Phase III, Randomized, Double-blind Study of Combination Therapy With D07001-Softgel Capsules and Capecitabine vs Placebo and Capecitabine in Patients With Advanced BTC After Failed on Gemcitabine, Platin, and FOLFOX or Irinotecan Regimens

The object of this trial is to evaluate the efficacy of D07001-softgel capsules + capecitabine compared with placebo + capecitabine by overall survival (OS).
Eligible patients with advanced biliary tract cancer (BTC) will be randomized (1:1:1) to receive either 60 mg D07001-softgel, 100 mg D07001-softgel, or placebo, combine with capecitabine. Treatment will be continued until disease progression, death, withdraw consent, or completing 12 treatment cycles , whichever occurs first.

Start Date01 Apr 2025

Sponsor / Collaborator

InnoPharmax, Inc.

NCT06764875

/ Not yet recruitingPhase 3

A Randomized, Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan Versus Trastuzumab, Chemotherapy, and Pembrolizumab for the First Line Treatment of HER2-positive Gastric Cancer (ARTEMIDE-Gastric01)

This is a Phase Ⅲ, randomized, open-label, Sponsor-blinded, 3-arm, global, multicenter study assessing the efficacy and safety of rilvegostomig in combination with fluoropyrimidine and T-DXd (Arm A) compared to trastuzumab, chemotherapy, and pembrolizumab (Arm B) in HER2-positive locally advanced or metastatic gastric or GEJ adenocarcinoma participants whose tumors express PD L1 CPS ≥ 1. Rilvegostomig in combination with trastuzumab and chemotherapy will be evaluated in a separate arm (Arm C) to assess the contribution of each component in the experimental arm.

Start Date28 Mar 2025

Sponsor / Collaborator

AstraZeneca PLC

NCT06374459

/ Not yet recruitingPhase 1/2IIT

A Phase Ib/II Trial of Zunsemetinib in Combination With Capecitabine in Patients With Hormone Receptor-Positive and HER2-Negative Metastatic Breast Cancer With Bone Metastasis

This is a phase Ib/II study evaluating the safety and efficacy of zunsemetinib (ATI-450) with capecitabine in patients with hormone receptor-positive and HER2-negative (HR+/HER2-) metastatic breast cancer (MBC).

Start Date28 Feb 2025

Sponsor / Collaborator

Washington University School of Medicine

[+2]

100 Clinical Results associated with Capecitabine

100 Translational Medicine associated with Capecitabine

100 Patents (Medical) associated with Capecitabine

8,630

Literatures (Medical) associated with Capecitabine

01 Dec 2025·Journal of Gastrointestinal Cancer

Impact of Retroperitoneal Lymphadenopathy (RPLN) on the Outcomes of Locally Advanced Gall Bladder Cancer (GBC) Following Chemotherapy (CT) or Chemotherapy Followed by Consolidation Chemoradiotherapy (CTRT)

Article

Author: Naik, Nagendra ; Priyanka, Parul ; Agrawal, Sushma

INTRODUCTION:

Retroperitoneal lymphadenopathy is considered a metastatic disease in GBC; however, some surgical series of radical surgery with enlarged RPLN who underwent RPLN dissection have shown results marginally inferior to those without enlarged RPLN. Radiological RPLN comprises a major proportion of advanced non-metastatic GBC. There is dilemma in the intent of treatment to be offered in such cases. We are reporting our series of outcome of GBC with RPLN treated with first-line CT followed by consolidation CTRT.

MATERIALS AND METHODS:

Non-metastatic locally advanced GBC with good performance status (KPS ≥ 80) were initiated on first-line CT (cisplatin-gemcitabine), and thereafter, responders were evaluated by CECT-angiography and PET-CT scan for resectability. If found unresectable, they were offered consolidation CTRT to a dose of 45 Gy by conventional fractionation (3D-CRT technique) along with concurrent capecitabine at 1250 mg/m² to GBC and regional lymphatics including RPLN. Thereafter, boost dose of 9 Gy/5# was given to GBC only. Response assessment was done using CECT abdomen by RECIST criteria v 1.1. Outcomes (overall survival) of the two groups (RPLN vs non-RPLN) were computed with Kaplan-Meier survival curves and chi-square tests using SPSS v 20.

RESULTS:

Among 189 patients of advanced non-metastatic GBC recruited from 2011 to 2022, 80 had RPLN. The demographic features of both groups were comparable. Overall, 68% of the patients were women, 30% underwent upfront stenting for obstructive jaundice, and 90% had T3 and T4 disease. Only 10% had undergone upfront laparoscopic staging and had pathologically proven RPLN. Forty percent of the patients received four cycles of CT only and 50% of the patients received six cycles or more and 33% received CTRT. By RECIST criteria, 10% vs 16% achieved complete response (CR), 39% vs 41% achieved partial response (PR), 16% vs 15% achieved stable disease (SD), 2.7% vs 6% had disease progression (PD), and 14.5% vs 3.7% were non-evaluable in non-RPLN group vs RPLN group, respectively. 12% vs 6% could undergo radical surgery in non-RPLN group vs RPLN group (p = 0.03). The median OS was 9 months (95% CI 7.6-10.3 months) vs 10 months (95% CI 8-9.8 months) (p = NS) in non-RPLN group vs RPLN group, respectively. In those who received CT only, the median OS was 7 months vs 8 months, while in those who received CT followed by CTRT, the median OS was 14 months vs 13 months (p = 0.65) in non-RPLN group vs RPLN group, respectively.

CONCLUSIONS:

Based on this analysis, we conclude that RPLN constitutes a major proportion of advanced non-metastatic GBC and has outcomes similar to those without RPLN if treated with radical intent. RPLN should not be considered a metastatic disease and should be treated with radical intent.

