Articles from Daiichi Sankyo

The first patient has been dosed in the TROPION-Lung12 phase 3 trial evaluating the efficacy and safety of adjuvant DATROWAY® (datopotamab deruxtecan) plus rilvegostomig or rilvegostomig monotherapy versus standard of care in patients with stage 1 adenocarcinoma non-small cell lung cancer (NSCLC) after complete surgical resection who are ctDNA-positive or have other high risk pathological features.

Daiichi Sankyo (TSE: 4568) and AstraZeneca’s (LSE/STO/Nasdaq: AZN) ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been approved in the U.S. for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer, as determined by an FDA-approved test, that has progressed on one or more endocrine therapies in the metastatic setting.

DATROWAY® (datopotamab deruxtecan-dlnk) has been approved in the U.S. for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.

The first patient has been dosed in the QuANTUM-Wild phase 3 trial evaluating Daiichi Sankyo’s (TSE: 4568) VANFLYTA® (quizartinib) in combination with standard intensive induction and consolidation chemotherapy followed by single-agent maintenance in adults with newly diagnosed FLT3-ITD negative acute myeloid leukemia (AML).

A pooled analysis of the TROPION-Lung05 phase 2 and the TROPION-Lung01 phase 3 trials showed datopotamab deruxtecan (Dato-DXd) demonstrated clinically meaningful tumor response in patients with previously treated advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC). These data, along with progression-free and overall survival results from the analysis, were presented during a late-breaking proffered paper session (LBA7) at the 2024 ESMO Asia (#ESMOAsia24) Congress.

Daiichi Sankyo (TSE: 4568) will present new clinical research across its oncology portfolio with more than 45 abstracts in multiple types of solid and blood cancers at the 2024 ESMO Asia Congress (#ESMOAsia24), San Antonio Breast Cancer Symposium (#SABCS24) and American Society of Hematology (#ASH24) Annual Meeting prior to its Science & Technology Day.

Daiichi Sankyo (TSE: 4568) will highlight new clinical research and real-world data from seven abstracts for TURALIO® (pexidartinib) at the Connective Tissue Oncology Society (#CTOS2024) 2024 Annual Meeting.

Daiichi Sankyo (TSE: 4568) and AstraZeneca (LSE/STO/Nasdaq: AZN) have submitted a new Biologics License Application (BLA) for accelerated approval in the U.S. for datopotamab deruxtecan (Dato-DXd) for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFR-mutated) non-small cell lung cancer (NSCLC) who have received prior systemic therapies, including an EGFR-directed therapy.

Daiichi Sankyo (TSE:4568) and AstraZeneca (LSE/STO/Nasdaq: AZN) have been awarded The Galien Foundation 2024 Prix Galien USA Award for Best Biotechnology Product for ENHERTU® (fam-trastuzumab deruxtecan-nxki).

The first patients have been dosed in three global, randomized phase 3 trials evaluating the efficacy and safety of datopotamab deruxtecan (Dato-DXd)-based combinations in patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC).

Daiichi Sankyo (TSE: 4568) and AstraZeneca's (LSE/STO/Nasdaq: AZN) supplemental Biologics License Application (sBLA) for ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been accepted and granted Priority Review in the U.S. for the treatment of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer who have received at least one endocrine therapy in the metastatic setting.

Topline results from the TROPION-Breast01 phase 3 trial of datopotamab deruxtecan (Dato-DXd) compared to investigator’s choice of chemotherapy, which previously met the dual primary endpoint of progression-free survival (PFS), did not achieve statistical significance in the final overall survival (OS) analysis in patients with inoperable or metastatic hormone receptor (HR) positive, HER2 low or negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer previously treated with endocrine-based therapy and at least one systemic therapy.

The HERTHENA-Lung02 phase 3 trial evaluating patritumab deruxtecan in patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who received prior EGFR tyrosine kinase inhibitor (TKI) treatment met its primary endpoint of progression-free survival (PFS), demonstrating a statistically significant improvement versus platinum plus pemetrexed induction chemotherapy followed by pemetrexed maintenance chemotherapy. Overall survival (OS) data were immature at the time of the analysis and the trial will continue to further assess OS, a secondary endpoint.

Initial results from dose escalation in the first-in-human phase 1 trial of DS-9606 suggest early promising clinical activity in patients with advanced solid tumors known to express Claudin-6 (CLDN6). These data were presented today during a Proffered Paper session (610O) at the 2024 European Society for Medical Oncology (#ESMO24).

Results from the DESTINY-Breast12 phase 3b/4 trial showed that ENHERTU® (trastuzumab deruxtecan) demonstrated substantial overall and intracranial clinical activity in a large cohort of patients with HER2 positive metastatic breast cancer who have brain metastases and received no more than two prior lines of therapy in the metastatic setting. Results will be presented today as a late-breaking proffered paper presentation (LBA18) at the European Society for Medical Oncology (#ESMO24) and simultaneously published in Nature Medicine.

Detailed results from the TROPION-Lung01 phase 3 trial showed a clinically meaningful trend toward improving overall survival (OS) with datopotamab deruxtecan (Dato-DXd) compared to docetaxel, the current standard of care chemotherapy, in adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) treated with at least one prior line of therapy. Results will be presented today during an oral presentation (OA08.03) at the IASLC 2024 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer (#WCLC24) and simultaneously published in the Journal of Clinical Oncology.

Results from an exploratory analysis of the TROPION-Lung01 phase 3 trial showed TROP2 as measured by quantitative continuous scoring (QCS), AstraZeneca’s proprietary computational pathology platform, was predictive of clinical outcomes in patients with advanced or metastatic non-small cell lung cancer (NSCLC) who were treated with datopotamab deruxtecan (Dato-DXd). In patients with TROP2-QCS biomarker positive tumors, datopotamab deruxtecan demonstrated a meaningfully greater magnitude of efficacy versus docetaxel than in the overall trial population. Results will be presented today during a Presidential Symposium (PL02.11) at the IASLC 2024 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer (#WCLC24).

Results from an interim analysis of the dose-optimization part of the ongoing IDeate-Lung01 phase 2 trial showed ifinatamab deruxtecan (I-DXd) continues to demonstrate promising objective response rates in patients with pretreated extensive-stage small cell lung cancer (ES-SCLC). These data were featured today as part of a press conference and will be presented during an oral presentation (OA04.03) on Sunday at the 2024 World Conference on Lung Cancer (#WCLC24) hosted by the International Association for the Study of Lung Cancer.

Daiichi Sankyo (TSE: 4568) will present new clinical research across its antibody drug conjugate (ADC) portfolio with more than 25 abstracts across multiple types of cancer at the IASLC 2024 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer (#WCLC24) and the 2024 European Society for Medical Oncology (#ESMO24).

ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been granted Breakthrough Therapy Designation (BTD) in the U.S. for the treatment of unresectable or metastatic hormone receptor positive HER2 low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (IHC >0 <1+) breast cancer patients who have received either two lines of endocrine therapy in the metastatic setting, or one line of endocrine therapy if they had demonstrated disease progression within six months of starting first-line treatment with endocrine therapy in combination with a CDK4/6 inhibitor or within 24 months of the start of adjuvant endocrine therapy.

Daiichi Sankyo (TSE: 4568) and Merck (NYSEMRK), known as MSD outside of the United States and Canada, have expanded their existing global co-development and co-commercialization agreement for three investigational DXd antibody drug conjugates to include Merck’s MK-6070, an investigational delta-like ligand 3 (DLL3) targeting T-cell engager. The companies will jointly develop and commercialize MK-6070 worldwide, except in Japan where Merck will maintain exclusive rights. Merck will be solely responsible for manufacturing and supply for MK-6070.

Daiichi Sankyo (TSE: 4568) and Merck (NYSEMRK), known as MSD outside of the United States and Canada, today announced that the first patient has been dosed in the IDeate-Lung02 phase 3 trial evaluating the efficacy and safety of investigational ifinatamab deruxtecan (I-DXd) in patients with relapsed small cell lung cancer (SCLC) versus treatment of physician’s choice of chemotherapy.

