Delving into the Latest Updates on Fam-trastuzumab deruxtecan-NXKI with Synapse

Overview

Basic Info

Drug Type

Antibody drug conjugate (ADC)

Synonyms

Fam-trastuzumab deruxtecan, T-DXd, Trastuzumab deruxtecan

+ [13]

Target

HER2 x Top I

Action

antagonists, inhibitors

Mechanism

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+ [6]

Active Indication

HER2 Positive Solid TumorsHR-positive/HER2-low Breast CarcinomaHormone receptor positive HER2 positive breast cancer+ [61]

Inactive Indication

Advanced Gastroesophageal Junction Adenocarcinoma

Originator Organization

Daiichi Sankyo Co., Ltd.

Active Organization

Daiichi Sankyo Co., Ltd.

Daiichi Sankyo, Inc.

AstraZeneca PLC

+ [8]

Inactive Organization

Daiichi Sankyo Taiwan Ltd.

Drug Highest PhaseApproved

First Approval Date

United States (20 Dec 2019),

HER2 Positive Breast Cancer

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

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Structure/Sequence

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Sequence Code 18481L

Source: *****

Sequence Code 44772H

Source: *****

A Phase 3, Multicenter, Randomized, Open-label Trial of Trastuzumab Deruxtecan in Combination With Pembrolizumab Versus Platinum-based Chemotherapy in Combination With Pembrolizumab, as First-line Therapy in Participants With Locally Advanced Unresectable or Metastatic HER2 Overexpressing and PD-L1 TPS <50% Non-squamous Non-small Cell Lung Cancer (DESTINY-Lung06)

This clinical trial is designed to assess the efficacy and safety of trastuzumab deruxtecan (T-DXd; Enhertu®) in combination with pembrolizumab versus platinum-based chemotherapy in combination with pembrolizumab in participants with no prior therapy for locally advanced unresectable or metastatic non-squamous NSCLC, whose tumors have HER2-overexpressing and PD-L1 TPS <50% without known AGA that have locally available therapies targeting their AGAs in first-line advanced/metastatic setting.

Start Date07 Sep 2025

Sponsor / Collaborator

Daiichi Sankyo Co., Ltd.

[+1]

NCT06486883

/ Not yet recruitingPhase 2

A Randomized Phase II Study to Evaluate the Safety and Efficacy of Trastuzumab Deruxtecan Versus CDK4/6 Inhibitor-based Endocrine Therapy as First-line Therapy of HR-positive and HER2-low/Ultralow Advanced Breast Cancer Patients Classified as Non-luminal Subtype According to Gene Expression Profiling.

This trial studies a type of advanced breast cancer defined as hormone receptor HR-positive/HER2-negative and classified as non-luminal by gene expression profiling (PAM50). Patients will be treated with trastuzumab deruxtecan (T-DXd) or with physician's choice of CDK4/6 inhibitor (CDK4/6i) plus endocrine therapy (ET). The main purpose of the study is to analyze the efficacy of T-DXd in patients who have HR-positive and HER2-low/ultralow advanced breast cancer classified as non-luminal subtype.

Start Date01 May 2025

Sponsor / Collaborator

Medica Scientia Innovation Research SL

NCT06750484

/ RecruitingPhase 2IIT

Open-label Single-arm Phase 2 Trial of Trastuzumab Deruxtecan in Previously Treated HER2-Immunohistochemistry (IHC) 0 Advanced Breast Cancer

The purpose of this study is to test the good and bad effects of a drug called trastuzumab deruxtecan (T-DXd) in adult patients with metastatic HER2-negative breast cancer and which patients might benefit the most from T-DXd.

Start Date01 May 2025

Sponsor / Collaborator

Yale University

[+2]

100 Clinical Results associated with Fam-trastuzumab deruxtecan-NXKI

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100 Translational Medicine associated with Fam-trastuzumab deruxtecan-NXKI

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

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780

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

31 Dec 2025·Human Vaccines & Immunotherapeutics

Cost-effectiveness of trastuzumab deruxtecan as a second-line treatment for HER2-mutant advanced non-small cell lung cancer

Article

Author: You, Shuhui ; Gong, Caifeng ; Cai, Qi ; Zhang, Wen ; Huang, Jinglong ; Zhou, Aiping