01 Dec 2025·CANCER CHEMOTHERAPY AND PHARMACOLOGY

DPYD genotype should be extended to rare variants: report on two cases of phenotype / genotype discrepancy

Article

Author: Goldwirt, Lauriane ; Teixeira, Luis ; Thomas, Fabienne ; Jacqz-Aigrain, Evelyne ; Vilquin, Paul ; Mourah, Samia ; Medard, Yves

The enzyme dihydropyrimidine dehydrogenase (DPD) is the primary catabolic pathway of fluoropyrimidines including 5 fluorouracil (5FU) and capecitabine. Cases of lethal toxicity have been reported in cancer patients with complete DPD deficiency receiving standard dose of 5FU or capecitabine. DPD is encoded by the pharmacogene DPYD in which more than 200 variants have been identified. Different approaches have been developed for screening DPD-deficiency, including DPYD genotyping and phenotyping. Plasma uracil ([U]) and dihydrouracil ([UH₂]) concentrations are routinely used as surrogate markers for systemic DPD activity: [U] ≥ 16 ng/ml and < 150 ng/ml, and [U] ≥ 150 ng/mL indicate partial and complete DPD deficient phenotype, respectively, while values of 5 or 10 for [UH2]/([U] ratio are often cited. Four clinically relevant DPYD defective variants (DPYD*13, DPYD*2A, p.Asp949Val and haplotype B3), are targeted in genetic testing via PCR. In practice, pretreatment [U], alone or combined with these 4 recommended DPYD alleles guides individual dosage selection, though this approach has limitations. This is illustrated by two cases showing discrepancy between DPD deficient phenotype and normal standard genotype. In these two cases, DPYD exome sequencing with Next Generation Sequencing identified rare inactive variants, establishing concordance between phenotype and genotype. In patient 1, [U] levels of 21.1 and 25.5 ng/mL, indicated partial deficiency though the targeted genotype was normal and 5FU dose was adjusted based on the phenotype. In patient 2, [U] levels of 16.2 and 15.2 ng/mL were near the 16 ng/ml threshold. With a normal genotype, he as considered non-deficient as targeted genotype was normal and the standard dose was administered. These two cases underscore the need to pair DPD phenotyping with whole DPYD gene sequencing, due to the frequent discrepancies between these pharmacogenetic tools, the burden of rare variants and ethnic differences in variant frequencies.

01 Dec 2025·Journal of Gastrointestinal Cancer

Nivolumab Combined with Chemotherapy in FGFR2 and PD-L1 Co-Expressing Metastatic Gastric Cancer: A Prospective Phase 2 NIVOFGFR2 Study

Article

Author: Guliyev, Fuad ; Otkhozoria, Nana ; Musayeva, Gunel ; Mahmudova, Samira ; Kahharov, Alisher ; Abbasov, Bahadur ; Tsimafeyeu, Ilya

BACKGROUND:

Immunotherapy is increasingly significant in treating metastatic gastric cancer. This prospective phase 2 study investigates the efficacy and safety of combining nivolumab with chemotherapy in patients with metastatic gastric cancer co-expressing FGFR2 and PD-L1.

METHODS:

Eligible patients were aged 18 years or older, with previously untreated HER-2 negative, PD-L1 positive, and FGFR2 positive metastatic gastric adenocarcinoma. Patients received nivolumab (360 mg every 3 weeks) in combination with chemotherapy (CAPOX: capecitabine 1000 mg/m² twice daily on days 1-14 and oxaliplatin 130 mg/m² on day 1, every 3 weeks). Tumor assessments were conducted using RECIST v1.1 every 8 weeks for 48 weeks, then every 12 weeks. The primary endpoint was the 1-year progression-free survival (PFS) rate. Secondary endpoints included median PFS, overall survival (OS), objective response rate (ORR), and grade ≥ 3 adverse events (AEs).

RESULTS:

From June 2022 to October 2023, 194 patients were assessed for eligibility, with 23 patients enrolled and treated. At a median follow-up of 17.3 months, the 1-year PFS rate was 30.4%, with a median PFS of 6.0 months (95% CI, 4.3-7.7). The median OS was 15.1 months (95% CI, 13.2-16.8). The ORR was 21.7%, with one complete response and four partial responses. Grade 3 or higher TRAEs were reported in 34.8% of patients, primarily associated with chemotherapy. No treatment-related deaths occurred.

CONCLUSIONS:

While the primary endpoint of improved 1-year PFS rate was not met, the study offers valuable insights into the potential benefits of combining nivolumab with chemotherapy in FGFR2 and PD-L1 co-expressing metastatic gastric cancer. Future research should optimize patient selection, assess combined immunotherapy and targeted anti-FGFR2 therapy, and further investigate the role of subsequent treatments to maximize therapeutic benefits.

324

News (Medical) associated with Capecitabine

06 Jan 2025

·www.astellas.com

China’s National Medical Products Administration (NMPA) Approves VYLOY(TM) (zolbetuximab) for First-Line Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

