HER2 antagonists(Receptor tyrosine-protein kinase erbB-2 antagonists), TOP1 inhibitors(DNA topoisomerase I inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects)

Therapeutic Areas

NeoplasmsDigestive System DisordersRespiratory Diseases+ [5]

Active Indication

Metastatic human epidermal growth factor 2 positive carcinoma of breastStomach CancerHER2 Positive Solid Tumors+ [66]

Inactive Indication

HER2 Positive Transitional Cell CarcinomaHER2-expressing Gastroesophageal Junction AdenocarcinomaMeningeal Carcinomatosis+ [1]

Originator Organization

Daiichi Sankyo Co., Ltd.

Active Organization

Daiichi Sankyo Co., Ltd.

AstraZeneca PLCAstraZeneca AB

+ [10]

Inactive Organization-

License Organization

Merck & Co., Inc.

AstraZeneca PLC

Daiichi Sankyo Co., Ltd.

+ [2]

Drug Highest PhaseApproved

First Approval Date

United States (20 Dec 2019),

HER2 Positive Breast Cancer

RegulationPriority Review (United States), Breakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Priority Review (China), Breakthrough Therapy (China), Conditional marketing approval (China), Orphan Drug (Japan), Orphan Drug (Australia), Priority Review (Australia), SAKIGAKE (Japan), Fast Track (United States)

Structure/Sequence

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Sequence Code 18481L

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Sequence Code 44772H

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195

Clinical Trials associated with Fam-trastuzumab deruxtecan-NXKI

NCT07578116

/ Not yet recruitingPhase 3IIT

Randomized Phase III Trial of Multimodality Therapy Versus Standard of Care Systemic Therapy in HER2 Positive (HER2+) De Novo (AJCC Stage IV) Oligometastatic Breast Cancer With Response to Initial Chemotherapy

This phase III trial evaluates the effect of adding locoregional therapy (surgery and radiation) and metastasis-directed stereotactic body radiation therapy (SBRT) to standard systemic therapy following standard HER2-targeted systemic therapy, compared to standard systemic therapy alone, in treating patients with HER2-positive stage IV breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or to a limited number of sites (oligometastatic). The usual approach for patients with (oligo)metastatic HER2-positive breast cancer is systemic drug treatment, which means medicines that travel through the whole body to treat both the breast and any areas where the cancer has spread. There are a number of approved HER2-targeted systemic therapy regimens available to patients. These typically include immunotherapy and/or chemotherapy. Immunotherapy drugs may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Unlike systemic therapy, locoregional therapies like surgery and radiation are focused treatments at the site of disease, delivered with the intent of sparing healthy tissues. Breast surgeries such as breast conserving therapy or total mastectomy are procedures in which the cancerous breast tissue (and healthy breast tissue in the case of total mastectomy) are surgically removed from the body. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Adding locoregional therapy, as well as metastasis-directed SBRT, to standard systemic therapy may help patients with (oligo)metastatic, HER2-positive stage IV breast cancer live longer overall or before their cancer progresses, and may help more patients achieve no evidence of disease, when compared to standard systemic therapy alone.

Start Date09 Mar 2027

Sponsor / Collaborator

SWOG

[+1]

NCT07126561

/ Not yet recruitingPhase 2IIT

Phase II Open Label Trial of Trastuzumab Deruxtecan (Enhertu, DS-8210) in HER2 Positive Newly Diagnosed Metastatic Esophageal, Gastric, GEJ Cancer Patients With an ECOG Performance Status of 2

Purpose: This clinical trial is designed to evaluate the safety and effectiveness of Trastuzumab Deruxtecan for patients with HER2 Positive Newly Diagnosed Metastatic Esophageal, Gastric, GEJ Cancer. The goal is to determine how well this treatment works and to identify any potential side effects.
Who Can Participate: We are looking for Participants with histologically confirmed HER2 positive locally advanced unresectable and/or metastatic esophageal, gastric or GEJ adenocarcinoma with an ECOG PS of 2 and measurable disease according to RECIST 1.1 within 42 days prior to registration. Participants will be carefully screened to ensure they meet the study requirements.
What to Expect: Participants will undergo 6.4mg/kg, IV infusion of Trastuzumab deruxtucan over the course of the study. They will receive detailed information about the study and will have the opportunity to ask questions before deciding to participate. Informed consent will be obtained to ensure that participants understand the study's purpose, procedures, risks, and benefits.
Safety Monitoring: The health and safety of participants are our top priority. An Independent Data and Safety Monitoring Committee (DSMC) will regularly review the study data to ensure participant safety and to monitor for any adverse events. Any serious side effects will be reported and addressed promptly.
Benefits and Risks: While the study aims to provide potential benefits, such as improved treatment options for HER2 Positive Newly Diagnosed Metastatic Esophageal, Gastric, GEJ Cancer there may also be risks involved. Participants will be informed of all possible risks before enrolling in the study.
Confidentiality: All personal information will be kept confidential, and data will be used only for research purposes.
Contact Information: For more information about this study, please contact PhaseIICRA@medicine.bsd.uchicago.edu

Start Date01 Nov 2026

Sponsor / Collaborator

The University of Chicago

NCT07137416

/ RecruitingPhase 1IIT

Phase 1b Study of Pidnarulex and Trastuzumab Deruxtecan in Patients With HER2 Expressing Solid Tumors

This phase I trial tests the safety, side effects, and best dose of pidnarulex in combination with trastuzumab deruxtecan in treating patients with breast cancer and other solid tumors that express varying levels of a protein called HER2 and that has spread from where it first started (primary site) to other places in the body (metastatic), that cannot be removed by surgery (unresectable), or that has spread to nearby tissue or lymph nodes (locally advanced). Pidnarulex is an enzyme inhibitor that causes cell death and prevents tumor cell growth. Trastuzumab deruxtecan is in a class of medications called antibody-drug conjugates. It is composed of a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called deruxtecan. Trastuzumab attaches to HER2 positive tumor cells in a targeted way and delivers deruxtecan to kill them. Giving pidnarulex in combination with trastuzumab deruxtecan may be safe, tolerable and/or effective in treating patients with metastatic, unresectable, or locally advanced HER2-expressing breast cancer or other solid tumors.

Start Date05 Oct 2026

Sponsor / Collaborator

National Cancer Institute

100 Clinical Results associated with Fam-trastuzumab deruxtecan-NXKI

100 Translational Medicine associated with Fam-trastuzumab deruxtecan-NXKI

100 Patents (Medical) associated with Fam-trastuzumab deruxtecan-NXKI

1,152

Literatures (Medical) associated with Fam-trastuzumab deruxtecan-NXKI

01 Jul 2026·Value in Health Regional Issues

Budget Impact Analysis of Fam-Trastuzumab-Deruxtecan as a Second Line in Patients With HER2-Positive Metastatic Breast Cancer in Oman

Article

Author: Aljaber, Rana ; Al Froukh, Rawan F ; Al Hashar, Amna

OBJECTIVES:

Despite advancements, breast cancer remains a major global health and financial challenge. Trastuzumab-based therapies, particularly Fam-Trastuzumab-Deruxtecan (T-DXd), have shown superior outcomes, leading to its recommendation as a preferred second-line treatment. However, its high cost necessitates a budget impact analysis (BIA) to evaluate financial feasibility. This study assesses the 1-year budget impact of replacing Trastuzumab Emtansine (TDM1) with T-DXd for HER2+ metastatic breast cancer in an Omani cancer center.

METHODS:

A static BIA model was built based on National Institute for Health and Care Excellence template with adaptation as required. The model time horizon was 1 year then projected over another 2 years, using 2022 as the baseline year, adopting Omani healthcare-payer perspective. The analysis considered 2 scenarios: (1) TDM1 as the current formulary drug and (2) T-DXd is introduced instead of TDM1, assuming that treatment share would be 100%. One-way sensitivity analysis is performed to assess the model's robustness.

RESULTS:

The BIA demonstrated that replacing TDM1 with T-DXd for the eligible patients would lead to increase in the budget expenditure. Over a 3-year period, considering the provided assumptions and input data, the cumulative excess amount to €5 909 481.67. The primary contributing factors are the drug acquisition cost and the median treatment duration. The sensitivity analysis results suggest the model is robust to changes in adverse drug reaction costs, unlike changes in treatment duration and drug cost.

CONCLUSIONS:

Although T-DXd improves clinical outcomes, its adoption as a second-line treatment in Oman poses a substantial financial burden, necessitating careful budget planning to ensure long-term affordability.

01 Jun 2026·BREAST

Antibody–drug conjugate sequencing in HER2-positive metastatic breast cancer: Real-world outcomes of trastuzumab deruxtecan with and without prior T-DM1 exposure

Article

Author: Bayram, Ertuğrul ; Deliktaş Onur, İlknur ; Yeşil Çınkır, Havva ; Majidova, Nargiz ; Gündüz, Şeyda ; Erdem, Dilek ; Karadurmuş, Nuri ; Er, Özlem ; Selçukbiricik, Fatih ; Başaran, Gül ; Güney, Bünyamin ; Gürsu, Rıza Umar ; Kalem, Ali ; Oruç, Ahmet ; Tünbekici, Salih ; Seyyar, Mustafa ; Güren, Ali Kaan ; Ateş, Öztürk ; Köylü, Bahadır ; Yazıcı, Melike ; Türker, Sema ; Güney, Gizem ; Akdoğan, Orhun ; Araz, Murat ; Göker, Erdem ; Kaban, Kerim ; Yılmaz, Mesut ; Aykan, Musa Barış ; Demir, Nazan ; Yıldız, İbrahim ; Molinas Mandel, Nil ; Kıkılı, Cevat İlteriş ; Biter, Sedat ; Korkmaz, Taner ; Çabuk, Devrim ; Tunalı, Didem ; Bilici, Ahmet ; Laçin, Şahin ; Sezer, Ahmet ; Altunok, Oğuz ; Şahin, Taha Koray ; Bayoğlu, İbrahim Vedat ; Çelik, Emir ; Aksoy, Sercan ; Açıkel Yüksel, Sakine Damla ; Ekinci, Ömer Burak ; Kemik, Fatih ; Özçelik, Hakan ; Güven, Deniz Can ; Yazıcı, Ozan ; Tural, Deniz

BACKGROUND:

Optimal sequencing of trastuzumab emtansine (T-DM1) and trastuzumab deruxtecan (T-DXd) in HER2 positive metastatic breast cancer (mBC) remains uncertain, and real-world evidence on the impact of prior T-DM1 exposure on subsequent T-DXd outcomes is limited.

METHODS:

We conducted a multicenter, retrospective cohort study across 21 oncology centers in Türkiye including consecutive adults with HER2 positive mBC who received at least one cycle of T-DXd between 2020 and 2025. Patients were classified as T-DM1 pretreated or T-DM1 naive at T-DXd initiation. The primary endpoint was progression free survival (PFS); secondary endpoints included objective response rate (ORR), duration of response (DOR), and overall survival (OS). To address confounding by indication, we applied stabilized inverse probability of treatment weighting (IPTW) based on prespecified clinical covariates and assessed covariate balance using standardized mean differences.

RESULTS:

Among 218 patients treated with T-DXd, 137 (62.8%) had received prior T-DM1 and 81 (37.2%) were T-DM1 naive. The ORR was 71.9%, including 15.2% complete and 56.7% partial responses. Median DOR in the overall cohort was 20.96 months (95% CI, 15.71-26.22). In the IPTW-weighted analysis, prior T-DM1 exposure was associated with significantly shorter PFS: 12.1 months (95% CI, 10.3-20.5) versus 26.0 months (95% CI, 18.9 - not reached) in T-DM1 naive patients (IPTW-weighted log-rank p = 0.006). Prior T-DM1 remained independently associated with higher progression risk (HR 1.99, 95% CI 1.09 - 3.62; p = 0.02). Median OS was 18.9 months (95% CI, 17.2-not reached) in T-DM1 pretreated patients and not reached in T-DM1 naive patients; the IPTW-weighted OS hazard ratio did not reach statistical significance (HR 1.80, 95% CI 0.86-3.79; p = 0.12).

CONCLUSIONS:

Trastuzumab deruxtecan demonstrated substantial real-world activity after prior T-DM1 exposure, but PFS was significantly shorter compared with T-DM1 naive patients, even after rigorous adjustment for measured confounding. These findings highlight the clinical relevance of antibody drug conjugate sequencing and support prospective studies to define the optimal positioning of T-DXd in HER2 positive mBC treatment algorithms.

01 Jun 2026·DRUGS

Sequential Use of Trastuzumab Deruxtecan and Sacituzumab Govitecan in Patients with Breast Cancer: A Pharmacological Approach to Support the Clinical Rationale

Review

Author: Mathijssen, Ron H J ; Bria, Emilio ; Curigliano, Giuseppe ; Danesi, Romano ; Inglese, Elvira ; Del Re, Marzia ; Blok, Erik J

Antibody-drug conjugates (ADCs) represent a major advance in breast cancer therapy, with trastuzumab deruxtecan and sacituzumab govitecan emerging as leading agents targeting distinct tumor antigens and employing different linker-payload designs. Trastuzumab deruxtecan is a second-generation HER2-directed ADC composed of trastuzumab linked via a cleavable tetrapeptide linker to the camptothecin derivative exatecan, a highly potent topoisomerase I inhibitor. Its high drug-to-antibody ratio (DAR 8:1), membrane-permeable payload, and efficient lysosomal release confer strong antitumor activity, including a robust bystander effect in HER2-low tumors. By contrast, sacituzumab govitecan is a TROP-2-targeted ADC conjugated through a hydrolysable CL2A linker to SN-38, the active metabolite of irinotecan. Sacituzumab govitecan features a high DAR (7.6:1) and allows extracellular as well as intracellular release of SN-38, enhancing bystander killing in tumors with heterogeneous TROP-2 expression, while maintaining a favorable toxicity profile due to the lower intrinsic potency of SN-38 relative to exatecan. Since both these ADCs are conjugated to topoisomerase I inhibitors, concerns about potential cross-resistance regarding their sequencing in clinical practice are being raised, and currently there is a lack of predictive biomarkers providing a rational basis for their sequential administration. Resistance mechanisms exhibit significant heterogeneity: resistance to trastuzumab deruxtecan has been associated with mutations in TOPO I and SLX4, impaired lysosomal function, and efflux via ABC transporters. In contrast, resistance to sacituzumab govitecan is linked to overexpression of multidrug resistance proteins, particularly BCRP-mediated efflux. Clinically, trastuzumab deruxtecan has shown substantial efficacy in both HER2-positive and HER2-low breast cancer, whereas sacituzumab govitecan has demonstrated efficacy across triple-negative and hormone receptor-positive/HER2-negative breast cancers. Collectively, these agents highlight how variations in target antigen, linker chemistry, and payload potency impact ADC activity, therapeutic index, and potential strategies for sequential treatment in advanced breast cancer.

