This is a Phase II, interventional, prospective, single-arm, multi-center study that will enroll patients with stage II/III triple negative breast cancer (TNBC) who have residual cancer burden (RCB) II/III after conventional neoadjuvant chemo-immunotherapy followed by surgery. Technological advances in ctDNA assays have improved both the sensitivity and reliability of molecular residual disease (MRD) detection to enable real-time measurement with clinical-grade assays.
The primary objective of this study will be to evaluate ctDNA-based MRD status in high-risk, early-stage TNBC patients by defining the proportion of TNBC patients with MRD-only recurrence (ctDNA positive without radiographically measurable recurrence) during post-surgery surveillance. The secondary objectives will evaluate the safety, preliminary efficacy, and survival outcomes of using Dato-DXd in participants with MRD-only TNBC.
Dato-DXd is an investigational antibody-drug conjugate (monoclonal antibody specific for TROP2 and a topoisomerase I (Topo-1) inhibitor) that has demonstrated promising efficacy in TNBC patients with a manageable safety profile.

Start Date01 Nov 2025

Sponsor / Collaborator

Lineberger Comprehensive Cancer Center

[+1]

NCT06954480

/ RecruitingPhase 2

An Open-label Randomised, Phase II Trial of Datopotamab Deruxtecan Plus Durvalumab Versus Datopotamab Deruxtecan in Patients With PDL1-negative Metastatic Triple-negative Breast Cancer

The DIAMOND study is being carried out to evaluate if Datopotamab deruxtecan (Dato-DX) in combination with Durvalumab is more effective than Dato-DXd alone in treating PDL1-negative advanced or metastatic triple negative breast cancer (TNBC). Globally, breast cancer is the most common malignancy in women and the second most common cancer overall. The term TNBC is used to define tumours that do not express oestrogen receptors, progesterone receptors and HER2 receptors. TNBC comprises 10 -15% of all breast cancers. It remains the subtype with poorest outcome and there is a significant need to develop new therapies for this group of patients especially. Moreover, the PDL1-negative tumour has demonstrated no benefit from standard 1st line treatment of chemotherapy plus immune checkpoint inhibitors.

Start Date27 Oct 2025

Sponsor / Collaborator

Queen Mary University of London

[+1]

NCT06822543

/ RecruitingPhase 2IIT

A Single Arm, Phase 2 Study of Datopotamab Deruxtecan, Carboplatin, and Pembrolizumab for Treatment-naive Brain Metastases From NSCLC (Non-small Cell Lung Cancer)

This is a Phase II, single-arm, multicenter trial for patients with metastatic non-small cell lung cancer who have brain metastases and no known actionable mutations. Eligible patients will receive a combination of Datopotamab-deruxtecan, Carboplatin, and Pembrolizumab every three weeks for four cycles, followed by maintenance therapy with Datopotamab-deruxtecan and Pembrolizumab until disease progression or intolerable toxicity. Patients with intracranial progression but no systemic progression may receive stereotactic radiosurgery and continue treatment based on the investigator's decision.

Start Date30 Sep 2025

Sponsor / Collaborator

Merck Sharp & Dohme LLC

[+1]

100 Clinical Results associated with Datopotamab Deruxtecan

100 Translational Medicine associated with Datopotamab Deruxtecan

100 Patents (Medical) associated with Datopotamab Deruxtecan

Literatures (Medical) associated with Datopotamab Deruxtecan

31 Dec 2025·mAbs

Antibodies to watch in 2025

Review

Author: Kapoor, Vaishali ; Kaplon, Hélène ; Crescioli, Silvia ; Reichert, Janice M. ; Visweswaraiah, Jyothsna ; Wang, Lin