- China has the highest number of cases and deaths from gastric cancer of any country worldwide1 - - Zolbetuximab is the first and only therapy approved in China to target claudin 18.2, a biomarker expressed by 35% of Chinese patients with advanced gastric and gastroesophageal junction (GEJ) cancer2 - - Treatment with the claudin 18.2-targeted monoclonal antibody shown to significantly extend both progression-free survival and overall survival in the Phase 3 GLOW and SPOTLIGHT trials3,4 - TOKYO, Jan. 06, 2025 – Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, “Astellas”) today announced that China’s National Medical Products Administration (NMPA) has approved VYLOYTM (zolbetuximab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients 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. Zolbetuximab is the first NMPA-approved monoclonal antibody to target gastric tumor cells that express the biomarker CLDN18.2, offering a highly targeted approach to cancer treatment. Gastric cancer is the third leading cause of cancer-related mortality in China, with more than 260,000 deaths reported from the disease in 2022.5 As early symptoms are often hard to detect, approximately 60% of Chinese patients are diagnosed at the advanced stage of the disease6 where treatment options are limited and outcomes are often poor. The average five-year survival rate for patients with advanced gastric cancer in China is 9.1%, driving the urgent need for novel therapeutic options that can slow disease progression and extend lives.7 Professor Xu Ruihua, Lead Primary Investigator of the Phase 3 GLOW Study, Director of the Cancer Prevention and Treatment Center of Sun Yat-sen University, President of the Chinese Society of Clinical Oncology (CSCO):“Approximately 30% of patients enrolled in the global Phase 3 GLOW trial were from mainland China. The results of this study demonstrated that the combination of zolbetuximab and chemotherapy provided significant survival benefits to patients with CLDN18.2-positive, HER2-negative advanced gastric and gastroesophageal junction (GEJ) cancers. The analysis of the China subgroup data showed that Chinese gastric cancer patients benefited substantially in terms of both survival and quality of life. We are excited that the NMPA has approved zolbetuximab, which will provide a valuable and effective first-line treatment option for patients with advanced gastric cancer in China.” Professor Xu Jianming, Lead Primary Investigator of the Phase 3 SPOTLIGHT Study in China, Fifth Medical Center of the Chinese People's Liberation Army General Hospital:“We are extremely encouraged that the NMPA has approved zolbetuximab in China. The SPOTLIGHT study explored the efficacy and safety of zolbetuximab combined with chemotherapy as a first-line treatment for patients with CLDN18.2-positive, HER2-negative advanced gastric and gastroesophageal junction cancer. The results showed statistically significant differences in key endpoints such as progression-free survival and overall survival. The survival and safety benefits seen in the China subgroup were consistent with the global trial population, and the results are expected to have far-reaching implications for meeting the clinical needs of Chinese patients with advanced gastric cancer. The trial provides valuable insights to guide the first-line treatment of advanced gastric cancer in China.” Moitreyee Chatterjee-Kishore, Ph.D., M.B.A., Senior Vice President and Head of Immuno-Oncology Development, Astellas:“Approximately 35% of Chinese patients with advanced and metastatic gastric and GEJ cancers have tumors that positively express CLDN18.2. By specifically targeting this biomarker with zolbetuximab we are able to stimulate selective cell death, reducing the overall number of CLDN18.2-positive cells in a tumor. The NMPA approval of zolbetuximab offers a new precision medicine for first-line use in China, supporting our ongoing ambition to drive progress and innovation in cancer care.” The NMPA’s approval of zolbetuximab is supported by data from the global Phase 3 GLOW and SPOTLIGHT clinical trials which included 145 and 36 patients from mainland China, respectively.3,4 The GLOW trial evaluated zolbetuximab plus CAPOX (a combination chemotherapy regimen that includes capecitabine and oxaliplatin) compared to placebo plus CAPOX.4 The SPOTLIGHT trial evaluated zolbetuximab plus mFOLFOX6 (a combination regimen that includes oxaliplatin, leucovorin and fluorouracil) compared to placebo plus mFOLFOX6.3 Treatment with zolbetuximab was shown to provide statistically significant improvements in progression-free survival (PFS) and overall survival (OS) compared to other standard of care chemotherapies in eligible patients with gastric and GEJ cancers.3,4 In the GLOW trial, a median PFS of 8.21 months was achieved with zolbetuximab plus CAPOX as first-line treatment versus 6.80 months with placebo plus CAPOX. The median OS was 14.39 months versus 12.16 months in the respective treatment groups.4 Similar efficacy results were seen in the SPOTLIGHT trial, where the median PFS was 10.61 months versus 8.67 months, and the median OS was 18.23 months versus 15.54 months, with zolbetuximab plus mFOLFOX6, compared to placebo plus mFOLFOX6.3 In both the GLOW and SPOTLIGHT trials, the incidence of serious treatment emergent adverse events (TEAEs) was similar in the zolbetuximab treatment groups compared to the controls. The most common all-grade TEAEs reported in the zolbetuximab treatment groups were nausea, vomiting and decreased appetite.3,4 Astellas has already reflected the impact from the NMPA approval of zolbetuximab in its financial forecast for the current fiscal year ending March 31, 2025. About Locally Advanced Unresectable Metastatic Gastric and Gastroesophageal Junction CancerGastric and gastroesophageal junction (G/GEJ) cancers are known to be histologically similar, are recommended to be managed in the same way in treatment guidelines, and frequently display aligned responses to treatment.8 Across China, more than 358,000 new cases of gastric cancer were diagnosed in 2022.5 Gastric cancer is the third most common cause of cancer-related mortality in China, responsible for more than 260,000 deaths in 2022.5 GEJ adenocarcinomas start in the first two inches (5 cm) where the esophagus joins the stomach.9 Because early-stage cancer symptoms frequently overlap with more common stomach-related conditions, G/GEJ cancers are often diagnosed in the advanced or metastatic stage, or once they have spread from the tumor’s origin to other body tissues or organs.10 Early signs and symptoms can include indigestion or heartburn, pain or discomfort in the abdomen, nausea and vomiting, bloating of the stomach after meals, and loss of appetite.10,11 Signs of more advanced G/GEJ cancer can include unexplained weight