The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) seeking accelerated approval of Daiichi Sankyo (TSE: 4568) and Merck’s (known as MSD outside of the United States and Canada) (NYSEMRK) patritumab deruxtecan (HER3-DXd) for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) previously treated with two or more systemic therapies.

Topline overall survival (OS) results from the TROPION-Lung01 phase 3 trial, which previously met the dual primary endpoint of progression-free survival (PFS), numerically favored datopotamab deruxtecan (Dato-DXd) compared to docetaxel in the overall trial population of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) treated with at least one prior line of therapy. Survival results did not reach statistical significance in the overall trial population. In the pre-specified subgroup of patients with nonsquamous NSCLC, datopotamab deruxtecan showed a clinically meaningful improvement in OS compared to docetaxel, the current standard of care chemotherapy.

Daiichi Sankyo (TSE: 4568) will present new clinical research across its oncology portfolio with more than 45 abstracts in multiple cancers at the 2024 American Society of Clinical Oncology Scientific Program (#ASCO24).

Positive topline results from the DESTINY-Breast06 phase 3 trial showed that ENHERTU® (trastuzumab deruxtecan) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to standard of care chemotherapy in the primary trial population of patients with HR positive, HER2 low (IHC 1+ or IHC 2+/ISH-) metastatic breast cancer following one or more lines of endocrine therapy.

Daiichi Sankyo (TSE: 4568) and AstraZeneca’s (LSE/STO/Nasdaq: AZN) ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been approved in the U.S. for the treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Daiichi Sankyo (TSE: 4568) and Merck (NYSEMRK), known as MSD outside of the United States and Canada, announced today that the first patient has been dosed in the REJOICE-Ovarian01 phase 2/3 trial evaluating the efficacy and safety of investigational raludotatug deruxtecan (R-DXd) in patients with platinum-resistant ovarian cancer. The phase 2 portion of the trial will be conducted to identify the dose of raludotatug deruxtecan to be used in the phase 3 part of the trial, which will evaluate raludotatug deruxtecan versus investigator’s choice of chemotherapy.

Daiichi Sankyo (TSE: 4568) and AstraZeneca's (LSE/STO/Nasdaq: AZN) supplemental Biologics License Application (sBLA) for ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been accepted and granted Priority Review in the U.S. for the treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+) solid tumors who have received prior treatment or who have no satisfactory alternative treatment options.

Daiichi Sankyo (TSE: 4568) and Merck (known as MSD outside of the United States and Canada) (NYSEMRK) announced today that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to the Biologics License Application (BLA) for patritumab deruxtecan (HER3-DXd) for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) previously treated with two or more systemic therapies.

The first patient has been dosed in two global, randomized phase 3 trials evaluating the efficacy and safety of Daiichi Sankyo (TSE: 4568) and AstraZeneca’s (LSE/STO/Nasdaq: AZN) datopotamab deruxtecan (Dato-DXd) in combination with durvalumab, AstraZeneca’s anti-PD-L1 therapy, in two types of breast cancer.

Daiichi Sankyo (TSE: 4568) will present new clinical research across its oncology portfolio in multiple types of solid and blood cancers at the 2023 ESMO Asia Congress (#ESMOAsia23), San Antonio Breast Cancer Symposium (#SABCS23) and American Society of Hematology (#ASH23) Annual Meeting prior to its annual R&D Day.

Positive results from the ongoing DESTINY-PanTumor02 phase 2 trial showed that ENHERTU® (trastuzumab deruxtecan) continued to demonstrate clinically meaningful and durable responses, leading to a clinically meaningful survival benefit in previously treated patients across multiple HER2 expressing advanced solid tumors. These results, which include the first progression-free survival (PFS) and overall survival (OS) findings reported from the trial, will be presented today as a late-breaking mini-oral session (LBA34) at the European Society for Medical Oncology (#ESMO23) 2023 Congress and simultaneously published in the Journal of Clinical Oncology.

Positive results from the pivotal TROPION-Lung01 phase 3 trial showed that datopotamab deruxtecan (Dato-DXd) demonstrated a statistically significant improvement for the primary endpoint of progression-free survival (PFS) compared to docetaxel, the current standard of care, in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) treated with at least one prior line of therapy. These data, the second of two positive late-breaking presentations (LBA12) from the datopotamab deruxtecan clinical development program, were featured during Presidential Symposium 3 at the European Society for Medical Oncology (#ESMO23) 2023 Congress.

Positive results from the pivotal TROPION-Breast01 phase 3 trial showed that datopotamab deruxtecan (Dato-DXd) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to investigator’s choice of chemotherapy in patients with inoperable or metastatic hormone receptor (HR) positive, HER2 low or negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer previously treated with endocrine-based therapy and at least one systemic therapy. These data, the first of two positive late-breaking presentations (LBA11) from the datopotamab deruxtecan clinical development program, were featured during Presidential Symposium 3 at the European Society for Medical Oncology (#ESMO23) 2023 Congress.

Updated results from the BEGONIA phase 1b/2 trial for the cohort of patients treated with datopotamab deruxtecan (Dato-DXd) plus durvalumab (Arm 7) showed that the combination demonstrated durable tumor responses and no new safety signals in patients with previously untreated advanced or metastatic triple negative breast cancer (TNBC) with six months additional follow-up from the previous data cut-off. These results were presented today during a mini oral session (379MO) at the European Society for Medical Oncology (#ESMO23) 2023 Congress.

Daiichi Sankyo (TSE: 4568) and Merck (known as MSD outside of the United States and Canada) (NYSEMRK) have entered into a global development and commercialization agreement for three of Daiichi Sankyo’s DXd antibody drug conjugate (ADC) candidates: patritumab deruxtecan (HER3-DXd), ifinatamab deruxtecan (I-DXd) and raludotatug deruxtecan (R-DXd). The companies will jointly develop and potentially commercialize these ADC candidates worldwide, except in Japan where Daiichi Sankyo will maintain exclusive rights. Daiichi Sankyo will be solely responsible for manufacturing and supply.

Daiichi Sankyo (TSE: 4568) will present new clinical research across its DXd antibody drug conjugate (ADC) portfolio in multiple types of cancer at the 2023 European Society for Medical Oncology (#ESMO23) Congress to be held October 20 - 24, 2023. Three late-breaking abstracts, including two Presidential Symposia presentations, are among the more than 20 abstracts showcasing Daiichi Sankyo’s leadership and progress in developing new standards of care for patients with cancer.

Positive topline results from the TROPION-Breast01 phase 3 trial showed datopotamab deruxtecan (Dato-DXd) demonstrated a statistically significant and clinically meaningful improvement for the primary endpoint of progression-free survival (PFS) compared to investigator’s choice of chemotherapy in patients with inoperable or metastatic hormone receptor (HR) positive, HER2 low or negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer previously treated with endocrine-based therapy and at least one systemic therapy.

Results from the primary analysis of the DESTINY-Lung02 phase 2 trial showed ENHERTU® (trastuzumab deruxtecan) continued to demonstrate strong and durable tumor responses in previously treated patients with HER2 mutant unresectable and/or metastatic non-squamous non-small cell lung cancer (NSCLC). These results, along with the first report on progression-free survival (PFS) and overall survival (OS), were presented today (MA 13.10) at the IASLC 2023 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer (#WCLC23) and simultaneously published in the Journal of Clinical Oncology.

Initial results from the TROPION-Lung04 phase 1b trial showed that datopotamab deruxtecan (Dato-DXd) in combination with durvalumab, an anti-PD-L1 therapy, with or without carboplatin demonstrated encouraging responses and no new safety signals in patients with previously untreated advanced or metastatic non-small cell lung cancer (NSCLC) without actionable genomic alterations. These data were presented today during a late-breaking oral presentation (OA05.06) at the IASLC 2023 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer (#WCLC23).

Updated results from a subgroup analysis of a phase 1/2 trial showed that ifinatamab deruxtecan (I-DXd) continues to demonstrate durable responses in patients with heavily pretreated advanced small cell lung cancer (SCLC). These data were presented today during an oral presentation (OA05.05) at the 2023 World Conference on Lung Cancer (#WCLC23) hosted by the International Association for the Study of Lung Cancer.

Results from the HERTHENA-Lung01 phase 2 trial showed that patritumab deruxtecan (HER3-DXd) demonstrated clinically meaningful and durable responses in patients with EGFR-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) following disease progression with an EGFR TKI and platinum-based chemotherapy. These data were presented today during an oral presentation (OA05.03) at the 2023 World Conference on Lung Cancer (#WCLC23) and simultaneously published in the Journal of Clinical Oncology.

Daiichi Sankyo (TSE: 4568) announced today that the first patient has been dosed in a first-in-human phase 1/2 trial evaluating DS-3939 in patients with several types of advanced solid tumors including non-small cell lung, breast, urothelial, ovarian, biliary tract, and pancreatic cancer.

ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been granted two additional Breakthrough Therapy Designations (BTDs) in the U.S. for the treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+) solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options, and for the treatment of patients with HER2 positive (IHC 3+) metastatic colorectal cancer who have received two or more prior regimens.

Daiichi Sankyo (TSE: 4568) will present new clinical research across its DXd antibody drug conjugate (ADC) portfolio in non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) at the IASLC 2023 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer (#WCLC23) being held September 9-12, 2023.

Daiichi Sankyo (TSE: 4568) today announced that VANFLYTA® (quizartinib) is now available by prescription in the U.S. VANFLYTA is the first and only FLT3 inhibitor to be approved by the U.S. Food and Drug Administration (FDA) specifically for FLT3-ITD positive acute myeloid leukemia (AML) and across the three phases of treatment – induction, consolidation and maintenance in patients without transplant – for newly diagnosed AML.

Topline results from the primary analysis of the ongoing DESTINY-PanTumor02 phase 2 trial showed ENHERTU® (trastuzumab deruxtecan) demonstrated clinically meaningful progression-free survival (PFS) and overall survival (OS) in previously treated patients across multiple HER2 expressing advanced solid tumors, two secondary endpoints of the trial.

Daiichi Sankyo (TSE: 4568) today announced that VANFLYTA® (quizartinib) has been approved by the U.S. Food and Drug Administration (FDA) in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive as detected by an FDA-approved test. VANFLYTA is not indicated as maintenance monotherapy following allogeneic hematopoietic stem cell transplantation (HSCT); improvement in overall survival with VANFLYTA in this setting has not been demonstrated.

Topline results from the TROPION-Lung01 phase 3 trial showed datopotamab deruxtecan (Dato-DXd) demonstrated a statistically significant improvement for the dual primary endpoint of progression-free survival (PFS) compared to docetaxel, the current standard of care chemotherapy, in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) treated with at least one prior therapy.

Updated results from the TROPION-Lung02 phase 1b trial showed that with additional enrollment and follow-up from the initial presentation datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab with or without platinum-based chemotherapy demonstrated promising clinical activity and no new safety signals in both previously untreated or pretreated patients with advanced or metastatic non-small cell lung cancer (NSCLC) without actionable genomic alterations (AGAs). Results will be presented on June 6 during an oral presentation (#9004) at the American Society of Clinical Oncology Annual Meeting (#ASCO23).

Positive results from an interim analysis of the ongoing DESTINY-PanTumor02 phase 2 trial showed that ENHERTU® (trastuzumab deruxtecan) demonstrated clinically meaningful and durable responses across a broad range of HER2 expressing advanced solid tumors in previously treated patients. These results will be presented today as a late-breaking oral presentation (abstract #LBA3000) at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting.

Daiichi Sankyo (TSE: 4568) will present new clinical research across its oncology portfolio at the 2023 American Society of Clinical Oncology Scientific Program (#ASCO23) and the European Hematology Association Congress (#EHA23).

