Daiichi Sankyo

ENHERTU® Approved in the U.S. as First Tumor Agnostic HER2 Directed Therapy for Previously Treated Patients with Metastatic HER2 Positive Solid Tumors

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Sabato, Aprile 6, 2024
Research, Women, FDA, Clinical Trials, Biotechnology, Pharmaceutical, Consumer, Health, Science, Oncology, Orbis, Urinary tract infection, Cardiac arrest, Stomatitis, Patient, Stroke, Lung cancer, University, Acute kidney injury, Neoplasm, Therapy, Anemia, Vomiting, Pleural effusion, Cellulitis, Shock (mechanics), Periodic breathing, Colorectal cancer, Abdominal pain, Safety, Immunohistochemistry, Fatigue, ADC, Daiichi Sankyo, Food, IHC, Sepsis, NSCLC, Appetite, Biliary tract, Constipation, NCCN, MD, Priority review, Fatality, Pneumonitis, HER2, ILD, Medication, Pneumonia, AstraZeneca, COVID-19, Biomarker, Diarrhea, Bleeding, MD Anderson Cancer Center, Nausea, Upper respiratory tract infection, Pharmaceutical industry

The first tumor agnostic approval of a HER2 directed therapy and ADC was based on efficacy data in 192 adult patients with previously treated unresectable or metastatic HER2 positive (IHC 3+) solid tumors who were enrolled in one of three multicenter phase 2 trials from the DESTINY clinical development program, including DESTINY-PanTumor02 , DESTINY-Lung01 or DESTINY-CRC02 .

Key Points: 
  • The first tumor agnostic approval of a HER2 directed therapy and ADC was based on efficacy data in 192 adult patients with previously treated unresectable or metastatic HER2 positive (IHC 3+) solid tumors who were enrolled in one of three multicenter phase 2 trials from the DESTINY clinical development program, including DESTINY-PanTumor02 , DESTINY-Lung01 or DESTINY-CRC02 .
  • In DESTINY-PanTumor02, efficacy was assessed in a subgroup of previously treated patients (n=111) with centrally or locally assessed HER2 positive (IHC 3+) solid tumors including either biliary tract, bladder, cervical, endometrial, ovarian, pancreatic or other tumors.
  • In DESTINY-Lung01, efficacy was assessed in a subgroup of patients (n=17) with centrally confirmed HER2 positive (IHC 3+) non-small cell lung cancer (NSCLC).
  • In DESTINY-CRC02, efficacy was assessed in the subgroup of patients (n=64) with centrally confirmed HER2 positive (IHC 3+) colorectal cancer.

REJOICE-Ovarian01 Phase 2/3 Trial of Raludotatug Deruxtecan Initiated in Patients with Platinum-Resistant Ovarian Cancer

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Mercoledì, Aprile 3, 2024
Pharmaceutical, Health, Oncology, Clinical Trials, MSD, DXD, CDH6, Survival, Glomus tumor, Patient, Merck & Co., SGO, MD, Society, Senior, MRK, Safety, Gynecologic Oncology (journal), Recurrence, ADC, Daiichi Sankyo, Annual general meeting, Pharmaceutical industry

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.

Key Points: 
  • 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.
  • Raludotatug deruxtecan is an investigational specifically engineered potential first-in-class CDH6 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed with Merck.
  • “Raludotatug deruxtecan has shown promising activity in a phase 1 trial of patients with advanced ovarian cancer,” said Mark Rutstein, MD, Global Head, Oncology Clinical Development, Daiichi Sankyo.
  • “We look forward to working with our colleagues at Daiichi Sankyo to further evaluate the potential of raludotatug deruxtecan to provide a new treatment option for patients with platinum-resistant ovarian cancer.”

