Datopotamab Deruxtecan

Revenue increased 19.7% to 1.167 trillion yen year-over-year driven by Enhertu ® and Datroway ® Fiscal year 2026 guidance for revenue and operating profit remains unchanged Earnings call to take place on Friday, October 30 at 5:30 pm Japan Standard Time TOKYO--(BUSINESS WIRE)--Daiichi Sankyo (TSE: 4568) reported financial results for the second quarter of fiscal year 2026, ending September 30, 2026. “Strong revenue growth continues in the second quarter of fiscal year 2026, driven by Enhertu and Datroway. These medicines have received nine new approvals across multiple indications since last quarter, including same day breast cancer approvals in Japan and China, which will allow us to bring these medicines to more patients,” said Hiroyuki Okuzawa, President and CEO of Daiichi Sankyo. “We also continue to explore novel combination strategies to deliver greater benefits to more patients through our DXd antibody drug conjugates as demonstrated by our new clinical trial collaboration to evaluate Datroway with ivonescimab.” Q2 FY2026 Results Global revenue increased 19.7% year-over-year to 1.167 trillion yen, driven by the company’s global oncology medicines. Operating profit increased 34.4% year-over-year to 193.8 billion yen. Global revenue was driven by Enhertu ® and Datroway ® , the company's two lead antibody drug conjugates (ADCs). Enhertu revenue, including milestone payments, was 500.0 billion yen, a 51.4% increase year-over-year. Datroway revenue, including milestone payments, was 54.4 billion yen, a 161.6% increase year-over-year. Revenue from the Oncology Business in the U.S., Europe and Canada was 422.6 billion yen, a year-over-year increase of 54.8%, with revenue driven by Enhertu and Datroway. Japan Business was 232.7 billion yen, a year-over-year decrease of 6.9%, with revenue driven by Lixiana ® , Tarlige ® , Enhertu and Pralia ® . ASCA (Asia, South and Central America) Business revenue was 142.5 billion yen, a 20.9% year-over-year increase, driven by Enhertu. European Union (EU) Specialty Business revenue was 149.2 billion yen, a 9.1% year-over-year increase, driven by Lixiana and Nilemdo ® /Nustendi ® . Full fiscal year 2026 guidance remains unchanged. Global revenue is anticipated to reach 2.34 trillion yen with an operating profit of 320.0 billion yen. Further details on financial performance can be found in the Financial Results Presentation Material . Daiichi Sankyo will host an investor and media conference call and webcast to discuss Q2 FY2026 results on Friday, October 30 at 5:30 pm Japan Standard Time. Q2 FY2026 and Recent Portfolio / Pipeline Highlights Daiichi Sankyo continued to advance its portfolio and pipeline with several milestones across its oncology portfolio, demonstrating momentum towards its goal of launching 20 new indications across five medicines by 2030. Eight additional breast cancer approvals for Enhertu and Datroway were received in China, the EU and Japan since Q1 FY2026. These approvals included Enhertu in combination with pertuzumab for the first-line treatment of patients with HER2 positive metastatic breast cancer based on DESTINY-Breast09 and Datroway for the first-line treatment of patients with unresectable or metastatic triple negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy based on TROPION-Breast02 . Additional approvals of Enhertu in the adjuvant setting of HER2 positive early breast cancer based on DESTINY-Breast05 were received in China and the EU. Enhertu also was approved for a tumor agnostic indication in China based on four phase 2 trials, including DESTINY-PanTumor02 , DESTINY-Lung01 , DESTINY-CRC02 and DESTINY-PanTumor03 . Data from DESTINY-Lung04 were presented during Presidential Symposium 2 at the IASLC 2026 World Conference on Lung Cancer, which showed Enhertu demonstrated a statistically significant and clinically meaningful improvement in progression-free survival versus global standard of care (platinum-pemetrexed doublet chemotherapy plus pembrolizumab) as a first-line treatment of patients with unresectable, locally advanced or metastatic HER2 mutant non-squamous non-small cell lung cancer (NSCLC). The results will be shared with global regulatory authorities for a potential new indication for Enhertu in this lung cancer setting. The Biologics License Application seeking accelerated approval in the U.S. for ifinatamab deruxtecan (I-DXd) for the treatment of patients with extensive-stage small cell lung cancer (ES-SCLC) was voluntarily withdrawn. Patient enrollment is near completion in the IDeate-Lung02 phase 3 trial, where these results may support the potential global submissions of ifinatamab deruxtecan for relapsed ES-SCLC. Daiichi Sankyo and