loss, weakness and fatigue, sensation of food getting stuck in the throat while eating, vomiting blood or having blood in the stool.10,11,12 Risk factors associated with G/GEJ cancer can include older age, male gender, family history, H. pylori infection, smoking, and gastroesophageal reflux disease (GERD).13,14 About the GLOW Phase 3 Clinical TrialGLOW 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 is PFS in participants treated with the combination of zolbetuximab plus CAPOX compared to those treated with placebo plus CAPOX. Secondary endpoints include OS, ORR, DOR, safety and tolerability, and quality-of-life parameters.4 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, 2023.4 For more information, please visit clinicaltrials.gov under Identifier NCT03653507. About the SPOTLIGHT Phase 3 Clinical TrialSPOTLIGHT 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 is progression-free survival (PFS) of participants treated with the combination of zolbetuximab plus mFOLFOX6 compared to those treated with placebo plus mFOLFOX6. Secondary endpoints include overall survival (OS), objective response rate (ORR), duration of response (DOR), safety and tolerability, and quality-of-life parameters.3 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, 2023.3 For more information, please visit clinicaltrials.gov under Identifier NCT03504397. About ZolbetuximabZolbetuximab is a first-in-class monoclonal antibody (mAb) specifically designed to target tumor cells that express CLDN18.2, a transmembrane protein. Zolbetuximab is the only CLDN18.2 targeted therapy to be approved in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients 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. Zolbetuximab has been approved in a number of countries around the world including Japan, the UK, Korea, the US, Canada, Brazil and China, plus has received marketing authorization from the European Commission which is valid in all 27 EU member states as well as Iceland, Liechtenstein, and Norway. Regulatory approvals were based on the positive results of the SPOTLIGHT and GLOW Phase III trials where zolbetuximab demonstrated statistically significant improvements in progression-free survival and overall survival compared to other standard of care chemotherapies in eligible patients with gastric and GEJ cancers.3,4 In both the GLOW and SPOTLIGHT Phase 3 clinical trials, approximately 38% of all patients screened, and 35% of patients screened in China, had tumors that were CLDN18.2 positive, defined as ≥75% of tumor cells demonstrating moderate to strong membranous CLDN18 immunohistochemical staining, assessed and confirmed using the VENTANA® CLDN18 (43-14A) RxDx Assay.3,4 By binding to CLDN18.2, zolbetuximab induces cancer cell death and tumor growth inhibition by activating two distinct immune system pathways — antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC).15 This targeted approach that specifically focuses on CLDN18.2, a biomarker shown to be positively expressed in gastric and GEJ cancers, could help to identify patients who are most likely to respond to treatment. Investigational Pipeline in CLDN18.2An expanded Phase 2 trial of zolbetuximab in metastatic pancreatic adenocarcinoma is in progress involving 393 patients worldwide. 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 ≥75% of tumor cells demonstrating moderate to strong membranous CLDN18 staining based on a validated immunohistochemistry assay). For more information, please visit clinicaltrials.gov under Identifier NCT03816163. 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 the agent(s) will receive regulatory approval and become commercially available for the uses being investigated. About AstellasAstellas 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 www.astellas.com. Cautionary NotesIn 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 World Cancer Research Fund International. Stomach Cancer Statistics. Available at: https://www.wcrf.org/cancer-trends/stomach-cancer-statistics/ Last accessed: January 2025.2 Shitara K, Xu R-H, Moran DM, et al. Global prevalence of CLDN18.2 in patients with locally advanced (LA) unresectable or metastatic gastric or gastroesophageal junction (mG/GEJ) adenocarcinoma: Biomarker analysis of two zolbetuximab phase 3 studies (SPOTLIGHT and GLOW). J Clin Oncol. 2023;41:4035.3 Shitara K, Lordick F, Bang Y-J, 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. The Lancet. 2023;401(10389):1655-1668.4 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):2133-2141.5 World Health Organization, International Agency for Research on Cancer. Globocan China Factsheet. Available at: https://gco-iarc-who-int.libproxy1.nus.edu.sg/media/globocan/factsheets/populations/160-china-fact-sheet.pdf Last accessed: January 2025.6 Astellas data on file. CancerMPact® Treatment Architecture - Gastric Cancer, China. Published May 2023. Based on fieldwork conducted in March 2023.7 Li H, Zhang H, Zhang H, et al. Survival of gastric cancer in China from 2000 to 2022: A nationwide systematic review of hospital-based studies. J Glob Health. 2022;12:11014.8 Barra WF, Moreira FC, Pereira Cruz AM, et al. GEJ cancers: gastric or esophageal tumors? Searching for the answer according to molecular identity. Oncotarget. 2017;8(61):104286-104294.9 American Cancer Society. About esophagus cancer (03-20-2020). Available at: https://www.cancer.org/content/dam/CRC/PDF/Public/8614.00.pdf. Last accessed: January 2025.10 American Cancer Society. Stomach Cancer Early Detection, Diagnosis, and Staging. Signs and Symptoms of Stomach Cancer (10-02-2024). Available at https://www.cancer.org/cancer/stomach-cancer/detection-diagnosis-staging/signs-symptoms.html. Last accessed: January 2025.11 National Cancer Institute. Stomach Cancer Symptoms (10-30-2024). Available at: https://www.cancer.gov/types/stomach/symptoms. Last accessed: January 2025.12 The Royal Marsden. Stomach cancer symptoms: What are the signs of gastric cancer? (05-23-2022). Available at: https://www.royalmarsden.nhs.uk/private-care/news-and-blogs/stomach-cancer-symptoms-what-are-signs-gastric-cancer. Last accessed: January 2025.13 American Cancer Society. Stomach cancer causes, risk factors and prevention (01-22-2021). Available at: https://www.cancer.org/content/dam/CRC/PDF/Public/8839.00.pdf. Last accessed: January 2025.14 American Cancer Society. Esophageal cancer causes, risk factors, and prevention (06-09-2020). Available at: https://www.cancer.org/content/dam/CRC/PDF/Public/8615.00.pdf. Last accessed: January 2025.15 Sahin U, Türeci Ö, Manikhas G, et al. FAST: a randomised phase II study of zolbetuximab (IMAB362) plus EOX versus EOX alone for first-line treatment of advanced CLDN18.2-positive gastric and gastro-oesophageal adenocarcinoma. Ann Oncol. 2021;32(5):609-19. Click below for a copy of the full press release