Datopotamab deruxtecan Biologics License Application accepted in the US for patients with previously treated metastatic HR-positive, HER2-negative breast cancer

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Martedì, Aprile 2, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, MSD, Breast cancer, Goserelin, Patient, Lung, Social media, Immunoglobulin G, National Cancer Institute, Neoplasm, Merck & Co., TNBC, Capecitabine, DXD, BRCA, Clinical Cancer Research, Metabolism, Immunology, Biopharmaceutical, World Health Organization, Cancer, Safety, ADC, BLA, Daiichi Sankyo, Vinorelbine, IHC, Mutation, NSCLC, Disease, Merck, AKT, Death, MD, AstraZeneca, PARP, Oncotarget, PFS, FDA, OS, HER2, Eribulin, Cleavage, Progression-free survival, Triple-negative breast cancer, Female, Emerging, Olaparib, Biology, Sapporo Medical University, Medicine, Pharmaceutical industry

The safety profile of datopotamab deruxtecan was consistent with that observed in other ongoing trials with no new safety concerns identified.

Key Points: 
  • The safety profile of datopotamab deruxtecan was consistent with that observed in other ongoing trials with no new safety concerns identified.
  • Additional regulatory submissions for datopotamab deruxtecan in lung and breast cancer are underway globally.
  • A comprehensive global clinical development program is underway with more than 20 trials evaluating the efficacy and safety of datopotamab deruxtecan across multiple cancers, including NSCLC, triple-negative breast cancer (TNBC) and HR-positive, HER2-negative breast cancer.
  • Comparative Overall Survival of CDK4/6 Inhibitors Plus Endocrine Therapy vs. Endocrine Therapy Alone for Hormone receptor-positive, HER2-negative metastatic breast cancer.

Datopotamab Deruxtecan Biologics License Application Accepted in the U.S. for Patients with Previously Treated Metastatic HR Positive, HER2 Negative Breast Cancer

Retrieved on: 
Martedì, Aprile 2, 2024
Oncology, Health, FDA, Clinical Trials, General Health, Pharmaceutical, OS, HER2, IHC, HR, Neutropenia, Congress, DXD, AstraZeneca, NSCLC, Progression-free survival, Patient, Stomatitis, Lung, Doctor of Philosophy, MD, Breast cancer, Anemia, PFS, Fatigue, ADC, Food, BLA, Daiichi Sankyo, PDUFA, Pharmaceutical industry

Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed by Daiichi Sankyo and AstraZeneca.

Key Points: 
  • Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed by Daiichi Sankyo and AstraZeneca.
  • The safety profile of datopotamab deruxtecan was consistent with that observed in other ongoing trials with no new safety concerns identified.
  • “The FDA’s acceptance of the BLA brings us closer to providing patients with previously treated HR positive, HER2 negative breast cancer an alternative option to conventional chemotherapy earlier in the metastatic setting,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo.
  • Additional regulatory submissions for datopotamab deruxtecan in lung and breast cancer are underway globally.

Bicara Therapeutics Expands Clinical Team with Appointments of Jeltje Schulten, M.D., MBA, as SVP of Clinical and Medical Affairs and Rita Dalal, MBBS, MPH, as VP of Clinical Development

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Martedì, Marzo 26, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Carcinoma, Alkermes, Erasmus University Rotterdam, Cetuximab, Patient, SVP, ImClone Systems, Biostatistics, Merck, Epidemiology, Management, University, MBA, Merck Group, Limited partnership, MPH, Therapy, International school, PPD, Eli Lilly and Company, Marketing, Avelumab, Daiichi Sankyo

“We are very pleased to welcome Jeltje and Rita to our talented team.

Key Points: 
  • “We are very pleased to welcome Jeltje and Rita to our talented team.
  • Dr. Schulten received her medical degree from Erasmus University, Rotterdam, Netherlands and her MBA from the International School of Management RSM, Rotterdam, Netherlands.
  • Dr. Rita Dalal is a trained physician with extensive and diverse clinical research experience including in solid tumor oncology.
  • Previously, Dr. Dalal held clinical research scientist positions with Merck Sharp & Dohme Corp. and Eli Lilly and Company.

Advances in Digitalization Presented at the 10th Annual Genedata Biopharma Partner Symposium

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Giovedì, Marzo 21, 2024
AbbVie, Peptide, ChromeOS, Automation, Sanofi, Organization, Canadian Aviation Regulations, AstraZeneca, Novo Nordisk, MAM, Novartis, GSK, Boehringer Ingelheim, UCB, Vivisection, Roche, NGS, RNA, Knowledge, Merck, Hyphen, Spacecraft, Janssen, Daiichi Sankyo, Digitization, Novozymes, Fine chemical

BASEL, Switzerland, March 21, 2024 /PRNewswire-PRWeb/ -- Genedata, the leading provider of enterprise software solutions for biopharmaceutical R&D, today announced the successful conclusion of the 10th Annual Genedata Biopharma Partner Symposium, held over 2 days from March 6–7, 2024 in Basel, Switzerland. This year's event marked the tenth year of bringing together Genedata customers to share best practices and demonstrate how they increase efficiency and productivity across entire organizations by leveraging the Genedata Biopharma Platform.

Key Points: 
  • BASEL, Switzerland, March 21, 2024 /PRNewswire-PRWeb/ -- Genedata, the leading provider of enterprise software solutions for biopharmaceutical R&D, today announced the successful conclusion of the 10th Annual Genedata Biopharma Partner Symposium, held over 2 days from March 6–7, 2024 in Basel, Switzerland.
  • The Genedata Biopharma Partner Symposium has firmly established itself as a community platform to exchange pioneering work in digitalizing biopharma R&D and establishing best practices based on the Genedata software platform.
  • "The Genedata Biopharma Partner Symposium has firmly established itself as a community platform to exchange pioneering work in digitalizing biopharma R&D and establishing best practices based on the Genedata software platform.
  • The record participation this year underscores the leading position of the Genedata Biopharma Platform within the biopharma industry," said Othmar Pfannes, Ph.D., CEO of Genedata.

D3 Bio Appoints Dr. Antoine Yver as Independent Board Member

Retrieved on: 
Giovedì, Marzo 14, 2024
AstraZeneca, Science, Patient, Disability studies, Cancer, MD, Senior, Master of Science, Drug development, Daiichi Sankyo

SHANGHAI, March 14, 2024 /PRNewswire/ -- D3 Bio, an emerging global biotechnology company that focuses on discovery, development, and registration of innovative cancer drugs, welcomes Antoine Yver, MD.

Key Points: 
  • SHANGHAI, March 14, 2024 /PRNewswire/ -- D3 Bio, an emerging global biotechnology company that focuses on discovery, development, and registration of innovative cancer drugs, welcomes Antoine Yver, MD.
  • Dr. Yver, the new board member of D3 Bio, said "I am deeply honored to join (D3 Bio) and humbled by the opportunity to substantially contribute to making the world better by delivering your important science for the advancement of care of patients with cancer around the world."
  • Dr. George Chen, Chairman and CEO at D3 Bio, said "I had the privilege of working with Dr. Yver at Astra Zeneca, and today I am honored to extend a warm welcome to Dr. Yver, our new independent board member.
  • Dr. Yver has been a special advisor to D3 Bio since March 2023, provided strategic and scientific advice, and made significant contributions to D3 Bio.

Daiichi Sankyo Adopts Genedata Biologics to Automate the Discovery of Novel Biological Therapeutics

Retrieved on: 
Martedì, Marzo 12, 2024
Patient, Software, Daiichi Sankyo, Pharmaceutical industry

BASEL, Switzerland, March 12, 2024 /PRNewswire-PRWeb/ -- Genedata, the leading provider of enterprise software solutions for biopharmaceutical R&D, announced today that Daiichi Sankyo, a global pharmaceutical company with corporate origins in Japan, has adopted Genedata Biologics® to automate its discovery workflows. The system integrates and automates complex biologics research processes resulting in a significant reduction in discovery timelines. By providing structured, high-quality, and comparable data, Genedata Biologics enables data-driven decisions to select the most promising lead candidates. "We are very pleased that Daiichi Sankyo has chosen Genedata Biologics to digitalize and automate their novel biologics research operations," said Othmar Pfannes, Ph.D., CEO of Genedata. "The implementation of the Genedata platform by yet another leading Japanese pharmaceutical company is a key milestone in our global expansion strategy and further validates the quality of our software. We are committed to continuing to support our Japanese customers with high priority, and to invest into further developing the Genedata Biopharma Platform for our customers in Japan and around the world to bring novel drugs to patients more quickly."