AstraZeneca entered into a clinical trial collaboration agreement with Summit Therapeutics Inc. to evaluate Datroway in combination with ivonescimab across multiple tumor types including lung and breast cancers. The companies intend to begin the collaboration with a phase 3 trial in first-line TNBC. Separately, the TROPION-Urothelial04 phase 3 trial evaluating Datroway as an adjuvant combination treatment in patients with muscle invasive urothelial cancer was initiated. Medicine Indication Q2 FY2026 and Recent Portfolio Updates Enhertu Breast Enhertu Approved in the EU as Adjuvant Treatment for Patients with Residual Disease After Neoadjuvant Treatment for HER2 Positive Early Breast Cancer ( October 2026 ) Enhertu Approved in China as Adjuvant Treatment for Patients with Residual Disease After Neoadjuvant Treatment for HER2 Positive Early Breast Cancer ( October 2026 ) Enhertu and Datroway Approved in Japan for Two New First-Line Indications for Patients with Metastatic Breast Cancer ( September 2026 ) Enhertu Plus Pertuzumab Approved in the EU as First New Regimen in More than a Decade for First-Line Treatment of Patients with HER2 Positive Metastatic Breast Cancer ( September 2026 ) Enhertu Plus Pertuzumab Approved in China as First-Line Treatment for Patients with HER2 Positive Metastatic Breast Cancer ( August 2026 ) Lung Enhertu Demonstrated a Median Progression-Free Survival of 14.3 Months as First-Line Therapy in Patients with HER2 Mutant Advanced Non-Small Cell Lung Cancer in DESTINY-Lung04 Phase 3 Trial ( September 2026 ) Tumor Agnostic Enhertu Approved in China as First and Only Tumor Agnostic HER2 Directed Medicine and Antibody Drug Conjugate for Previously Treated Patients with HER2 Positive Metastatic Solid Tumors ( October 2026 ) Datroway Breast and Lung Daiichi Sankyo and AstraZeneca Enter into Clinical Trial Collaboration with Summit Therapeutics to Evaluate Datroway in Combination with Ivonescimab Across Multiple Tumor Types ( October 2026 ) Breast Datroway Approved in China as First and Only TROP2 Directed Antibody Drug Conjugate with Overall Survival Benefit for Treatment of Patients with Metastatic Triple Negative Breast Cancer Who Are Not Candidates for PD 1/PD-L1 Inhibitor Therapy ( October 2026 ) Enhertu and Datroway Approved in Japan for Two New First-Line Indications for Patients with Metastatic Breast Cancer ( September 2026 ) Datroway Approved in the EU as Only TROP2 Directed Medicine with Overall Survival Benefit for the First-Line Treatment of Patients with Metastatic TNBC Who Are Not Candidates for Immunotherapy ( July 2026 ) Datroway Urothelial TROPION-Urothelial04 Phase 3 Trial of Datroway Initiated as Adjuvant Therapy in Patients with High-Risk Muscle Invasive Urothelial Cancer ( August 2026 ) I-DXd Lung Ifinatamab Deruxtecan Biologics License Application for Certain Patients with Previously Treated Extensive-Stage Small Cell Lung Cancer Voluntarily Withdrawn ( September 2026 ) Corporate Highlights Daiichi Sankyo appointed Ken Keller to the newly created role of Chief Commercialization Officer effective April 1, 2027, where he will be responsible for accelerating further growth of the company’s oncology and specialty medicine business through a new globally integrated Commercialization Unit. Daiichi Sankyo received a favorable judgment from the Tokyo District Court dismissing all damage claims filed by Northern TK Venture (NTK). About Daiichi Sankyo Daiichi Sankyo (TSE: 4568) is a global healthcare company committed to being a trusted healthcare innovator, contributing to the enrichment of quality of life around the world through its strengths in science and technology. At Daiichi Sankyo, we believe progress depends on asking more of science, challenging assumptions and pursuing better answers. Progress like this is built by people who never stop learning, questioning and pushing what's possible. Together, we work to bring new breakthrough medicines within reach for patients and help shape what comes next in oncology and beyond. For more information, please visit and connect with us on LinkedIn . Forward-Looking Statements Management strategies and plans, financial forecasts, future projections and policies, and R&D information that Daiichi Sankyo discloses in this material are all classified as Daiichi Sankyo’s future prospects. These forward-looking statements, including words such as “advance,” “anticipate,” “favorable,” “goal,” “momentum,” and “progress” were determined by Daiichi Sankyo based on information obtained as of today with certain assumptions, premises and future forecasts, and thus, there are various inherent risks as well as uncertainties involved. As such, please note that actual results of Daiichi Sankyo