An open label phase II platform modular study exploring the efficacy and safety of the Valemetostat (EZH1/2 inhibitor) in patients with selected solid tumors (EZHiSWITCH)

Start Date05 Mar 2026

Sponsor / Collaborator

Institut Gustave Roussy EURL

NCT07303387

/ RecruitingPhase 2IIT

An Open Label Phase II Platform Modular Study Exploring the Efficacy and Safety of the Valemetostat (EZH1/2 Inhibitor) in Patients With Selected Solid Tumors

Rational, objective and design: Some cancer-protecting genes are inactivated when the EZH2 enzyme is too active or the SWI/SNF complex is less active. The EZH1/2 enzymes and the SWI/SNFs complex play opposing roles in gene expression: we hypothesize that valemetostat, an inhibitor of the EZH1/2 enzymes, will stop/slow down the growth of cancer cells by reactivating these genes. Numerous clinical trials are currently underway worldwide to optimize the development of valemetostat tosylate and potentially offer a new targeted therapeutic option for patients suffering from various cancer pathologies.
The aim of this research is to evaluate the efficacy of valemetostat on solid tumors, which have an alteration in certain genes: SMARC (B1/A4/A2/C1/C2), ARID (1A/1B), PBRM1, BAP1 and other SWI/SNF sub-units. The research will be conducted in two phases: 1) Pre-selection of patients with the desired alterations. 2) Treatment with valemetostat, 200mg/day, for a maximum of 2 years, with examinations every 28 days.
This is a multicenter, international, phase II open-label, multicenter modular study exploring the efficacy and safety of valemetostat. Module 1 will be the SWI/SNF basket monotherapy study describe below. Such design will allow the study to evolve considering signals for further monotherapy and/or combination modules.
The Primary endpoint of the study is Overall Response Rate at 24 weeks, defined as the proportion of patients with a confirmed best overall response.
Trial population: Adult patients with histologically/cytologically confirmed progressive metastatic or recurrent solid tumor, who have selected chromatin remodeling deficiency in at least one of the following genes: SMARCB1, SMARCA4, SMARCA2, SMARCC1, SMARCC2, ARID1A, ARID1B, PBRM1, BAP1and other SWI/SNF sub-units; or molecularly (Wildtype) and phenotypically-selected Clear cell endometrial or ovarian carcinoma cancers. Patients must be using an effective method of contraception and have signed the consent form. They must not participate in another clinical study with an investigational product during the last 3 weeks, during the study treatment and not have a contraindication to the study treatment (…) Intervention: After confirmation by IHC of the loss of expression in tumors cells of SMARCB1, SMARCA4, SMARCA2, SMARCC1, SMARCC2, ARID1A, ARID1B, PBRM1, BAP1and other SWI/SNF sub-units and validation of inclusion/exclusion criteria patients will included in different cohorts (refer to investigation scheme). All patients will receive Valemetostat (200 mg per day), divided into 28-day periods called treatment cycles, for a maximum of two years. The main interventions scheduled are blood samples (to evaluate biological parameters and for translational research), electrocardiogram, echocardiography and CTscan. For patients who have consented, sequential biopsies will be performed as follow: at baseline, on treatment and at progression.
Ethical consideration: This research will make it possible to collectively evaluate the interest of EZH1/2 inhibitor in solids tumors with SWI/SNF defect. Individually, by participating in this research, patients could benefit from these treatments based on cell-based results and in the treatment of relapsed/refractory peripheral T-cell lymphomas, with an improvement in symptoms and quality of life. As with any research, the investigational drug and other procedures that take place may involve risks, some of which are already known and others not yet described. The main risks (described in the consent form) are side effects of the valemetostat. If they agree, patients will also be monitored more closely with their safety assessed through patient-reported outcomes (PRO), the evaluation of their experience through qualitative interviews & assessment of quality of care and the evaluation of their biometric physiological via a wearable device.

Start Date05 Mar 2026

Sponsor / Collaborator

Gustave Roussy, Cancer Campus, Grand Paris

[+1]

NCT07244341

/ RecruitingPhase 1

A Phase 1, Multicenter Trial Evaluating the Safety, Tolerability, and Efficacy of Valemetostat (DS-3201) in Combination With Darolutamide in Metastatic Castration Resistant Prostate Cancer (mCRPC)

This study will assess the safety and tolerability of valemetostat in combination with darolutamide in participants with Metastatic Castration Resistant Prostate Cancer (mCRPC).

Start Date03 Dec 2025

Sponsor / Collaborator

Daiichi Sankyo Co., Ltd.

[+1]

100 Clinical Results associated with Valemetostat Tosilate

100 Translational Medicine associated with Valemetostat Tosilate

100 Patents (Medical) associated with Valemetostat Tosilate

Literatures (Medical) associated with Valemetostat Tosilate

01 May 2026·Transplantation and Cellular Therapy

Valemetostat is efficacious against recurrent adult T cell leukemia/lymphoma skin lesions and cutaneous graft-versus-host disease

Article

Author: Fuji, Shigeo ; Matsuoka, Yoshiki ; Yuda, Sayako ; Satomi, Hidetoshi ; Amemiya, Yuka ; Shingai, Yasuhiro ; Honma, Keiichiro ; Ishikawa, Jun ; Yokota, Takafumi ; Ikeda-Hosoya, Mako ; Tada, Yuma ; Nakahara, Wataru

01 Mar 2026·JOURNAL OF CLINICAL PHARMACOLOGY

Comment on “Population Pharmacokinetics of Valemetostat and Exposure–Response Analyses of Efficacy and Safety in Patients with Relapsed/Refractory Peripheral T‐Cell Lymphoma”

Letter

Author: Kumar, Ajay ; Cheeda, Diksha ; Bhise, Manish R.

01 Mar 2026·HEMATOLOGICAL ONCOLOGY

Valemetostat Therapy for Relapsed Adult T‐Cell Leukemia/Lymphoma After Allogeneic Hematopoietic Stem Cell Transplantation

Article

Author: Nakamura, Yukinori ; Furukawa, Shota ; Ito, Ayumu ; Inamoto, Yoshihiro ; Fujii, Takayuki ; Hirakawa, Tsuneaki ; Fukuda, Takahiro ; Watanabe, Mizuki ; Usui, Asako ; Takeda, Wataru ; Nagata, Mamoru

ABSTRACT:

This retrospective study evaluated 11 patients who received valemetostat, a novel selective dual inhibitor of the enhancer of zeste homologs 1 and 2, as a salvage therapy for relapsed adult T‐cell leukemia/lymphoma after allogeneic hematopoietic cell transplantation (allo‐HCT). The median age of the patients at allo‐HCT was 64 (range: 43–70) years. The median interval between allo‐HCT and valemetostat therapy was 210 (range: 35–682) days. The median lactate dehydrogenase and soluble interleukin‐2 receptor levels were 238 (range: 184–298) U/L and 818 (range: 435–2193) U/mL, respectively. Eight patients initially received valemetostat at a reduced dose because of thrombocytopenia. The median treatment duration was 156 (range: 39–645) days, with five patients continuing treatment. The best response rate was 73%, including clinical responses (complete or partial response) in six patients and molecular responses defined by clearance of blood measurable residual disease in two patients. The reasons for treatment discontinuation were adverse events (cytomegalovirus infection, pericardial effusion, and dysgeusia) ( n = 3) and progressive disease ( n = 3). None of the patients developed graft‐versus‐host disease. The median overall survival after valemetostat therapy was 294 (range: 56–645) days. At the last follow‐up, four patients were alive without disease, four were alive with disease, and three died due to progressive disease. Hence, valemetostat is a promising salvage therapy for relapsed adult T‐cell leukemia/lymphoma after allo‐HCT.

News (Medical) associated with Valemetostat Tosilate

17 Apr 2026

·investors.oricpharma.com

ORIC® Pharmaceuticals Presents Preclinical Data to Support the Potential of Rinzimetostat Across Prostate Cancer and in Emerging Resistance Settings at the 2026 American Association for Cancer Research (AACR) Annual Meeting

SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, April 17, 2026 (GLOBE NEWSWIRE) -- ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, today announced the presentation of multiple poster presentations at the 2026 American Association for Cancer Research (AACR) Annual Meeting highlighting the potential of rinzimetostat (ORIC-944), a potent and selective allosteric inhibitor of PRC2 to treat prostate cancer. The posters can be found in the publication section of ORIC’s website here. “Our research continues to show the therapeutic potential of PRC2 inhibition across the prostate cancer disease spectrum, by reducing tumor adaptability and sustaining the benefit derived from androgen-receptor targeted therapies,” said Lori Friedman, PhD, chief scientific officer. “Additionally, our preclinical studies reveal that targeting PRC2 via EED has potential advantages over targeting EZH2, which, together with the clinical data generated to date, furthers our conviction that rinzimetostat is a potential best-in-class PRC2 inhibitor.” Poster presentations: Rinzimetostat blockade of PRC2 activity, a key mechanism of treatment resistance, improves response of androgen receptor pathway inhibition across a spectrum of prostate cancer models Key findings of the presentation: In a transcriptomics analysis of >1,100 prostate samples spanning normal prostate, primary prostate cancer, and metastatic disease, PRC2 activity was observed early in the development of prostate cancer and was sustained during disease progression and treatment resistance, highlighting it as a critical therapeutic target. More than half of localized primary tumors demonstrated elevated PRC2 activity vs. normal prostate tissue, and an elevated PRC2 activity in locally advanced tumors associates with poor survival, indicative of a key role early in the disease. Elevated PRC2 activity was observed in the vast majority of both metastatic CSPC and metastatic CRPC tumors relative to normal prostate tissue. Rinzimetostat in combination with darolutamide demonstrated antitumor activity across a breadth of in vivo models representing the prostate cancer continuum, including CSPC and CRPC. More than half of localized primary tumors demonstrated elevated PRC2 activity vs. normal prostate tissue, and an elevated PRC2 activity in locally advanced tumors associates with poor survival, indicative of a key role early in the disease. Elevated PRC2 activity was observed in the vast majority of both metastatic CSPC and metastatic CRPC tumors relative to normal prostate tissue. Rinzimetostat, an allosteric EED inhibitor with best-in-class properties for the treatment of prostate cancer, is effective in PRC2 methyltransferase-resistant settings in preclinical studies Key findings of the presentation: PRC2 inhibition induces transcriptional and chromatin effects that restrain tumor plasticity and enhance antitumor activity of androgen receptor inhibitors in prostate cancer models. Differential potency of PRC2 inhibitors on EZH1- vs. EZH2-containing complexes impacts activity in resistance contexts, providing potential advantages for EED targeting. Rinzimetostat retained antitumor activity in prostate cancer cells with overexpressed EZH1 in vitro, while potency was diminished for mevrometostat or tazemetostat. Preclinical studies show that rinzimetostat overcomes acquired resistance mechanisms observed in the clinic for tazemetostat and valemetostat. Rinzimetostat demonstrates improved solubility, oral bioavailability, CYP profile, and clinical half-life versus comparator compounds. Rinzimetostat retained antitumor activity in prostate cancer cells with overexpressed EZH1 in vitro, while potency was diminished for mevrometostat or tazemetostat. Preclinical studies show that rinzimetostat overcomes acquired resistance mechanisms observed in the clinic for tazemetostat and valemetostat. About ORIC Pharmaceuticals, Inc. ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients’ lives by Overcoming Resistance In Cancer. ORIC’s clinical stage product candidates include (1) rinzimetostat, an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (2) enozertinib, a brain-penetrant inhibitor targeting EGFR exon 20 and EGFR PACC mutations, being developed for NSCLC. ORIC has offices in South San Francisco and San Diego, California. For more information, please go to www.oricpharma.com, and follow us on X or LinkedIn. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, the continued clinical development of rinzimetostat; the potential advantages of rinzimetostat; statements regarding the potential best-in-class properties of rinzimetostat; the development plans and timelines for rinzimetostat and enozertinib; plans underlying ORIC’s clinical trials and development; and statements by the company’s chief scientific officer. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. The forward-looking statements contained herein are based upon ORIC’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those projected in any forward-looking statements due to numerous risks and uncertainties, including but not limited to: risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and operating as an early clinical stage company; ORIC’s ability to develop, initiate or complete preclinical studies and clinical trials for, obtain approvals for and commercialize any of its product candidates; changes in ORIC’s plans to develop and commercialize its product candidates; the potential for clinical trials of rinzimetostat, enozertinib or any other product candidates to differ from preclinical, initial, interim, preliminary or expected results; negative impacts of health emergencies, economic instability or international conflicts on ORIC’s operations, including clinical trials; the risk of the occurrence of any event, change or other circumstance that could give rise to the termination of ORIC’s license and collaboration agreements or its clinical trial collaboration and supply agreements; the potential market for ORIC’s product candidates, and the progress and success of competing therapeutics currently available or in development; ORIC’s ability to raise any additional funding it will need to continue to pursue its business and product development plans; regulatory developments in the United States and foreign countries; ORIC’s reliance on third parties, including contract manufacturers and contract research organizations; ORIC’s ability to obtain and maintain intellectual property protection for its product candidates; the loss of key scientific or management personnel; competition in the industry in which ORIC operates; general economic and market conditions; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in ORIC’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (the SEC) on February 23, 2026, and ORIC’s future reports to be filed with the SEC. These forward-looking statements are made as of the date of this press release, and ORIC assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Contact: Dominic Piscitelli, Chief Financial Officer dominic.piscitelli@oricpharma.com info@oricpharma.com

