumab: 1 infusion every 3 or 6 weeks (1 or 2 infusions in a cycle). People can be in the study and will receive study treatment until their cancer worsens, they cannot tolerate the study treatment, or they need to start another cancer treatment. People may receive pembrolizumab for up to 2 years. People will visit the clinic on certain days to receive their study treatment and have health checks. The study doctors will check if people had any medical problems from taking zolbetuximab or the other study treatments. On some visits they will have scans to check for any changes in their cancer. People will have the option of giving a tumor sample if they stop treatment because their cancer has worsened. People will visit the clinic after they stop their study treatment. People will be asked about any medical problems and will have a health check. People will continue to have scans every 9 or 12 weeks to check for any changes in their cancer. They will have telephone health checks every 3 months. The number of visits and checks done at each visit will depend on the health of each person and whether they completed their study treatment or not.

Start Date22 May 2025

Sponsor / Collaborator

Astellas Pharma Global Development, Inc.

NCT06881017

/ Not yet recruitingPhase 2IIT

Establishment of Precision Targeted Therapy Strategies for Advanced Gastric Cancer Based on Novel Molecular Subtyping: an Umbrella Phase II Exploratory Clinical Study

This study is a prospective, umbrella-design, Phase II clinical trial. Eligible participants with advanced or metastatic gastric cancer who are treatment-naïve for advanced-stage systemic therapy will undergo biomarker profiling (HER2, CLDN18.2, and PD-L1) via next-generation sequencing (NGS) or immunohistochemistry (IHC). Participants will be stratified into distinct molecular subtypes and assigned subtype-specific therapeutic regimens. The primary objectives are to assess treatment efficacy (e.g., objective response rate) and safety profiles across molecularly defined cohorts.

Start Date01 May 2025

Sponsor / Collaborator

China Medical University

100 Clinical Results associated with Zolbetuximab

100 Translational Medicine associated with Zolbetuximab

100 Patents (Medical) associated with Zolbetuximab

132

Literatures (Medical) associated with Zolbetuximab

01 Apr 2026·DEN open

Endoscopic Complete Response to Zolbetuximab for Advanced Gastric Cancer With Claudin 18.2 Positive: A Case Report

Article

Author: Yoshioka, Tsubasa ; Kimura, Rika ; Yamaba, Tomohiro ; Uchiyama, Gaku ; Sasaki, Akinori ; Tachibana, Ayu ; Okamoto, Risa

ABSTRACT:

Recently, zolbetuximab combined with chemotherapy has been approved as a first‐line treatment for advanced gastric cancer (GC). However, to date, no endoscopic images demonstrating endoscopic complete response (eCR) to zolbetuximab plus chemotherapy have been reported. Herein, we report the case of an 80‐year‐old man who presented with epigastric pain and loss of appetite and was diagnosed with undifferentiated GC and peritoneal metastasis. The patient received modified FOLFOX6 plus zolbetuximab because genetic testing revealed HER2‐negative and claudin 18.2‐positive. He experienced grade 2 nausea, which improved with the administration of antiemetic agents. Computed tomography performed at month 5 showed resolution of peritoneal dissemination. Endoscopic examination during the same period showed the disappearance of the primary gastric tumor with scarring. Biopsy of the scar area revealed only inflammatory cells; therefore, the primary lesion was defined as an eCR. To the best of our knowledge, this is the first report of eCR to zolbetuximab and chemotherapy in a patient with GC and claudin 18.2 positive. This case report suggested that chemotherapy combined with zolbetuximab may offer greater therapeutic benefit than chemotherapy combined with immune checkpoint inhibitors in patients with undifferentiated GC. Further analysis is expected to enable the identification of patients with claudin 18.2‐positive GC in whom zolbetuximab treatment is effective.

Deutsches Arzteblatt International

Gastric carcinoma—diagnosis, staging, and treatment

Review

Author: Moehler, Markus ; Nothacker, Monika ; Huber, Yvonne ; Jansen, Petra Lynen ; Langer, Thomas ; Unverzagt, Susanne

BACKGROUND:

Gastric carcinoma ranks tenth in incidence among all cancers in men and women in Germany. 5565 women and 9027 men received a diagnosis of gastric carcinoma in Germany in 2022.

METHODS:

The German clinical practice guideline was comprehensively revised with the interdisciplinary participation of German specialty societies under the leadership of the German Society for Gastroenterology, Digestive and Metabolic Disorders, according to the methodological specifications of the Association of Scientific Medical Societies in Germany (Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften, AWMF).

RESULTS:

The new recommendations promote preventive measures in the presence of risk factors such as hereditary diseases or infection with Helicobacter pylori. Combinations of chemotherapy with immunotherapy, such as nivolumab, pembrolizumab, and tislelizumab, prolong median overall survival compared to chemotherapy alone (e.g., nivolumab plus chemotherapy, 14.4 vs. 11.1 months, HR 0.71) and markedly prolong 5-year survival to 16%. In patients with high claudin18.2 expression, the antibody zolbetuximab, combined with chemotherapy, prolongs median survival to 16.4 vs. 13.4 months (HR 0.77). For patients in good general health, further chemotherapy or biomarker-defined approved second-line (trastuzumab deruxtecan, pembolizumab) or third-line treatment (e.g., trifluridine tipirazole) and advanced molecular-pathological diagnostic testing should be offered at centers for personalized oncology in case of treatment failure. The biomarkers HER2, PD-L1, MSI, and claudin18.2 enable new targeted therapies in palliative situations with long-term improvement in outcome.

CONCLUSION:

The diagnostic evaluation of gastric carcinoma should include high-resolution video endoscopy, and its treatment should be stage-adapted and interdisciplinary. Monoclonal antibodies and immune checkpoint inhibitors are increasingly being used for palliative treatment. The new modifications to the clinical practice guideline will promote the use of uniform strategies for perioperative and palliative treatment and supportive measures.

01 Dec 2025·CANCER CHEMOTHERAPY AND PHARMACOLOGY

Population pharmacokinetic analysis of fluorouracil and oxaliplatin in the absence or presence of zolbetuximab in locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma

Article

Author: Bonate, Peter L ; Yang, Jianning ; Yamada, Akihiro ; Poondru, Srinivasu ; Heo, Nakyo

PURPOSE:

Zolbetuximab, a monoclonal antibody targeting claudin 18.2 (CLDN18.2), is approved in combination with chemotherapy for human epidermal growth factor receptor 2 (HER2)-negative, CLDN18.2-positive, unresectable, advanced or recurrent gastric cancer (in Japan) and in combination with fluoropyrimidine- and platinum-containing chemotherapy for first-line locally advanced unresectable or metastatic HER2-negative, CLDN18.2-positive gastric or gastroesophageal junction (G/GEJ) adenocarcinoma (in geographies including but not limited to the US, Europe, and China). Noncompartmental analysis (NCA) was previously used to evaluate the effect of zolbetuximab on pharmacokinetics (PK) of 5-fluorouracil (5-FU) and oxaliplatin; however, limitations of NCA confounded the results. This study utilized population pharmacokinetic (PopPK) analysis to address these limitations.

METHODS:

In Cohort 2 of the phase 2 ILUSTRO study (NCT03505320), patients with locally advanced unresectable or metastatic HER2-negative, CLDN18.2-positive G/GEJ adenocarcinoma received zolbetuximab with modified folinic acid, 5-FU, and oxaliplatin. PopPK models were developed to evaluate the impact of zolbetuximab on PK of 5-FU and oxaliplatin (including simultaneous analysis of free and total platinum).

RESULTS:

PK of 5-FU was adequately described by a 1-compartment model with zero-order input and first-order elimination. PK of free and total platinum was simultaneously described by a 3-compartment model with zero-order input, first-order elimination, and time-dependent free fraction. No impact of zolbetuximab on 5-FU PK or on systemic clearance or free fraction of oxaliplatin in plasma was observed. The effect of zolbetuximab on oxaliplatin distribution volume (12.3% decrease) was statistically significant but not considered clinically relevant.

CONCLUSION:

PopPK analysis suggests no effect of zolbetuximab on 5-FU or oxaliplatin PK.

119

News (Medical) associated with Zolbetuximab

15 Jan 2026

·www.fiercebiotech.com

JPM26: Astellas CEO resists \'rescue BD\' as $6B Xtandi patent cliff nears

“We have made the decision that we don’t want to do rescue BD, which is to just fill that gap,” Astellas Pharma CEO Naoki Okamura said at Fierce JPM Week 2026.\n Xtandi, Astellas Pharma’s roughly $6 billion prostate cancer juggernaut by annual sales, is set to lose U.S. patent protection in 2027. As the company continues looking for external innovation to secure sustainable growth, CEO Naoki Okamura does not want the company to make acquisitions for the sole purpose of preventing a revenue decline.“We have made the decision that we don’t want to do rescue BD, which is to just fill that gap,” Okamura said during a fireside chat at Fierce JPM Week 2026. “We will invest in [the] much longer term.”Astellas has a “healthy appetite for business development,” Okamura said. But rather than as a way to scale up, dealmaking for Okamura is about “new technologies, new assets that strengthen our pipeline, or even better, a technology platform.”“We have no intention to have a large-scale M&A [deal] to elevate the size of the company,” he said.Last year, Astellas struck a potential $1.34 billion deal to license a CLDN18.2-targeted antibody-drug conjugate from Chinese biotech Evopoint Biosciences. That ADC program adds to Astellas’ first-in-class CLDN18.2 therapy Vyloy and ASP2138, a CLDN18.2 bispecific. With these three modalities, Astellas is “trying to dominate the CLDN18.2 space,” Okamura said. The bispecific agent could potentially treat patients with lower expression levels of CLDN18.2 compared with Vyloy, he explained. And, while Vyloy is currently approved alongside chemotherapy, an ADC construct holds potential to free patients from systemic chemotherapy.Astellas has not been a drugmaker defined by therapeutic areas or modalities. Having a select group of focus areas has its pros and cons, Okamura said. The upsides are apparent, including growing expertise and long-term relationships with relevant stakeholders.“The flip side is that if you stick to [a] certain therapeutic area too much, you will reduce the possibility of building up the long-term product portfolio,” Okamura said.Astellas instead starts with “biology with strong disease linkage,” Okamura explained. “We identify the best modality to address this biology. Then, we try to figure out what is the best patient population to benefit from this combination of biology-modality.”Nevertheless, Astellas intends to prioritize areas in which it already has expertise—both for internal research and business development. For now, these areas are targeted protein degradation, immuno-oncology, blindness/regeneration and genetic regulation.To navigate the post-Xtandi era, Astellas has identified five strategic brands with blockbuster sales potential. Besides Vyloy, these include Pfizer-partnered bladder cancer ADC Padcev, acute myeloid leukemia treatment Xospata, geographic atrophy med Izervay and menopause therapy Veozah.Among them, Padcev has seen explosive growth thanks to its establishment as the new standard of care in first-line bladder cancer. The Nectin-4 agent is expected to garner even more interest with its recent progress in muscle-invasive bladder cancer. Astellas is projecting Padcev peak annual sales between $2.8 billion and $3.5 billion, although the U.S. portion of that number is not booked by the Japanese pharma. In contrast to Padcev’s all-but-certain growth trajectory, the futures of Izervay and Veozah look less clear. For Izervay, Astellas’ peak sales projection ranges between $1.4 billion and $2.8 billion, and the company expects Veozah could reach around $1 billion to $1.7 billion at peak, according to Okamura’s presentation Monday at the J.P. Morgan Healthcare Conference.However, Astellas recently downgraded its Izervay sales projection from $750 million to $550 million for this fiscal year, which will end in March. Part of the problem relates to patient access, which Okamura said is difficult for Astellas to change. And it’s not just Izervay that’s suffering. Apellis Pharmaceuticals’ rival complement inhibitor Syfovre has also struggled to sustain its momentum, as the company Monday reported a preliminary 4% year-over-year sales decline for 2025.In turn, Astellas is trying to focus on the part of the drug\'s commercialization that it can control—physician education.Izervay’s initial uptake has been slower than expected because Astellas needs to educate retinal specialists about the drug’s treatment effect. Unlike other eye disease such as wet age-related macular degeneration, GA patients cannot feel how Izervay is working, Okamura told Fierce. Retinal specialists need to be assured that continued treatment with Izervay offers a better chance at disease improvement, he said. With that education effort in place, Astellas is now targeting community ophthalmologists. The company is taking a stratified approach to community outreach and is in the process of identifying key prescribers. Okamura noted that Astellas has experience targeting a relatively large, nonspecialist audience.As for menopause drug Veozah, the biggest uncertainty may lie in how competition with Bayer’s Lynkuet plays out.Okamura doesn’t view having Bayer, a women’s health veteran, as a competitor as necessarily bad given that both companies can help drive awareness. If the entire market grows bigger, Veozah may be better off even if it’s getting a smaller piece of the entire pie, the Astellas chief executive suggested.Bayer\'s Lynkuet is a dual-action drug targeting both NK3 and NK1 receptors, while Veozah, which holds a first-mover advantage, only targets NK3. Okamura argued that differentiation between the two approaches might come to the fore over time as real-world data emerge. Beyond specific products, one big uncertainty hovering over Astellas is changing U.S. drug pricing policy. While many Big Pharma companies have signed most-favored-nation deals with the Trump administration, it remains unclear whether midsized drugmakers like Astellas will be required to do the same.Astellas has been watching recent developments around MFN and is preparing proactively to respond if the scope of the policy reaches the company, Okamura said.For his prediction for 2026, Okamura said he remains optimistic about the biopharma industry despite the surprising lack of deal announcements at JPM this year.“There are many things moving under this,” Okamura said. “So, I still believe that 2026 is going to be another productive and prosperous year.”

$JPM26: Astellas CEO resists \'rescue BD\' as $6B Xtandi patent cliff nears$

ADC

08 Jan 2026

·www.prnewswire.com

VYLOY™ (zolbetuximab) Plus Chemotherapy Associated with Enhanced Survival Outcomes when Common Adverse Events are Effectively Managed, According to New Ad Hoc Analyses

Exploratory ad hoc analyses from SPOTLIGHT and GLOW trials report quantitative differences in median progression-free survival (mPFS) and median overall survival (mOS) for patients treated with VYLOY plus chemotherapy when data from patients who discontinued early due to common adverse events were censored Effective management of adverse events remains an important component of supportive care for patients receiving treatment for advanced gastric or GEJ cancer NORTHBROOK, Ill., Jan. 8, 2026 /PRNewswire/ -- Astellas Pharma U.S., Inc. (Head of US Commercial: Mike Petroutsas, "Astellas") today announced the publication of exploratory ad hoc analyses from the combined Phase 3 SPOTLIGHT (NCT03504397) and GLOW (NCT03653507) studies in patients with HER2-negative, CLDN18.2-positive advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma in ESMO Open, characterizing the management of adverse events on treatment adherence and efficacy of VYLOY (zolbetuximab) plus chemotherapy and evaluating strategies for managing these side effects. The exploratory analyses, which included 1,072 patients, reported higher mPFS and mOS estimates for patients treated with zolbetuximab plus chemotherapy after censoring data from patients who discontinued early or had inadequate treatment exposure due to nausea and/or vomiting.1 Pooled data from the analyses show that mPFS with zolbetuximab plus chemotherapy was 10.4 months (95% confidence interval [CI]: 8.8-12.2), and 8.2 months (95% CI: 7.7-8.4) with placebo plus chemotherapy. The hazard ratio [HR] versus placebo was 0.65 (95% CI: 0.56-0.76).1 Similarly, mOS with zolbetuximab plus chemotherapy was 17.9 months (95% CI: 16.4-19.5) and 13.7 months (95% CI: 12.4-15.3) with placebo plus chemotherapy with a HR versus placebo of 0.69 (95% CI: 0.60-0.80).1 Sam Klempner, MD, Gastrointestinal Medical Oncologist, Massachusetts General Hospital, Boston: "Nausea and vomiting are important symptoms that can affect patient comfort and treatment continuity for advanced gastric or GEJ cancer, particularly during early cycles when these symptoms are most common. Supportive care measures are therefore an important part of managing patients receiving cancer therapy." Zolbetuximab (VYLOY) is an FDA approved monoclonal antibody for patients with HER2-negative, CLDN18.2-positive advanced gastric or GEJ cancer. In combination with chemotherapy, zolbetuximab demonstrated statistically significant improvements in PFS and OS compared with placebo plus chemotherapy in the SPOTLIGHT and GLOW Phase 3 clinical trials.2,3 In SPOTLIGHT and GLOW, the incidence of serious treatment emergent adverse events (TEAEs) was similar in the zolbetuximab treatment groups compared with placebo plus chemotherapy. The most common all-grade TEAEs reported in the zolbetuximab treatment groups were nausea, vomiting and decreased appetite.2,3 The ad-hoc analyses in these studies showed an association between nausea and vomiting and higher treatment discontinuation rates compared with placebo. Timothy Forrest, RN, BSN, Massachusetts General Hospital, Boston: "Early cycles are a critical window for supporting patients starting treatment for advanced gastric or GEJ cancer. Since we know nausea and vomiting are common in this setting, preparing patients, monitoring closely, and using guideline-aligned supportive care can make a meaningful difference to their comfort and ability to continue treatment as planned." Within the published exploratory analyses, the effect of guideline-aligned supportive care on early nausea and vomiting associated with zolbetuximab plus chemotherapy was assessed.1 Data indicate that use of a guideline-recommended three-drug antiemetic regimen was associated with a higher proportion of patients who did not experience nausea or vomiting at cycle 1 dose 1 (C1D1; 60.8% and 75.3%, respectively).1 Additionally, across the SPOTLIGHT and GLOW trials, 57.9% of patients who received steroids at C1D1 did not experience nausea (versus 49.7% without steroids) and 63.7% did not experience vomiting at C1D1 (versus 62.6% with no steroids).1 Finally, results from the combined analysis suggest that a faster initial infusion may have contributed to adverse events such as nausea and vomiting observed during the first infusion. The authors noted that infusion-rate modifications may help mitigate these symptoms.1 Exploratory ad hoc analyses are hypothesis generating, and further work investigating the clinical validity of these results would be of value. Astellas is committed to supporting patients and the oncology care community by continuing to generate insights that enhance the patient and healthcare professional experience and better understand supportive care needs and treatment experiences. About the SPOTLIGHT Phase 3 Clinical Trial SPOTLIGHT is a Phase 3, global, multi-center, double-blind, randomized study assessing the efficacy and safety of zolbetuximab plus mFOLFOX6 (a combination chemotherapy regimen that includes oxaliplatin, leucovorin, and fluorouracil) compared to placebo plus mFOLFOX6 as a first-line treatment in patients with locally advanced, unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma whose tumors were CLDN18.2 positive. The study enrolled 565 patients at 215 study locations in the U.S., Canada, United Kingdom, Australia, Europe, South America, and Asia. The primary endpoint was progression-free survival (PFS) of participants treated with the combination of zolbetuximab plus mFOLFOX6 compared to those treated with placebo plus mFOLFOX6. Secondary endpoints included overall survival (OS), objective response rate (ORR), duration of response (DOR), safety and tolerability, and quality-of-life parameters. Data from the SPOTLIGHT clinical trial were presented during the 2023 American Society of Clinical Oncology (ASCO) Gastrointestinal (GI) Cancers Symposium in an oral presentation on January 19, 2023, and were subsequently published in The Lancet on April 14, 2023. The final analyses of SPOTLIGHT and GLOW, including additional supporting data in the appendix, were later published as a Letter to the Editor in the New England Journal of Medicine in 2024. For more information, please visit clinicaltrials.gov under Identifier NCT03504397. About the GLOW Phase 3 Clinical Trial GLOW is a Phase 3, global, multi-center, double-blind, randomized study assessing the efficacy and safety of zolbetuximab plus CAPOX (a combination chemotherapy regimen that includes capecitabine and oxaliplatin) compared to placebo plus CAPOX as a first-line treatment in patients with locally advanced unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma whose tumors were CLDN18.2 positive. The study enrolled 507 patients at 166 study locations in the U.S., Canada, United Kingdom, Europe, South America, and Asia, including Japan. The primary endpoint was PFS in participants treated with the combination of zolbetuximab plus CAPOX compared to those treated with placebo plus CAPOX. Secondary endpoints included OS, ORR, DOR, safety and tolerability, and quality-of-life parameters. Data from the GLOW study were initially presented at the March 2023 ASCO Plenary Series with an updated oral presentation at the 2023 ASCO Annual Meeting on June 3, 2023, and were subsequently published in Nature Medicine on July 31, 2023. For more information, please visit clinicaltrials.gov under Identifier NCT03653507. About VYLOY VYLOY (zolbetuximab) is a monoclonal antibody (mAb) specifically designed to target tumor cells that express claudin 18.2 (CLDN18.2), a transmembrane protein. By binding to CLDN18.2, zolbetuximab induces cancer cell death and inhibits tumor growth by activating two distinct immune system pathways - antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC), as demonstrated in preclinical studies. In both the SPOTLIGHT and GLOW Phase 3 clinical trials, approximately 38% of patients screened had tumors that were CLDN18.2 positive, defined as ≥75% of tumor cells demonstrating moderate to strong membranous CLDN18.2 immunohistochemical staining. Astellas collaborated with Roche on the Ventana™ CLDN18 (43-14a) RXDX assay which, where approved, can be used by pathologists or laboratories to identify patients eligible for targeted treatment with zolbetuximab. About Astellas Astellas is a global life sciences company committed to turning innovative science into value for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at . U.S. VYLOY ( zolbetuximab-clzb) Indication and Important Safety Information INDICATION VYLOY, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive as determined by an FDA-approved test. Warnings and Precautions Hypersensitivity reactions, including serious anaphylaxis reactions, and serious and fatal infusion-related reactions (IRR) have been reported in clinical studies when VYLOY has been administered. Any grade hypersensitivity reactions, including anaphylactic reactions, occurring with VYLOY in combination with mFOLFOX6 or CAPOX was 18%. Severe (Grade 3 or 4) hypersensitivity reactions, including anaphylactic reactions, occurred in 2% of patients. Seven patients (1.3%) permanently discontinued VYLOY for hypersensitivity reactions, including two patients (0.4%) who permanently discontinued VYLOY due to anaphylactic reactions. Seventeen (3.2%) patients required dose interruption, and three patients (0.6%) required infusion rate reduction due to hypersensitivity reactions. All grade IRRs occurred in 3.2% in patients administered VYLOY in combination with mFOLFOX6 or CAPOX. Severe (Grade 3) IRRs occurred in 2 (0.4%) patients who received VYLOY. An IRR led to permanent discontinuation of VYLOY in 2 (0.4%) patients and dose interruption in 7 (1.3%) patients. The infusion rate was reduced for VYLOY for 2 (0.4%) patients due to an IRR. Monitor patients during infusion with VYLOY and for 2 hours after completion of infusion or longer if clinically indicated, for hypersensitivity reactions with symptoms and signs that are highly suggestive of anaphylaxis (urticaria, repetitive cough, wheeze and throat tightness/change in voice). Monitor patients for signs and symptoms of IRRs including nausea, vomiting, abdominal pain, salivary hypersecretion, pyrexia, chest discomfort, chills, back pain, cough and hypertension. If a severe or life-threatening hypersensitivity or IRR reaction occurs, discontinue VYLOY permanently, treat symptoms according to standard medical care, and monitor until symptoms resolve. For any Grade 2 hypersensitivity or IRR, interrupt the VYLOY infusion until Grade ≤1, then resume at a reduced infusion rate for the remaining infusion. Follow Grade 2 management for Grade 3 infusion-related nausea and vomiting. Premedicate the patient with antihistamines for the subsequent infusions, and closely monitor the patient for symptoms and signs of a hypersensitivity reaction. The infusion rate may be gradually increased as tolerated. Severe Nausea and Vomiting. VYLOY is emetogenic. Nausea and vomiting occurred more often during the first cycle of treatment. All grade nausea and vomiting occurred in 82% and 67% respectively of patients treated with VYLOY in combination with mFOLFOX6 and 69% and 66% in combination with CAPOX, respectively. Severe (Grade 3) nausea occurred in 16% and 9% of patients treated with VYLOY in combination with mFOLFOX6 or CAPOX respectively. Severe (Grade 3) vomiting occurred in 16% and 12% of patients treated with VYLOY in combination with mFOLFOX6 or CAPOX. Nausea led to permanent discontinuation of VYLOY in combination with mFOLFOX6 or CAPOX in 18 (3.4%) patients and dose interruption in 147 (28%) patients. Vomiting led to permanent discontinuation of VYLOY in combination with mFOLFOX6 or CAPOX in 20 (3.8%) patients and dose interruption in 150 (28%) patients. Pretreat with antiemetics prior to each infusion of VYLOY. Manage patients during and after infusion with antiemetics or fluid replacement. Interrupt the infusion, or permanently discontinue VYLOY based on severity. ADVERSE REACTIONS Most common adverse reactions (≥15%): Nausea, vomiting, fatigue, decreased appetite, diarrhea, peripheral sensory neuropathy, abdominal pain, constipation, decreased weight, hypersensitivity reactions, and pyrexia. Most common laboratory abnormalities (≥15%): Decreased neutrophil count, decreased leucocyte count, decreased albumin, increased creatinine, decreased hemoglobin, increased glucose, decreased lymphocyte count, increased aspartate aminotransferase, decreased platelets, increased alkaline phosphatase, increased alanine aminotransferase, decreased glucose, decreased sodium, decreased phosphate, decreased potassium, and decreased magnesium. SPOTLIGHT Study: 279 patients with locally advanced unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma whose tumors were CLDN18.2 positive who received at least one dose of VYLOY in combination with mFOLFOX6 Serious adverse reactions occurred in 45% of patients treated with VYLOY in combination with mFOLFOX6; the most common serious adverse reactions (≥2%) were vomiting (8%), nausea (7%), neutropenia (2.9%), febrile neutropenia (2.9%), diarrhea (2.9%), intestinal obstruction (3.2%), pyrexia (2.5%), pneumonia (2.5%), respiratory failure (2.2%), pulmonary embolism (2.2%), decreased appetite (2.1%) and sepsis (2.0%). Fatal adverse reactions occurred in 5% of patients who received VYLOY in combination with mFOLFOX6 including sepsis (1.4%), pneumonia (1.1%), respiratory failure (1.1%), intestinal obstruction (0.7%), acute hepatic failure (0.4%), acute myocardial infarction (0.4%), death (0.4%), disseminated intravascular coagulation (0.4%), encephalopathy (0.4%), and upper gastrointestinal hemorrhage (0.4%). Permanent discontinuation of VYLOY due to an adverse reaction occurred in 20% of patients; the most common adverse reactions leading to discontinuation (≥2%) were nausea and vomiting. Dosage interruptions of VYLOY due to an adverse reaction occurred in 75% of patients; the most common adverse reactions leading to dose interruption (≥5%) were nausea, vomiting, neutropenia, abdominal pain, fatigue, and hypertension. GLOW Study: 254 patients with locally advanced unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma whose tumors were CLDN18.2 positive who received at least one dose of VYLOY in combination with CAPOX Serious adverse reactions occurred in 47% of patients treated with VYLOY in combination with CAPOX; the most common serious adverse reactions (≥2%) were vomiting (6%), nausea (4.3%), decreased appetite (3.9%), decreased platelet count (3.1%), upper gastrointestinal hemorrhage (2.8%), diarrhea (2.8%), pneumonia (2.4%), pulmonary embolism (2.3%), and pyrexia (2.0%). Fatal adverse reactions occurred in 8% of patients who received VYLOY in combination with CAPOX including sepsis (1.2%), pneumonia (0.4%), death (0.8%), upper gastrointestinal hemorrhage (0.8%), cerebral hemorrhage (0.8%), abdominal infection (0.4%), acute respiratory distress syndrome (0.4%), cardio-respiratory arrest (0.4%), decreased platelet count (0.4%), disseminated intravascular coagulation (0.4%), dyspnea (0.4%), gastric perforation (0.4%), hemorrhagic ascites (0.4%), procedural complication (0.4%), sudden death (0.4%), and syncope (0.4%). Permanent discontinuation of VYLOY due to an adverse reaction occurred in 19% of patients; the most common adverse reaction leading to discontinuation (≥2%) was vomiting. Dosage interruption of VYLOY due to an adverse reaction occurred in 55% of patients; the most common adverse reactions leading to dose interruption (≥2%) were nausea, vomiting, neutropenia, thrombocytopenia, anemia, fatigue, infusion-related reaction, and abdominal pain. SPECIFIC POPULATIONS Lactation Advise lactating women not to breastfeed during treatment with VYLOY and for 8 months after the last dose. Full U.S. Prescribing Information Cautionary Notes In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice. References 1 Shitara K, Smyth E, Lordick F, et al. Impact and effective management of nausea/vomiting on patients treated with zolbetuximab + chemotherapy: Insights from the phase 3 SPOTLIGHT and GLOW studies. ESMO Open. 2026. Available at: (25)01801-0/fulltext. Last accessed: January 2026. 2 Shitara K, Lordick F, Bang YJ, et al. Zolbetuximab plus mFOLFOX6 in patients with CLDN18.2-positive, HER2-negative, untreated, locally advanced unresectable or metastatic gastric or gastro-oesophageal junction adenocarcinoma (SPOTLIGHT): a multicentre, randomised, double-blind, phase 3 trial. Lancet 2023;401(10389):1655-1668. Errata in: Lancet 2023;402(10398):290; Lancet 2024;403(10421):30. 3 Shah MA, Shitara K, Ajani JA, et al. Zolbetuximab plus CAPOX in CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma: the randomized, phase 3 GLOW trial. Nat Med 2023;29(8):2133-2141. SOURCE Astellas Pharma Inc. 21% more press release views with Request a Demo

Clinical ResultPhase 3ASCOImmunotherapyDrug Approval

10 Dec 2025

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Astellas to Present New Clinical Data Across Its Gastrointestinal Cancers Portfolio at 2026 ASCO GI Cancers Symposium

- Data reflect new insights and precision oncology advancements in portfolio and pipeline - - Cohort results from Phase 2 ILUSTRO study evaluating a zolbetuximab triplet combination regimen in first-line advanced gastric and gastroesophageal junction (GEJ) cancer featured in late-breaking oral presentation - TOKYO, Dec. 10, 2025 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced it will present data on potential treatments for pancreatic and gastric/gastroesophageal junction (G/GEJ) cancer at the 2026 American Society of Clinical Oncology (ASCO) Gastrointestinal (GI) Cancers Symposium taking place January 8-10, 2026 in San Francisco, California. 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. Moitreyee Chatterjee-Kishore, Ph.D., M.B.A., Head of Oncology Development, Astellas "At Astellas, we are harnessing next-generation treatment modalities and a precision biomarker-driven approach to deliver treatments that make a meaningful difference for patients with gastrointestinal cancers. We're excited to share data at ASCO GI from our growing portfolio of assets in GI cancers – which showcase our commitment to better understanding how to treat these diseases – including emerging data from zolbetuximab as well as progress on ASP3082 (setidegrasib), our investigational KRAS G12D targeted protein degrader. Together with the passionate GI cancer community of patients, physicians, and advocates, we are working to transform outcomes for patients and pave the future of cancer care." Astellas Presentations at ASCO GI 2026 About Astellas Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at . About VYLOY™ (zolbetuximab) VYLOY (zolbetuximab) is a first-in-class monoclonal antibody (mAb) specifically designed to target tumor cells that express claudin 18.2 (CLDN18.2), a transmembrane protein. By binding to CLDN18.2, VYLOY (zolbetuximab) induces cancer cell death and inhibits tumor growth by activating two distinct immune system pathways - antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC), as demonstrated in preclinical studies. VYLOY (zolbetuximab) was the first CLDN18.2-targeted therapy to receive regulatory approval anywhere in the world and is currently the only approved treatment, in combination with chemotherapy, for CLDN18.2-positive (HER2-negative) gastric or gastroesophageal junction (GEJ) cancer in several countries, including China, the European Union, Japan, and the United States. In both the SPOTLIGHT and GLOW Phase 3 clinical trials, which assessed the efficacy and safety of zolbetuximab plus chemotherapy in patients with locally advanced unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma, approximately 38% of patients screened had tumors that were CLDN18.2 positive, defined as ≥75% of tumor cells demonstrating moderate to strong membranous CLDN18.2 immunohistochemical staining. This represents a substantial patient group that could benefit from targeted first-line therapy.1,2 Astellas collaborated with Roche on the Ventana™ CLDN18 (43-14a) RXDX assay, which, where approved, can be used by pathologists or laboratories to identify patients eligible for targeted treatment with VYLOY (zolbetuximab). Astellas is exploring zolbetuximab in combination with pembrolizumab and chemotherapy as a first-line treatment for patients with CLDN18.2-positive, HER2-negative, PD-L1-positive locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma in the investigational Phase III LUCERNA study. For more information, visit clinicaltrials.gov with identifier NCT06901531. About ASP3082 (setidegrasib) ASP3082 is a selective protein degrader discovered fully in-house that targets mutated KRAS G12D, which is found in approximately 40% of pancreatic ductal adenocarcinomas.3 A potential first-in-class therapy, ASP3082 is currently being evaluated in a Phase 1 clinical trial for patients with metastatic or locally advanced unresectable solid tumors with KRAS G12D mutations. In addition, Astellas is advancing ASP4396 which also targets mutated KRAS G12D and is in Phase 1 study. For more information, visit clinicaltrials.gov with identifier NCT05382559 (ASP3082) or NCT06364696 (ASP4396). The safety and efficacy of the agents under investigation have not been established for the uses being considered. There is no guarantee that the agents will receive regulatory approval and become commercially available for the uses being investigated. U.S. VYLOY ( zolbetuximab-clzb) Indication and Important Safety Information INDICATION VYLOY, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive as determined by an FDA-approved test. Warnings and Precautions Hypersensitivity reactions, including serious anaphylaxis reactions, and serious and fatal infusion-related reactions (IRR) have been reported in clinical studies when VYLOY has been administered. Any grade hypersensitivity reactions, including anaphylactic reactions, occurring with VYLOY in combination with mFOLFOX6 or CAPOX was 18%. Severe (Grade 3 or 4) hypersensitivity reactions, including anaphylactic reactions, occurred in 2% of patients. Seven patients (1.3%) permanently discontinued VYLOY for hypersensitivity reactions, including two patients (0.4%) who permanently discontinued VYLOY due to anaphylactic reactions. Seventeen (3.2%) patients required dose interruption, and three patients (0.6%) required infusion rate reduction due to hypersensitivity reactions. All grade IRRs occurred in 3.2% in patients administered VYLOY in combination with mFOLFOX6 or CAPOX. Severe (Grade 3) IRRs occurred in 2 (0.4%) patients who received VYLOY. An IRR led to permanent discontinuation of VYLOY in 2 (0.4%) patients and dose interruption in 7 (1.3%) patients. The infusion rate was reduced for VYLOY for 2 (0.4%) patients due to an IRR. Monitor patients during infusion with VYLOY and for 2 hours after completion of infusion or longer if clinically indicated, for hypersensitivity reactions with symptoms and signs that are highly suggestive of anaphylaxis (urticaria, repetitive cough, wheeze and throat tightness/change in voice). Monitor patients for signs and symptoms of IRRs including nausea, vomiting, abdominal pain, salivary hypersecretion, pyrexia, chest discomfort, chills, back pain, cough and hypertension. If a severe or life-threatening hypersensitivity or IRR reaction occurs, discontinue VYLOY permanently, treat symptoms according to standard medical care, and monitor until symptoms resolve. For any Grade 2 hypersensitivity or IRR, interrupt the VYLOY infusion until Grade ≤1, then resume at a reduced infusion rate for the remaining infusion. Follow Grade 2 management for Grade 3 infusion-related nausea and vomiting. Premedicate the patient with antihistamines for the subsequent infusions, and closely monitor the patient for symptoms and signs of a hypersensitivity reaction. The infusion rate may be gradually increased as tolerated. Severe Nausea and Vomiting. VYLOY is emetogenic. Nausea and vomiting occurred more often during the first cycle of treatment. All grade nausea and vomiting occurred in 82% and 67% respectively of patients treated with VYLOY in combination with mFOLFOX6 and 69% and 66% in combination with CAPOX, respectively. Severe (Grade 3) nausea occurred in 16% and 9% of patients treated with VYLOY in combination with mFOLFOX6 or CAPOX respectively. Severe (Grade 3) vomiting occurred in 16% and 12% of patients treated with VYLOY in combination with mFOLFOX6 or CAPOX. Nausea led to permanent discontinuation of VYLOY in combination with mFOLFOX6 or CAPOX in 18 (3.4%) patients and dose interruption in 147 (28%) patients. Vomiting led to permanent discontinuation of VYLOY in combination with mFOLFOX6 or CAPOX in 20 (3.8%) patients and dose interruption in 150 (28%) patients. Pretreat with antiemetics prior to each infusion of VYLOY. Manage patients during and after infusion with antiemetics or fluid replacement. Interrupt the infusion, or permanently discontinue VYLOY based on severity. ADVERSE REACTIONS Most common adverse reactions (≥15%): Nausea, vomiting, fatigue, decreased appetite, diarrhea, peripheral sensory neuropathy, abdominal pain, constipation, decreased weight, hypersensitivity reactions, and pyrexia. Most common laboratory abnormalities (≥15%): Decreased neutrophil count, decreased leucocyte count, decreased albumin, increased creatinine, decreased hemoglobin, increased glucose, decreased lymphocyte count, increased aspartate aminotransferase, decreased platelets, increased alkaline phosphatase, increased alanine aminotransferase, decreased glucose, decreased sodium, decreased phosphate, decreased potassium, and decreased magnesium. SPOTLIGHT Study: 279 patients with locally advanced unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma whose tumors were CLDN18.2 positive who received at least one dose of VYLOY in combination with mFOLFOX6 Serious adverse reactions occurred in 45% of patients treated with VYLOY in combination with mFOLFOX6; the most common serious adverse reactions (≥2%) were vomiting (8%), nausea (7%), neutropenia (2.9%), febrile neutropenia (2.9%), diarrhea (2.9%), intestinal obstruction (3.2%), pyrexia (2.5%), pneumonia (2.5%), respiratory failure (2.2%), pulmonary embolism (2.2%), decreased appetite (2.1%) and sepsis (2.0%). Fatal adverse reactions occurred in 5% of patients who received VYLOY in combination with mFOLFOX6 including sepsis (1.4%), pneumonia (1.1%), respiratory failure (1.1%), intestinal obstruction (0.7%), acute hepatic failure (0.4%), acute myocardial infarction (0.4%), death (0.4%), disseminated intravascular coagulation (0.4%), encephalopathy (0.4%), and upper gastrointestinal hemorrhage (0.4%). Permanent discontinuation of VYLOY due to an adverse reaction occurred in 20% of patients; the most common adverse reactions leading to discontinuation (≥2%) were nausea and vomiting. Dosage interruptions of VYLOY due to an adverse reaction occurred in 75% of patients; the most common adverse reactions leading to dose interruption (≥5%) were nausea, vomiting, neutropenia, abdominal pain, fatigue, and hypertension. GLOW Study: 254 patients with locally advanced unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma whose tumors were CLDN18.2 positive who received at least one dose of VYLOY in combination with CAPOX Serious adverse reactions occurred in 47% of patients treated with VYLOY in combination with CAPOX; the most common serious adverse reactions (≥2%) were vomiting (6%), nausea (4.3%), decreased appetite (3.9%), decreased platelet count (3.1%), upper gastrointestinal hemorrhage (2.8%), diarrhea (2.8%), pneumonia (2.4%), pulmonary embolism (2.3%), and pyrexia (2.0%). Fatal adverse reactions occurred in 8% of patients who received VYLOY in combination with CAPOX including sepsis (1.2%), pneumonia (0.4%), death (0.8%), upper gastrointestinal hemorrhage (0.8%), cerebral hemorrhage (0.8%), abdominal infection (0.4%), acute respiratory distress syndrome (0.4%), cardio-respiratory arrest (0.4%), decreased platelet count (0.4%), disseminated intravascular coagulation (0.4%), dyspnea (0.4%), gastric perforation (0.4%), hemorrhagic ascites (0.4%), procedural complication (0.4%), sudden death (0.4%), and syncope (0.4%). Permanent discontinuation of VYLOY due to an adverse reaction occurred in 19% of patients; the most common adverse reaction leading to discontinuation (≥2%) was vomiting. Dosage interruption of VYLOY due to an adverse reaction occurred in 55% of patients; the most common adverse reactions leading to dose interruption (≥2%) were nausea, vomiting, neutropenia, thrombocytopenia, anemia, fatigue, infusion-related reaction, and abdominal pain. SPECIFIC POPULATIONS Lactation Advise lactating women not to breastfeed during treatment with VYLOY and for 8 months after the last dose. Full U.S. Prescribing Information Cautionary Notes In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice. References 1 Shitara K, et al. Zolbetuximab plus mFOLFOX6 in patients with CLDN18.2-positive, HER2-negative, untreated, locally advanced unresectable or metastatic gastric or gastro-oesophageal junction adenocarcinoma (SPOTLIGHT): a multicentre, randomised, double-blind, phase 3 trial. Lancet. 2023;401(10389):1655-1668. 2 Shah MA, et al. Zolbetuximab plus CAPOX in CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma: the randomized, phase 3 GLOW trial. Nat Med. 2023;29(8):2133-2141. 3 Lee, JK et al. Comprehensive pan-cancer genomic landscape of KRAS altered cancers and real-world outcomes in solid tumors. NPJ Precis Oncol. 2022;9;6(1):91. SOURCE Astellas Pharma Inc. 21% more press release views with Request a Demo

ASCOPhase 1Clinical ResultPhase 3Drug Approval

100 Deals associated with Zolbetuximab

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KEGG	Wiki	ATC	Drug Bank
-	Zolbetuximab	-	DB15118

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Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Advanced Gastroesophageal Junction Adenocarcinoma	Canada	Astellas Pharma Canada, Inc.	09 Jan 2025
CLDN18.2 positive Gastroesophageal junction adenocarcinoma	United Kingdom	Astellas Pharma, Inc.	14 Aug 2024
CLDN18.2 positive stomach adenocarcinoma	United Kingdom	Astellas Pharma, Inc.	14 Aug 2024
CLDN18.2 positive Stomach Cancer	Japan	Astellas Pharma, Inc.	26 Mar 2024

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Locally Advanced Gastroesophageal Junction Adenocarcinoma	Phase 3	United States	Astellas Pharma Global Development, Inc.	28 Nov 2018
Locally Advanced Gastroesophageal Junction Adenocarcinoma	Phase 3	China	Astellas Pharma Global Development, Inc.	28 Nov 2018
Locally Advanced Gastroesophageal Junction Adenocarcinoma	Phase 3	Japan	Astellas Pharma Global Development, Inc.	28 Nov 2018
Locally Advanced Gastroesophageal Junction Adenocarcinoma	Phase 3	Argentina	Astellas Pharma Global Development, Inc.	28 Nov 2018
Locally Advanced Gastroesophageal Junction Adenocarcinoma	Phase 3	Canada	Astellas Pharma Global Development, Inc.	28 Nov 2018
Locally Advanced Gastroesophageal Junction Adenocarcinoma	Phase 3	Croatia	Astellas Pharma Global Development, Inc.	28 Nov 2018
Locally Advanced Gastroesophageal Junction Adenocarcinoma	Phase 3	Greece	Astellas Pharma Global Development, Inc.	28 Nov 2018
Locally Advanced Gastroesophageal Junction Adenocarcinoma	Phase 3	Ireland	Astellas Pharma Global Development, Inc.	28 Nov 2018
Locally Advanced Gastroesophageal Junction Adenocarcinoma	Phase 3	Malaysia	Astellas Pharma Global Development, Inc.	28 Nov 2018
Locally Advanced Gastroesophageal Junction Adenocarcinoma	Phase 3	Netherlands	Astellas Pharma Global Development, Inc.	28 Nov 2018

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03504397 (SPOTLIGHT, ESMO_ASIA2025)	Phase 3	CLDN18.2 positive Gastroesophageal junction adenocarcinoma \| CLDN18.2 positive stomach adenocarcinoma First line CLDN18.2+ \| HER2−	374	Zolbetuximab plus mFOLFOX6/CAPOX	jnyeautujy(cvnckpidoj) = The most common grade ≥3 AEs occurring in ≥20% of patients in zolbetuximab arm were neutropenia (20.7%) and vomiting (20.2%). ejdmjufctx (xithsfskfv ) View more	Positive	05 Dec 2025
				Placebo plus mFOLFOX6/CAPOX
ESMO_ASIA2025	Not Applicable	Advanced Gastroesophageal Junction Adenocarcinoma First line	22	Zolbetuximab (Zolb) + chemo	xcokgsopps(wmsfyzoaln) = abdominal pain (18%) zbdojcdlzw (yrpxzynmyx ) View more	Positive	05 Dec 2025
ESMO_ASIA2025	Not Applicable	Advanced gastric carcinoma	17	Zolbetuximab+antiemetic therapy+atypical antipsychotics	ktoujfkrnq(awgwujykuh) = hymehllypd avozozhcft (iitplczvcp ) View more	Positive	05 Dec 2025
NCT03504397 (SPOTLIGHT \| SPOTLIGHT study, CTgov)	Phase 3	-	565	folinic acid+zolbetuximab+oxaliplatin+fluorouracil	hjmzhdpnlq(opjanjiibx) = xuzpccaeri qtwlrdefrl (qnelghqpka, jpnyjvweua - mbdrnmzgpy) View more	-	26 Feb 2025
NCT03653507 (GLOW, CTgov)	Phase 3	Locally Advanced Gastroesophageal Junction Adenocarcinoma \| Metastatic Gastroesophageal Junction Adenocarcinoma	507	CAPOX+Zolbetuximab (CAPOX+ Zolbetuximab)	yxpxhbhbpb(fdmdtidfbx) = lqkxjyhvam pgccjlzrba (lhlbvbnmqz, gbeahkapjf - ikqaylqhhg) View more	-	27 Jan 2025
				Placebo (CAPOX+ Placebo)	yxpxhbhbpb(fdmdtidfbx) = drqeqlhusc pgccjlzrba (lhlbvbnmqz, lfyknmpwkp - jqwplkycei) View more
NCT03504397 (SPOTLIGHT, NEWS) Manual	Phase 3	Gastroesophageal junction adenocarcinoma First line CLDN18.2 Positive \| HER2 Negative	61	佐妥昔单抗+mFOLFOX6	ocmmaxjtfm(rmjxdjjrxk) = gpywmitaeq ptcphljvcj (rztmbtkpfr, 6.7 - 16.7) View more	Positive	28 Sep 2024
				安慰剂+mFOLFOX6	ocmmaxjtfm(rmjxdjjrxk) = nipxqnfwmo ptcphljvcj (rztmbtkpfr, 6.0 - 8.4) View more
NCT03653507 (GLOW, NEWS) Manual	Phase 3	Stomach Cancer \| Gastroesophageal junction adenocarcinoma First line HER2 Negative \| CLDN18.2 Positive	145	佐妥昔单抗联合CAPOX	mzxrseznvr(uyevvhpnco) = avemmvriwo vdiugpikez (kmbbxjqyrf, 6.1 - 9.1) View more	Positive	28 Sep 2024
				安慰剂联合CAPOX	mzxrseznvr(uyevvhpnco) = rhjgevjtka vdiugpikez (kmbbxjqyrf, 5.0 - 8.0) View more
NCT03653507 \| NCT03504397 (SPOTLIGHT \| GLOW, ESMO2024)	Phase 3	CLDN18.2 positive Gastroesophageal junction adenocarcinoma First line CLDN18.2+ \| HER2-	1,072	Zolbetuximab + chemotherapy	fcakfedxge(yivlzmacob) = ixmurjossa plfvyphgxx (whnchakhsn, 8.4 - 10.4) View more	Positive	16 Sep 2024
				Placebo + chemotherapy	fcakfedxge(yivlzmacob) = pfupixjnpn plfvyphgxx (whnchakhsn, 7.6 - 8.4) View more
NCT03504397 (SPOTLIGHT, ASCO2024) Manual	Phase 3	CLDN18.2 positive Gastroesophageal junction adenocarcinoma \| CLDN18.2 positive Stomach Cancer First line HER2 Negative \| CLDN18.2 Positive	565	Zolbetuximab + mFOLFOX6	ftcbjwcsha(bbedgycrnx) = miupzxjbja sotsehitsg (uruvwgelwv ) View more	Positive	24 May 2024
				Placebo + mFOLFOX6	ftcbjwcsha(bbedgycrnx) = bglfjidbyz sotsehitsg (uruvwgelwv ) View more
NCT03653507 \| NCT03504397 (Pubmed \| Future Oncol)	Phase 3	Gastrooesophageal junction cancer CLDN18.2-positive \| HER2-negative	-	Zolbetuximab plus chemotherapy	tgjhlqthcg(qqcaprahmt) = qifmtbnnuk ggffdvfxep (zoshpsgupb ) View more	Positive	24 May 2024
				Placebo plus chemotherapy	tgjhlqthcg(qqcaprahmt) = mdrcymbwqu ggffdvfxep (zoshpsgupb ) View more

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