may diverge materially from the outlook of Daiichi Sankyo or the content of this material. Furthermore, there is no assurance that any forward-looking statements in this material will be realized. Regardless of the actual results or facts, Daiichi Sankyo is not obliged and does not have in its policy the duty to update the content of this material from the date of this material onward. Some of the compounds under discussion are investigational agents and are not approved by the FDA or any other regulatory agency worldwide as a treatment for indications under investigation. Efficacy and safety have not been established in areas under investigation. There are no guarantees that these compounds will become commercially available in indications under investigation. Daiichi Sankyo takes reasonable care to ensure the accuracy of the content of this material but shall not be obliged to guarantee the absolute accuracy, appropriateness, completeness and feasibility, etc. of the information described in this material. Furthermore, any information regarding companies, organizations or any other matters outside the Daiichi Sankyo Group that is described within this material has been compiled or cited using publicly available information or other information, and Daiichi Sankyo has not performed in-house inspection of the accuracy, appropriateness, completeness and feasibility, etc. of such information, and does not guarantee the accuracy thereof. The information described in this material may be changed hereafter without notice. Accordingly, this material or the information described herein should be used at your own judgment, together with any other information you may otherwise obtain. This material does not constitute a solicitation of application to acquire or an offer to sell any security in the United States, Japan or elsewhere. This material disclosed here is for reference purposes only. Final investment decisions should be made at your own discretion. Daiichi Sankyo assumes no responsibility for any damages resulting from the use of this material or its content, including without limitation damages related to the use of erroneous information. Contacts MEDIA CONTACTS: Global: Jennifer Brennan jennifer.brennan@daiichisankyo.com +1 908 900 3183 (mobile) INVESTOR RELATIONS CONTACT: DaiichiSankyoIR_jp@daiichisankyo.com Japan: DS-PR_jp@daiichisankyo.com

Second Prix Galien Award for Daiichi Sankyo and AstraZeneca’s Enhertu following receipt of the Prix Galien USA Award in 2024 TOKYO--(BUSINESS WIRE)--Enhertu ® (trastuzumab deruxtecan) has been awarded the 2026 International Prix Galien Award for Best Biotechnology Product, a recognition awarded every two years by The Galien Foundation. This is the second award granted to Enhertu, following receipt of the Prix Galien USA Award for Best Biotechnology Product in 2024. The Prix Galien is among the global health innovation industry’s most renowned honors, recognizing outstanding biomedical and medical technology product achievements that improve the human condition, and is considered the industry’s equivalent of the Nobel Prize. Medicines that have been recognized with a National Prix Galien Award within the prior two years are eligible for the International Prix Galien Award. Enhertu was one of six nominees for the 2026 International Prix Galien Award for Best Biotechnology Product. Winners are selected by an international committee comprised of chairs from each of the member nations, including Africa, Belgium/Luxembourg, Bridges, Canada, China, France, Germany, Greece, India, Italy, Japan, Korea, Poland, Switzerland, the Netherlands, the UK and the USA. The award was presented during a ceremony at the American Museum of Natural History in New York on Thursday, October 29, 2026. Enhertu is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN). “We are honored to receive this second Prix Galien award, which recognizes the impressive advances Enhertu has made possible for certain patients with cancer around the world. Since its first U.S. approval in 2019, Enhertu has transformed the treatment and classification of metastatic breast cancer by pioneering the establishment of HER2 low and HER2 ultralow breast cancer as clinically distinct patient segments,” said Hiroyuki Okuzawa, President and CEO of Daiichi Sankyo. “Enhertu also has delivered a series of additional practice-changing results that have reshaped standards of care across early stage and metastatic settings of HER2 positive breast cancer and HER2 positive metastatic gastric cancer, while also becoming the first HER2 directed tumor agnostic medicine for HER2 positive solid tumors. We are extremely proud that scientists at Daiichi Sankyo invented the DXd antibody drug conjugate technology behind Enhertu, and we look to continue this important work through the development of additional breakthrough medicines for cancer.” The Galien Foundation fosters, recognizes and rewards excellence in scientific innovation to improve human health. Its vision is to serve as a catalyst for the development of the next generation of treatments and technologies that will transform medical practice and save lives. Founded in France in 1970 by pharmacist Roland Mehl in honor of Galen, the father of medical science and modern pharmacology, the Prix Galien is widely regarded as the equivalent of the Nobel Prize in biopharmaceutical research. About Enhertu Enhertu (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the U.S. only) is a HER2 directed ADC. Designed using the proprietary DXd ADC Technology of Daiichi Sankyo, Enhertu is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC scientific platform. Enhertu consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. Enhertu (5.4 mg/kg) followed by THP is approved in more than five countries/regions worldwide as a neoadjuvant treatment for adult patients with HER2 positive (IHC 3+ or ISH+) stage 2 or stage 3 breast cancer based on the results from the DESTINY-Breast11 trial. Enhertu (5.4 mg/kg) is approved in more than 35 countries/regions worldwide for the adjuvant treatment of adult patients with HER2 positive breast cancer who have residual invasive disease following neoadjuvant trastuzumab (with or without pertuzumab) and taxane-based treatment based on the DESTINY-Breast05 trial. Enhertu (5.4 mg/kg) in combination with pertuzumab is approved in more than 40 countries/regions worldwide as a first-line treatment for adult patients with unresectable or metastatic HER2 positive (IHC 3+ or ISH+) breast cancer, as determined by a locally or regionally approved test, based on the results from the DESTINY-Breast09 trial. Enhertu (5.4 mg/kg) is approved in more than 100 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+ or ISH+) breast cancer who have received a prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial. Enhertu (5.4 mg/kg) is approved in more than 75 countries/regions worldwide 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 a locally or regionally approved test, that have progressed on one or more endocrine therapies in the metastatic setting based on the results from the DESTINY-Breast06 trial. Enhertu (5.4 mg/kg) is approved in more than 100 countries/regions worldwide 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 systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial. Enhertu (5.4 mg/kg) is approved in more than 80 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 ( ERBB2 ) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 and/or DESTINY-Lung05 trials. Continued approval in China and the U.S. for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Enhertu (6.4 mg/kg) is approved in more than 90 countries/regions worldwide for the treatment of adult patients with locally advanced or metastatic HER2 positive (IHC 3+ or IHC 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01 , DESTINY-Gastric02 and/or DESTINY-Gastric04 trials. Enhertu (5.4 mg/kg) is approved in more than 50 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+) solid tumors who have received prior treatment and have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02 , DESTINY-Lung01 , DESTINY-CRC02, DESTINY-PanTumor03 and/or HERALD trials. Continued approval in China and the U.S. for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. About the Enhertu Clinical Development Program A comprehensive global clinical development program is underway evaluating the efficacy and safety of Enhertu as a monotherapy or in combination or sequentially with other cancer medicines across multiple HER2 targetable cancers. About the Daiichi Sankyo and AstraZeneca Collaboration Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize Enhertu in March 2019 and Datroway ® in July 2020 , except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of Enhertu and Datroway. Enhertu U.S. Indications and Important Safety Information Indications ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for: HER2-Positive Early Breast Cancer As neoadjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) Stage II or III breast cancer, as determined by an FDA-authorized test followed by a taxane, trastuzumab, and pertuzumab (THP) As monotherapy in adult patients with HER2-positive (IHC 3+ or ISH+) breast cancer who have residual invasive disease after neoadjuvant HER2-targeted treatment HER2-Positive Metastatic Breast Cancer In combination with pertuzumab as first-line treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer, as determined by an FDA-authorized test As monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting, or, in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy HER2-Low and HER2-Ultralow Metastatic Breast Cancer As monotherapy 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-authorized test, that has progressed on one or more endocrine therapies in the metastatic setting As monotherapy for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer, as determined by an FDA-authorized test, who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy HER2-Mutant Unresectable or Metastatic Non-Small Cell Lung Cancer (NSCLC) As monotherapy for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-authorized test, and who have received a prior systemic therapy This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. HER2-Positive Locally Advanced or Metastatic Gastric Cancer As monotherapy for the treatment of adult patients with locally advanced or metastatic HER2-positive (IHC 3+ or IHC 2+/ISH positive) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen HER2-Positive (IHC 3+) Unresectable or Metastatic Solid Tumors As monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive (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 and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Important Safety Information WARNING: INTERSTITIAL LUNG DISEASE and EMBRYO-FETAL TOXICITY Interstitial lung disease (ILD) and pneumonitis, including severe, life-threatening, and fatal cases, have been reported with ENHERTU. Monitor for and promptly investigate signs and symptoms including cough, dyspnea, fever, and other new or worsening respiratory symptoms. Permanently discontinue ENHERTU in all patients with Grade 2 or higher ILD/pneumonitis. Advise patients of the risk and to immediately report symptoms. Exposure to ENHERTU during pregnancy can cause embryo-fetal harm. Advise patients of these risks and the need for effective contraception. Contraindications None. Warnings and Precautions Interstitial Lung Disease / Pneumonitis Severe, life-threatening, or fatal interstitial lung disease (ILD), including pneumonitis, can occur in patients treated with ENHERTU. A higher incidence of Grade 1 and 2 ILD/pneumonitis has been observed in patients with moderate renal impairment. Advise patients to immediately report cough, dyspnea, fever, and/or any new or worsening respiratory symptoms. Monitor patients for signs and symptoms of ILD. Promptly investigate evidence of ILD. Evaluate patients with suspected ILD by radiographic imaging. Consider consultation with a pulmonologist. For asymptomatic ILD/pneumonitis (Grade 1), interrupt ENHERTU until resolved to Grade 0, then if resolved in ≤28 days from date of onset, maintain dose. If resolved in >28 days from date of onset, reduce dose 1 level. Consider corticosteroid treatment as soon as ILD/pneumonitis is suspected (e.g., ≥0.5 mg/kg/day prednisolone or equivalent). For symptomatic ILD/pneumonitis (Grade 2 or greater), permanently discontinue ENHERTU. Promptly initiate systemic corticosteroid treatment as soon as ILD/pneumonitis is suspected (e.g., ≥1 mg/kg/day prednisolone or equivalent) and continue for at least 14 days followed by gradual taper for at least 4 weeks. HER2-Positive, HER2-Low, and HER2-Ultralow Breast Cancer, HER2-Mutant NSCLC, and Solid Tumors (Including IHC 3+) (5.4 mg/kg) ENHERTU as Monotherapy In patients treated with ENHERTU 5.4 mg/kg, ILD occurred in 12% of patients. Median time to first onset was 5.5 months (range: 0.9 to 31.5). Fatal outcomes due to ILD and/or pneumonitis occurred in 0.9% of patients treated with ENHERTU. ENHERTU in Combination with Pertuzumab In patients treated with ENHERTU 5.4 mg/kg in combination with pertuzumab (N=431), ILD occurred in 12% of patients. Median time to first onset was 8.0 months (range: 0.6 to 33.8). Fatal outcomes due to ILD and/or pneumonitis occurred in 0.5% of patients treated with ENHERTU in combination with pertuzumab. ENHERTU followed by THP In patients treated with ENHERTU 5.4 mg/kg followed by THP in DESTINY-Breast11, ILD occurred in 4.4% of patients. Median time to first onset was 2.7 months (range: 1.1 to 6.0). Fatal outcomes due to ILD and/or pneumonitis occurred in 1 patient (0.3%) treated with ENHERTU followed by THP. HER2-Positive Locally Advanced or Metastatic Gastric Cancer (6.4 mg/kg) In patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma treated with ENHERTU 6.4 mg/kg, ILD occurred in 10% of patients. Median time to first onset was 2.8 months (range: 1.2 to 21). Neutropenia Severe neutropenia, including febrile neutropenia, can occur in patients treated with ENHERTU. Monitor complete