AACR

08 Dec 2025

·www.businesswire.com

Daiichi Sankyo Showcases Strength of Industry-Leading ADC Portfolio with Latest Research Updates from Five Landmark Breast Cancer Trials at SABCS

Additional data from DESTINY-Breast11, DESTINY-Breast05, DESTINY-Breast09, DESTINY-Breast03 and TROPION-Breast02 reinforce practice-changing results of ENHERTU ® and DATROWAY ® across a broad spectrum of patients with breast cancer Trials-in-progress across breast cancer portfolio of Daiichi Sankyo demonstrate company’s commitment to creating new standards of care Science & Technology Day to be held following SABCS to discuss R&D and oncology business updates TOKYO & BASKING RIDGE, N.J.--(BUSINESS WIRE)--Daiichi Sankyo (TSE: 4568) will present new breast cancer clinical research across its DXd antibody drug conjugate (ADC) portfolio from more than 30 abstracts at the 2025 San Antonio Breast Cancer Symposium (#SABCS25), which include four rapid fire mini-oral sessions and other presentations from five landmark trials of ENHERTU® (trastuzumab deruxtecan) and DATROWAY® (datopotamab deruxtecan) across a broad spectrum of breast cancer. Four rapid fire mini-oral sessions will feature ENHERTU data in the curative-intent and metastatic settings of HER2 positive breast cancer, including two presentations from the DESTINY-Breast11 phase 3 trial highlighting patient reported outcomes (RF6-06) and further safety analyses (RF6-02) of ENHERTU followed by paclitaxel, trastuzumab and pertuzumab (THP) compared to dose-dense doxorubicin and cyclophosphamide followed by THP (ddAC-THP) in the neoadjuvant setting (before surgery) in patients with high-risk, locally advanced HER2 positive early-stage breast cancer. Additional efficacy and safety data (RF6-01) from the DESTINY-Breast05 phase 3 trial comparing ENHERTU to trastuzumab emtansine (T-DM1) as a post-neoadjuvant (after surgery) therapy in patients with high-risk HER2 positive early breast cancer with residual invasive disease in the breast and/or axillary lymph nodes also will be highlighted. The fourth rapid fire presentation will feature patient reported outcomes (RF6-07) from the ENHERTU plus pertuzumab arm of the DESTINY-Breast09 phase 3 trial as a first-line treatment of HER2 positive metastatic breast cancer. Interim results from DESTINY-Breast09 were recently published in The New England Journal of Medicine, marking the eighth pivotal trial of ENHERTU to be published in the prestigious journal. Additional updates from two other landmark breast cancer trials include poster presentations featuring the final analysis and five-year follow-up of efficacy and safety data (PS5-01-30) from the DESTINY-Breast03 phase 3 trial comparing ENHERTU versus T-DM1 as a second-line treatment of HER2 positive metastatic breast cancer, and further safety analysis (PS5-03-05) from the TROPION-Breast02 phase 3 trial of DATROWAY, the first trial ever to demonstrate a significant improvement in overall survival compared to chemotherapy as first-line treatment for patients with locally recurrent inoperable or metastatic triple negative breast cancer (TNBC) for whom immunotherapy is not an option. “Our latest research across these five landmark trials demonstrate how the DXd antibody drug conjugate portfolio of Daiichi Sankyo continues to potentially transform standards of care for patients with breast cancer,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “We remain committed to following the science and collaborating with the breast cancer community to create innovative medicines that advance the treatment of breast cancer.” Additional data from the DESTINY clinical trial program to be highlighted in poster presentations at SABCS include an exploratory post-hoc subgroup analysis by hormone receptor status from the DESTINY-Breast12 phase 3b/4 trial (PS5-01-27) of ENHERTU in patients with HER2 positive metastatic breast cancer and brain metastases; the final results from the ENHERTU monotherapy and ENHERTU plus pertuzumab arms of the DESTINY-Breast07 phase 1b/2 trial (PS5-01-14) in patients with previously untreated HER2 positive metastatic breast cancer; and, initial characteristics of first enrolled patients from the DESTINY Breast Respond HER2 Low Europe non-interventional study (PS5-08-14) of ENHERTU in HER2 low metastatic breast cancer. Collaborations Supporting Innovation in Breast Cancer Research Additional data presented at SABCS include results from four externally sponsored trials across the DXd ADC pipeline of Daiichi Sankyo. Two spotlight poster presentations will report interim results from the HALLOW prospective observational trial (PD13-11) evaluating the efficacy and safety of ENHERTU in patients with HER2 low (IHC 1+ or 2+/ISH-) metastatic breast cancer with and without active brain metastases in Japan, and a post-hoc pooled efficacy analysis (PD13-10) from the TUXEDO-3 phase 2 trial of patritumab deruxtecan (HER3-DXd) in patients with HER2 positive metastatic breast cancer and active brain metastases or leptomeningeal disease previously treated with ENHERTU. Results from cohorts 1 and cohorts 2 of the TUXEDO-3 trial were recently published in The Lancet Oncology and results from cohort 3 were published in Nature Medicine. Two poster presentations will report on the intracranial and/or extracranial activity of ENHERTU and DATROWAY. A translational ctDNA analysis of intracranial and extracranial activity (PS2-08-20) of ENHERTU from the DEBBRAH phase 2 trial in patients with HER2 positive and HER2 low breast cancer with leptomeningeal disease will be highlighted, as well as results of intracranial activity (PS1-09-02) of DATROWAY from the DATO-BASE phase 2 trial in patients with HER2 negative breast cancer with leptomeningeal disease. Trials-in-Progress Across Breast Cancer Portfolio of Daiichi Sankyo Several trials-in-progress poster presentations at SABCS further highlight research underway to address a broad spectrum of unmet needs for patients with breast cancer. Additional externally sponsored trials for ENHERTU and DATROWAY include the PONTIAC phase 2 trial (PS5-07-15) evaluating ENHERTU versus CDK4/6 inhibitor-based endocrine therapy as a first-line treatment of non-luminal HR positive, HER2 low and HER2 ultralow advanced breast cancer; a phase 1b trial (PS5-09-22) evaluating ENHERTU in combination with valemetostat, an EZH1/2 inhibitor, in patients with HER2 low, HER2 ultralow and HER2 null metastatic breast cancer; and the TROPION-Breast06 phase 3b trial (PS5-07-21) of DATROWAY in patients with HR positive, HER2 IHC 0 inoperable or metastatic breast cancer refractory to endocrine therapy. Three additional trials-in-progress from the HERTHENA clinical development program of patritumab deruxtecan (HER3-DXd) also will be highlighted. These include the HERTHENA-Breast04 phase 3 trial (PS5-07-22) evaluating patritumab deruxtecan versus physician’s choice of treatment in patients with HR positive, HER2 negative unresectable locally advanced or metastatic breast cancer; the HERTHENA-Breast03 phase 2 trial (PS5-12-21) evaluating neoadjuvant patritumab deruxtecan plus pembrolizumab before or after pembrolizumab plus chemotherapy in patients with high-risk early-stage TNBC or HR low positive/HER2 negative breast cancer; and, the HERTHENA-Breast01 phase 1b/2 trial (PS5-12-23) evaluating patritumab deruxtecan in combination with HER2 targeted agents in patients with HER2 positive unresectable locally advanced or metastatic breast cancer. Science & Technology Day Daiichi Sankyo will hold its annual Science & Technology Day for investors on Monday, December 15, 2025, from 5:30 to 7:30 pm ET / Tuesday, December 16, 2025, from 7:30 – 9:30 am JST. Executives from Daiichi Sankyo will provide an update on R&D, business and manufacturing developments across the portfolio. Daiichi Sankyo Presentation Highlights at SABCS Presentation Title Author Abstract Presentation (CST) ENHERTU (trastuzumab deruxtecan; T-DXd) Patient-reported outcomes in DESTINY-Breast11: neoadjuvant treatment with trastuzumab deruxtecan (T-DXd) alone or followed by paclitaxel + trastuzumab + pertuzumab (THP) vs dose-dense doxorubicin + cyclophosphamide followed by THP (ddAC-THP) in high-risk, HER2+ early-stage breast cancer S. Modi RF6-06 Rapid Fire 6 Mini-Oral Session Wednesday, December 10 1:00 – 2:00 pm DESTINY-Breast11 safety: neoadjuvant trastuzumab deruxtecan (T-DXd) alone or followed by paclitaxel + trastuzumab + pertuzumab (THP) vs dose-dense doxorubicin + cyclophosphamide followed by THP (ddAC-THP) in high-risk, HER2+ early-stage breast cancer G. Curigliano RF6-02 Rapid Fire 6 Mini-Oral Session Wednesday, December 10 1:00 – 2:00 pm Additional efficacy and safety from the DESTINY-Breast05 study of trastuzumab deruxtecan (T-DXd) vs trastuzumab emtansine (T‑DM1) in patients with high-risk human epidermal growth factor receptor 2–positive (HER2+) primary early breast cancer with residual invasive disease after neoadjuvant therapy S. Loibl RF6-01 Rapid Fire 6 Mini-Oral Session Wednesday, December 10 1:00 – 2:00 pm Trastuzumab deruxtecan (T-DXd) + pertuzumab vs taxane + trastuzumab + pertuzumab (THP) for first-line treatment of patients with HER2 positive (HER2+) advanced/metastatic breast cancer: patient-reported outcomes from the DESTINY-Breast09 study M. Rimawi RF6-07 Rapid Fire 6 Mini-Oral Session Wednesday, December 10 1:00 – 2:00 pm Trastuzumab deruxtecan (T-DXd) versus trastuzumab emtansine (T-DM1) in patients with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer: final analysis from DESTINY-Breast03 S. Im PS5-01-30 Poster Session 5 Friday, December 12 12:30 – 2:00 pm Trastuzumab deruxtecan (T-DXd) monotherapy and T-DXd + pertuzumab in patients with previously untreated HER2+ unresectable/metastatic breast cancer: final results from DESTINY-Breast07 F. Andre PS5-01-14 Poster Session 5 Friday, December 12 12:30 – 2:00 pm Outcomes by hormone receptor status in patients with HER2+ advanced/metastatic breast cancer with brain metastases treated with trastuzumab deruxtecan (T-DXd): a post-hoc subgroup analysis of DESTINY-Breast12 H. Wildiers PS5-01-27 Poster Session 5 Friday, December 12 12:30 – 2:00 pm DESTINY-Breast Respond HER2 low Europe: description of first enrolled patients in the non-interventional study of T-DXd in HER2 low metastatic breast cancer V. Guarneri PS5-08-14 Poster Session 5 Friday, December 12 12:30 – 2:00 pm Interim analysis results for the effectiveness and safety of trastuzumab deruxtecan in patients with HER2 low breast cancer and brain metastases: the HALLOW study N. Niikura PD13-11 Poster Spotlight 13 Friday, December 12 7:00 – 8:30 am Translational analysis of cerebrospinal fluid and plasma circulating tumor DNA from breast cancer patients with leptomeningeal disease treated with trastuzumab deruxtecan (T-DXd) in the DEBBRAH trial A. Fitzpatrick PS2-08-20 Poster Session 2 Wednesday, December 10 5:00 – 6:30 pm Trials-in-Progress A randomized phase 2 study to evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) versus CDK4/6 inhibitor-based endocrine therapy as first-line therapy of hormone receptor-positive and HER2 low/ultralow advanced breast cancer patients classified as non-luminal subtype according to gene expression profiling: the PONTIAC study J. Cortes PS5-07-15 Poster Session 5 Friday, December 12 12:30 – 2:00 pm Phase 1b study of EZH1/2 inhibitor valemetostat in combination with trastuzumab deruxtecan in subjects with HER2 low/ultralow/null metastatic breast cancer S. Damodaran PS5-09-22 Poster Session 5 Friday, December 12 12:30 – 2:00 pm DATROWAY (datopotamab deruxtecan; Dato-DXd) First-line datopotamab deruxtecan (Dato-DXd) vs chemotherapy in patients with locally recurrent inoperable or metastatic triple negative breast cancer (TNBC) for whom immunotherapy was not an option: additional safety analyses from the TROPION-Breast02 study T. Traina PS5-03-05 Poster Session 5 Friday, December 12 12:30 – 2:00 pm Intracranial activity of datopotamab deruxtecan (Dato-DXd) for patients with HER2 negative breast cancer and leptomeningeal disease: results from cohort C of the DATO-Base phase 2 trial P. Tarantino PS1-09-02 Poster Session 1 Wednesday, December 10 12:30 – 2:00 pm Trials-in-Progress TROPION-Breast06: multicenter, multinational, open-label, single-arm, phase 3b study of datopotamab deruxtecan (Dato-DXd) in patients with locally advanced inoperable or metastatic HR+/HER2 IHC 0 breast cancer refractory to endocrine therapy K. Jhaveri PS5-07-21 Poster Session 5 Friday, December 12 12:30 – 2:30 pm Patritumab Deruxtecan (HER3-DXd) Outcome of patritumab deruxtecan (HER3-DXd) in patients with HER2 positive metastatic breast cancer and CNS involvement previously treated with T-DXd: a subanalysis of TUXEDO-3 R. Bartsch PD13-10 Poster Spotlight 13 Friday, December 12 7:00 – 8:30 am Trials-in-Progress HERTHENA-Breast04: a phase 3, randomized, open-label study evaluating the efficacy and safety of patritumab deruxtecan (HER3-DXd) versus treatment of physician’s choice in hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) unresectable locally advanced or metastatic breast cancer B. Pistilli PS5-07-22 Poster Session 5 Friday, December 12 12:30 – 2:00 pm HERTHENA-Breast03: a phase 2, randomized, open-label study evaluating neoadjuvant patritumab deruxtecan (HER3-DXd) + pembrolizumab before or after pembrolizumab + chemotherapy for early-stage TNBC or HR-low+/HER2− breast cancer J. O’Shaughnessy PS5-12-21 Poster Session 5 Friday, December 12 12:30 – 2:00 pm HERTHENA-Breast01: a phase 1b/2, multicenter, open-label, dose-finding study to evaluate the safety and antitumor activity of patritumab deruxtecan (HER3-DXd) in HER2+ unresectable locally advanced or metastatic breast cancer S. Tolaney PS5-12-23 Poster Session 5 Friday, December 12 12:30 – 2:00 pm 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, raludotatug deruxtecan, patritumab 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 needs. For more information, please visit www.daiichisankyo.com.

Phase 2Phase 3Clinical ResultADCPhase 1

13 Oct 2025

·www.businesswire.com

Daiichi Sankyo Continues to Transform Standards of Care for Patients with Three Landmark Breast Cancer Trials and Additional Data Across Industry-Leading ADC Portfolio at ESMO

Back-to-back Presidential Symposium presentations of ENHERTU from DESTINY-Breast11 and DESTINY-Breast05 demonstrate its potential to become a foundational treatment in curative-intent settings of HER2 positive early breast cancer Late-breaking data from TROPION-Breast02 showcase that DATROWAY is the first and only therapy to significantly improve overall survival versus chemotherapy as first-line treatment for patients with first-line metastatic triple negative breast cancer for whom immunotherapy is not an option Data from eight additional trials – DESTINY-Breast09, REJOICE-Ovarian01, IDeate-Lung01, TROPION-PanTumor03, DESTINY-Gastric04, DESTINY-CRC02, DESTINY-PanTumor02 and DS-3939 – further support the strength of the DXd ADC portfolio of Daiichi Sankyo across multiple types of cancer Investor conference call to discuss ESMO TOKYO & BASKING RIDGE, N.J.--(BUSINESS WIRE)--Daiichi Sankyo (TSE: 4568) will present new clinical research across its DXd antibody drug conjugate (ADC) portfolio with four late-breaking presentations from more than 20 abstracts at the 2025 European Society for Medical Oncology (#ESMO25) Congress. Data at ESMO will spotlight the company’s advances towards creating new standards of care for patients with breast cancer, including back-to-back presentations during Presidential Symposium I featuring data from the DESTINY-Breast11 (291O) and DESTINY-Breast05 (LBA1) phase 3 trials. Results of these two landmark trials will showcase the potential of ENHERTU® (trastuzumab deruxtecan) to become a foundational treatment in curative-intent settings of HER2 positive early breast cancer. Late-breaking DATROWAY® (datopotamab deruxtecan) data from the TROPION-Breast02 phase 3 trial (LBA21), representing the first trial ever to demonstrate a significant improvement in overall survival compared to chemotherapy as first-line treatment for patients with locally recurrent inoperable or metastatic triple negative breast cancer (TNBC) for whom immunotherapy is not an option, will be featured in a proffered paper session. “Data from these three landmark trials demonstrate how the DXd ADC portfolio of Daiichi Sankyo continues to transform standards of care for patients with breast cancer. The findings from DESTINY-Breast11 and DESTINY-Breast05 highlight the potential of ENHERTU to become a foundational treatment in the curative-intent settings of HER2 positive early breast cancer,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “Additionally, the DATROWAY results from TROPION-Breast02 represent the first time ever that an overall survival benefit has been demonstrated in the first-line setting of patients with metastatic triple negative breast cancer for whom immunotherapy is not an option. Couple these impressive results for DATROWAY with previous results seen with ENHERTU in the HER2 positive, HER2 low and HER2 ultralow disease settings, Daiichi Sankyo will now have two medicines with the potential to treat approximately 90 percent of patients with metastatic breast cancer.” Additional breast cancer data at ESMO includes a mini oral presentation of data from Arm 7 and Arm 8 of the BEGONIA phase 1/2 trial (555MO) evaluating DATROWAY plus durvalumab in patients with first-line metastatic TNBC. The efficacy and safety of this combination strategy is being further investigated in three phase 3 trials – TROPION-Breast03, TROPION-Breast04 and TROPION-Breast05 – across stages and treatment settings of TNBC. Trials Supporting Three Recent Breakthrough Therapy Designations Showcased Data from additional late-stage trials – DESTINY-Breast09, REJOICE-Ovarian01 and IDeate-Lung01 – that supported three recent Breakthrough Therapy Designations (BTD) in the U.S. for ENHERTU, raludotatug deruxtecan (R-DXd) and ifinatamab deruxtecan (I-DXd) will be showcased at ESMO. Two late-breaking proffered paper sessions will highlight the primary analysis from the phase 2 part of the REJOICE-Ovarian01 phase 2/3 trial (LBA42) of raludotatug deruxtecan in patients with previously treated platinum-resistant ovarian cancer, and additional analyses of key subgroups of interest from the DESTINY-Breast09 phase 3 trial (LBA18) evaluating ENHERTU plus pertuzumab versus THP (taxane, trastuzumab, pertuzumab) for the first-line treatment of patients with HER2 positive metastatic breast cancer. Results of DESTINY-Breast09 formed the basis for a supplemental Biologic License Application in the U.S. for ENHERTU, which was recently granted Priority Review under the Real-Time Oncology Review program. Detailed results highlighting the intracranial activity of ifinatamab deruxtecan from the IDeate-Lung01 phase 2 trial (2760MO) in patients with previously treated extensive-stage small cell lung cancer (ES-SCLC) and baseline brain metastases will be highlighted during a mini oral session. The primary results of IDeate-Lung01 were presented last month at the 2025 World Conference on Lung Cancer (#WCLC25). Progress Continues in Multiple Cancers Across the DXd ADC Portfolio of Daiichi Sankyo Additional mini oral sessions at ESMO will feature the first presentation of data from two early phase trials from the DXd ADC portfolio of Daiichi Sankyo. These include preliminary results from the first-in-human phase 1/2 trial of DS-3939 (917O), the sixth DXd ADC in clinical development, in patients with previously treated advanced solid tumors refractory to standard treatment, as well as initial results from a sub-study of the TROPION-PanTumor03 phase 2 trial (3072MO) evaluating DATROWAY plus rilvegostomig, AstraZeneca’s PD-1/TIGIT bispecific antibody, in patients as first-line or second-line locally advanced or metastatic urothelial carcinoma. Final analyses from two trials – DESTINY-CRC02 and DESTINY-PanTumor02 – that supported the tumor agnostic indication of ENHERTU, which is now approved in more than 10 countries/regions worldwide, will be presented. A mini oral session will feature the final analysis from the DESTINY-CRC02 phase 2 trial (737MO) of ENHERTU in patients with previously treated HER2 positive metastatic colorectal cancer while two poster presentations will highlight the final results (957P) and an exploratory biomarker analysis (145P) from part 1 of the DESTINY-PanTumor02 phase 2 trial in patients with previously treated HER2 expressing solid tumors. Additional regulatory submissions seeking a tumor agnostic approval in patients with HER2 positive metastatic solid tumors currently are under review in the EU and Japan. Further sub-analyses from the DESTINY-Gastric04 phase 3 trial of ENHERTU versus ramucirumab plus paclitaxel in the second-line treatment of patients with HER2 positive metastatic gastric cancer or gastroesophageal junction (GEJ) adenocarcinoma will be presented as a poster presentation (2099P) reporting the concordance of central HER2 testing with local HER2 testing along with additional efficacy and safety analyses. Data from DESTINY-Gastric06, a phase 2 trial in patients from China with HER2 expressing advanced gastric or GEJ adenocarcinoma who have received at least two prior regimens including a fluoropyrimidine agent and a platinum agent, will be presented in two poster presentations. The first poster (2105P) will feature an analysis of patients that received prior anti-HER2 treatment other than or in addition to trastuzumab. The second poster (2175P) will report the risk of hepatitis B virus reactivation in patients with past or resolved HBV or inactive chronic HBV infection treated with ENHERTU. Updates of progress in lung cancer include a mini oral session reporting updated results from a phase 1/2 trial of gocatamig (2758MO), a DLL3 targeting T-cell engager being jointly developed by Merck, in patients with small cell lung cancer and other neuroendocrine cancers, as well as a poster presentation that will highlight the initial safety results from a phase 1b trial of valemetostat (2023P), a dual EZH1 and EZH2 inhibitor, in combination with DATROWAY in patients with previously treated advanced non-squamous non-small cell lung cancer (NSCLC). Trials-in-Progress Across Daiichi Sankyo’s Oncology Portfolio Several trials-in-progress poster presentations at ESMO further highlight the Daiichi Sankyo R&D strategy of continuing to expand the DXd ADC portfolio to address a broad spectrum of unmet needs for patients with cancer. A trial-in-progress poster will highlight the design of the DESTINY-Endometrial01 phase 3 trial (1223TiP) evaluating ENHERTU in combination with rilvegostomig or pembrolizumab versus platinum-based chemotherapy (carboplatin and paclitaxel) in combination with pembrolizumab as a first-line therapy in patients with HER2 expressing (IHC 3+/ 2+), mismatch repair proficient (pMMR) primary advanced or recurrent endometrial cancer. Three phase 2 trials-in-progress will include the HERTHENA-Breast03 trial (463eTiP) evaluating neoadjuvant patritumab deruxtecan (HER3-DXd) plus pembrolizumab before or after pembrolizumab plus chemotherapy in patients with high-risk early-stage TNBC or HR low positive/HER2 negative breast cancer; the REJOICE-GI01 trial (1001TiP) evaluating the efficacy and safety of raludotatug deruxtecan in patients with gastrointestinal cancers, including pancreatic ductal adenocarcinoma, gastroesophageal adenocarcinoma, biliary tract and colorectal cancer; and, the KEYMAKER-U01 sub-studies 01H/01I (2081eTiP) evaluating ifinatamab deruxtecan, raludotatug deruxtecan or docetaxel in patients with stage IV NSCLC. The design of two additional early phase trials will be shared, including the phase 1/2 trial (2792TiP) evaluating ifinatamab deruxtecan and gocatamig in patients with relapsed/refractory ES-SCLC and a phase 1b trial (977P) of valemetostat in combination with ipilimumab in patients with refractory genitourinary tumors, including prostate cancer, urothelial carcinomas and renal clear cell carcinoma. Investor Briefing During ESMO Daiichi Sankyo will hold a virtual conference call for investors on Tuesday, October 21, 2025 from 8:00 to 9:30 am EDT / 9:00 to 10:30 pm JST. Executives from Daiichi Sankyo will provide an overview of the ESMO data. Daiichi Sankyo Oral Presentations at ESMO Presentation Title Author Abstract Presentation (CEST) Breast Trastuzumab deruxtecan (T-DXd) vs trastuzumab emtansine (T-DM1) in patients with high-risk human epidermal growth factor receptor 2-positive (HER2+) primary breast cancer with residual invasive disease after neoadjuvant therapy: interim analysis of DESTINY-Breast05 C. Geyer LBA1 Presidential Symposium I Saturday, October 18 4:30 – 6:15 pm DESTINY-Breast11: neoadjuvant trastuzumab deruxtecan alone (T-DXd) or followed by paclitaxel + trastuzumab + pertuzumab (T-DXd-THP) vs SOC for high-risk HER2+ early breast cancer N. Harbeck 291O Presidential Symposium I Saturday, October 18 4:30 – 6:15 pm Trastuzumab deruxtecan (T-DXd) + pertuzumab vs taxane + trastuzumab + pertuzumab (THP) for patients with HER2+ advanced/metastatic breast cancer: additional analyses of DESTINY-Breast09 in key subgroups of interest S. Loibl LBA18 Proffered Paper Session Sunday, October 19 8:30 – 10:00 am First-line datopotamab deruxtecan (Dato-DXd) vs chemotherapy in patients with locally recurrent inoperable or metastatic triple negative breast cancer for whom immunotherapy was not an option: primary results from the randomized, phase 3 TROPION-Breast02 trial R. Dent LBA21 Proffered Paper Session Sunday, October 19 8:30 – 10:00 am Datopotamab deruxtecan (Dato-DXd) + durvalumab as first-line treatment for unresectable locally advanced/ metastatic triple negative breast cancer: final results from the phase 1b/2 BEGONIA study P. Schmid 555MO Mini Oral Session Monday, October 20 10:15 – 11:45 am Lung Intracranial activity of ifinatamab deruxtecan (I-DXd) in patients with extensive-stage small cell lung cancer and baseline brain metastases: primary analysis of IDeate-Lung01 P. Rocha 2760MO Mini Oral Session Saturday, October 18 4:30 – 6:00 pm Updated results from a phase 1/2 study of gocatamig for small cell lung cancer and other neuroendocrine cancers H. Beltran 2758MO Mini Oral Session Saturday, October 18 4:30 – 6:00 pm Ovarian Raludotatug deruxtecan (R-DXd) in patients with platinum-resistant ovarian cancer: primary analysis of the phase 2 dose- optimization part of the REJOICE-Ovarian01 study I. Ray-Coquard LBA42 Proffered Paper Session Sunday, October 19 2:45 – 4:15 pm Bladder Datopotamab deruxtecan (Dato-DXd) + rilvegostomig in patients with locally advanced or metastatic urothelial cancer: results from the phase 2 TROPION-PanTumor03 study S. Rha 3072MO Mini Oral Session Friday, October 17 4:00 – 5:30 pm CRC Trastuzumab deruxtecan (T‑DXd) in patients with HER2 positive (HER2+) metastatic colorectal cancer: final analysis of DESTINY-CRC02, a randomized, phase 2 trial K. Raghav 737MO Mini Oral Session Sunday, October 19 2:45 – 4:15 pm PanTumor DS-3939, a tumor-associated mucin 1 (TA-MUC1)-directed antibody drug conjugate (ADC), in patients with advanced/metastatic solid tumors: initial results from a first-in-human study M. Patel 917O Proffered Paper Session Sunday, October 19 2:45 – 4:20 pm Daiichi Sankyo Poster Presentations at ESMO Presentation Title Author Abstract Presentation (CDT) Breast Final real-world safety and effectiveness results of REALITY-01 study: trastuzumab deruxtecan (T-DXd) in patients received ≥2 prior treatment lines for HER2+ metastatic or unresectable breast cancer J. Pierga 539P Poster Session The effectiveness of post-trastuzumab deruxtecan (T-DXd) treatment regimens and the incidence of recurrent interstitial lung disease (ILD) in patients with HER2+ metastatic breast cancer who discontinued T-DXd due to ILD J. Tsurutani 540P Poster Session HERTHENA-Breast03: a phase 2, randomized, open-label study evaluating neoadjuvant patritumab deruxtecan + pembrolizumab before or after pembrolizumab + chemotherapy for early-stage TNBC or HR low+/HER2− breast cancer M. Danso 463eTiP ePoster Lung Phase 1b study of valemetostat in combination with datopotamab deruxtecan (Dato-DXd) in advanced non-squamous non-small cell lung cancer: initial safety results A. Spira 2023P Poster Session A phase 1b/2 study of gocatamig (MK-6070; HPN328) and ifinatamab deruxtecan for relapsed/refractory extensive-stage small cell lung cancer J. Sun 2792TiP Poster Session KEYMAKER-U01 phase 2 substudies 01H/01I: ifinatamab deruxtecan (I-DXd), raludotatug deruxtecan (R-DXd) or docetaxel in stage IV non-small cell lung cancer E. Nadal 2081eTiP ePoster Gastrointestinal Trastuzumab deruxtecan (T-DXd) vs ramucirumab plus paclitaxel in second-line treatment of patients with HER2+ unresectable/metastatic gastric cancer/gastroesophageal junction adenocarcinoma: additional data from DESTINY-Gastric04 F. Pietrantonio 2099P Poster Session Trastuzumab deruxtecan (T-DXd) in patients with HER2+ gastric cancer or gastroesophageal junction adenocarcinoma who received prior anti-HER2 treatment other than/in addition to trastuzumab in DESTINY-Gastric06 Z. Peng 2105P Poster Session Risk of hepatitis B virus reactivation in patients with past or resolved HBV or inactive chronic HBV infection treated with trastuzumab deruxtecan (T-DXd) in the DESTINY-Gastric06 L. Shen 2175P Poster Session Raludotatug deruxtecan in participants with gastrointestinal cancers: phase 2 REJOICE-GI01 trial M. Ueno 1001TiP Poster Session Endometrial A randomized phase 3 study of first-line trastuzumab deruxtecan (T-DXd) with rilvegostomig or pembrolizumab in patients with HER2 expressing, mismatch repair-proficient, primary advanced or recurrent endometrial cancer: DESTINY-Endometrial01/GOG-3098/ENGOT-EN24 B. Slomovitz 1223TiP Poster Session PanTumor Trastuzumab deruxtecan (T-DXd) for pretreated patients with HER2 expressing solid tumors: DESTINY-PanTumor02 part 1 final analysis V. Makker 957P Poster Session Trastuzumab deruxtecan (T-DXd) in pretreated patients with HER2 expressing solid tumors: exploratory biomarker analysis of DESTINY-PanTumor02 part 1 D. Oh 145P Poster Session DS3201 (valemetostat), an EZH1/2 inhibitor, with ipilimumab in patients with refractory genitourinary tumors S. Goswami 977P Poster Session About the ADC Portfolio of Daiichi Sankyo The Daiichi Sankyo ADC portfolio consists of seven ADCs in clinical development crafted from two distinct ADC technology platforms discovered in-house by Daiichi Sankyo. The ADC platform furthest in clinical development is Daiichi Sankyo’s DXd ADC Technology where each ADC consists of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADC portfolio currently consists of ENHERTU, a HER2 directed ADC, and DATROWAY, a TROP2 directed ADC, which are being jointly developed and commercialized globally with AstraZeneca. Patritumab deruxtecan (HER3-DXd), a HER3 directed ADC, ifinatamab deruxtecan (I-DXd), a B7-H3 directed ADC, and raludotatug deruxtecan (R-DXd), a CDH6 directed ADC, are being jointly developed and commercialized globally with Merck & Co., Inc, Rahway, NJ, USA. DS-3939, a TA-MUC1 directed ADC, is being developed by Daiichi Sankyo. The second Daiichi Sankyo ADC platform consists of a monoclonal antibody attached to a modified pyrrolobenzodiazepine (PBD) payload. DS-9606, a CLDN6 directed PBD ADC, is the first of several planned ADCs in clinical development utilizing this platform. Ifinatamab deruxtecan, patritumab deruxtecan, raludotatug deruxtecan, DS-3939 and DS-9606 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established. About Daiichi Sankyo Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical needs. For more information, please visit www.daiichisankyo.com.