Clinical ResultDrug ApprovalASCOPhase 3Phase 2

06 Jan 2025

·www.prnewswire.com

China's National Medical Products Administration (NMPA) Approves VYLOY™ (zolbetuximab) for First-Line Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

- China has the highest number of cases and deaths from gastric cancer of any country worldwide1 - - Zolbetuximab is the first and only therapy approved in China to target claudin 18.2, a biomarker expressed by 35% of Chinese patients with advanced gastric and gastroesophageal junction (GEJ) cancer2 - - Treatment with the claudin 18.2-targeted monoclonal antibody shown to significantly extend both progression-free survival and overall survival in the Phase 3 GLOW and SPOTLIGHT trials3,4 - TOKYO, Jan. 5, 2025 /PRNewswire/ -- Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, "Astellas") today announced that China's National Medical Products Administration (NMPA) has approved VYLOY™ (zolbetuximab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients 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. Zolbetuximab is the first NMPA-approved monoclonal antibody to target gastric tumor cells that express the biomarker CLDN18.2, offering a highly targeted approach to cancer treatment. Gastric cancer is the third leading cause of cancer-related mortality in China, with more than 260,000 deaths reported from the disease in 2022.5 As early symptoms are often hard to detect, approximately 60% of Chinese patients are diagnosed at the advanced stage of the disease6 where treatment options are limited and outcomes are often poor. The average five-year survival rate for patients with advanced gastric cancer in China is 9.1%, driving the urgent need for novel therapeutic options that can slow disease progression and extend lives.7 Professor Xu Ruihua, Lead Primary Investigator of the P hase 3 GLOW Study, Director of the Cancer Prevention and Treatment Center of Sun Yat-sen University, President of the Chinese Society of Clinical Oncology (CSCO): "Approximately 30% of patients enrolled in the global Phase 3 GLOW trial were from mainland China. The results of this study demonstrated that the combination of zolbetuximab and chemotherapy provided significant survival benefits to patients with CLDN18.2-positive, HER2-negative advanced gastric and gastroesophageal junction (GEJ) cancers. The analysis of the China subgroup data showed that Chinese gastric cancer patients benefited substantially in terms of both survival and quality of life. We are excited that the NMPA has approved zolbetuximab, which will provide a valuable and effective first-line treatment option for patients with advanced gastric cancer in China." Professor Xu Jianming, Lead Primary Investigator of the Phase 3 SPOTLIGHT Study in China, Fifth Medical Center of the Chinese People's Liberation Army General Hospital: "We are extremely encouraged that the NMPA has approved zolbetuximab in China. The SPOTLIGHT study explored the efficacy and safety of zolbetuximab combined with chemotherapy as a first-line treatment for patients with CLDN18.2-positive, HER2-negative advanced gastric and gastroesophageal junction cancer. The results showed statistically significant differences in key endpoints such as progression-free survival and overall survival. The survival and safety benefits seen in the China subgroup were consistent with the global trial population, and the results are expected to have far-reaching implications for meeting the clinical needs of Chinese patients with advanced gastric cancer. The trial provides valuable insights to guide the first-line treatment of advanced gastric cancer in China." Moitreyee Chatterjee-Kishore, Ph.D., M.B.A., Senior Vice President and Head of Immuno-Oncology Development, Astellas: "Approximately 35% of Chinese patients with advanced and metastatic gastric and GEJ cancers have tumors that positively express CLDN18.2. By specifically targeting this biomarker with zolbetuximab we are able to stimulate selective cell death, reducing the overall number of CLDN18.2-positive cells in a tumor. The NMPA approval of zolbetuximab offers a new precision medicine for first-line use in China, supporting our ongoing ambition to drive progress and innovation in cancer care." The NMPA's approval of zolbetuximab is supported by data from the global Phase 3 GLOW and SPOTLIGHT clinical trials which included 145 and 36 patients from mainland China, respectively.3,4 The GLOW trial evaluated zolbetuximab plus CAPOX (a combination chemotherapy regimen that includes capecitabine and oxaliplatin) compared to placebo plus CAPOX.4 The SPOTLIGHT trial evaluated zolbetuximab plus mFOLFOX6 (a combination regimen that includes oxaliplatin, leucovorin and fluorouracil) compared to placebo plus mFOLFOX6.3 Treatment with zolbetuximab was shown to provide statistically significant improvements in progression-free survival (PFS) and overall survival (OS) compared to other standard of care chemotherapies in eligible patients with gastric and GEJ cancers.3,4 In the GLOW trial, a median PFS of 8.21 months was achieved with zolbetuximab plus CAPOX as first-line treatment versus 6.80 months with placebo plus CAPOX. The median OS was 14.39 months versus 12.16 months in the respective treatment groups.4 Similar efficacy results were seen in the SPOTLIGHT trial, where the median PFS was 10.61 months versus 8.67 months, and the median OS was 18.23 months versus 15.54 months, with zolbetuximab plus mFOLFOX6, compared to placebo plus mFOLFOX6.3 In both the GLOW and SPOTLIGHT trials, the incidence of serious treatment emergent adverse events (TEAEs) was similar in the zolbetuximab treatment groups compared to the controls. The most common all-grade TEAEs reported in the zolbetuximab treatment groups were nausea, vomiting and decreased appetite.3,4 Astellas has already reflected the impact from the NMPA approval of zolbetuximab in its financial forecast for the current fiscal year ending March 31, 2025. About Locally Advanced Unresectable Metastatic Gastric and Gastroesophageal Junction Cancer Gastric and gastroesophageal junction (G/GEJ) cancers are known to be histologically similar, are recommended to be managed in the same way in treatment guidelines, and frequently display aligned responses to treatment.8 Across China, more than 358,000 new cases of gastric cancer were diagnosed in 2022.5 Gastric cancer is the third most common cause of cancer-related mortality in China, responsible for more than 260,000 deaths in 2022.5 GEJ adenocarcinomas start in the first two inches (5 cm) where the esophagus joins the stomach.9 Because early-stage cancer symptoms frequently overlap with more common stomach-related conditions, G/GEJ cancers are often diagnosed in the advanced or metastatic stage, or once they have spread from the tumor's origin to other body tissues or organs.10 Early signs and symptoms can include indigestion or heartburn, pain or discomfort in the abdomen, nausea and vomiting, bloating of the stomach after meals, and loss of appetite.10,11 Signs of more advanced G/GEJ cancer can include unexplained weight loss, weakness and fatigue, sensation of food getting stuck in the throat while eating, vomiting blood or having blood in the stool.10,11,12 Risk factors associated with G/GEJ cancer can include older age, male gender, family history, H. pylori infection, smoking, and gastroesophageal reflux disease (GERD).13,14 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 is PFS in participants treated with the combination of zolbetuximab plus CAPOX compared to those treated with placebo plus CAPOX. Secondary endpoints include OS, ORR, DOR, safety and tolerability, and quality-of-life parameters.4 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, 2023.4 For more information, please visit clinicaltrials.gov under Identifier NCT03653507. 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 is progression-free survival (PFS) of participants treated with the combination of zolbetuximab plus mFOLFOX6 compared to those treated with placebo plus mFOLFOX6. Secondary endpoints include overall survival (OS), objective response rate (ORR), duration of response (DOR), safety and tolerability, and quality-of-life parameters.3 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, 2023.3 For more information, please visit clinicaltrials.gov under Identifier NCT03504397. About Zolbetuximab Zolbetuximab is a first-in-class monoclonal antibody (mAb) specifically designed to target tumor cells that express CLDN18.2, a transmembrane protein. Zolbetuximab is the only CLDN18.2 targeted therapy to be approved in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients 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. Zolbetuximab has been approved in a number of countries around the world including Japan, the UK, Korea, the US, Canada, Brazil and China, plus has received marketing authorization from the European Commission which is valid in all 27 EU member states as well as Iceland, Liechtenstein, and Norway. Regulatory approvals were based on the positive results of the SPOTLIGHT and GLOW Phase III trials where zolbetuximab demonstrated statistically significant improvements in progression-free survival and overall survival compared to other standard of care chemotherapies in eligible patients with gastric and GEJ cancers.3,4 In both the GLOW and SPOTLIGHT Phase 3 clinical trials, approximately 38% of all patients screened, and 35% of patients screened in China, had tumors that were CLDN18.2 positive, defined as ≥75% of tumor cells demonstrating moderate to strong membranous CLDN18 immunohistochemical staining, assessed and confirmed using the VENTANA® CLDN18 (43-14A) RxDx Assay.3,4 By binding to CLDN18.2, zolbetuximab induces cancer cell death and tumor growth inhibition by activating two distinct immune system pathways — antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC).15 This targeted approach that specifically focuses on CLDN18.2, a biomarker shown to be positively expressed in gastric and GEJ cancers, could help to identify patients who are most likely to respond to treatment. Investigational Pipeline in CLDN18.2 An expanded Phase 2 trial of zolbetuximab in metastatic pancreatic adenocarcinoma is in progress involving 393 patients worldwide. 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 ≥75% of tumor cells demonstrating moderate to strong membranous CLDN18 staining based on a validated immunohistochemistry assay). For more information, please visit clinicaltrials.gov under Identifier NCT03816163. 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 the agent(s) will receive regulatory approval and become commercially available for the uses being investigated. 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 . 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 SOURCE Astellas Pharma Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultDrug ApprovalPhase 3ASCOPhase 1

27 Dec 2024

·pipelinereview.com

DATROWAY® Approved in Japan as the First TROP-2 Directed Therapy for Patients with Previously Treated Unresectable or Recurrent HR Positive, HER2 Negative Breast Cancer

First global approval based on TROPION-Breast01 where DATROWAY significantly reduced the risk of disease progression or death by 37% versus chemotherapy Second DXd antibody drug conjugate approved in Japan based on Daiichi Sankyo’s DXd technology TOKYO, Japan I December 27, 2024 I Daiichi Sankyo’s (TSE:4568) DATROWAY® (datopotamab deruxtecan) has been approved in Japan for the treatment of adult patients with hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) unresectable or recurrent breast cancer after prior chemotherapy. In Japan, breast cancer is the most common cancer in women.1 Approximately 92,000 cases of breast cancer were diagnosed in Japan in 2022, with approximately 17,600 deaths.1 It is estimated that 70% of diagnosed cases are considered what has been historically called HR positive, HER2 negative breast cancer (measured as HER2 score of IHC 0, IHC 1+ or IHC 2+/ISH-).2 DATROWAY is the first ever TROP-2 directed medicine to be approved in Japan for HR positive, HER2 negative breast cancer and is the second DXd antibody drug conjugate (ADC) approved based on Daiichi Sankyo’s DXd ADC Technology. The approval of DATROWAY by the Japan Ministry of Health, Labour and Welfare (MHLW) is based on results from the TROPION-Breast01 phase 3 trial. In this trial, DATROWAY significantly reduced the risk of disease progression or death by 37% compared to investigator’s choice of chemotherapy (hazard ratio [HR]=0.63, 95% confidence interval [CI]: 0.52-0.76; p<0.0001) in patients with HR positive, HER2 negative metastatic breast cancer as assessed by blinded independent central review (BICR). Median progression-free survival (PFS) was 6.9 months in patients treated with DATROWAY compared to 4.9 months in those treated with chemotherapy. “This first global approval of DATROWAY provides patients in Japan with metastatic HR positive, HER2 negative breast cancer a new alternative to conventional chemotherapy, which is often associated with poor response rates,” said Wataru Takasaki, PhD, Senior Advisor, Daiichi Sankyo. “DATROWAY also is the second DXd antibody drug conjugate approved in Japan based on technology invented by Daiichi Sankyo, emphasizing our commitment to creating new, innovative standards of care for patients with cancer.” In TROPION-Breast01, adverse reactions occurred in 93.6% (337/360 patients) of the 360 patients (including 31 Japanese patients) in the DATROWAY (6 mg/kg) arm. The most common adverse reactions included nausea (51.1%), stomatitis (50.0%), alopecia (36.4%), fatigue (23.6%), and dry eye (21.7%). In Japanese patients, interstitial lung disease (ILD) occurred in 6.5% of patients treated with DATROWAY. DATROWAY is approved in Japan with a Warning for ILD. As cases of ILD, including fatal cases, have occurred in DATROWAY-treated patients. DATROWAY is to be used in close collaboration with a respiratory disease expert. Patients should be closely observed during therapy by monitoring for early signs or symptoms of ILD (such as dyspnea, cough or fever) and performing periodical percutaneous oxygen saturation (SpO2) tests, chest X-ray scans and chest CT scans. If abnormalities are observed, discontinue administration of DATROWAY and take appropriate measures, such as corticosteroid administration. Prior to initiation of DATROWAY therapy, a chest CT scan should be performed and medical history taken to confirm the absence of any comorbidity or history of ILD with the patient and carefully consider the eligibility of the patient for DATROWAY therapy. Additional regulatory submissions for DATROWAY in breast cancer are under review in the EU, China, U.S. and other regions. About TROPION-Breast01 TROPION-Breast01 is a global, randomized, multicenter, open-label phase 3 trial evaluating the efficacy and safety of intravenous DATROWAY (6 mg/kg) once per 21-day cycle versus investigator’s choice of single-agent chemotherapy (eribulin, capecitabine, vinorelbine or gemcitabine) in adult patients with unresectable or metastatic HR positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who progressed on and are not suitable for endocrine therapy per investigator assessment and have received at least one additional systemic therapy for unresectable or metastatic disease. Following disease progression or discontinuation of DATROWAY or chemotherapy, patients had the option to receive subsequent treatment at the discretion of their physician. Crossover between trial arms was not permitted. The dual primary endpoints of TROPION-Breast01 are PFS as assessed by BICR and overall survival. Key secondary endpoints include overall response rate, duration of response, investigator-assessed PFS, disease control rate, time to first subsequent therapy and safety. The PFS data and additional results for key secondary endpoints of TROPION-Breast01 were published in the Journal of Clinical Oncology . TROPION-Breast01 enrolled 732 patients in Africa, Asia, Europe, North America and South America. For more information visit ClinicalTrials.gov. About Hormone Receptor Positive, HER2 Negative Breast Cancer Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.3 More than two million breast cancer cases were diagnosed in 2022 with more than 665,000 deaths globally.3 In Japan, breast cancer is the most common cancer in women, with approximately 92,000 cases of breast cancer diagnosed in 2022.1 While survival rates are high for those diagnosed with early breast cancer, only about 30% of patients diagnosed with or who progress to metastatic disease are expected to live five years following diagnosis.2 Approximately 70% of diagnosed cases are considered what has been historically called HR positive, HER2 negative breast cancer (measured as HER2 score of IHC 0, IHC 1+ or IHC 2+/ISH-).2 Endocrine therapies are widely given consecutively in the early lines of treatment for HR positive metastatic breast cancer.4 However, after initial treatment, further efficacy from endocrine therapy is often limited.4 The current standard of care following endocrine therapy is chemotherapy, which is associated with poor response rates and outcomes.4,5,6,7 About DATROWAY DATROWAY (datopotamab deruxtecan) is a TROP-2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, DATROWAY is one of six DXd ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programs in AstraZeneca’s ADC scientific platform. DATROWAY is comprised of a humanized anti-TROP-2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. DATROWAY (6 mg/kg) is approved in Japan for the treatment of adult patients with HR positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) unresectable or recurrent breast cancer after prior chemotherapy based on results from the TROPION-Breast01 trial. About the DATROWAY Clinical Development Program A comprehensive global clinical development program is underway with more than 20 trials evaluating the efficacy and safety of DATROWAY across multiple cancers, including non-small cell lung cancer, triple negative breast cancer, and HR positive, HER2 low or negative breast cancer. The program includes seven phase 3 trials in lung cancer and five phase 3 trials in breast cancer evaluating DATROWAY as a monotherapy and in combination with other anticancer treatments in various settings. About the Daiichi Sankyo and AstraZeneca Collaboration Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize ENHERTU® in March 2019 and DATROWAY in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of ENHERTU and DATROWAY. About the ADC Portfolio of Daiichi Sankyo The Daiichi Sankyo ADC portfolio consists of seven ADCs in clinical development crafted from two distinct ADC technology platforms discovered in-house by Daiichi Sankyo. The ADC platform furthest in clinical development is Daiichi Sankyo’s DXd ADC Technology where each ADC consists of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADC portfolio currently consists of ENHERTU, a HER2 directed ADC, and DATROWAY, a TROP-2 directed ADC, which are being jointly developed and commercialized globally with AstraZeneca. Patritumab deruxtecan (HER3-DXd), a HER3 directed ADC, ifinatamab deruxtecan (I-DXd), a B7-H3 directed ADC, and raludotatug deruxtecan (R-DXd), a CDH6 directed ADC, are being jointly developed and commercialized globally with Merck & Co., Inc, Rahway, NJ, USA. DS-3939, a TA-MUC1 directed ADC, is being developed by Daiichi Sankyo. The second Daiichi Sankyo ADC platform consists of a monoclonal antibody attached to a modified pyrrolobenzodiazepine (PBD) payload. DS-9606, a CLDN6 directed PBD ADC, is the first of several planned ADCs in clinical development utilizing this platform. Ifinatamab deruxtecan, patritumab deruxtecan, raludotatug deruxtecan, DS-3939 and DS-9606 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established. About Daiichi Sankyo Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical need. For more information, please visit www.daiichisankyo.com . References: 1 World Health Organization. Global Cancer Observatory: Japan. Accessed December 2024. 2 National Cancer Institute. SEER Cancer Stat Facts: Female Breast Cancer Subtypes. Accessed December 2024. 3 Bray F, et al. CA Cancer J Clin. 2024; 10.3322/caac.21834. 4 Manohar P, et al. Cancer Biol Med. 2022 Feb 15; 19(2):202–212. 5 Cortes J, et al. Lancet. 2011;377:914-923. 6 Yuan P, et al. Eur J Cancer. 2019;112:57-65. 7 Jerusalem G, et al. JAMA Oncol. 2018;4(10):1367–1374. SOURCE: Daiichi Sankyo

Phase 3Drug ApprovalADCClinical Result

100 Deals associated with Capecitabine

External Link

KEGG	Wiki	ATC	Drug Bank
D01223	Capecitabine	L01BC06	DB01101

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Gastrooesophageal junction cancer	US	CHEPLAPHARM Arzneimittel GmbH	14 Dec 2022
Pancreatic Cancer	US	CHEPLAPHARM Arzneimittel GmbH	14 Dec 2022
Rectal Cancer	JP	Chugai Pharmaceutical Co., Ltd.	19 Sep 2016
Esophageal Carcinoma	AU	Dr. Reddy's Laboratories (Australia) Pty Ltd.	24 Jun 2013
Locally advanced breast cancer	EU	Accord Healthcare SLU	20 Apr 2012
Locally advanced breast cancer	EU	KRKA dd	20 Apr 2012
Locally advanced breast cancer	EU	Teva Pharmaceuticals Europe BV	20 Apr 2012
Locally advanced breast cancer	IS	Accord Healthcare SLU	20 Apr 2012
Locally advanced breast cancer	IS	Teva Pharmaceuticals Europe BV	20 Apr 2012
Locally advanced breast cancer	IS	KRKA dd	20 Apr 2012
Locally advanced breast cancer	LI	KRKA dd	20 Apr 2012
Locally advanced breast cancer	LI	Accord Healthcare SLU	20 Apr 2012
Locally advanced breast cancer	LI	Teva Pharmaceuticals Europe BV	20 Apr 2012
Locally advanced breast cancer	NO	KRKA dd	20 Apr 2012
Locally advanced breast cancer	NO	Accord Healthcare SLU	20 Apr 2012
Locally advanced breast cancer	NO	Teva Pharmaceuticals Europe BV	20 Apr 2012
Stomach Cancer	CN	Chugai Pharmaceutical Co., Ltd.	17 Oct 2008
Breast cancer recurrent	JP	CHEPLAPHARM Arzneimittel GmbH	12 Dec 2007
Colonic Cancer	JP	Chugai Pharmaceutical Co., Ltd.	30 Apr 2003
Advanced gastric carcinoma	EU	CHEPLAPHARM Arzneimittel GmbH	02 Feb 2001

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic gastric adenocarcinoma	Phase 3	US	Eli Lilly & Co.	20 Jan 2015
Metastatic gastric adenocarcinoma	Phase 3	JP	Eli Lilly & Co.	20 Jan 2015
Metastatic gastric adenocarcinoma	Phase 3	AR	Eli Lilly & Co.	20 Jan 2015
Metastatic gastric adenocarcinoma	Phase 3	BE	Eli Lilly & Co.	20 Jan 2015
Metastatic gastric adenocarcinoma	Phase 3	CA	Eli Lilly & Co.	20 Jan 2015
Metastatic gastric adenocarcinoma	Phase 3	CZ	Eli Lilly & Co.	20 Jan 2015
Metastatic gastric adenocarcinoma	Phase 3	DK	Eli Lilly & Co.	20 Jan 2015
Metastatic gastric adenocarcinoma	Phase 3	FI	Eli Lilly & Co.	20 Jan 2015
Metastatic gastric adenocarcinoma	Phase 3	FR	Eli Lilly & Co.	20 Jan 2015
Metastatic gastric adenocarcinoma	Phase 3	DE	Eli Lilly & Co.	20 Jan 2015

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02767661 (MECCA, Pubmed \| Literature) Manual	Phase 3	Hormone receptor positive HER2 negative breast cancer Hormone Receptor Positive \| HER2 Negative	254	metronomic capecitabine + an aromatase inhibitor	ijeszsbsgu(nyezzsuzgp) = xbnpucfocz ujztwlrvlg (lwljwklkvs ) View more	Positive	02 Jan 2025
				An aromatase inhibitor	ijeszsbsgu(nyezzsuzgp) = teyuatocfo ujztwlrvlg (lwljwklkvs ) View more
NCT03329248 (QUILT-3.060, CTgov)	Phase 1/2	Pancreatic Cancer	6	SBRT+GI-4000+lovaza+Leucovorin+ETBX-011+fluorouracil+ALT-803+nab-paclitaxel+cyclophosphamide+haNK for infusion+Bevacizumab+Oxaliplatin+Capecitabine	dlgcjgsrux(emeezjxwhk) = kmmcesgzfs qcbupiwcxo (tgljyrjeub, bfmbsuataq - omrwmzhtnq) View more	-	12 Dec 2024
NCT04324476 (Pubmed) Manual	Phase 2	Metastatic Colorectal Carcinoma	52	CAPOX/CAPIRI plus bevacizumab	ambogplair(uyxtekvdbs) = vrfjdbckzn zolzqvcyhf (ibrgmjdinh, 9.0 - 12.4) View more	Positive	11 Dec 2024
NCT03563157 (CTgov)	Phase 1/2	Metastatic Colorectal Carcinoma	2	SBRT+Aldoxorubicin Hydrochloride+GI-6301+GI-4000+ETBX-061+Cetuximab+ETBX-051+Leucovorin+ETBX-011+5-Fluorouracil+ALT-803+ETBX-021+nab-paclitaxel+CYCLOPHOSPHAMIDE+Avelumab+haNK+GI-6207+Regorafenib+Oxaliplatin+Capecitabine (NANT Colorectal Cancer (CRC) Vaccine)	eadinnngpd(clgscswxgq) = pigounawaw scityiulyj (nrzsmwfkxs, vrqeudqknh - vwjfkbwudr) View more	-	11 Dec 2024
				Regorafenib (Regorafenib)	pimknnhuss(jltqzrpasi) = mjhaxqovxt lnmfcuezfj (onspdjitad, qhktvaoiqi - negzkbuagw) View more
ESMO_ASIA2024	Not Applicable	Head and Neck Neoplasms	101	Capecitabine 2000 mg + Cyclophosphamide 100 mg	qgbvtlaqft(ikvaomalbt) = most patients experiencing manageable Grade 1 mucositis cskmklpuak (ootemhnoax )	Positive	07 Dec 2024
ESMO_ASIA2024	Not Applicable	Colorectal Cancer	214	capecitabine (Age ≥60 years)	bfcbdtvrou(wtmwrvbahm) = qrgqwxmmxe xgmivpvcqe (mqayolxkkm )	-	07 Dec 2024
				Capecitabine monotherapy	bfcbdtvrou(wtmwrvbahm) = rtqospkgtr xgmivpvcqe (mqayolxkkm )
NCT03487666 (CTgov)	Phase 2	Triple Negative Breast Cancer	45	Nivolumab (Arm A- Nivolumab)	qlpqcnecfe(lkoeyupyix) = maxntdqeko bdfuabqyph (oqmpnvzsga, nmtczmfrkd - ndonazgxar) View more	-	03 Dec 2024
				Capecitabine (Arm B- Capecitabine)	qlpqcnecfe(lkoeyupyix) = eetxonxauk bdfuabqyph (oqmpnvzsga, ppniwvtfey - kjknrkfqil) View more
NCT03259035 (CCTG CO.28 \| NEO \| CO.28, CTgov)	Phase 2	Rectal Cancer	58	folinic acid+oxaliplatin+capecitabine+fluorouracil	zuzzoibnml(gomjtzgcfd) = hmxnedpsbp bqicrlzipk (edabsaudwi, yyeaglnzyq - xspeoymtnp) View more	-	10 Oct 2024
NCT03691051 (PERMEATE, Pubmed \| EClinicalMedicine) Manual	Phase 2	HER2 Positive Breast Cancer HER2 Positive	78	Pyrotinib plus capecitabine	gyqqbqxxxv(sanbtxikfz) = zvsfvtldam ysqczbojbl (mlbbzvnjfk, 24.4 - not reached) View more	Positive	01 Oct 2024
				Pyrotinibcapecitabine (Radiotherapy-naïve brain metastases)	gyqqbqxxxv(sanbtxikfz) = mykabkptxr ysqczbojbl (mlbbzvnjfk, 12.6 - 33.3) View more
ASTRO2024	Not Applicable	Breast Cancer	-	Concurrent chemoradiotherapy with capecitabine 1000mg/m2 bid	nxttedqsrt(jtrwupintb) = None but 1 patient discontinued concurrent medication because of gastrointestinal reaction obcgenvslm (vozbkuilyq ) View more	-	01 Oct 2024
				Low-dose maintenance therapy with capecitabine 500mg tid

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