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U.S. FDA Grants Orphan Drug Designation to Adcentrx Therapeutics' ADRX-0405 STEAP1 ADC for Gastric Cancer
U.S. FDA Grants Orphan Drug Designation to Adcentrx Therapeutics' ADRX-0405 STEAP1 ADC for Gastric Cancer

Yahoo

time08-07-2025

  • Business
  • Yahoo

U.S. FDA Grants Orphan Drug Designation to Adcentrx Therapeutics' ADRX-0405 STEAP1 ADC for Gastric Cancer

Orphan drug designation highlights the potential for ADRX-0405 to address the high unmet need in gastric cancer SAN DIEGO, July 8, 2025 /PRNewswire/ -- Adcentrx Therapeutics ("Adcentrx"), a clinical-stage biotechnology company redefining Antibody-Drug Conjugate (ADC) therapies for cancer treatment and other life-threatening diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to ADRX-0405, for the treatment of patients with gastric cancer. ADRX-0405 is a STEAP1 ADC being evaluated in the Phase 1a portion of an ongoing Phase 1a/b clinical trial (NCT06710379) for the treatment of select advanced solid tumors, including metastatic castration resistant prostate cancer, gastric cancer, and non-small cell lung cancer. While STEAP1 is primarily associated with prostate cancer, there is a meaningful amount of target expression in gastric cancer, making this a potential indication of interest for future clinical development. "Receiving orphan drug designation from FDA is a notable milestone for Adcentrx and reinforces the potential for ADRX-0405 to improve the lives of patients with gastric cancer," said Hui Li, Ph.D., Founder and Chief Executive Officer of Adcentrx. "We are encouraged by the progress of our Phase 1a trial and look forward to further evaluating the safety, tolerability and anti-tumor activity of ADRX-0405 in gastric and other cancers." Gastric cancer, or stomach cancer, is a serious malignancy that develops in the stomach lining and is often diagnosed at advanced stages. The American Cancer Society estimates there will be 30,300 new cases of gastric cancer in the U.S. in 2025, meeting FDA's criteria for a rare disease. The orphan drug designation is a program designed to stimulate the development of treatments for rare diseases, defined as conditions affecting fewer than 200,000 people in the U.S. Benefits of this designation include access to grant funding and scientific assistance, tax credits for qualified clinical trials, waiver of Prescription Drug User Fee Act (PDUFA) application fees, and the potential for seven years of market exclusivity following regulatory approval. About ADRX-0405ADRX-0405 is a clinical-stage next-generation ADC targeting six-transmembrane epithelial antigen of the prostate 1 (STEAP1), a cell surface protein that is upregulated in prostate cancer and certain other cancers with limited expression in normal healthy tissue. The ADC is composed of a humanized IgG1 antibody coupled with a novel topoisomerase inhibitor linker-payload through Adcentrx's innovative i-Conjugation® technology platform – a core component in the design of the company's ADCs. The platform utilizes a cleavable linker and stable conjugation chemistry to enhance payload delivery. This novel technology enables a highly stable ADC with a drug-antibody ratio of eight (DAR 8) to maximize payload delivery to solid tumors. ADRX-0405 preclinical studies have demonstrated its favorable pharmacokinetics, safety profile, and significant efficacy across multiple animal tumor models. ADRX-0405 is currently being evaluated in a Phase 1a/b clinical trial. For more information about the ADRX-0405 Phase 1a/b clinical trial, please refer to the Study ID NCT06710379 on About Adcentrx TherapeuticsAdcentrx is a biotechnology company focused on accelerating breakthroughs in protein conjugate therapeutic development for cancer and other life-threatening diseases. Adcentrx has pioneered the development of an ADC technology platform addressing key components of protein conjugate design to solve challenges typically seen in ADCs. Adcentrx is developing a robust pipeline including two clinical-stage ADCs and multiple preclinical ADCs, all with first-in-class and best-in-class potential. For more information about Adcentrx and its innovative ADC technologies, please visit Contact Information:Investor Relationsir@ View original content to download multimedia: SOURCE Adcentrx Therapeutics