The commercial development of antibody therapeutics is a global enterprise involving thousands of biopharmaceutical firms and supporting service organizations. To date, their combined efforts have resulted in over 200 marketed antibody therapeutics and a pipeline of nearly 1,400 investigational product candidates that are undergoing evaluation in clinical studies as treatments for a wide variety of diseases. Here, we discuss key events in antibody therapeutics development that occurred during 2024 and forecast key events related to the late-stage clinical pipeline that may occur in 2025. In particular, we report on 21 antibody therapeutics granted a first approval in at least one country or region during 2024, including bispecific antibodies tarlatamab (IMDELLTRA®), zanidatamab (Ziihera®), zenocutuzumab (BIZENGRI®), odronextamab (Ordspono®), ivonescimab (®), and antibody-drug conjugate (ADC) sacituzumab tirumotecan (®). We also discuss 30 investigational antibody therapeutics for which marketing applications were undergoing review by at least one regulatory agency, as of our last update on December 9, 2024, including ADCs datopotamab deruxtecan, telisotuzumab vedotin, patritumab deruxtecan, trastuzumab botidotin, becotatug vedotin, and trastuzumab rezetecan. Of 178 antibody therapeutics we include in the late-stage pipeline, we summarize key data for 18 for which marketing applications may be submitted by the end of 2025, such as bi- or multispecific antibodies denecimig, sonelokimab, erfonrilimab, and anbenitamab. Key trends in the development and approval of antibody formats such as bispecifics and ADCs, as well as clinical-phase transition and global approval success rates for these antibody formats, are reported.

01 Dec 2025·Current Neurology and Neuroscience Reports

Emerging Therapies for Brain Metastases in NSCLC, Breast Cancer, and Melanoma: A Critical Review

Review

Author: Gowda, Maya ; Camacho, Alejandra M ; Ranjan, Tulika ; Ahluwalia, Manmeet S ; Podder, Vivek

PURPOSE OF REVIEW:

Advancements in precision medicine have shifted the treatment paradigm of brain metastases (BM) from non-small cell lung cancer (NSCLC), breast cancer, and melanoma, especially through targeted therapies focused on specific molecular drivers. These novel agents have improved outcomes by overcoming challenges posed by the blood-brain barrier (BBB) and resistance mechanisms, enabling more effective treatment of BM.

RECENT FINDINGS:

In NSCLC, therapies such as osimertinib have improved efficacy in treating EGFR-mutant BM, with emerging combinations such as amivantamab and lazertinib offering promising alternatives for patients resistant to frontline therapies. In HER2-positive breast cancer, significant advancements with tucatinib and trastuzumab deruxtecan (T-DXd) have transformed the treatment landscape, achieving improved survival and intracranial control in patients with BM. Similarly, in triple-negative breast cancer (TNBC), novel therapies such as sacituzumab govitecan (SG) and datopotamab deruxtecan (Dato-DXd) offer new hope for managing BM. For melanoma, the combination of immune checkpoint inhibitors such as nivolumab and ipilimumab has proven effective in enhancing survival for patients with BM, both in BRAF-mutant and wild-type cases. Developing targeted therapies penetrating the BBB has revolutionized BM treatment by targeting key drivers like EGFR, ALK, HER2, and BRAF. Despite improved survival, challenges persist, particularly for patients with resistant genetic alterations. Future research should optimise combination therapies, overcome resistance, and refine treatment sequencing. Continued emphasis on personalized, biomarker-driven approaches offers the potential to further improve outcomes, even for complex cases.

01 Dec 2025·BREAST

FDA and EMA approval of datopotamab-deruxtecan: A paradigm shift in breast cancer drug evaluation?

Article

Author: Orlandi, Armando

The January 2025 FDA and EMA approvals of datopotamab-deruxtecan for metastatic HR-positive, HER2-negative breast cancer represents an unprecedented regulatory decision. The TROPION-Breast01 trial demonstrated significant progression-free survival improvement (6.9 vs 4.9 months; HR 0.63) but failed to show overall survival benefit (18.6 vs 18.3 months; HR 1.01)[1,2]. This marks the first full approval of a breast cancer therapeutic that failed a co-primary overall survival endpoint. Subsequently, the European Medicines Agency also granted marketing authorization in January 2025, creating a concerning precedent across both major regulatory agencies. With both major regulatory agencies now having approved this agent, breast cancer specialists must grapple with fundamental questions: What constitutes meaningful clinical benefit in heavily pretreated patients? How should we interpret trials with divergent endpoint results? This commentary examines the implications for breast cancer practice and argues for urgent reassessment of evidence standards as the therapeutic landscape evolves.

499

News (Medical) associated with Datopotamab Deruxtecan

10 Nov 2025

·www.prnewswire.com

Compugen Reports Third Quarter 2025 Results

COM701 Phase 1 data presented at ESMO 2025 characterized patients who derived clinical benefit and informed the design of the ongoing MAIA-ovarian platform trial Enrolling patients in the U.S., Israel and France in the MAIA-ovarian platform trial evaluating COM701 maintenance therapy in patients with platinum sensitive ovarian cancer with interim analysis now estimated in Q1 2027 SITC 2025 – Compugen presented Phase 1 trial design for GS-0321 (COM503), licensed to Gilead Partner AstraZeneca shared promising rilvegostomig results from two Phase 2 trials, one in NSCLC and one in bladder cancer at ESMO 2025 Solid financial position with refined cash runway expected to fund operations into Q3 2027 HOLON, Israel, Nov. 10, 2025 /PRNewswire/ -- Compugen Ltd. (NASDAQ: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in predictive computational target discovery powered by AI/ML, today reported financial results for the third quarter of 2025 and provided a corporate update. "I am thrilled to lead Compugen as our strong fundamentals and differentiated science gain clinical momentum," said Eran Ophir, Ph.D., President and CEO of Compugen. "Recent data at ESMO from our partner AstraZeneca and others reinforce our long-held view that not all anti-TIGIT antibodies are the same, and that the antibody-Fc format matters. This is because Fc reduced anti-TIGIT programs, like our fully owned anti-TIGIT, COM902, and AstraZeneca's anti-PD-1/TIGIT bispecific rilvegostomig, preserve beneficial T cells and avoid depletion of peripheral T-regs in contrast to Fc-active anti-TIGITs and therefore have the potential for improved efficacy and safety profile. At ESMO, AstraZeneca presented data from ARTEMIDE-01 showing rilvegostomig was well tolerated with promising efficacy confirming its potential in checkpoint naïve NSCLC with notable low rate of treatment related discontinuation supporting differentiation of the Fc-reduced format. AstraZeneca also presented data from TROPION-PanTumor03, evaluating the combination of rilvegostomig and Datroway, which showed promising efficacy and manageable safety underscoring the potential of next-generation IO bispecific plus ADCs. In addition, AstraZeneca announced it expects to launch its eleventh Phase 3 trial for rilvegostomig." Dr. Ophir continued, "We presented pooled Phase 1 data at ESMO 2025 showing that COM701, our Fc-reduced anti-PVRIG antibody, is well tolerated as monotherapy and in combination and delivers durable responses in heavily pretreated platinum resistant ovarian cancer patients, with a median progression-free survival of 10.5 months in patients who derived clinical benefit. The data also showed that COM701 biology is differentiated, reflected in responses seen across PD-L1 expression levels. This data is important as it characterized responding patients, guiding the design of our ongoing blinded and randomized MAIA-ovarian platform trial evaluating single agent COM701 maintenance therapy in platinum sensitive ovarian cancer. Sites have been activated in the U.S., Israel and France, and we now estimate interim analysis in Q1 2027. We are also advancing GS-0321, a potential first-in-class anti-IL18BP antibody licensed to Gilead and presented the trial design at SITC last week." Dr. Ophir concluded, "Our solid financial position with cash runway expected into the third quarter of 2027 enables us to advance our differentiated IO pipeline and leverage our AI/ML powered computational discovery platform Unigen™ to discover novel ways to activate the immune system against cancer. I am confident in our fully owned programs, strengthened by validating partnerships with AstraZeneca and Gilead, which together offer over $1 billion in potential milestones and royalties." Third Quarter 2025 Financial Highlights Cash: As of September 30, 2025, Compugen had approximately $86.1 million in cash, cash equivalents, short-term bank deposits, and investment in marketable securities. Compugen expects that its cash and cash-related balances will be sufficient to fund its operating plans into the third quarter of 2027. This does not include any cash inflows. The Company has no debt. During October 2025, subsequent to the financial results for the quarter ended September 30, 2025, a total of approximately 0.8 million shares were sold through the Company's ATM facility contributing net proceeds of approximately $1.6 million. Revenue: Compugen reported approximately $1.9 million in revenues for the third quarter ended September 30, 2025, compared to approximately $17.1 million in revenues for the comparable period in 2024. The revenues reported in the third quarters of 2025 and 2024 reflect recognition of portions of both the upfront payment and the IND milestone payment from the license agreement with Gilead. R&D expenses for the third quarter of 2025 were approximately $5.8 million compared to approximately $6.3 million for the comparable period in 2024. G&A expenses were approximately $2.2 million for the third quarter of 2025 and $2.6 million for the comparable period in 2024. Net loss for the third quarter of 2025 was approximately $6.98 million, or $0.07 per basic and diluted share, compared with a net profit of approximately $1.28 million, or $0.01 per basic and diluted share, in the third quarter of 2024. Full financial tables are included below Conference Call and Webcast Information The Company will hold a conference call today, November 10, 2025, at 8:30 AM ET to review its third quarter 2025 results. To access the conference call by telephone, please dial 1-866-744-5399 from the United States, or +972-3-918-0644 internationally. The call will also be available via live webcast through Compugen's website, located at the following link. Following the live audio webcast, a replay will be available on the Company's website. About Compugen Compugen is a clinical-stage therapeutic discovery and development company utilizing its broadly applicable predictive AI/ML powered computational discovery platform (Unigen™) to identify novel drug targets and biological pathways for developing cancer immunotherapies. Compugen has two differentiated Fc-reduced programs targeting TIGIT: COM902, a fully owned potential best-in-class Fc-reduced high affinity anti-TIGIT antibody in Phase 1 development and rilvegostomig, an Fc-reduced PD-1/TIGIT bispecific antibody in Phase 3 development by AstraZeneca through a license agreement for the development of bispecific and multispecific antibodies. The TIGIT component of rilvegostomig is derived from COM902. In Phase 1 development Compugen has COM701, a potential first-in-class anti-PVRIG Fc-reduced antibody and GS-0321 (previously COM503), a potential first-in-class, high affinity anti-IL-18 binding protein antibody, licensed to Gilead. In addition, the Company's therapeutic pipeline of early-stage immuno-oncology programs consists of research programs aiming to address new mechanisms to activate the immune system against cancer. Compugen is headquartered in Israel, with offices in San Francisco, CA. Compugen's shares are listed on Nasdaq and the Tel Aviv Stock Exchange under the ticker symbol CGEN. Forward-Looking Statement This press release contains "forward-looking statements" within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended, and the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are based on the current beliefs, expectations, and assumptions of Compugen. Forward-looking statements can be identified using terminology such as "will," "may," "expects," "anticipates," "believes," "potential," "plan," "goal," "estimate," "likely," "should," "confident," and "intends," and similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements include, but are not limited to, statements regarding the progress and promising results of AstraZeneca's rilvegostomig program; statements regarding our COM701 Phase 1 data presented at ESMO and conclusions derived therefrom; statements regarding the timing of interim analysis results; statements regarding the improved efficacy and safety profile of Fc reduced anti-TIGITs; statements to the effect that our cash and cash-related balances will be sufficient to fund our operating plans into the third quarter of 2027; statements that our cash position will enable us to advance our differentiated IO pipeline and leverage our AI/ML powered computational discovery platform Unigen™ to discover novel ways to activate the immune system against cancer; and statements regarding potential milestones and royalties These forward-looking statements involve known and unknown risks and uncertainties that may cause the actual results, performance, or achievements of Compugen to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Among these risks: clinical development involves a lengthy and expensive process, with an uncertain outcome and we may encounter substantial delays or even an inability to begin clinical trials for any specific product or may not be able to conduct or complete our trials on the timelines we expect; the clinical trials of any product candidates that Compugen, or any current or future collaborators, may develop may fail to satisfactorily demonstrate safety and efficacy to the FDA, and Compugen, or any collaborators, may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of these product candidates; Compugen's business model is substantially dependent on entering into collaboration agreements with third parties and Compugen may not be successful in generating adequate revenues or commercializing aspects of its business model; Compugen's approach to the discovery of therapeutic products is based on its proprietary computational target discovery infrastructure, which is unproven clinically; general market, political and economic conditions in the countries in which Compugen operates, including Israel; the effect of the evolving nature of the recent war in Israel; and Compugen does not know whether it will be able to discover and develop additional potential product candidates or products of commercial value. These risks and other risks are more fully discussed in the "Risk Factors" section of Compugen's most recent Annual Report on Form 20-F as filed with the Securities and Exchange Commission (SEC) as well as other documents that may be subsequently filed by Compugen from time to time with the SEC. In addition, any forward-looking statements represent Compugen's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. Compugen does not assume any obligation to update any forward-looking statements unless required by law. Company Contact: Yvonne Naughton, Ph.D. Vice President, Head of Investor Relations and Corporate Communications Email: [email protected] Tel: +1 (628) 241-0071 SOURCE Compugen Ltd. 21% more press release views with Request a Demo

Phase 1Clinical ResultFinancial StatementLicense out/inImmunotherapy

10 Nov 2025

·www.businesswire.com

DS3610 Enters Clinical Development in Patients with Advanced Solid Tumors as First STING Agonist ADC in Industry-Leading ADC Portfolio of Daiichi Sankyo

TOKYO & BASKING RIDGE, N.J.--(BUSINESS WIRE)--The first patient has been dosed in a first-in-human phase 1 trial evaluating DS3610 in patients with advanced, metastatic or unresectable solid tumors. DS3610 is an investigational STING agonist antibody drug conjugate (ADC) containing an immunomodulatory payload discovered by Daiichi Sankyo (TSE:4568). Despite the availability of various cancer immunotherapies, there remains an unmet need for novel treatment options with distinct mechanisms of action that may overcome resistance to current immunotherapy, enhance tumor responses and delay disease progression in solid tumors. “By combining precise tumor targeting with an immunotherapy payload, Daiichi Sankyo is exploring a new way to harness the body’s own defenses to attack cancer,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “The initiation of this first-in-human trial of DS3610 represents an important step forward in advancing the next wave of our antibody drug conjugate portfolio and reaffirms our commitment to creating transformative medicines for patients with cancer.” About the Phase 1 Trial The multicenter, open-label, first-in-human phase 1 trial will assess the safety, tolerability, preliminary efficacy and pharmacokinetics of DS3610 in patients with advanced, metastatic or unresectable solid tumors for which no additional standard therapy is available. The dose escalation trial will assess the safety and tolerability of increasing doses of DS3610 to determine the recommended doses for expansion in patients with advanced, metastatic or unresectable solid tumors. The trial will evaluate safety endpoints including dose-limiting toxicities and adverse events. Pharmacokinetic and immunogenicity endpoints will also be assessed, as well as exploratory efficacy endpoints including objective response rate, disease control rate, duration of response, time to response, progression-free survival and overall survival. The trial is expected to enroll patients across multiple sites globally, including Asia, Europe and North America. For more information, please visit ClinicalTrials.gov. About DS3610 DS3610 is an investigational STING agonist ADC consisting of a monoclonal antibody with novel Fc modifications attached to an immunomodulatory payload that acts as an agonist of a stimulator of interferon genes (STING). DS3610 delivers a STING agonist payload directly to tumor environments and induces the immune system in the body to target cancer cells. About the ADC Portfolio of Daiichi Sankyo The Daiichi Sankyo ADC portfolio consists of eight ADCs in clinical development crafted from ADC technology discovered in-house by Daiichi Sankyo. The DXd ADC Technology platform of Daiichi Sankyo consists of six ADCs in clinical development where each ADC is comprised of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADCs include ENHERTU® and DATROWAY®, which are being jointly developed and commercialized globally with AstraZeneca, and ifinatamab deruxtecan (I-DXd), raludotatug deruxtecan (R-DXd) and patritumab deruxtecan (HER3-DXd), which are being jointly developed and commercialized globally with Merck & Co., Inc, Rahway, NJ, USA. DS-3939 is being developed by Daiichi Sankyo. Additional ADCs being developed by Daiichi Sankyo include DS-9606, which consists of a monoclonal antibody attached to a modified pyrrolobenzodiazepine (PBD) payload and DS3610, which consists of an antibody attached to a novel immunomodulatory payload that acts as an agonist of STING. Ifinatamab deruxtecan, patritumab deruxtecan, raludotatug deruxtecan, DS-3939, DS-9606 and DS3610 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established. About Daiichi Sankyo Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical need. For more information, please visit www.daiichisankyo.com.

ADCImmunotherapyPhase 1

07 Nov 2025

·firstwordpharma.com

Trodelvy falls short in breast cancer study, but hints of longer OS keep hopes alive

Gilead Sciences' effort to push its cancer drug Trodelvy (sacituzumab govitecan-hziy) into earlier use hit a setback after the Trop-2-directed antibody-drug conjugate (ADC) failed to meet its main goal in a Phase III breast cancer trial. Company shares were down close to 4% on Friday.The ASCENT-07 study tested Trodelvy as a first-line treatment post-endocrine therapy in patients who are candidates for cytotoxic chemotherapy. The ADC was pitted against physician's choice chemotherapy across 654 patients with locally advanced, inoperable, or HR-positive/HER2-negative metastatic disease.Trodelvy did not significantly delay progression, missing the primary endpoint, but Gilead said early signs pointed toward a potential overall survival (OS) benefit — an "early trend" in favour of the ADC that the company will continue to follow as more data mature. The drug's safety profile remained consistent with earlier studies, with no new safety signals observed."Trodelvy remains a standard of care for pre-treated HR-positive/HER2-negative metastatic breast cancer based on the demonstrated overall survival results seen in the TROPiCS-02 study," said Dietmar Berger, Gilead’s chief medical officer. Currently, it is approved for second-line or later metastatic triple-negative breast cancer (TNBC) and for certain patients with pre-treated HR-positive/HER2-negative metastatic breast cancer.At the European Society for Medical Oncology (ESMO) meeting last month, Gilead reported stronger news from its other front-line Trodelvy programmes. In the ASCENT-03 and ASCENT-04 trials, Trodelvy outperformed chemotherapy in metastatic TNBC, either alone or in combination with Merck & Co.'s Keytruda (pembrolizumab). Those results landed in the same spotlight as AstraZeneca and Daiichi Sankyo's Datroway (datopotamab deruxtecan), which produced a five-month survival gain in the TROPION-Breast02 study.While Datroway's OS advantage captured attention, Dana-Farber oncologist Ana Garrido-Castro suggested TROPION-Breast02 and ASCENT-03 can be considered practice-changing abstracts. For more, see – ESMO Spotlight: Patient breakthrough trumps Datroway vs. Trodelvy showdown in TNBC.

Phase 3Clinical ResultADCDrug Approval

100 Deals associated with Datopotamab Deruxtecan

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16410

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
EGFR positive non-small cell lung cancer	United States	Daiichi Sankyo, Inc.	23 Jun 2025
ER-positive/HER2-negative Breast Cancer	Australia	AstraZeneca Pty Ltd.	20 May 2025
Advanced Lung Non-Small Cell Carcinoma	Canada	AstraZeneca Canada, Inc.	01 Mar 2025
Hormone receptor positive HER2 negative breast cancer	Japan	Daiichi Sankyo Co., Ltd.	27 Dec 2024

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
EGFR-mutated non-small Cell Lung Cancer	NDA/BLA	United States	AstraZeneca PLC	12 Nov 2024
EGFR-mutated non-small Cell Lung Cancer	NDA/BLA	United States	Daiichi Sankyo Co., Ltd.	12 Nov 2024
Locally Advanced Lung Non-Squamous Non-Small Cell Carcinoma	NDA/BLA	United States	Daiichi Sankyo, Inc.	19 Feb 2024
Locally Advanced Lung Non-Squamous Non-Small Cell Carcinoma	NDA/BLA	United States	AstraZeneca PLC	19 Feb 2024
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	NDA/BLA	United States	AstraZeneca PLC	19 Feb 2024
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	NDA/BLA	United States	Daiichi Sankyo, Inc.	19 Feb 2024
Bladder Cancer	Phase 3	United States	Daiichi Sankyo Co., Ltd.	26 Sep 2025
Bladder Cancer	Phase 3	Japan	Daiichi Sankyo Co., Ltd.	26 Sep 2025
Metastatic urothelial carcinoma	Phase 3	United States	Daiichi Sankyo Co., Ltd.	26 Sep 2025
Metastatic urothelial carcinoma	Phase 3	Japan	Daiichi Sankyo Co., Ltd.	26 Sep 2025

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03742102 (BEGONIA, ESMO2025) Manual	Phase 1/2	Triple Negative Breast Cancer First line HER2 Negative \| HR Negative	95	Dato-DXd + durvalumab	kxueswhzmv \| ulkeykjzoc(dfiloivlds) = nvwrucnthc ploihthjjo (kitcdbixei, 10.5 - 27.3) View more	Positive	17 Oct 2025
				Dato-DXd + durvalumabDurvalumab (PD-L1-high)	ulkeykjzoc \| kafunsyojg(kmiwyxqbep) = dmjkxbvokm fzyijvxqoy (ofmlbofocy, 64.5 - 93.0) View more
NCT05374512 (TROPION-Breast02, ESMO2025)	Phase 3	Triple Negative Breast Cancer First line HR Negative \| HER2 Negative	644	Dato-DXd (6 mg/kg IV Q3W)	ikejthbrki(iedajhttcz) = iuesrpcwya aqrxkcdzxi (dvzxcnipxa, 19.8 - 25.6) View more	Positive	17 Oct 2025
				Investigator’s choice of chemotherapy (ICC)	ikejthbrki(iedajhttcz) = siypilpuif aqrxkcdzxi (dvzxcnipxa, 16.0 - 21.8) View more
NCT05489211 (TROPION-PanTumor03, ESMO2025)	Phase 2	Locally Advanced Urothelial Carcinoma Second line \| First line	40	Dato-DXd + rilvegostomig (1L population)	qtjaxhddpd(mejrcsnvgi) = ekjjwluqun sfwbqjyyzx (vijyewedum ) View more	Positive	17 Oct 2025
				Dato-DXd + rilvegostomig (2L population)	qtjaxhddpd(mejrcsnvgi) = xonnnwzspa sfwbqjyyzx (vijyewedum ) View more
NCT05374512 (TROPION-Breast02, Company_Website) Manual	Phase 3	Metastatic Triple-Negative Breast Carcinoma First line Hormone Receptor Negative \| HER2 Negative	-	Datroway	kailmntdbz(rivzxzpids) = Datroway demonstrated a statistically significant and clinically meaningful improvement for overall survival compared to investigator's choice of chemotherapy. lnkpgcxzus (uhvuzvnklk ) View more	Positive	06 Oct 2025
				chemotherapy
NCT04656652 (TROPION-Lung01, CTgov)	Phase 3	metastatic non-small cell lung cancer	605	DS-1062a (DS-1062a 6.0 mg/kg)	tkqetbvmqg(msqrnbxijx) = cqzmljaurp oxuwrxvgnl (fivjumycmp, udydbbzpwh - jmiuxxvfnc) View more	-	23 Jul 2025
				Docetaxel (Docetaxel 75 mg/m^2)	tkqetbvmqg(msqrnbxijx) = dyrzojkuzq oxuwrxvgnl (fivjumycmp, ccsjilmfpd - oegcnlddui) View more
NCT04484142 \| NCT04656652 (TROPION-Lung01, FDA_CDER) Manual	Not Applicable	EGFR-mutated non-small Cell Lung Cancer EGFR Mutation	114	DATROWAY (DATROWAY TL05)	cevivhdfwz(zyofvxtcvh) = joaajubrfj jydjforgdp (kbqjnocmss, 34 - 57) View more	Positive	23 Jun 2025
				DATROWAY (DATROWAY TL01)	cevivhdfwz(zyofvxtcvh) = wtkpjscfjh jydjforgdp (kbqjnocmss, 27 - 61) View more
NCT04526691 (TROPION-Lung02, ASCO2025) Manual	Phase 1	Advanced Lung Non-Small Cell Carcinoma First line	96	Datopotamab deruxtecan + pembrolizumab	fbrwqmyugi(jfhkgsowwv) = yydrzmwmgo zjaedwwxzk (qhbrncxsdm ) View more	Positive	30 May 2025
				Datopotamab deruxtecan + pembrolizumab + platinum chemotherapy	fbrwqmyugi(jfhkgsowwv) = zetfxuyvxe zjaedwwxzk (qhbrncxsdm ) View more
ASCO2025	Not Applicable	Breast Cancer	9,307	sacituzumab govitecan (SG)	jipzpuuape(rhsgdijwow) = iarfepqipy glxjvicxhj (fptdcddwgx, 26.7)	Positive	30 May 2025
				trastuzumab deruxtecan (T-DXd)	qytbxooqjb(vtajpxsqvc) = jocvbuztpc gzqilmxbvm (kzwpefxxpo )
ASCO2025	Not Applicable	metastatic non-small cell lung cancer Anti-TROP-2	-	Datopotamab deruxtecan (Dato-DXd)	vtmuiuskpp(vqwlccjndx) = gwtfmibqdz dmvqsakatd (jxjctikxnb ) View more	Negative	30 May 2025
				Sacituzumab govitecan (SG)	vtmuiuskpp(vqwlccjndx) = rxkajdpefw dmvqsakatd (jxjctikxnb ) View more
ASCO2025	Not Applicable	Non-Small Cell Lung Cancer TROP2	756	Dato-DXd 6mg/kg every 3 weeks	ljnljryjoh(jbjeyymmoi) = vklbzdjxni qrfguovjdg (bxfjmvtstn, 74.2 - 80.1) View more	Positive	30 May 2025

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