1,147

News (Medical) associated with Fam-trastuzumab deruxtecan-NXKI

7 hours ago

·www.prnewswire.com

Paradigm Health Implements New Clinical Trial Solution to Support Observational Study Presented at ASCO

Paradigm Health's Scalable Platform for Integrated Research and Evidence (SPIRE) helps trial sponsors generate high-quality clinical trial data across community healthcare practices Columbus, Ohio and CHICAGO, June 1, 2026 /PRNewswire/ -- Paradigm Health today announced its role in the execution of a multicenter, hybrid, observational post-marketing commitment study in the United States evaluating an FDA-approved therapy in patients with human epidermal growth factor receptor 2 (HER2) immunohistochemistry (IHC) 3+ solid tumors. The trial uses Paradigm Health's SPIRE model as the technology-enabled infrastructure to accelerate end-to-end trial operations, from trial design, site selection, patient identification, and data collection, to efficient evidence generation. A principal investigator from Florida Cancer Specialists & Research Institute (FCS) presented a poster on the trial design and operations at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting on June 1. The abstract (TPS11202) is titled A pragmatic, hybrid observational study evaluating the effectiveness of trastuzumab deruxtecan (T-DXd) in patients with human epidermal growth factor receptor 2 (HER2) immunohistochemistry (IHC) 3+ solid tumors: DESTINY-PanTumor04. Study authors also include researchers from Paradigm Health, AstraZeneca (trial sponsor), and Daiichi Sankyo. The SPIRE infrastructure uses the same data collection technology that underpins the proof-of-concept currently underway with the U.S. Food & Drug Administration (FDA) to evaluate the implementation of Real-Time Clinical Trials. The trial was designed to track approximately 100 patients at up to 30 U.S. locations, from community practices to academic medical centers. The SPIRE model provides the end-to-end infrastructure that can help sponsors design pragmatic trials and embed into study sites to automate data collection, identify eligible patients faster, and expedite transmission of analysis-ready data to sponsors. By streamlining these labor-intensive steps, SPIRE enables researchers across community settings, hospitals, and academic medical centers to participate in the same late-phase clinical trials. "This research shows how SPIRE can be used in a broad range of healthcare settings. Already, 13 community oncology centers are participating in this study," said Kent Thoelke, Founder and CEO of Paradigm Health. "By connecting fragmented clinical databases and other data sources, we can lower the operational burden for research staff while maintaining the completeness and accuracy needed by trial sponsors. This helps make clinical research feasible for more study sites, ultimately, opening research up to more patients." The poster highlights the study's pragmatic trial elements achieved through the SPIRE model, including broad eligibility criteria, routine clinical practice settings, integration of primary and secondary sources into study data collection, and pragmatic endpoints. Paradigm Health's SPIRE model optimizes the trial design, site selection, and simplification of patient identification and enrollment, improving data accuracy and completeness, all aimed at making clinical trial workflows feasible for more sites. SPIRE-enabled pragmatic prospective studies are uniquely positioned to evaluate effectiveness in routine care and enroll patient populations that are reflective of real-world healthcare settings. "Observational and late-phase studies require the technological infrastructure to operate within clinical care delivery, and my team at FCS is at the forefront of this technological modernization," said Lucio Gordan, President and Managing Physician at FCS. "Paradigm Health's SPIRE was designed to help trial sites align clinical workflows with research operations, expediting analysis-ready data capture without increasing burden on providers or site staff." About Paradigm Health Paradigm Health has engineered an AI-powered platform to make clinical trials more accessible and efficient, so that patients, researchers, and study sponsors can maximize the impact of clinical research. Incubated by ARCH Venture Partners and backed by leading healthcare and life sciences investors, Paradigm Health aims to break down barriers across the trial ecosystem through one seamless infrastructure implemented at healthcare provider organizations, bringing potentially life-saving therapies to patients faster. For more information, visit . About SPIRE Scalable Platform for Integrated Research and Evidence (SPIRE) is an end-to-end, technology-enabled alternative to traditional CRO-led approaches for prospective, pragmatic studies, particularly for approved products and products nearing approval with established safety profiles. The solution combines: EHR-integrated technology embedded directly into patient visits, in community, rural, and academic settings across 46 of 50 states Data-driven study design and site selection informed by care patterns and site capabilities Full-service study conduct support across site selection, startup, enrollment, data management, safety, and closeout SPIRE Intended Use Cases SPIRE is intended for prospective, pragmatic U.S. studies for assets that are approved of nearing approval, including: Post-marketing requirements and commitments with observational designs Phase IV safety and/or effectiveness Label expansion Comparative effectiveness Prospective registries and external control arms Hybrid studies incorporating randomized and pragmatic elements About Paradigm Health's Collaboration with FDA on Real-Time Clinical Trials In April 2026, Paradigm Health announced a landmark research collaboration with the FDA focused on advancing a new model to accelerate clinical trial execution and regulatory review. The model uses Paradigm Health's technology-enabled Study Conduct platform to allow real-time review by the FDA, by automating data collection and analysis, and streamlining the reporting of key safety and efficacy signals to trial sponsors and the FDA. SOURCE Paradigm Health, Inc. 21% more press release views with Request a Demo

Clinical StudyImmunotherapyASCO

13 hours ago

·www.biospace.com

Callio Therapeutics to Present Phase 1 Trial Design of CLIO-8221, Novel Dual-Payload ADC, at ASCO 2026

SEATTLE and SINGAPORE, May 27, 2026 (GLOBE NEWSWIRE) -- Callio Therapeutics, a biotherapeutics company advancing dual-payload antibody-drug conjugates (ADCs) with a targeted, multi-mechanism approach to cancer treatment, today announced that it will present a trial-in-progress poster highlighting the Phase 1 trial design of CLIO-8221 at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting (May 29-June 2) in Chicago. CLIO-8221 is a first-in-class dual-payload ADC currently in Phase 1 clinical development ( NCT07300943 ) for HER2-expressing solid tumors. “CLIO-8221 is the first program from Callio Therapeutics’ dual-payload ADC pipeline to enter the clinic, advancing our strategy to develop rationally designed payload combinations for hard-to-treat tumors,” said Naomi Hunder, MD, Chief Medical Officer of Callio Therapeutics. “Developed with our proprietary linker technology and payload combination platform, CLIO-8221 is a first-in-class dual-payload ADC designed to deliver a topoisomerase 1 inhibitor and an ATR inhibitor directly to HER2-expressing tumors to address key mechanisms of resistance to existing HER2-targeted ADCs, including trastuzumab deruxtecan. With our Phase 1 trial now enrolling patients with advanced HER2-expressing solid tumors, we look forward to generating clinical data that will inform its potential as a differentiated treatment option.” “Patients with HER2-expressing solid tumors who progress on currently available HER2-targeted therapies continue to have limited treatment options,” said Timothy A. Yap, MBBS, PhD, lead investigator at The University of Texas MD Anderson Cancer Center for the CLIO-8221 Phase 1 trial, and presenting author of the poster. “CLIO-8221 represents an innovative dual-payload approach to overcome resistance associated with existing HER2-targeted ADCs. This trial marks an important step in evaluating whether combining topoisomerase 1 and ATR inhibition within a single HER2-targeted ADC can expand treatment possibilities for patients with HER2-expressing solid tumors.” The Phase 1 clinical trial recruitment is ongoing in Australia and the United States, and the company plans to activate sites in China. At ASCO, Callio Therapeutics will present previously disclosed preclinical data (AACR 2026) that support the therapeutic potential of CLIO-8221 and the Phase 1 trial design: By simultaneously delivering a topoisomerase 1 inhibitor (exatecan) and an ATR inhibitor (berzosertib), CLIO-8221 drives direct tumor cell killing at doses that also support a robust bystander effect, achieving superior in vivo efficacy compared to single-payload ADCs CLIO-8221 demonstrated potent anti-tumor activity across varying HER2 expression levels and drove tumor regression after a single dose in both trastuzumab deruxtecan-sensitive and -insensitive models CLIO-8221 exhibited a highly favorable safety profile; it was well-tolerated in non-human primates with no significant adverse effects observed at doses of 70 mg/kg (highest dose tested), establishing a No-Observed-Adverse-Effect Level (NOAEL) significantly higher than that of trastuzumab deruxtecan Phase 1 of the study is a dose escalation with optional dose level expansions, and dose escalation may enroll across HER2-expressing cancers, including cancers that did not respond to or relapsed after trastuzumab deruxtecan treatment Presentation details: Poster/Abstract Title: Phase 1/2 Study of CLIO-8221, a HER2-targeted, dual-payload exatecan and ATR inhibitor antibody-drug conjugate (ADC) in patients with advanced HER2-expressing solid tumors Poster Session : Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology Date & Time : May 30, 2026, 1:30 PM - 4:30 PM CDT Location: McCormick Place, Hall A – Posters and Exhibits Presenter : Timothy A. Yap, MBBS, PhD, The University of Texas MD Anderson Cancer Center Abstract Number: TPS3162 Poster Board: 295b The full abstract is available on the ASCO Annual Meeting website. The poster will be available on the ASCO website on May 30, 2026. About CLIO-8221 HER2 is a clinically validated target for antibody-drug conjugates (ADCs), with multiple approved therapies demonstrating meaningful benefit across tumor types, however, most patients eventually progress on treatment despite retaining HER2 expression. Mechanistic resistance to cytotoxic payloads has emerged as a key reason for treatment failure. CLIO-8221 is a novel, first-in-class dual-payload ADC targeting HER2, designed to address this challenge. CLIO-8221 delivers two mechanistically complementary payloads, a topoisomerase 1 (Topo1) inhibitor and an ATR inhibitor, directly to HER2-expressing tumors. While Topo1 inhibitors have shown strong clinical activity, activation of the DNA damage response following Topo1 inhibitor-induced replication stress represents a potential major driver of resistance. By simultaneously inhibiting Topo1 and blocking the DNA damage response through ATR inhibition, CLIO-8221 is engineered to overcome payload insensitivity and sensitize tumors to Topo1 inhibition. Developed using proprietary linker and ADC platform technologies, CLIO-8221 aims to maximize anti-tumor activity while reducing systemic toxicity, offering the potential for deeper and more durable responses in patients who have progressed on existing HER2-targeted therapies. About Callio Therapeutics Callio Therapeutics is a clinical‑stage company engineering oncology-focused dual-payload ADCs for the next frontier of targeted cancer therapy. Powered by a proprietary platform featuring adaptable, modular linker technology, Callio Therapeutics is developing a focused pipeline of dual-payload ADCs engineered with rational, synergistic payload combinations matched to specific tumor biology and to counter multiple mechanisms of resistance. CLIO-8221, the company’s lead candidate, is a HER2-targeted dual-payload ADC currently being evaluated in a Phase 1 clinical trial. Callio Therapeutics is built on technology and programs licensed from Hummingbird Bioscience, an AI-enabled biotherapeutics company and R&D collaborator. Headquartered in Seattle and Singapore, and backed by top life science investors, Callio Therapeutics is built to discover and deliver, with an experienced team with a track record of success. For more information, visit and follow Callio Therapeutics on LinkedIn. Contacts Media: Crystal Ho media@calliotx.com Ally Stubin – ICR Healthcare Ally.Stubin@ICRHealthcare.com (646) 667-1861 Investors: ir@calliotx.com Stephanie Carrington – ICR Healthcare stephanie.carrington@ICRHealthcare.com (646) 277-1282

Phase 1ASCOADCAACR

29 May 2026

·www.biospace.com

Parexel to Present Real-World Oncology Research and Launch New Patient-Focused Campaign at ASCO 2026

Two virtual posters accepted exploring rejections in oncology marketing applications and real-world pulmonary safety of T-DXd in HER2-positive metastatic breast cancer From Insights to Life campaign reinforces Parexel’s commitment and position as the leading patient-first clinical development partner RALEIGH, N.C., May 28, 2026 (GLOBE NEWSWIRE) -- Parexel, a leading global clinical development partner providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry, today announced two virtual research posters accepted for presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, May 29-June 2, in Chicago. The research examines critical challenges in oncology drug development and real-world safety outcomes for a HER2-targeted therapy, grounding Parexel’s ASCO presence in the evidence that advances cancer care. The company also unveiled From Insights to Life , a new patient-focused creative campaign reflecting Parexel’s commitment to helping sponsors advance their programs so patients can return to what matters most to them. Virtual Poster Presentations As part of ASCO 2026, Parexel is presenting two virtual research posters, one analyzing common deficiencies in oncology marketing applications that lead to FDA rejections and another focused on the pulmonary safety pro trastuzumab deruxtecan (T-DXd) in HER2-positive metastatic breast cancer. Virtual Poster: Deficiencies in oncology marketing applications leading to FDA rejections: An assessment of complete response letters Virtual Poster: Real-World Risk of Interstitial Lung Disease and Pneumonitis with Trastuzumab Deruxtecan vs Trastuzumab in HER2-Positive Metastatic Breast Cancer: A Propensity Score-Matched Analysis Parexel’s oncology experience over the past five years spans more than 560 clinical studies, more than 104,000 patients and more than 26,000 sites across more than 50 countries. Over that same period, Parexel Biotech delivered the data supporting six U.S. Food and Drug Administration (FDA) and three European Medicines Agency (EMA) new solid-tumor oncology drug approvals. “ASCO is where the oncology community comes together to advance science that matters for patients, and Parexel’s presence reflects that same commitment,” said Jozsef Palatka, M.D., Senior Vice President and Global Therapeutic Head of Oncology at Parexel, who will lead the company’s on-site activities at the meeting. “The research we are presenting exemplifies the rigor we bring to every program. Translating real-world evidence into confident clinical development decisions is how we help sponsors advance therapies forward for the patients who need them.” Joining Dr. Palatka on-site will be Charlotte Moser , Chief Medical Officer, Jim Anthony , Chief Commercial Officer and President, Parexel Biotech, Stacy Hurt , Chief Patient Officer, Mike D’Ambrosio , Senior Vice President and Global Head of Real World Research, and members of Parexel’s medical, commercial and marketing teams. From Insights to Life The company also announced the launch of From Insights to Life , a new patient-focused creative campaign centered on real people, representing different disease states and demographics, navigating the space between a medical diagnosis and daily living. Inspired by patient experiences and driven by a sense of purpose, the campaign reaffirms Parexel’s commitment to delivering clinical trials that support patients in continuing to live the lives they love. “What patients want most is to feel genuinely seen by the people working on their behalf, recognized for the full life they are striving to return to,” said Stacy Hurt, Chief Patient Officer at Parexel. “At Parexel, truly listening to patients is the principle that guides every decision we make, every trial we design and every partnership we form. From Insights to Life captures something I have felt throughout my relationship with Parexel—when patients are placed at the center of everything we do, it fundamentally changes what is possible. It’s the difference between advancing science and creating solutions that genuinely change people’s lives.” From Insights to Life builds on the foundation of Parexel’s award-winning Insights Generation Engine campaign, which was recognized by PR Week’s 2026 Corporate Healthcare Campaign Award . Where Insights Generation Engine celebrates the expertise of Parexel’s colleagues, From Insights to Life extends that commitment outward to the patients who Parexel serves. The campaign will roll out throughout 2026 with additional original compositions unveiled across Parexel's website, digital and social channels, and activations at milestone biopharmaceutical industry events, such as the American Diabetes Association and the World Orphan Drug Congress. Each new patient-focused campaign image reinforces Parexel’s mission—translating insight into meaningful impact across the clinical development journey and accelerating life-changing medicines to patients. About Parexel Parexel is a leading global clinical development partner providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our 22,000+ global employees work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere. Our proven track record spans 40+ years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights -driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart®. We continue to earn recognition industrywide, including the 2025 Scrip Award for “Best Contract Research Organization – Full-Service Provider,” the 2024 Fierce Biotech CRO Award for "Innovative Approaches to Patient-Centric Research" and the 2024 and 2023 Society for Clinical Research Sites (SCRS) Eagle Award for advancing the clinical research profession through strong site partnerships. For more information, visit parexel.com and follow us on LinkedIn, X, Facebook and Instagram. Media Heather Zoumas-Lubeski +1 (984) 218-5539 heather.zoumas-lubeski@parexel.com Danaka Williams +1 (984) 298-4207 Danaka.Williams@parexel.com A photo accompanying this announcement is available at

Clinical StudyASCO

100 Deals associated with Fam-trastuzumab deruxtecan-NXKI

External Link

KEGG	Wiki	ATC	Drug Bank
-	Fam-trastuzumab deruxtecan-NXKI	L01XC	DB14962

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Metastatic human epidermal growth factor 2 positive carcinoma of breast	United States	Daiichi Sankyo, Inc.	15 May 2026
Stomach Cancer	India	AstraZeneca PLC	07 Oct 2025
HER2 Positive Solid Tumors	United Kingdom	Daiichi Sankyo UK Ltd.	09 Apr 2025
HR-positive/HER2-low Breast Carcinoma	United States	Daiichi Sankyo Co., Ltd.	28 Jan 2025
Hormone receptor positive HER2 positive breast cancer	South Korea	Daiichi Sankyo Co., Ltd.	19 Sep 2022
HER2 mutant non-small cell lung cancer	United States	Daiichi Sankyo, Inc.	11 Aug 2022
HER2 Positive Stomach Adenocarcinoma	Australia	AstraZeneca Pty Ltd.	08 Oct 2021
HER2-Low Breast Carcinoma	Australia	AstraZeneca Pty Ltd.	08 Oct 2021
Metastatic breast cancer	Canada	AstraZeneca Canada, Inc.	15 Apr 2021
HER2 positive Gastroesophageal Junction Adenocarcinoma	United States	Daiichi Sankyo, Inc.	15 Jan 2021
HER2-positive gastric cancer	Japan	Daiichi Sankyo Co., Ltd.	25 Sep 2020
HER2 Positive Breast Cancer	United States	Daiichi Sankyo, Inc.	20 Dec 2019

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Solid tumor	Phase 3	United States	Daiichi Sankyo, Inc.	23 Dec 2025
Solid tumor	Phase 3	China	Daiichi Sankyo, Inc.	23 Dec 2025
Solid tumor	Phase 3	Japan	Daiichi Sankyo, Inc.	23 Dec 2025
Solid tumor	Phase 3	Australia	Daiichi Sankyo, Inc.	23 Dec 2025
Solid tumor	Phase 3	Brazil	Daiichi Sankyo, Inc.	23 Dec 2025
Solid tumor	Phase 3	France	Daiichi Sankyo, Inc.	23 Dec 2025
Solid tumor	Phase 3	Israel	Daiichi Sankyo, Inc.	23 Dec 2025
Solid tumor	Phase 3	Italy	Daiichi Sankyo, Inc.	23 Dec 2025
Solid tumor	Phase 3	South Korea	Daiichi Sankyo, Inc.	23 Dec 2025
Solid tumor	Phase 3	Spain	Daiichi Sankyo, Inc.	23 Dec 2025

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT07151586 (ALTER, AACR2026)	Phase 2	Triple Negative Breast Cancer HER2-low	260	Alternating sacituzumab-govitecan and trastuzumab-deruxtecan	granhlwjaz(kyaxnhfcjc) = ajwkrlctbj nxniripsmx (phsxnmmsql ) View more	Positive	21 Apr 2026
				Sacituzumab-govitecan	granhlwjaz(kyaxnhfcjc) = mkrzoricpn nxniripsmx (phsxnmmsql ) View more
NCT04379596 (DESTINY-Gastric03, AACR2026)	Phase 1/2	Adenocarcinoma of Esophagus \| HER2-positive gastric cancer \| Gastroesophageal junction adenocarcinoma First line HER2-positive	30	trastuzumab deruxtecan + rilvegostomig + fluoropyrimidine (HER2-positive gastric cancer, gastroesophageal junction adenocarcinoma, or esophageal adenocarcinoma)	effdzzpisi(psapnknfek) = iiyrvrkznp cqacwmcbtf (ogvzyoslxd ) View more	Positive	21 Apr 2026
AACR2026	Not Applicable	HER2 Positive Ovarian Cancer \| HER2-Expressing Endometrial Carcinoma HER2 expressing	33	Trastuzumab deruxtecan	uoddinjizq(fqjqrurvbw) = npooxmwlwn ixjhukavhs (juzvxqlbma ) View more	Positive	20 Apr 2026
				Trastuzumab deruxtecan (Ovarian cancer)	uoddinjizq(fqjqrurvbw) = qjqgomrbjm ixjhukavhs (juzvxqlbma ) View more
AACR2026	Not Applicable	Metastatic Colorectal Carcinoma Second line HER2-amplified \| MSS	3,734	trastuzumab deruxtecan	vprxtznedb(uvijzecqgu): HR = 1.14 (95.0% CI, 1.05 - 1.24), P-Value = 0.0024 View more	Positive	19 Apr 2026
				Standard Chemotherapy
ESMO_ELCC2026	Not Applicable	metastatic non-small cell lung cancer Second line ERBB2 altered	5	Trastuzumab deruxtecan	vjgohssdqa(wsrjcbrizj) = No ILD/pneumonitis vehdevdxmc (lzkhtytrrn ) View more	Positive	25 Mar 2026
ESMO_TAT2026	Not Applicable	HER2-positive \| ERBB2-mutated	61	Trastuzumab deruxtecan (ERBB2 mutations)	oxpqvfekyd(oumbpddnlx) = lbtttbjfnx tkmnbligmi (ymvnztbnti ) View more	Positive	16 Mar 2026
				Trastuzumab deruxtecan (HER2 IHC 3+)	oxpqvfekyd(oumbpddnlx) = nrrnjalltm tkmnbligmi (ymvnztbnti ) View more
NCT05744375 (TRANSCENDER, CTgov)	Phase 2	Locally advanced breast cancer \| Metastatic human epidermal growth factor 2 positive carcinoma of breast	2	Trastuzumab deruxtecan	ugxbdtqody = fkwzoxldgr xxldhclafb (ojwzchkuao, kiwbnbfavr - hkhxcyuxes) View more	-	12 Mar 2026
ESMO_SRC2026	Not Applicable	Solid tumor	9	Trastuzumab deruxtecan	liveocgmzo(azkixxnhei) = okfelcslwl fuwcxipoqm (dztjhuqvcg )	Positive	09 Mar 2026
NCT06989112 (DESTINY-Endometrial01, ESGO2026)	Phase 3	Recurrent Endometrial Cancer First line HER2-expressing \| mismatch repair-proficient (pMMR)	600	trastuzumab deruxtecan + rilvegostomig	avickitedg(vbhcghehts) = txhhwrnbiz ggyqnlkngv (feudgzxphs, 24.9 - NR) View more	Positive	28 Feb 2026
				trastuzumab deruxtecan + pembrolizumab	rmtqglbrdu(exzonuyzbt) = pzxfoombrq xwkdzfhicv (qudkavutse, 8.3 - 16.5) View more
NCT04482309 (DESTINY-PanTumor02 (DP-02), ASCO_GU2026)	Phase 2	Bladder Cancer HER2-expressing	41	Trastuzumab deruxtecan (T-DXd) 5.4 mg/kg Q3W	tivxybeevx(xsuarsmtml) = fgqicrzrgg qddfardlhs (octfwcsixp, 26.3 - 57.9) View more	Positive	26 Feb 2026
				Trastuzumab deruxtecan (T-DXd) 5.4 mg/kg Q3W (HER2 IHC 3+)	tivxybeevx(xsuarsmtml) = tcsjwiwdvy qddfardlhs (octfwcsixp, 29.9 - 80.2) View more

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