Zai Lab Announces Positive Topline Phase 3 Results for Bemarituzumab in Fibroblast Growth Factor Receptor 2b (FGFR2b) Positive First-Line Gastric Cancer
Zai Lab Announces Positive Topline Phase 3 Results for Bemarituzumab in Fibroblast Growth Factor Receptor 2b (FGFR2b) Positive First-Line Gastric Cancer

Yahoo

time30-06-2025

  • Business
  • Yahoo

Zai Lab Announces Positive Topline Phase 3 Results for Bemarituzumab in Fibroblast Growth Factor Receptor 2b (FGFR2b) Positive First-Line Gastric Cancer

At an Interim Analysis, Bemarituzumab Plus Chemotherapy Significantly Improved Overall Survival in People With FGFR2b Overexpression Compared to Chemotherapy Alone SHANGHAI & CAMBRIDGE, Mass., June 30, 2025--(BUSINESS WIRE)--Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced the Phase 3 FORTITUDE-101 clinical trial evaluating first-line bemarituzumab plus chemotherapy (mFOLFOX6) met its primary endpoint of overall survival (OS) at a pre-specified interim analysis. Bemarituzumab plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in OS as compared to placebo plus chemotherapy in people living with unresectable locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) cancer with FGFR2b overexpression and who are non-HER2 positive. FGFR2b overexpression was defined as 2+/3+ staining in ≥10% of tumor cells by centrally performed immunohistochemistry (IHC) testing. Gastric cancer is the fifth leading cause of cancer-related death worldwide, with nearly one million new cases and over 650,000 deaths globally each year 1, highlighting a critical unmet medical need. In China, there are over 350,000 new cases each year. The disease is associated with a poor prognosis, particularly in advanced stages where the five-year survival rate is less than 10%. There are currently no approved therapies specifically targeting FGFR2b overexpression in gastric cancer in China. "Bemarituzumab is the first FGFR2b inhibitor to demonstrate a statistically and clinically significant overall survival benefit in a randomized Phase 3 trial for the first-line treatment of FGFR2b-positive gastric cancer," said Dr. Rafael Amado, M.D., President, Head of Global Research and Development at Zai Lab. "The success of the global Phase 3 FORTITUDE-101 study highlights the potential of bemarituzumab to redefine the standard of care for a patient population that has faced poor outcomes with existing therapies. We are proud to have contributed meaningfully to this pivotal trial, including a substantial number of patients enrolled in China. Based on these results, and the regulatory Breakthrough Designation, we plan to move rapidly toward regulatory submission in China to bring this transformative therapy to patients as quickly as possible." The most common treatment-emergent adverse events (>25%) in patients treated with bemarituzumab plus chemotherapy were reduced visual acuity, punctate keratitis, anaemia, neutropenia, nausea, corneal epithelium defect and dry eye. While ocular events were consistent with the Phase 2 experience and observed in both arms, they occurred with greater frequency and severity in the Phase 3 bemarituzumab arm. Detailed results from the trial will be shared at a future medical meeting. Zai Lab holds the development and commercialization rights for bemarituzumab for mainland China, Hong Kong, Macau, and Taiwan. Bemarituzumab has been granted Breakthrough Therapy designation by the China Center for Drug Evaluation of the National Medical Products Administration for the treatment of FGFR2b-positive gastric and gastroesophageal junction adenocarcinoma. A Phase 3 study of bemarituzumab plus chemotherapy and nivolumab is also ongoing in patients with first-line gastric cancer, with data readout anticipated in H2 2025. About FGFR2b The FGFR2b protein (also known as fibroblast growth factor receptor 2b) is an emerging biomarker which, when overexpressed, promotes aberrant signaling leading to tumor cell proliferation.2 The FGFR2b protein is overexpressed by G/GEJ tumor cells in approximately 38% of patients with advanced G/GEJ cancer. FGFR2b protein overexpression is defined as 2+/3+ staining intensity on tumor cell membrane, as detected by immunohistochemistry (IHC) testing. In approximately 16% of patients with advanced G/GEJ cancer, FGFR2b protein overexpression is observed on ≥10% of tumor cells by IHC.3 About FORTITUDE-101 FORTITUDE-101 is a randomized, multi-center, double-blind, placebo-controlled Phase 3 study of bemarituzumab plus mFOLFOX6 versus placebo plus mFOLFOX6 as first-line therapy in advanced G/GEJ cancer with FGFR2b overexpression. The FORTITUDE-101 trial spanned 300 sites across 37 countries, with 547 patients enrolled. The primary outcome measure of the trial is overall survival in patients with FGFR2b ≥10% 2+/3+ tumor cell staining. Key secondary outcome measures include progression-free survival and overall response rate. Candidates were excluded from the trial if they were known to be human epidermal growth factor receptor 2 (HER2) positive. FORTITUDE-101 included more comprehensive ocular-related monitoring than previous studies of bemarituzumab. About Gastric Cancer in China Gastric cancer is the fifth most common cancer worldwide, while China bears one of the highest gastric cancer burdens in the world with an estimated 358,700 new cases and 260,400 deaths annually.4 In China, approximately 80% of gastric cancer patients are diagnosed at an advanced or metastatic stage5. For those diagnosed with Stage IV gastric cancer, the overall 5-year survival rate is less than 10%6. Patients with advanced gastric and GEJ cancer that overexpress the FGFR2b protein may be associated with poor prognosis7-10. About Zai Lab Zai Lab is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States. We are focused on discovering, developing, and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience, and infectious disease. Our goal is to leverage our competencies and resources to positively impact human health worldwide. For additional information about Zai Lab, please visit or follow us at Zai Lab Forward Looking Statements This press release contains forward-looking statements relating to our future expectations, plans, and prospects, including, without limitation, statements regarding the prospects and plans for developing and commercializing bemarituzumab, the potential benefits of bemarituzumab, and the potential treatment of gastric and gastroesophageal junction cancer. All statements, other than statements of historical fact, included in this press release are forward-looking statements, and can be identified by words such as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "goal," "intend," "may," "plan," "possible," "potential," "will," "would," and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical fact or guarantees or assurances of future performance. Forward-looking statements are based on our expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. We may not actually achieve the plans, carry out the intentions, or meet the expectations or projections disclosed in our forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) our ability to successfully commercialize and generate revenue from our approved products, (2) our ability to obtain funding for our operations and business initiatives, (3) the results of our clinical and pre-clinical development of our product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of our product candidates, (5) risks related to doing business in China, and (6) other factors identified in our most recent annual and quarterly reports and in other reports we have filed with the U.S. Securities and Exchange Commission (SEC). We anticipate that subsequent events and developments will cause our expectations and assumptions to change, and we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Our SEC filings can be found on our website at and the SEC's website at REFERENCES Bray F, et al. CA Cancer J Clin. 2024;74(3);229-263 Wainberg ZA, et al. Lancet Oncol. 2022;23(11):1430-40 Rha SY, et al. JCO Precis Oncol. 2025; 9 (e2400710). DOI:10.1200/PO-24-00710 Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024;74(3):229-263. Health Commission of The People's Republic Of China N. National guidelines for diagnosis and treatment of gastric cancer 2022 in China (English version). Chin J Cancer Res. 2022;34(3):207-237. Li HQ, Zhang H, Zhang HJ, Wang YX, Wang XB, Hou HF. Survival of gastric cancer in China from 2000 to 2022: A nationwide systematic review of hospital-based studies. J Glob Health 2022;12:11014. Catenacci D, et al. Presented at American Society of Clinical Oncology; June 4-8, 2021; Online Virtual Scientific Program. Abstract 4010. Ahn S, et al. Mod Pathol. 2016;29:1095-1103. Ishiwata T. Front Biosci (Landmark Ed). 2018;23:626-639. Wainberg ZA, et al. Lancet Oncol. 2022;23:1430-1440. View source version on Contacts For more information, please contact: Investor Relations: Christine Chiou / Lina Zhang+1 (917) 886-6929 / +86 136 8257 / Media: Shaun Maccoun / Xiaoyu Chen+1 (857) 270-8854 / +86 185 0015 / Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

Alibaba touts world's first AI model to detect stomach cancer, even at early stages
Alibaba touts world's first AI model to detect stomach cancer, even at early stages

South China Morning Post

time26-06-2025

  • Health
  • South China Morning Post

Alibaba touts world's first AI model to detect stomach cancer, even at early stages

Alibaba Group Holding unveiled what it says is the world's first artificial intelligence (AI) model to detect gastric cancer, even in early stages, by scanning computed tomography (CT) images. Known as Grape – a name derived from 'gastric cancer risk assessment procedure' – the system is a deep-learning framework that can analyse three-dimensional CT scans to detect and segment gastric cancer, also known as stomach cancer. It was co-developed by Alibaba's Damo Academy and the Zhejiang Cancer Hospital, both in Hangzhou in the eastern Chinese province of Zhejiang. Alibaba owns the Post. Diagnosis of gastric cancer currently requires an endoscopy, an invasive procedure where a camera and tiny biopsy instruments are inserted through the throat. Fewer than 30 per cent of patients in China were willing to follow doctors' advice to have an endoscopy, said Cheng Xiangdong, a gastric surgeon at the Zhejiang Cancer Hospital, in a video published by Damo on Wednesday. The Grape model significantly outperformed radiologists, achieving sensitivity of 85.1 per cent and specificity of 96.8 per cent, according to a paper published in the journal Nature Medicine on Tuesday. Sensitivity measures the ability to detect disease, while specificity measures the ability to avoid false detection in healthy patients. This exceeded the results of radiologists working without the model by 21.8 per cent and 14 per cent, respectively, particularly in early-stage stomach cancer, the paper said. The first of its kind model 'may change the gastric-cancer screening approach in our country and even globally', Cheng said, adding that the percentage of early-stage detections could 'increase significantly'. The fourth leading cause of cancer-related deaths worldwide, gastric cancer can remain symptom-free even at advanced stages. Damo said in a statement on Wednesday that in one such real-world case, a person with the late-stage disease could have been diagnosed six months earlier via CT scans, but radiologists missed it.

Low PNI Tied to Higher Mortality Risk in Gastric Cancer
Low PNI Tied to Higher Mortality Risk in Gastric Cancer

Medscape

time09-06-2025

  • Health
  • Medscape

Low PNI Tied to Higher Mortality Risk in Gastric Cancer

Prognostic nutritional index (PNI) was a valuable predictor for oncological outcomes and morbidity among European patients with gastric cancer undergoing multimodal curative-intent treatment. A low PNI was associated with decreased odds of achieving Textbook Outcome (TO) and an increased risk for 90-day mortality. METHODOLOGY: Researchers used data from the European Gastric Cancer Association GASTRODATA registry between 2017 and 2022 to analyse 721 patients with gastric cancer who underwent multimodal treatment. The primary outcome was TO achievement; the secondary outcome was 90-day mortality, defined as death within 90 days after surgery. The PNI was calculated using a cutoff value of 45.5 on the basis of the receiver operating characteristic curve analysis. The majority of patients had advanced tumours (cT3-4, 75.2%) and metastatic lymph nodes (57.7%). Overall, 70% of patients had a high PNI, with a median of 49.5. TAKEAWAY: The PNI demonstrated a sensitivity of 76% and a specificity of 39.9% to predict TO and a sensitivity of 72% and a specificity of 74% to predict 90-day mortality. A low PNI was significantly associated with decreased odds of achieving TO (odds ratio [OR], 0.57; 95% CI, 0.37-0.89) and an increased risk for 90-day mortality (OR, 4.99; 95% CI, 2.32-10.73). Moreover, a low PNI was associated with increased risks for postoperative complications (OR, 1.79), unplanned intensive care unit admissions (OR, 3.44), and longer hospital stays (OR, 1.91). The PNI was strongly correlated with both pathological nodal and tumour stages (correlation coefficient [rho], −0.189; P < .0001 and rho, −0.163; P < .0001, respectively). IN PRACTICE: "PNI was a valuable predictor for oncological outcomes and morbidity among European GC [gastric cancer] patients undergoing multimodal curative-intent treatment," the authors wrote. "While low PNI was associated with decreased odds of TO achievement and increased risk of 90-day mortality, further prospective large-scale and nutritional intervention studies are warranted to standardize the PNI threshold and improve its clinical applicability as well as surgical outcomes following oncologic surgery," they concluded. SOURCE: This study was led by Zuzanna Pelc, Department of Surgical Oncology, Medical University of Lublin, Lublin, Poland. It was published online on May 28, 2025, in the International Journal of Cancer . LIMITATIONS: The retrospective design limited the ability to reassess the PNI after surgery to evaluate trends during multimodal treatment. The studied cohort's heterogeneity, with half of the patients omitting neoadjuvant chemotherapy, may have affected result interpretation. The PNI cutoff of 45.5 showed moderate discriminative ability for predicting TO, suggesting that it should be interpreted within a broader clinical context rather than as a standalone predictor. DISCLOSURES: No funding information was provided for this study. One author reported being a consultant for J&J, Medicaroid, and Olympus, outside of this study. The other authors reported having no conflicts of interest.

ENHERTU® (trastuzumab deruxtecan) Receives Time-Limited Reimbursement Recommendation from Canada's Drug Agency for Gastric Cancer
ENHERTU® (trastuzumab deruxtecan) Receives Time-Limited Reimbursement Recommendation from Canada's Drug Agency for Gastric Cancer

Yahoo

time23-05-2025

  • Business
  • Yahoo

ENHERTU® (trastuzumab deruxtecan) Receives Time-Limited Reimbursement Recommendation from Canada's Drug Agency for Gastric Cancer

MISSISSAUGA, ON, May 23, 2025 /CNW/ - AstraZeneca (AZ) and Daiichi Sankyo (DS) are pleased to announce that Canada's Drug Agency (CDA, formerly CADTH) has issued a Time-Limited Reimbursement (TLR) recommendation – the first in gastric cancer – for ENHERTU® (trastuzumab deruxtecan) based on the unmet need of adult patients with unresectable, locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. Additionally, the pan-Canadian Pharmaceutical Alliance (pCPA), AstraZeneca, and Daiichi Sankyo have recently signed a Letter of Intent (LOI) through the recently introduced Temporary Access Process (pTAP). This step, alongside the CDA TLR processes, paves the way for jurisdictional reimbursement. "As early participants in these innovative drug reimbursement processes, AstraZeneca and Daiichi Sankyo are pleased to accelerate access to innovative treatments for Canadian patients, particularly in areas of great unmet need, such as HER2+ gastric cancer," says Gaby Bourbara, President, AstraZeneca Canada. "The TLR/pTAP process is intended for a subset of medicines assessed with a very specific set of criteria, and we look forward to continuing to work with our partners within the drug reimbursement ecosystem to unlock additional mechanisms for accelerating access to more medicines in the future." It is estimated that these processes will make ENHERTU available to gastric cancer patients close to two years faster than traditional reimbursement pathways which would have required the completion and review of the Phase III DESTINY-Gastric04 study. "Daiichi Sankyo and our partners at AstraZeneca are committed to ongoing collaboration with the HTA bodies to identify and leverage new ways to make medicines accessible to patients across the country as fast as possible following Health Canada approval," says Fatih Yedikardeş, Country Manager, Daiichi Sankyo Canada. For medications that show early promise and have been given conditional regulatory approval, the TLR and pTAP processes represent a path for accelerated access while ongoing confirmatory trials are in progress.1,2 Health Canada granted a Notice of Compliance with conditions (NOC/c) for ENHERTU (trastuzumab deruxtecan) on January 17, 2025, for the treatment of adult patients with unresectable, locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen.3 The conditional approval was authorized based on results from DESTINY-Gastric024 and DESTINY-Gastric015 Phase II trials. The confirmatory Phase III trial, DESTINY-Gastric046 is currently underway and is a global, randomized, open-label, trial evaluating the efficacy and safety of trastuzumab deruxtecan (6.4 mg/kg) versus ramucirumab and paclitaxel in patients with HER2- positive (IHC 3+ or IHC 2+/ISH+) unresectable and/or metastatic gastric or GEJ adenocarcinoma with disease progression on or after a trastuzumab-containing regimen. About Gastric Cancer Gastric (stomach) cancer is the fifth most common cancer worldwide and the fourth leading cause of cancer mortality with a five-year survival rate of 7.5% for metastatic disease.7,8 In Canada, it is estimated that 4,200 people will be diagnosed, and 2,000 people will die from the disease this year.9 About ENHERTU ENHERTU (trastuzumab deruxtecan) is a HER2-directed antibody-drug conjugate. Designed using Daiichi Sankyo's proprietary DXd antibody drug conjugate (ADC) technology, ENHERTU consists of a HER2 monoclonal antibody attached to a topoisomerase I