Daiichi Sankyo (TSE: 4568) today announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) of quizartinib in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and as continuation monotherapy following consolidation, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive.

New data from Daiichi Sankyo’s (TSE: 4568) patritumab deruxtecan (HER3-DXd) from two early trials in patients with previously treated EGFR-mutated metastatic non-small cell lung cancer (NSCLC) (#PS1-2) or HER3 expressing metastatic breast cancer (#PS2-4) were presented during two Presidential Sessions at the Japanese Society of Medical Oncology (#JSMO2023) Annual Meeting.

Positive topline results from an analysis of the ongoing DESTINY-PanTumor02 phase 2 trial showed treatment with Daiichi Sankyo and AstraZeneca’s ENHERTU® (trastuzumab deruxtecan) met the pre-specified target for objective response rate (ORR) and demonstrated durable response across multiple HER2 expressing advanced solid tumors in heavily pre-treated patients.

Daiichi Sankyo (TSE: 4568) today announced that the new dosing regimen for TURALIO® (pexidartinib) is now available in the U.S. for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery. A new 125 mg capsule of TURALIO is now available and the 200 mg capsule has been discontinued.

Daiichi Sankyo (TSE: 4568) today announced that the first patient has been dosed in the global, randomized TROPION-Lung07 phase 3 trial evaluating datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab with or without platinum chemotherapy, in patients with previously untreated advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with PD-L1 expression less than 50% (TPS<50%) and without actionable genomic alterations.

Updated results from the TROPION-PanTumor01 phase 1 trial showed datopotamab deruxtecan (Dato-DXd) continued to demonstrate encouraging responses in patients with heavily pretreated metastatic triple negative breast cancer (TNBC) and disease progression following standard treatment. Results were presented today as a poster presentation (Abstract #P6-10-03) at the 2022 San Antonio Breast Cancer Symposium (#SABCS22).

Initial results from the TROPION-PanTumor01 phase 1 trial of datopotamab deruxtecan (Dato-DXd) showed encouraging and durable efficacy in patients with heavily pretreated hormone receptor (HR) positive, HER2 low (immunohistochemistry [IHC] 1+ or IHC 2+/in-situ hybridization [ISH]-) or HER2 negative (IHC 0) unresectable or metastatic breast cancer. Safety data were consistent with previous trials of datopotamab deruxtecan. Results were presented today as a Spotlight Poster Discussion (Abstract #PD13-08) at the 2022 San Antonio Breast Cancer Symposium (#SABCS22).

Updated results from the DESTINY-Breast03 phase 3 trial (Abstract #GS2-02) showed that ENHERTU® (trastuzumab deruxtecan) demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) compared to trastuzumab emtansine (T-DM1) in patients with HER2 positive unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane. These results and primary results from the DESTINY-Breast02 phase 3 trial (Abstract #GS2-01) will be presented today at the 2022 San Antonio Breast Cancer Symposium (#SABCS22), with the updated results from DESTINY-Breast03 simultaneously published in The Lancet.

Daiichi Sankyo (TSE: 4568) continues to boldly challenge the breast cancer treatment landscape with the presentation of 30 abstracts from its innovative DXd antibody drug conjugate (ADC) portfolio at the 2022 San Antonio Breast Cancer Symposium (#SABCS22) to be held December 6 to 10, 2022.

Daiichi Sankyo (TSE: 4568) received notification of acceptance by the U.S. Food and Drug Administration (FDA) of the New Drug Application (NDA) of quizartinib in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and as continuation monotherapy following consolidation, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive. The application has been granted Priority Review.

Detailed positive results from an interim analysis of the DESTINY-Lung02 phase 2 trial showed ENHERTU® (trastuzumab deruxtecan) demonstrated clinically meaningful tumor responses in previously treated patients with HER2 mutant unresectable and/or metastatic non-squamous non-small cell lung cancer (NSCLC). Results will be presented today as a late breaking presentation (LBA55) at the European Society for Medical Oncology (#ESMO22) 2022 Congress.