blood counts prior to initiation of ENHERTU and prior to each dose, and as clinically indicated. For Grade 3 neutropenia (Absolute Neutrophil Count [ANC] 38.3º C or a sustained temperature of ≥38º C for more than 1 hour), interrupt ENHERTU until resolved, then reduce dose by 1 level. HER2-Positive, HER2-Low, and HER2-Ultralow Breast Cancer, HER2-Mutant NSCLC, and Solid Tumors (Including IHC 3+) (5.4 mg/kg) ENHERTU as Monotherapy In patients treated with ENHERTU 5.4 mg/kg, a decrease in neutrophil count was reported in 65% of patients. Nineteen percent had Grade 3 or 4 decreased neutrophil count. Median time to first onset of decreased neutrophil count was 22 days (range: 2 to 939). Febrile neutropenia was reported in 1% of patients. ENHERTU in Combination with Pertuzumab In patients treated with ENHERTU 5.4 mg/kg in combination with pertuzumab (N=431), decreased neutrophil count occurred in 79% of patients. Median time to first onset was 22 days (range: 5 to 994). Twenty-nine percent had Grade 3 or 4 decreased neutrophil count. Febrile neutropenia was reported in 2.6% of patients. ENHERTU followed by THP In patients treated with ENHERTU 5.4 mg/kg followed by THP in DESTINY-Breast11, a decrease in neutrophil count was reported in 58% of patients. Seventeen percent had Grade 3 or 4 decreased neutrophil count. Median time to first onset of decreased neutrophil count was 42 days (range: 11 to 165). Febrile neutropenia was reported in 0.9% of patients. HER2-Positive Locally Advanced or Metastatic Gastric Cancer (6.4 mg/kg) In patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma treated with ENHERTU 6.4 mg/kg, a decrease in neutrophil count was reported in 72% of patients. Fifty-one percent had Grade 3 or 4 decreased neutrophil count. Median time to first onset of decreased neutrophil count was 16 days (range: 4 to 187). Febrile neutropenia was reported in 4.8% of patients. Left Ventricular Dysfunction Patients treated with ENHERTU may be at increased risk of developing left ventricular dysfunction. Left ventricular dysfunction (LVD) has been observed with anti-HER2 therapies, including ENHERTU. Assess left ventricular ejection fraction (LVEF) prior to initiation of ENHERTU and at regular intervals during treatment as clinically indicated. Manage LVD through treatment interruption. When LVEF is >45% and absolute decrease from baseline is 10-20%, continue treatment with ENHERTU. When LVEF is 40-45% and absolute decrease from baseline is 20%, interrupt ENHERTU and repeat LVEF assessment within 3 weeks. If LVEF of 20% is confirmed, permanently discontinue ENHERTU. Permanently discontinue ENHERTU in patients with symptomatic congestive heart failure. Treatment with ENHERTU has not been studied in patients with a history of clinically significant cardiac disease or LVEF 6 months and 39% were exposed for >1 year. In this pooled safety population, the most common (≥20%) adverse reactions, including laboratory abnormalities, were decreased white blood cell count (73%), nausea (72%), decreased hemoglobin (67%), decreased neutrophil count (65%), decreased lymphocyte count (60%), fatigue (55%), decreased platelet count (48%), increased aspartate aminotransferase (46%), increased alanine aminotransferase (43%), increased blood alkaline phosphatase (39%), vomiting (38%), alopecia (37%), constipation (32%), decreased blood potassium (32%), decreased appetite (31%), diarrhea (30%), and musculoskeletal pain (24%). ENHERTU in Combination with Pertuzumab The pooled safety population reflects exposure to ENHERTU 5.4 mg/kg in combination with pertuzumab intravenously every 3 weeks in 431 patients in DESTINY-Breast07 (n=50), and DESTINY-Breast09 (n=381). Among these patients, 86% were exposed for >6 months and 73% were exposed for >1 year. In this pooled safety population, the most common (≥20%) adverse reactions, including laboratory abnormalities, were decreased white blood cell count (86%), decreased hemoglobin (80%), decreased neutrophil count (79%), nausea (74%), increased alanine aminotransferase (65%), diarrhea (64%), increased aspartate aminotransferase (63%), decreased lymphocyte count (61%), decreased platelet count (55%), increased blood alkaline phosphatase (54%), decreased blood potassium (54%), fatigue (53%), alopecia (48%), vomiting (46%), upper respiratory tract infection (32%), constipation (31%), decreased appetite (31%), decreased weight (28%), musculoskeletal pain (23%), increased blood bilirubin (23%) and abdominal pain (22%). Contacts MEDIA CONTACTS: Global: Jennifer Brennan jennifer.brennan@daiichisankyo.com +1 908 900 3183 (mobile) Japan: DS-PR_jp@daiichisankyo.com INVESTOR RELATIONS CONTACT: DaiichiSankyoIR_jp@daiichisankyo.com Read full story here