The study of DESTINY-Lung01 and DESTINY-Lung02 demonstrated the favorable efficacy and optimal dosage of trastuzumab deruxtecan (T-DXd) in managing the human epidermal growth factor receptor 2 (HER2)-mutant non-small cell lung cancer (NSCLC) patients who had received previous treatment. The study sought to assess the cost-effectiveness of T-DXd in both the United States (US) and Chinese healthcare systems. Markov models were developed to evaluate the overall cost, incremental cost-effectiveness ratio (ICER), quality-adjusted life years (QALYs), and life years (LYs) of treatment with T-DXd compared with docetaxel, nivolumab, and pyrotinib for patients in the US and China. The level of willingness-to-pay (WTP) in the US and China is 150,000/QALYs and 32,517/QALYs, respectively. Sensitivity analyses were carried out to ensure the precision of the model. T-DXd yielded additional QALYs of 0.63 and 0.06 with an ICER of $338997.84 and $1437258.33 per QALY, respectively, in the US compared to the docetaxel and nivolumab regimens. And T-DXd yielded additional QALYs of 0.63, 0.06, and 0.13 with an ICER of $137959.45, $623805.93, and $515447.12 per QALY, respectively, in China compared to the docetaxel, nivolumab, and pyrotinib regimens. Sensitivity analysis showed that the cost of drugs is the most influential factor. T-DXd provides substantial therapeutic benefit for NSCLC patients with HER2 mutations who have had previous treatment but is not deemed cost-effective in either the US or China when compared to docetaxel, nivolumab, and pyrotinib. Price reduction is perhaps the main way to make T-DXd cost-effective.

01 Jun 2025·American Society of Clinical Oncology educational book. American Society of Clinical Oncology. Annual Meeting

Emerging Paradigms in Genitourinary Cancers: Integrating Molecular Imaging, Hypoxia-Inducible Factor–Targeted Therapies, and Antibody-Drug Conjugates in Renal Cell and Urothelial Carcinomas

Review

Author: Hofman, Michael S. ; Wulff-Burchfield, Elizabeth M. ; Eapen, Renu ; McKay, Rana R.

Novel approaches in molecular imaging and targeted therapeutics are transforming the management of renal cell carcinoma (RCC) and urothelial carcinoma (UC). This review focuses on three key areas of innovation: molecular imaging, hypoxia-inducible factor-2α (HIF-2α) inhibition, and antibody-drug conjugates (ADCs). In molecular imaging, prostate-specific membrane antigen positron emission tomography/computed tomography has shown promise in RCC, while novel tracers targeting carbonic anhydrase IX and nectin-4 are emerging for RCC and UC, respectively. These approaches may enable better characterization of disease and treatment response monitoring. HIF-2α inhibition represents a breakthrough in targeting the fundamental pathobiology of clear cell RCC, with belzutifan demonstrating significant clinical benefit in both von Hippel-Lindau disease and sporadic RCC. Next-generation HIF-2α inhibitors, including casdatifan, show promising early clinical results with distinct pharmacologic properties. ADCs have become a cornerstone of UC treatment, with enfortumab vedotin plus pembrolizumab now approved as first-line therapy. Multiple human epidermal growth factor receptor 2 (HER2)-directed ADCs have shown efficacy in HER2-expressing UC, including trastuzumab deruxtecan, which recently received tumor-agnostic approval. While ADC development in RCC faces unique challenges, novel approaches including immunostimulatory payloads and bispecific antibodies are being explored. The integration of these advances in molecular imaging and therapeutics offers opportunities for more personalized treatment approaches in RCC and UC.

01 Jun 2025·ORAL ONCOLOGY

The impact of HER2-Low expression in salivary duct carcinoma: Clinicopathologic features, survival outcomes, and association with androgen receptor-targeted therapy

Article

Author: Hirai, Hideaki ; Takahashi, Hideaki ; Okami, Kenji ; Nagao, Toshitaka ; Hanyu, Kenji ; Iwaki, Sho ; Okada, Takuro ; Sato, Yukiko ; Kano, Satoshi ; Kawakita, Daisuke ; Fushimi, Chihiro ; Nakaguro, Masato ; Tsukahara, Kiyoaki ; Honma, Yoshitaka ; Sakai, Akihiro ; Utsumi, Yoshitaka ; Imaizumi, Sae ; Sekimizu, Mariko ; Urano, Makoto ; Yamamoto, Hidetaka ; Hanazawa, Toyoyuki ; Yamauchi, Mayu ; Saigusa, Natsuki ; Ozawa, Hiroyuki ; Saito, Yuki ; Yamamura, Koji ; Yamazaki, Keisuke ; Arai, Tomoyuki ; Matsuki, Takashi ; Ueki, Yushi ; Sato, Yuichiro ; Tada, Yuichiro ; Tanaka, Ryoko ; Imanishi, Yorihisa ; Shimizu, Akira