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100 Deals associated with Valemetostat Tosilate

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Indication	Country/Location	Organization	Date
Adult T-Cell Leukemia-Lymphoma	Japan	Daiichi Sankyo Co., Ltd.	26 Sep 2022
Peripheral T-Cell Lymphoma	Japan	Daiichi Sankyo Co., Ltd.	26 Sep 2022

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Indication	Highest Phase	Country/Location	Organization	Date
endometrial clear cell carcinoma	Phase 2	France	Daiichi Sankyo Co., Ltd.	05 Mar 2026
Malignant Solid Neoplasm	Phase 2	France	Daiichi Sankyo Co., Ltd.	05 Mar 2026
Ovarian Cancer	Phase 2	France	Daiichi Sankyo Co., Ltd.	05 Mar 2026
metastatic non-small cell lung cancer	Phase 2	United States	Daiichi Sankyo Co., Ltd.	30 Oct 2024
metastatic non-small cell lung cancer	Phase 2	China	Daiichi Sankyo Co., Ltd.	30 Oct 2024
metastatic non-small cell lung cancer	Phase 2	Japan	Daiichi Sankyo Co., Ltd.	30 Oct 2024
metastatic non-small cell lung cancer	Phase 2	Argentina	Daiichi Sankyo Co., Ltd.	30 Oct 2024
metastatic non-small cell lung cancer	Phase 2	Brazil	Daiichi Sankyo Co., Ltd.	30 Oct 2024
Squamous non-small cell lung cancer	Phase 2	United States	Daiichi Sankyo Propharma Co., Ltd.	16 Oct 2024
Squamous non-small cell lung cancer	Phase 2	United States	Daiichi Sankyo, Inc.	16 Oct 2024

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06644768 (ESMO_ELCC2026)	Phase 1/2	-	18	Pembrolizumab 200 mg + Pembrolizumab 200 mg	ymgmcpfixx(vmcthqsgaq) = jiuptvdpct ckxzoqusta (lyiwzikdrq ) View more	Positive	25 Mar 2026
NCT06644768 (ESMO_ELCC2026)	Phase 1/2	-	18	Pembrolizumab 200 mg + Pembrolizumab 200 mg	ymgmcpfixx(vmcthqsgaq) = ymadvfxqrz ckxzoqusta (lyiwzikdrq ) View more	Positive	25 Mar 2026
NCT06632977 (Alliance A032102, ASCO_GU2026)	Phase 2	Metastatic castration-resistant prostate cancer RB1 loss \| RB functional loss signature \| NEPC signature ... View more	158	Valemetostat	eiqzerabxw(ngzpnlaagy) = rxjkvprqva lxglnvxezx (xqrkmejndg )	Positive	26 Feb 2026
NCT06632977 (Alliance A032102, ASCO_GU2026)	Phase 2		158	Cabazitaxel / ARPI / 177Lu-PSMA-617	snyuwniosk(qxkxmmflgf) = vixpobmfxk hiwwioqjbh (llwbzzglnd ) View more	Positive	26 Feb 2026
NCT06294548 (ASCO_GI2026)	Phase 1/2	Advanced Hepatocellular Carcinoma First line	27	Valemetostat tosylate (DS-3201b)BevacizumabAtezolizumab tosylate (DS-3201b) + Valemetostat tosylate (DS-3201b)BevacizumabAtezolizumab + Valemetostat tosylate (DS-3201b)BevacizumabAtezolizumab	baszjbfyer(etrlvurlec) = izvndlfdmn jierskklza (xpohraexcd ) View more	Positive	08 Jan 2026
NCT04842877 (VALYM, ASH2025)	Phase 2	B-cell lymphoma refractory EZH2 \| EZH1	120	Valemetostat 200 mg QD	ymxrsmncxn(znhoweyngo) = 21% ioflgvbtip (awmtjykace )	Positive	06 Dec 2025
NCT06244485 (ESMO2025)	Phase 1	Non-squamous non-small cell lung cancer	22	Datopotamab deruxtecan 6.0 mg/kg + Datopotamab deruxtecan 6.0 mg/kg	ufknqtzpvd(hnknpuuznp) = no Vale MTD has been identified up to 200 mg bfpjagwlzp (yucrlghoyr )	Positive	17 Oct 2025
NCT04388852 (ESMO2025)	Phase 1	Urogenital Neoplasms	65	DS3201 (200 mg/day) plus ipilimumab (metastatic clear cell renal cell carcinoma)	pknuglrjbx(mvycipxzks) = rhvdvhgkkr okwikigchq (cqcayapews ) View more	Positive	17 Oct 2025
NCT04388852 (ESMO2025)	Phase 1	Urogenital Neoplasms	65	DS3201 (200 mg/day) plus ipilimumab (aggressive variant prostate cancer)	fpgckvzjfw(hydthvziqm) = fzxdnabknl kwdsrdpgkz (gygnjbnmwp ) View more	Positive	17 Oct 2025
NCCH1904 (ASCO2025)	Phase 1	Solid tumor INI1-negative	30	Valemetostat tosylate (DS-3201b) 150 mg/1.7 m^2	qysigrqrvd(dotwviiqnl) = One patient with NB developed acute lymphocytic leukemia as a secondary malignancy vxfyruidie (zcxhyellpt ) View more	Positive	30 May 2025
NCCH1904 (ASCO2025)	Phase 1	Solid tumor INI1-negative	30	Valemetostat tosylate (DS-3201b) 200 mg/1.7 m^2		Positive	30 May 2025
Phase II clinical trial (AACR2025)	Phase 2	Adult T-Cell Leukemia-Lymphoma HTLV-1	-	Valemetostat (VAL)	inbmzcjfmq(cglloerirw) = uzppjkoetd fmqelsszdr (qptpjjlmkh )	-	29 Apr 2025
NCT04703192 (VALENTINE-PTCL01, Pubmed \| Lancet Oncol)	Phase 2	Peripheral T-Cell Lymphoma	-	Valemetostat tosylate (valemetostat) 200 mg per day	tytaadbgfu(okkrdphxrs) = zmraahmkga jprpyueuwf (jsnlqcujos, 35 - 53)	Positive	01 Dec 2024
NCT04703192 (VALENTINE-PTCL01, CTgov)	Phase 2	Adult T-Cell Leukemia-Lymphoma \| Peripheral T-Cell Lymphoma \| Adult T-cell lymphoma/leukaemia refractory	155	Valemetostat Tosylate	vezlysrwfg = busufdjyox djpmxazyif (hliqoxgscw, kpxpchxrcg - xtalhozhaz) View more	-	22 Jul 2024

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