Daiichi Sankyo (TSE: 4568) and Sarah Cannon Research Institute (SCRI) announced that extended follow-up data from a phase 1/2 trial of DS-7300, a specifically designed potential first-in-class B7-H3 directed DXd antibody drug conjugate (ADC), continues to show promising durable tumor response in patients with several types of heavily pretreated cancers including lung, prostate or esophageal cancer. These data were presented today in a Proffered Paper session (Abstract #453O) at the European Society of Medical Oncology (#ESMO22) Congress.

Daiichi Sankyo (TSE: 4568) continues to make bold strides in oncology with the presentation of new clinical research across its innovative DXd antibody drug conjugate (ADC) portfolio in a broad range of cancers including lung, breast, gastric, esophageal and prostate at the 2022 European Society for Medical Oncology (#ESMO22) Congress to be held September 9 to 13, 2022.

Positive topline results from the DESTINY-Breast02 phase 3 trial of ENHERTU® (trastuzumab deruxtecan) versus physician’s choice of treatment showed the trial met the primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) in patients with HER2 positive unresectable and/or metastatic breast cancer previously treated with trastuzumab emtansine (T-DM1). The trial also met the key secondary endpoint of improved overall survival.

An arbitrator issued a decision today in a dispute between Daiichi Sankyo Company, Ltd. and Seagen, Inc., denying all claims made by Seagen. Specifically, Daiichi Sankyo retains all patent rights to its antibody drug conjugate (ADC) technology and will continue to develop and commercialize these medicines as planned.

Daiichi Sankyo (TSE: 4568) and AstraZeneca’s (LSE/STO/Nasdaq: AZN) ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been approved in the U.S. for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DoR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Initial results from the TROPION-Lung02 phase 1b trial showed that datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab with or without platinum chemotherapy demonstrated promising clinical activity and a tolerable safety profile in patients with previously untreated or pretreated advanced or metastatic non-small cell lung cancer (NSCLC) without actionable genomic alterations. Results were presented today during a late-breaking mini-oral presentation (#MA13.07) at the IASLC 2022 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer (#WCLC22).

Daiichi Sankyo (TSE: 4568) announced today that the first patient has been dosed in the global HERTHENA-Lung02 phase 3 trial evaluating the efficacy and safety of patritumab deruxtecan (HER3-DXd) versus platinum-based chemotherapy in patients with EGFR-mutated locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with disease progression following treatment with one or more EGFR tyrosine kinase inhibitors (TKIs) including a third-generation EGFR TKI.

Daiichi Sankyo (TSE: 4568) and AstraZeneca’s (LSE/STO/Nasdaq: AZN) ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been approved in the U.S. for the treatment of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy.

Daiichi Sankyo (TSE: 4568) and AstraZeneca (LSE/STO/Nasdaq: AZN) have received notification of acceptance by the U.S. Food and Drug Administration (FDA) of the supplemental Biologics License Application (sBLA) of ENHERTU® (fam-trastuzumab deruxtecan-nxki) for the treatment of adult patients with unresectable or metastatic HER2 low (immunohistochemistry (IHC) 1+ or IHC 2+/in-situ hybridization (ISH)-negative) breast cancer who have received a prior therapy in the metastatic setting. The application has been granted Priority Review.

Daiichi Sankyo (TSE: 4568) announced today that the first patient has been dosed in a global phase 2 trial evaluating the efficacy and safety of DS-7300 in patients with pretreated extensive-stage small cell lung cancer (SCLC). DS-7300 is a specifically designed potential first-in-class B7-H3 directed antibody drug conjugate (ADC) discovered and being developed by Daiichi Sankyo.

Daiichi Sankyo (TSE: 4568) today announced that the first patient was dosed in the global TROPION-Breast02 phase 3 trial evaluating the efficacy and safety of datopotamab deruxtecan (Dato-DXd) versus investigator’s choice of chemotherapy in patients with previously untreated locally recurrent inoperable or metastatic triple negative breast cancer (TNBC) not eligible to receive PD-1/PD-L1 inhibitor therapy.