OBJECTIVES:

Recent advances in systemic therapy for salivary duct carcinoma (SDC) have been driven by the development of HER2- and androgen receptor (AR)-targeted therapies. Trastuzumab deruxtecan has proven effective not only in HER2-positive but also HER2-low breast and gastro-esophageal cancers. However, the significance of HER2-low expression in SDC remains unknown. This study aimed to investigate the clinicopathologic characteristics, prognostic implications, and impact on efficacy to AR-targeted therapy in HER2-low SDC.

MATERIALS AND METHODS:

This was a multi-center, observational study. HER2 status was reclassified as follows: HER2-positive (IHC3+ or 2+/ISH+ ), HER2-low (IHC1+ or 2+/ISH-), and HER2-zero (IHC0). The subjects were compared in three groups: total population, curative treatment cohort, and AR-targeted therapy cohort.

RESULTS:

The total population consisted of 526 patients, of whom, 271 (52 %), 184 (35 %), and 71 (13 %) had HER2-positive, -low, and -zero tumors, respectively. Sex, M category, histological origin, Ki67, and p53 expression differed significantly between the HER2-low and HER2-positive cases. No differences in relapse-free or overall survival were observed for HER2 status in the curative treatment cohort; however, in the AR-targeted therapy cohort, the HER2-low group had significantly better response rates (41.6 % vs. 18.9 %, Odds ratio = 0.30, P = 0.012) and longer median progression-free survival (6.9 vs. 4.2 months, Hazard ratio = 1.61, P = 0.029) than those of the HER2-positive group.

CONCLUSION:

HER2-low showed different clinicopathologic features from HER2-positive cases, with no prognostic differences observed in patients who underwent curative treatment. Still, HER2-low may be associated with the efficacy of AR-targeted therapy.

751

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

29 Apr 2025

·endpts.com

AstraZeneca posts another Truqap study fail, says China import tax could triple

AstraZeneca’s Truqap is 2-for-4 in its pivotal cancer trials. It said it was shutting down a Phase 3 Truqap study in a hard-to-treat form of prostate cancer after an interim analysis suggested its likely failure. The disclosure was made alongside AstraZeneca’s first-quarter earnings report on Tuesday, during which the UK company also made a series of updates regarding its ongoing legal issues in China. The CAPItello-280 trial was testing the AKT inhibitor on top of chemotherapy and androgen-deprivation therapy in patients with metastatic castration-resistant prostate cancer. A prespecified interim analysis determined that the Truqap approach was unlikely to meet the dual primary endpoints of radiographic progression-free survival and overall survival versus control. AstraZeneca CEO Pascal Soriot said on a media call that the company still believes Truqap’s potential sales could be in the $1 billion to $3 billion range. “We still believe Truqap has potential, but of course, having missed on this prostate study, the potential will be smaller,” he said. Hello, James Reynolds You’re an essential part of the biopharma world. Share your voice on this important question to help shape our understanding of the industry. Can you help us out? Hello, James Reynolds You’re an essential part of the biopharma world. Share your voice on this important question to help shape our understanding of the industry. Can you help us out? Soriot said the company knew that the trial in this particular setting was “more risky” than in other cancer niches. The trial was one of five in the CAPItello program, which has so far yielded two hits and two misses. The CAPItello-291 study in second-line HR+/HER2- breast cancer with certain mutations succeeded in 2022 and formed the basis for Truqap’s approval in late 2023. But a second breast cancer trial, in first-line triple negative disease, failed last summer. A further twist came last November , with a win in de novo prostate cancer. Following the shutdown of CAPItello-280, only one late-stage trial of Truqap is underway. CAPItello-292 will test the drug as first-line therapy for advanced or metastatic HR+/HER2- breast cancer, in combination with a CDK4/6 inhibitor and Faslodex. Data are due next year and will be key to the drug making good on its blockbuster promise. The company also abandoned mid-stage trials of a PAR2 antagonist called MEDI0618 in migraine and an NGFxTNF bispecific, MEDI7352, in osteoarthritis pain and diabetic neuropathy. Pain indications are notoriously difficult to treat. So is Alzheimer’s disease, and AstraZeneca also stopped work on a Phase 1-stage amyloid beta mAb dubbed MEDI1814. Elsewhere, AstraZeneca said the unpaid tax bill it is facing in China would be larger than it had previously thought — meaning the fine authorities can impose could be bigger still. In February, AstraZeneca said the alleged unpaid taxes, which are probably tied to imports of Imfinzi and Imjudo, amounted to around $900,000. It now says that according to the Shenzhen City Customs Office, there are further suspected unpaid import taxes of $1.6 million, which AstraZeneca believes is related to sales of Enhertu. Since a punitive fine of up to five times the unpaid taxes can be imposed if AstraZeneca is found liable, the pharma could be facing a total bill of up to $15 million. There was better news on the other investigation AstraZeneca is subject to in China, which concerns the suspected unlawful collection of personal data . The company said the Shenzhen Bao’an District Public Security Bureau had determined that there was no illegal gain to the company resulting from personal information infringement. And Soriot said there were no concerns so far that cuts to the US regulator would affect the approval timelines of AstraZeneca’s products, as has happened to Stealth BioTherapeutics’ rare disease drug. “So far, we haven’t seen any delay in the processing of our applications. We haven’t seen delays in the meetings we regularly would have with FDA staff to discuss our submissions,” he said on the call.

Phase 3

29 Apr 2025

·www.astrazeneca.com

Q1 2025 results

Pascal Soriot, Chief Executive Officer, AstraZeneca, commenting on the results said: “Our strong growth momentum has continued into 2025 and we have now entered an unprecedented catalyst-rich period for our company. Already this year we have announced five positive Phase III study readouts, including most recently the highly anticipated DESTINYBreast09 for Enhertu, as well as SERENA-6 for camizestrant and MATTERHORN for Imfinzi; the latter two of these will feature in the ASCO 2025 plenary sessions, reflecting the significance of these data to the oncology community. Our company is firmly committed to investing and growing in the US and we continue to benefit from our broad-based source of revenue and global manufacturing footprint, including eleven production sites in the US covering small molecules, biologics as well as cell therapy. Additionally, we have even greater US investment in manufacturing and R&D planned, leveraging our two large R&D sites in Gaithersburg MD and Cambridge MA. Overall, we are making excellent progress toward our ambition of eighty billion dollars in Total Revenue by 2030.” Q1 2025 results announcement PDF 965KB Q1 2025 results presentation PDF 3,268KB Q1 2025 results clinical trials appendix PDF 3,212KB Adrian Kemp Company Secretary AstraZeneca PLC Corporate and financial

Phase 3Cell TherapyClinical ResultFinancial Statement

28 Apr 2025

·www.fiercepharma.com

Daiichi Sankyo, AstraZeneca's highly touted ADC Datroway off to 'smooth market launch'

Daiichi Sankyo reported sales of 1.4 billion Japanese yen ($10 million) for promising antibody-drug conjugate Datroway, which was approved in Japan in December and in the U.S. in January. As the second antibody-drug conjugate launched by Daiichi Sankyo and AstraZeneca, Datroway has a tough act to follow, coming on the heels of the companies’ emerging ADC cancer powerhouse Enhertu. But so far, so good for the TROP2-directed treatment, which was endorsed in Japan in December and in the U.S. in January. Through the end of March—which concluded Daiichi’s fiscal year—Datroway generated (PDF) sales of 1.4 billion Japanese yen ($10 million).It was an indication of a “smooth market launch,” Daiichi CEO Hiroyuki Okuzawa said on a conference call late last week.Datroway has been approved for unresectable or metastatic, hormone receptor positive, HER2-negative breast cancer in patients who have tried prior endocrine-based therapy and chemotherapy.A much larger market opportunity awaits for Datroway, however, as a potential treatment for non-small cell lung cancer (NSCLC). Its entrance into the indication could come in the second half of this year as the companies are awaiting a July 12 FDA decision date for Datroway to treat patients with EGFR-mutated NSCLC who have received prior systemic therapies.The submission came after the companies pulled their original FDA filing for Datroway in second-line nonsquamous NSCLC after the phase 3 Tropion-Lung01 study showed mixed results. The pair has refiled in pretreated EGFR-mutated NSCLC using a pooled subgroup analysis from Tropion-Lung01 and the phase 2 Tropion-Lung05 trial. For now, Daiichi is projecting sales of Datroway in the new fiscal year to reach 4.7 billion Japanese yen ($33 million). As the company works to hit that goal, a recent approval in Europe should help.In 2020, AZ made a big bet on Datroway, paying Daiichi $1 billion upfront and committing up to $5 billion tied to potential regulatory and sales milestones. AZ has projected peak sales of Datroway at $5 billion.Datroway is competing with Gilead Sciences' TROP2-targeted ADC Trodelvy, which has been on the market since 2020, has been approved in three indications and generated sales of $1.3 billion last year. Earlier this month, Gilead reported a key trial win as a combination of Trodelvy and Merck’s Keytruda bested Keytruda alone in patients with previously untreated metastatic triple-negative breast cancer. The bright expectations for Datroway have come following the success of Enhertu, which logged sales of $3.7 billion in Daiichi's 2024 fiscal year. The company is projecting sales of the treatment to reach 662 billion Japanese yen in this fiscal year ($4.6 billion).As for the company overall, Daiichi’s revenue came in at 1.886 trillion Japanese yen ($13.2 billion) for the year, which was an 18% increase from FY 2023.The Tokyo-based company expects to see a slowdown in growth in this fiscal year, estimating its sales will reach 2 trillion Japanese yen ($14 billion), or roughly a 6% increase. The projection does not include any potential tariff implications, Daiichi said.

Clinical ResultDrug ApprovalPhase 3ADC

100 Deals associated with Fam-trastuzumab deruxtecan-NXKI

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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
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
Non-squamous non-small cell lung cancer	Phase 3	-	Daiichi Sankyo Co., Ltd.	07 Sep 2025
HER2 positive Gastrooesophageal junction cancer	Phase 3	United States	Daiichi Sankyo, Inc.	21 Mar 2025
HER2 positive Gastrooesophageal junction cancer	Phase 3	China	Daiichi Sankyo, Inc.	21 Mar 2025
HER2 positive Gastrooesophageal junction cancer	Phase 3	Japan	Daiichi Sankyo, Inc.	21 Mar 2025
HER2 positive Gastrooesophageal junction cancer	Phase 3	Argentina	Daiichi Sankyo, Inc.	21 Mar 2025
HER2 positive Gastrooesophageal junction cancer	Phase 3	Australia	Daiichi Sankyo, Inc.	21 Mar 2025
HER2 positive Gastrooesophageal junction cancer	Phase 3	Austria	Daiichi Sankyo, Inc.	21 Mar 2025
HER2 positive Gastrooesophageal junction cancer	Phase 3	Belgium	Daiichi Sankyo, Inc.	21 Mar 2025
HER2 positive Gastrooesophageal junction cancer	Phase 3	Brazil	Daiichi Sankyo, Inc.	21 Mar 2025
HER2 positive Gastrooesophageal junction cancer	Phase 3	Canada	Daiichi Sankyo, Inc.	21 Mar 2025

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


AACR2025	Not Applicable	Breast Cancer HER2 expression	375	Trastuzumab deruxtecan (T-DXd)	yjazlsguxx(spzmeqnjdx) = one patient with a somatic ERBB2 mutation (V597M) in the trastuzumab binding region who showed no response to T-DXd despite being HER2 IHC 2+ gnzljzrnzo (cdmxpvhref ) View more	Positive	29 Apr 2025
NCT04784715 (DESTINY-Breast09, PipelineReview) Manual	Phase 3	Metastatic human epidermal growth factor 2 positive carcinoma of breast First line HER2 Positive	-	ENHERTU + pertuzumab	ybevnaknzk(fjzqlybrtv) = highly statistically significant and clinically meaningful improvement. fzrjgwlcpf (vhetcetbbt ) View more	Positive	21 Apr 2025
				THP
NCT04494425 (DB-06 \| DESTINY-Breast06, CTgov)	Phase 3	Metastatic human epidermal growth factor 2 positive carcinoma of breast \| Hormone receptor positive HER2 positive breast cancer \| Advanced breast cancer	866	T-DXd (T-DXd)	ltwpzygyyo(muoevbnofo) = hbmjyyonzn gciianwkcp (wbjfhgfjpb, xdvgiumbzj - kwstrtteqo) View more	-	02 Apr 2025
				nab-paclitaxel+paclitaxel+capecitabine (Chemotherapy)	ltwpzygyyo(muoevbnofo) = jgxtczfhfr gciianwkcp (wbjfhgfjpb, nflogggudn - wugtbkzmln) View more
NCT04686305 (DL-03, ESMO_ELCC2025)	Phase 1	metastatic non-small cell lung cancer \| Metastatic Non-Squamous Non-Small Cell Lung Carcinoma \| Locally Advanced Lung Non-Small Cell Carcinoma First line HER2 overexpression	34	Trastuzumab deruxtecan (T-DXd)	qbtonlemuq(xnssrbixpd) = ijkcwmvzbj ggthmpqliv (zqsfydiiid ) View more	Positive	26 Mar 2025
DESTINY-Gastric04 (NEWS) Manual	Phase 3	HER2-positive gastric cancer Second line HER2 Positive	-	ENHERTU	arjuxrbgdz(mcoygxlxba) = yzgbzfcylf drbbzoyrcu (ybwzffvwwb, 9.6 - 14.3) View more	Positive	03 Mar 2025
				irinotecan or paclitaxel	arjuxrbgdz(mcoygxlxba) = hvdceicevc drbbzoyrcu (ybwzffvwwb, 6.9 - 10.7) View more
ESMO_TAT2025	Not Applicable	-	48	trastuzumab deruxtecan (High SAT density (HU))	hobjufsnne(fwjvljxskw) = tkbfflfyfb bnthhqdwbq (aoffyguwri )	Positive	03 Mar 2025
				trastuzumab deruxtecan (High VAT density (HU))	pyxxrbpkas(ilmksjxmbo) = irerzrxfnh ycsgltwxbm (lsdyxuutyy )
NCT04379596 (DESTINY-Gastric03, ASCO_GI2025) Manual	Phase 1/2	HER2-positive gastric cancer \| HER2 positive Esophageal Carcinoma \| HER2 positive Gastroesophageal Junction Adenocarcinoma First line HER2 Positive	75	T-DXd 6.4 mg/kg + FP + Pembrolizumab	ghuvqnhvck(mprsdoiwqn) = zyteculsga hnlwmnxzgq (bnisnmxnxb ) View more	Positive	23 Jan 2025
				T-DXd 5.4 mg/kg + FP + Pembrolizumab	ghuvqnhvck(mprsdoiwqn) = ibzitutzti hnlwmnxzgq (bnisnmxnxb ) View more
NCT04042701 (DS8201-A-U106, ESMO_IO2024) Manual	Phase 1	Non-Small Cell Lung Cancer HER2 Expression \| ERBB2 Mutation (Activating)	55	Trastuzumab deruxtecan (T-DXd) + Pembrolizumab (cohort 3 (HER2E; immunohistochemistry 1+, 2+, or 3+))	sjolvweapo(ttdmwsqahg) = rtggxuhdik xikruznryn (hecvzzvtxm, 32.2 - 75.6) View more	Positive	12 Dec 2024
				Trastuzumab deruxtecan (T-DXd) + Pembrolizumab (cohort 4 (HER2m))	sjolvweapo(ttdmwsqahg) = pivfzduleh xikruznryn (hecvzzvtxm, 48.2 - 82.0) View more
NCT04989816 (DESTINY-Gastric06, ESMO_ASIA2024) Manual	Phase 2	HER2-positive gastric cancer \| HER2 positive Gastroesophageal Junction Adenocarcinoma HER2 Positive	95	Trastuzumab deruxtecan 6.4 mg/kg	fcuqwelrhz(pntberemcw) = lkpoftduib ndoxbwwqpo (bdqlgrbetl ) View more	Positive	07 Dec 2024
NCT04482309 (DP-02, ESMO_ASIA2024)	Phase 2	HER2 Positive Cancer HER2 IHC 3+ \| HER2 IHC 2+ \| in situ hybridization-positive ... View more	-	Trastuzumab deruxtecan (T-DXd) 5.4 mg/kg	ekrdlpxcnq(pnngkjazkd) = mcxvytbtkr ilypzixuvn (cybycvkyuz, 5.6 - 8.0) View more	Positive	07 Dec 2024

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Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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Fam-trastuzumab deruxtecan-NXKI

Overview

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Approval

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