inhibitor payload, an exatecan derivative, via a stable tetrapeptide-based cleavable linker. About the Daiichi Sankyo and AstraZeneca Collaboration Daiichi Sankyo Company, Limited (referred to as Daiichi Sankyo) and AstraZeneca entered into a global collaboration to jointly develop and commercialize ENHERTU in March 2019 and datopotamab deruxtecan (Dato-DXd) 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 datopotamab deruxtecan. About AstraZeneca AstraZeneca is a global, science-led biopharmaceutical business whose innovative medicines are used by millions of patients worldwide. The company's core areas of scientific focus are Oncology; Cardiovascular, Renal and Metabolic (CVRM); Rare Disease; Respiratory & Immunology; and Vaccine & Immune Therapies. In Canada, the company employs more than 2,400 people and recently announced a major expansion of its research footprint in Mississauga – including the expansion of its AstraZeneca R&D Hub and the creation of a new Alexion Development Hub for Rare Diseases. AstraZeneca was recently recognized as one of Canada's Top 100 Employers, one of Canada's Most Admired Corporate Cultures, and a Greater Toronto Top Employer. AstraZeneca is committed to contributing to a more sustainable future for people, society and planet, taking important steps to help tackle some of the most pressing sustainability challenges globally – from climate and biodiversity loss, to health equity and health system resilience. AstraZeneca was one of the first seven companies globally to have its net zero targets verified by the Science-Based Targets initiative (SBTi) Corporate Net-Zero Standard. For more information, please visit the company's website at About Daiichi Sankyo Daiichi Sankyo is dedicated to creating new modalities and innovative medicines by leveraging our world-class science and technology for our purpose "to contribute to the enrichment of quality of life around the world." In addition to our current portfolio of medicines for cancer and cardiovascular disease, Daiichi Sankyo is primarily focused on developing novel therapies for people with cancer as well as other diseases with high unmet medical needs. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation to realize our 2030 Vision to become an "Innovative Global Healthcare Company Contributing to the Sustainable Development of Society." For more information, please visit References______________________________1 Canada's Drug Agency - Procedures for Time-Limited Reimbursement Recommendations: Available at: Accessed on May 6, 2025.2 pCPA Temporary Access Process (pTAP). Available at: . Accessed on May 6, 2025.3 ENHERTU® (trastuzumab deruxtecan), Product Monograph, AstraZeneca Canada Inc., January 17, 2025.4 Van Cutsem E. et al. Trastuzumab deruxtecan in patients in the USA and Europe with HER2-positive advanced gastric or gastroesophageal junction cancer with disease progression on or after a trastuzumab-containing regimen (DESTINY-Gastric02): primary and updated analyses from a single-arm, phase 2 study. Lancet Onco.l 2023; 24: 744–56.5 Shitara, K. et al. Trastuzumab Deruxtecan in Previously Treated HER2-Positive Gastric Cancer. N Engl J Med. 2020; 382: 2419-30.6 Daiichi Sankyo Co. Ltd. Trastuzumab Deruxtecan for Subjects With HER2-Positive Gastric Cancer or Gastro-Esophageal Junction Adenocarcinoma After Progression on or After a Trastuzumab-Containing Regimen (DESTINY-Gastric04). Available at: Accessed on May 6, 2025.7 SEER Cancer Stat Facts: Stomach Cancer. Available at: Accessed May 6, 2025.8 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):209-249.9 Canadian Cancer Society. Stomach Cancer Statistics. Available at: Accessed on May 6, 2025. SOURCE AstraZeneca Canada Inc. View original content to download multimedia: Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

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