Key Points: 
  • BASEL, Switzerland, March 12, 2024 /PRNewswire-PRWeb/ -- Genedata, the leading provider of enterprise software solutions for biopharmaceutical R&D, announced today that Daiichi Sankyo, a global pharmaceutical company with corporate origins in Japan, has adopted Genedata Biologics ® to automate its discovery workflows.
  • The system integrates and automates complex biologics research processes resulting in a significant reduction in discovery timelines.
  • By providing structured, high-quality, and comparable data, Genedata Biologics enables data-driven decisions to select the most promising lead candidates.
  • "We are very pleased that Daiichi Sankyo has chosen Genedata Biologics to digitalize and automate their novel biologics research operations," said Othmar Pfannes, Ph.D., CEO of Genedata.

Lung Cancer Research Foundation Announces Research Grant Awards

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Martedì, Marzo 12, 2024
Spacecraft, Lung cancer, Cancer, Patient, ADC, Biomarker, Research, AstraZeneca, Daiichi Sankyo, Fine chemical

NEW YORK, March 12, 2024 /PRNewswire/ -- The Lung Cancer Research Foundation (LCRF) has announced three research grant awards funded by Daiichi Sankyo and AstraZeneca, totaling $810,000, focused on further developing the understanding of the proposed mechanism of action of antibody drug conjugates (ADCs), exploring biomarkers and blood-based biomarkers for the primary and acquired resistance mechanisms to TROP2- or HER2-directed ADCs and exploring the use of ADCs in lung cancer types beyond non-small cell lung cancer (NSCLC).

Key Points: 
  • NEW YORK, March 12, 2024 /PRNewswire/ -- The Lung Cancer Research Foundation (LCRF) has announced three research grant awards funded by Daiichi Sankyo and AstraZeneca, totaling $810,000, focused on further developing the understanding of the proposed mechanism of action of antibody drug conjugates (ADCs), exploring biomarkers and blood-based biomarkers for the primary and acquired resistance mechanisms to TROP2- or HER2-directed ADCs and exploring the use of ADCs in lung cancer types beyond non-small cell lung cancer (NSCLC).
  • ADCs are designed to specifically target cancer cells and selectively deliver a highly potent payload, which may limit damage to healthy cells.
  • "LCRF is honored to continue its long legacy of identifying and supporting outstanding lung cancer research projects over the years, and we are excited to present these grants made possible by this research collaboration," said Dr. Antoinette Wozniak, LCRF's chief scientific officer.
  • "The study of ADCs is an exciting development in lung cancer research with considerable promise for increased positive outcomes for patients."

Two Datopotamab Deruxtecan Applications Validated in the EU for Patients with Advanced Nonsquamous Non-Small Cell Lung Cancer or HR Positive, HER2 Negative Breast Cancer

Retrieved on: 
Lunedì, Marzo 4, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, NSCLC, Breast cancer, AstraZeneca, EMA, Doctor of Philosophy, MAA, MD, News, Cancer, Lung, Daiichi Sankyo, ADC, IHC, HER2, HR, DXD, European Medicines Agency, Patient, Maas, Medicine, Lung cancer, Congress, Breast

The European Medicines Agency (EMA) has validated two marketing authorization applications (MAAs) for Daiichi Sankyo (TSE: 4568) and AstraZeneca’s (LSE/STO/Nasdaq: AZN) datopotamab deruxtecan (Dato-DXd) in two types of cancer.

Key Points: 
  • The European Medicines Agency (EMA) has validated two marketing authorization applications (MAAs) for Daiichi Sankyo (TSE: 4568) and AstraZeneca’s (LSE/STO/Nasdaq: AZN) datopotamab deruxtecan (Dato-DXd) in two types of cancer.
  • One MAA is for the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who require systemic therapy following prior treatment.
  • Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed by Daiichi Sankyo and AstraZeneca.
  • “The EMA validation is an important first step toward bringing this TROP2 directed antibody drug conjugate to eligible patients in Europe with nonsquamous lung cancer and HR positive, HER2 negative breast cancer,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo.