Daiichi Sankyo

Patritumab Deruxtecan Demonstrated Clinically Meaningful and Durable Responses in Patients with EGFR-Mutated Metastatic Non-Small Cell Lung Cancer in HERTHENA-Lung01 Phase 2 Trial

Retrieved on: 
Sunday, September 10, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Neutropenia, Brain, Central nervous system, PRS, HER3, Liver disease, American Journal of Clinical Oncology, TSE, DOR, DCR, Trastuzumab deruxtecan, Lung cancer, ILD, TKI, NSCLC, Treatment of lung cancer, History, Immunotherapy, CNS, PFS, Associate, Patritumab, ORR, Radiation, Journal, HIV disease progression rates, MD, EGFR, Patient, Leukopenia, Daiichi Sankyo, Anemia, Hypokalemia, DXD, Weakness, Memorial Sloan Kettering Cancer Center, ADC, CRS, Diagnosis, Neoplasm, R, Thrombocytopenia, SD, Conference, PR, Fatigue, Medical imaging, Fine chemical, Pharmaceutical industry

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.

Key Points: 
  • 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.
  • Patritumab deruxtecan is a specifically engineered potential first-in-class HER3 directed antibody drug conjugate (ADC) designed using Daiichi Sankyo’s (TSE: 4568) proprietary DXd ADC technology.
  • One complete response (CR), 66 partial responses (PRs) and 99 cases of stable disease (SD) were seen.
  • As of the snapshot data cutoff of May 18, 2023, the median trial duration was 18.9 (14.9-27.5) months, and 13 patients were continuing to receive patritumab deruxtecan.

Datopotamab Deruxtecan Plus Durvalumab Showed Promising Clinical Activity in the First-Line Advanced Non-Small Cell Lung Cancer Setting in TROPION-Lung04 Phase 1b Trial

Retrieved on: 
Sunday, September 10, 2023
Research, Clinical Trials, Other Health, Biotechnology, General Health, Pharmaceutical, Health, Science, Oncology, Other Science, PRS, DCR, International Association, Lung cancer, ILD, NSCLC, Carboplatin, Lung, AstraZeneca, Alvin J. Siteman Cancer Center, HIV disease progression rates, MD, Patient, EGFR, DXD, Daiichi Sankyo, Anemia, Washington University School of Medicine, ADC, Spacecraft, Thrombocytopenia, ORR, Conference, TSE, Disease, ALK, Pharmaceutical industry, Fine chemical, Durvalumab

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).

Key Points: 
  • 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).
  • Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) being jointly developed by Daiichi Sankyo (TSE: 4568) and AstraZeneca (LSE/STO/Nasdaq: AZN).
  • Response rates were higher in patients receiving datopotamab deruxtecan plus durvalumab and carboplatin (triplet; n=13) which demonstrated an ORR of 76.9% (95% CI: 46.2-95.0), including 10 PRs and a DCR of 92.3% (95% CI: 64.0-99.8).
  • “The TROPION-Lung04 results offer preliminary evidence for the efficacy of datopotamab deruxtecan in combination with durvalumab and chemotherapy in first-line advanced non-small cell lung cancer with no new safety signals.

Ifinatamab Deruxtecan Continues to Demonstrate Durable Responses in Patients with Advanced Small Cell Lung Cancer in Early Trial

Retrieved on: 
Sunday, September 10, 2023
Pharmaceutical, Health, Oncology, Clinical Trials, Learning, Carcinoma, Brain, PRS, TSE, DOR, COVID-19, Survival, Cancer, International Association, Lung cancer, ILD, Pneumonitis, Neoplasm, Appetite, Immunotherapy, PFS, SCLC, Vomiting, HIV disease progression rates, MD, Patient, DXD, Daiichi Sankyo, Anemia, Irinotecan, Nausea, ADC, Conference, ORR, Pneumonia, Fatigue, Taxane, Sarah Cannon Research Institute, Medical imaging, Pharmaceutical industry

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).

Key Points: 
  • 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).
  • Ifinatamab deruxtecan is a specifically engineered potential first-in-class B7-H3 directed antibody drug conjugate (ADC) designed using Daiichi Sankyo’s (TSE: 4568) proprietary DXd ADC technology.
  • “With limited effective treatment options beyond traditional chemotherapy and immunotherapy, small cell lung cancer can be difficult to treat,” said Melissa Johnson, MD, Director, Lung Cancer Research, Sarah Cannon Research Institute.
  • The median duration of follow up was 11.7 months (95% CI: 4.63-12.88) and two patients remain on treatment with ifinatamab deruxtecan.

DS-3939 Enters Clinical Development in Patients Across Several Types of Advanced Solid Cancers

Retrieved on: 
Thursday, September 7, 2023
Pharmaceutical, Health, Oncology, Clinical Trials, Pancreatic cancer, ADC, Cancer, Biliary tract, Breast, MD, Patient, DXD, Daiichi Sankyo, TSE, Medical imaging, Fine chemical

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.

Key Points: 
  • 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.
  • DS-3939 is a specifically engineered potential first-in-class tumor-associated mucin-1 (TA-MUC1) directed antibody drug conjugate (ADC) designed using Daiichi Sankyo’s proprietary DXd ADC technology.
  • TA-MUC1 is a tumor-specific transmembrane glycoprotein and is overexpressed in most human epithelial cancers, making it a promising target for cancer therapy.1,2 Currently, there are no TA-MUC1 directed therapies approved for any type of cancer.
  • “With DS-3939, we are pairing our unique DXd antibody drug conjugate technology with a TA-MUC1 antibody in order to evaluate this novel treatment strategy for patients with several types of advanced cancer,” said Mark Rutstein, MD, Global Head, Oncology Clinical Development, Daiichi Sankyo.

DPHARM Idol Presenting Companies Announced to Compete for Most Disruptive New Company in Clinical Trials at DPHARM from the Conference Forum

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Friday, September 8, 2023
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NEW YORK, Sept. 8, 2023 /PRNewswire-PRWeb/ -- The Conference Forum announced the 2023 presenting companies that will compete for the title of most innovative new company to disrupt clinical trial operations at DPHARM: Disruptive Innovations to Modernize Clinical Research conference in Boston, MA on September 21, 2023.

Key Points: 
  • The Conference Forum announced the 2023 presenting companies who will compete for the title of most innovative new company to disrupt clinical trial operations at DPHARM: Disruptive Innovations to Modernize Clinical Research conference in Boston, MA on September 21, 2023.
  • NEW YORK, Sept. 8, 2023 /PRNewswire-PRWeb/ -- The Conference Forum announced the 2023 presenting companies that will compete for the title of most innovative new company to disrupt clinical trial operations at DPHARM: Disruptive Innovations to Modernize Clinical Research conference in Boston, MA on September 21, 2023.
  • The presenting pre-approved companies will pitch how they are solving problems in clinical trials in front of 15 judges representing R&D executives, patient advocates, and life science investors.
  • "DPHARM Idol Disrupt puts the spotlight on a few fearless companies rewriting the rules of patient-centric breakthroughs.

Susan G. Komen® Nashville MORE THAN PINK Walk Returns to Raise Funds for Breast Cancer Patient Care Services and Financial Assistance Programs

Retrieved on: 
Thursday, September 7, 2023
Vanderbilt-Ingram Cancer Center, State, Health care, Y'all, LC, NewsChannel 5, Health equity, Grand Ole Opry, Master of ceremonies, Toyota, THAN, Priscilla Block, Bank of America, F&M Bank, Susan, Breast cancer, Daiichi Sankyo, H.E.R, Crunch Fitness, Walking, Cool Springs, Ascend Federal Credit Union, Health, Bank, CoolSprings Galleria, Disease, Birth control, Pharmaceutical industry, Nightclub, Walgreens, Stand, Amazon

NASHVILLE, Tenn., Sept. 7, 2023 /PRNewswire/ -- Susan G. Komen ®, the world's leading breast cancer organization, will hold an in-person MORE THAN PINK Walk to raise critical funds that support breast research and patient care services to better serve those impacted by the disease.

Key Points: 
  • NASHVILLE, Tenn., Sept. 7, 2023 /PRNewswire/ -- Susan G. Komen ®, the world's leading breast cancer organization, will hold an in-person MORE THAN PINK Walk to raise critical funds that support breast research and patient care services to better serve those impacted by the disease.
  • "We are excited to provide a space for the breast cancer community to gather and raise funds to end this disease," said Joshua Daniel, State Executive Director at Susan G. Komen.
  • "This event helps raise critical funds for patient care programs including Komen's Patient Care Helpline, which helps provide financial assistance to those impacted by the disease, and Stand for H.E.R.
  • A portion of the proceeds from each ticket sold will be donated to Komen to aid in the fight against breast cancer.

Ibex Launches Galen™ Breast HER2, Supporting Improved Biomarker Scoring in Breast Cancer Patients

Retrieved on: 
Thursday, September 7, 2023
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TEL AVIV, Israel, Sept. 7, 2023 /PRNewswire/ -- Ibex Medical Analytics (Ibex), the leader in AI-powered cancer diagnostics, today announced the launch of Galen™ Breast HER2, an AI-powered solution that aids pathologists in setting a higher standard for accurate and reproducible HER2 (human epidermal growth factor receptor 2) scoring in breast cancer patients.

Key Points: 
  • HER2, one of the proteins responsible for division and proliferation of breast cancer cells, is expressed in many breast tumors and its accurate assessment is critical for identifying patients who are likely to benefit from HER2-directed therapies.
  • Traditionally, pathologists evaluate HER2 in tumor samples visually, which may result in varied interpretations as scoring is semi-quantitative and thus somewhat subjective1.
  • Galen Breast HER2 was developed and validated by Ibex in collaboration with AstraZeneca and Daiichi Sankyo .
  • Information about Galen Breast HER2 and Galen Breast will be available at the 35th European Congress of Pathology in Dublin, Ireland, between September 9-13 (Ibex Medical Analytics - booth number 23).

Ibex Raises $55 Million in Series C Funding to Drive Global Adoption of AI for Cancer Diagnosis

Retrieved on: 
Wednesday, September 6, 2023
University, Marie Cassidy, Pathology, Cancer, KLAS, AstraZeneca, Research report, TEL, University of Pittsburgh Medical Center, Hospital, Octopus Group, Laboratory, Daiichi Sankyo, Diagnosis, Entrepreneurship, UPMC, AI, Growth, Health, Breast cancer, Medical device, Ibex

TEL AVIV, Israel, Sept. 6, 2023 /PRNewswire/ -- Ibex Medical Analytics (Ibex), the leader in AI-powered cancer diagnostics, today announced it has closed a $55 million Series C financing round led by 83North. Additional participants in the round were Sienna Venture Capital and existing investors in the company, Octopus Ventures, aMoon, Planven Entrepreneur Ventures and Dell Technologies Capital. The financing brings total funding to over $100 million since Ibex's inception in 2016.

Key Points: 
  • The financing brings total funding to over $100 million since Ibex's inception in 2016.
  • Ibex is transforming cancer diagnostics with AI-powered solutions that help pathologists improve the quality of diagnosis and support laboratories with enhanced efficiency and better turnaround times.
  • Cancer incidence is rising around the world while its diagnosis becomes more complex and nuanced, causing heavy workloads for pathologists and laboratories.
  • We are eager to see Ibex forge the way with new uses of AI in cancer diagnosis, supporting providers as they work to improve patient care and outcomes."

Guardant Health Receives Regulatory Approval in Japan for Guardant360® CDx as Companion Diagnostic to ENHERTU® for Treatment of Non-Small Cell Lung Cancer Patients with HER2 Mutations

Retrieved on: 
Tuesday, September 5, 2023
Biotechnology, Health, Science, Research, Oncology, MHLW, HER2, Woman, ERBB2, NSCLC, Lung cancer, GH, Lung, Helmy Eltoukhy, Patient, Daiichi Sankyo, MSI, Blood, FDA, Pembrolizumab, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, News, Food, