Astellas' VYLOY™ (zolbetuximab-clzb) Approved by U.S. FDA for Treatment of Advanced Gastric and GEJ Cancer
Astellas Pharma Inc. announced FDA approval of VYLOY™ (zolbetuximab-clzb) for first-line treatment of advanced gastric and gastroesophageal junction (GEJ) cancer in adults with CLDN18.2-positive tumors. VYLOY is the first and only CLDN18.2-targeted therapy approved in the U.S.
The approval is based on results from the Phase 3 SPOTLIGHT and GLOW clinical trials, which met primary endpoints of progression-free survival and overall survival. Approximately 38% of patients screened had CLDN18.2-positive tumors. An FDA-approved companion diagnostic test from Roche is used to identify eligible patients.
VYLOY is now approved in five markets worldwide, including Japan, the UK, EU, South Korea, and the U.S. Astellas has reflected the impact of this approval in its financial forecast for the fiscal year ending March 31, 2025.
Astellas Pharma Inc. ha annunciato l'approvazione della FDA per VYLOY™ (zolbetuximab-clzb) come trattamento di prima linea per il cancro gastrico avanzato e del giunzione gastroesofagea (GEJ) negli adulti con tumori positivi al CLDN18.2. VYLOY è la prima e unica terapia mirata al CLDN18.2 approvata negli Stati Uniti.
L'approvazione si basa sui risultati dei trial clinici di fase 3 SPOTLIGHT e GLOW, che hanno raggiunto gli obiettivi primari di sopravvivenza libera da progressione e sopravvivenza totale. Circa il 38% dei pazienti sottoposti a screening aveva tumori positivi al CLDN18.2. Un test diagnostico companion approvato dalla FDA di Roche viene utilizzato per identificare i pazienti idonei.
VYLOY è ora approvato in cinque mercati globali, tra cui Giappone, Regno Unito, UE, Corea del Sud e Stati Uniti. Astellas ha riflesso l'impatto di questa approvazione nelle sue previsioni finanziarie per l'anno fiscale che si concluderà il 31 marzo 2025.
Astellas Pharma Inc. anunció la aprobación de la FDA para VYLOY™ (zolbetuximab-clzb) como tratamiento de primera línea para el cáncer gástrico avanzado y de la unión gastroesofágica (GEJ) en adultos con tumores positivos para CLDN18.2. VYLOY es la primera y única terapia dirigida a CLDN18.2 aprobada en EE. UU.
La aprobación se basa en los resultados de los ensayos clínicos de fase 3 SPOTLIGHT y GLOW, que cumplieron con los objetivos primarios de supervivencia libre de progresión y supervivencia general. Aproximadamente el 38% de los pacientes evaluados tenía tumores positivos para CLDN18.2. Se utiliza un test de diagnóstico companion aprobado por la FDA de Roche para identificar a los pacientes elegibles.
VYLOY ahora está aprobado en cinco mercados en todo el mundo, incluidos Japón, Reino Unido, UE, Corea del Sur y EE. UU. Astellas ha reflejado el impacto de esta aprobación en sus previsiones financieras para el año fiscal que finaliza el 31 de marzo de 2025.
Astellas Pharma Inc.는 VYLOY™ (zolbetuximab-clzb)의 FDA 승인을 발표했습니다. 이는 CLDN18.2 양성 종양이 있는 성인의 진행성 위암 및 위식도 접합부 (GEJ) 암에 대한 1차 치료로 승인된 것입니다. VYLOY는 미국에서 승인된 첫 번째이자 유일한 CLDN18.2 표적 치료제입니다.
이 승인은 3상 SPOTLIGHT 및 GLOW 임상 시험의 결과에 기반하고 있으며, 이 시험들은 무진행 생존율 및 전체 생존율의 주 목표를 충족했습니다. 선별검사에서 약 38%의 환자가 CLDN18.2 양성 종양을 가지고 있었습니다. 환자를 식별하기 위해 Roche의 FDA 승인 동반 진단 테스트가 사용됩니다.
VYLOY는 이제 일본, 영국, EU, 한국, 미국을 포함한 전 세계 5개 시장에서 승인되었습니다. Astellas는 2025년 3월 31일로 종료되는 회계 연도에 대한 재무 예측에 이 승인 소식을 반영했습니다.
Astellas Pharma Inc. a annoncé l'approbation par la FDA de VYLOY™ (zolbetuximab-clzb) pour le traitement de première ligne du cancer gastrique avancé et du junction gastro-œsophagien (GEJ) chez les adultes ayant des tumeurs positives pour CLDN18.2. VYLOY est la première et seule thérapie ciblée CLDN18.2 approuvée aux États-Unis.
L'approbation est basée sur les résultats des essais cliniques de phase 3 SPOTLIGHT et GLOW, qui ont atteint les objectifs primaires de survie sans progression et de survie globale. Environ 38% des patients examinés avaient des tumeurs positives pour CLDN18.2. Un test de diagnostic compagnon approuvé par la FDA de Roche est utilisé pour identifier les patients éligibles.
VYLOY est maintenant approuvé dans cinq marchés à travers le monde, y compris le Japon, le Royaume-Uni, l'UE, la Corée du Sud et les États-Unis. Astellas a intégré l'impact de cette approbation dans ses prévisions financières pour l'exercice se terminant le 31 mars 2025.
Astellas Pharma Inc. gab die FDA-Zulassung für VYLOY™ (zolbetuximab-clzb) bekannt. Es handelt sich um die Erstlinienbehandlung von fortgeschrittenem Magen- und gastroösophagealen Junction (GEJ)-Krebs bei Erwachsenen mit CLDN18.2-positiven Tumoren. VYLOY ist die erste und einzige CLDN18.2-zielte Therapie, die in den USA zugelassen wurde.
Die Zulassung basiert auf den Ergebnissen der Phase 3 SPOTLIGHT- und GLOW-Studien, die die primären Endpunkte der progressionsfreien Überlebenszeit und der Gesamtüberlebenszeit erreichten. Etwa 38% der gesichteten Patienten hatten CLDN18.2-positive Tumoren. Ein von Roche entwickelter FDA-zugelassener Begleitdiagnosetest wird verwendet, um geeignete Patienten zu identifizieren.
VYLOY ist nun in fünf Märkten weltweit zugelassen, darunter Japan, das Vereinigte Königreich, die EU, Südkorea und die USA. Astellas hat die Auswirkungen dieser Zulassung in seiner Finanzprognose für das zum 31. März 2025 endende Geschäftsjahr berücksichtigt.
- First and only CLDN18.2-targeted therapy approved in the U.S. for advanced gastric and GEJ cancer
- Met primary and key secondary endpoints in Phase 3 clinical trials
- Approved in five major markets worldwide
- Companion diagnostic test available to identify eligible patients
- 38% of screened patients had CLDN18.2-positive tumors, indicating potential market size
- to patients with CLDN18.2-positive tumors (approximately 38% of those screened)
- Common adverse events include nausea, vomiting, and decreased appetite
VYLOY is the first and only CLDN18.2-targeted treatment approved in the
In the SPOTLIGHT and GLOW clinical trials, approximately
Moitreyee Chatterjee-Kishore, Ph.D., M.B.A., Senior Vice President and Head of Immuno-Oncology Development, Astellas
"The approval of VYLOY as the first and only targeted therapy for CLDN18.2-positive patients in the
Samuel J. Klempner, M.D., Associate Professor, Harvard Medical School, Medical Oncologist at Massachusetts General Hospital, Boston
"While there have been advances in the first-line treatment of locally advanced unresectable and metastatic gastric and GEJ cancers in the last several years, there is still a tremendous unmet need among our patients. The approval of VYLOY, based on the pivotal Phase 3 SPOTLIGHT and GLOW trials, brings forward a novel biomarker and new therapy for patients whose tumors are CLDN18.2 positive, and for those on the frontlines of treatment decision-making."
The approval is based on results from the Phase 3 SPOTLIGHT and GLOW clinical trials.2,3 The SPOTLIGHT study evaluated VYLOY plus mFOLFOX6 (a combination chemotherapy regimen that includes oxaliplatin, leucovorin, and fluorouracil) compared to placebo plus mFOLFOX6. The GLOW study evaluated VYLOY plus CAPOX (a combination chemotherapy regimen that includes capecitabine and oxaliplatin) compared to placebo plus CAPOX. Both trials met their primary endpoint, progression-free survival (PFS), as well as a key secondary endpoint, overall survival (OS), in patients treated with VYLOY plus chemotherapy compared to placebo plus chemotherapy. Across the SPOTLIGHT and GLOW trials, the most common all-grade treatment-emergent adverse events (TEAEs) reported in the VYLOY treatment arms were nausea, vomiting and decreased appetite.2,3
An FDA-approved test is used to identify patients who may be eligible for VYLOY.1 The VENTANA CLDN18 (43-14A) RxDx Assay from Roche is an FDA-approved IHC test used to help determine CLDN18.2 status. Testing is available in the
Following today's FDA decision, VYLOY is now approved in five markets worldwide —
Astellas has already reflected the impact from this approval in its financial forecast for the current fiscal year ending March 31, 2025.
*VYLOYhcp.com is in the process of being deployed. If you cannot access the site right away, please try again soon.
About VYLOY™ (zolbetuximab-clzb)
VYLOY™ (zolbetuximab-clzb) is a claudin 18.2-directed cytolytic antibody that is approved by the
VYLOY (zolbetuximab-clzb)
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.
IMPORTANT SAFETY INFORMATION
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
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
ADVERSE REACTIONS
Most common adverse reactions (≥
Most common laboratory abnormalities (≥
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
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
SPECIFIC POPULATIONS
Lactation Advise lactating women not to breastfeed during treatment with VYLOY and for 8 months after the last dose.
For more information, please see the
About Locally Advanced Unresectable Metastatic Gastric and Gastroesophageal Junction Cancer
Gastric and gastroesophageal junction (G/GEJ) cancer is the fifth most commonly diagnosed cancer worldwide.5 GEJ adenocarcinoma is a cancer that starts at the area where the esophagus joins the stomach.6 In the
INVESTIGATIONAL STUDIES
About 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
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, 2023.2
For more information, please visit clinicaltrials.gov under Identifier NCT03504397.
About 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
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, 2023.3
For more information, please visit clinicaltrials.gov under Identifier NCT03653507.
Investigational Pipeline in CLDN18.2
A Phase 2 trial of zolbetuximab in metastatic pancreatic adenocarcinoma is in progress. The trial is a randomized, multi-center, open-label study, evaluating the safety and efficacy of investigational zolbetuximab in combination with gemcitabine plus nab-paclitaxel as a first-line treatment in patients with metastatic pancreatic adenocarcinoma with CLDN18.2 positive tumors (defined as ≥
In addition to zolbetuximab, ASP2138 is under development in our Primary Focus Immuno-Oncology area and is currently recruiting patients. ASP2138 is a bispecific monoclonal antibody that binds to CD3 and CLDN18.2, and it is currently in a Phase 1/1b study in participants with metastatic or locally advanced unresectable gastric or GEJ adenocarcinoma or metastatic pancreatic adenocarcinoma whose tumors have CLDN18.2 expression. The safety and efficacy of the agent under investigation have not been established for the uses being considered. For more information, please visit clinicaltrials.gov under Identifier NCT05365581.
There is no guarantee that these agent(s) will receive regulatory approval and become commercially available for the uses being investigated.
About Astellas
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into VALUE for patients. For more information, please visit our website at https://www.astellas.com/en.
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
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1 VYLOY [package insert]. Northbrook, IL: Astellas Inc.
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.
4 DATA ON FILE.
5 Sung H, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021;71(3):209-49.
6 American Cancer Society. About esophagus cancer (03-20-2020). Available at https://www.cancer.org/content/dam/CRC/PDF/Public/8614.00.pdf. Accessed 11-13-2023.
7 National Cancer Institute. Surveillance, Epidemiology, and End Results Program. Cancer stat facts: stomach cancer. Available at https://seer.cancer.gov/statfacts/html/stomach.html. Accessed 04-26-2024.
8 National Institutes of Health National Center for Advancing Translational Sciences. About - Genetic and Rare Diseases Information Center. https://rarediseases.info.nih.gov/about. Accessed 11-13-2023.
9 American Cancer Society. Signs and symptoms of stomach cancer (01-22-2021). Available at https://www.cancer.org/cancer/stomach-cancer/detection-diagnosis-staging/signs-symptoms.html. Accessed 11-13-2023.
10 National Cancer Institute. Stomach Cancer Symptoms (05-31-2023). Available at https://www.cancer.gov/types/stomach/symptoms. Accessed 08-28-2024.
11 American Cancer Society. Stomach cancer risk factors (01-22-2021). Available at https://www.cancer.org/cancer/types/stomach-cancer/causes-risks-prevention/risk-factors.html. Accessed 11-13-2023.
12 American Cancer Society. Esophageal cancer risk factors (06-09-2020). Available at https://www.cancer.org/cancer/esophagus-cancer/causes-risks-prevention/risk-factors.html. Accessed 11-13-2023.
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FAQ
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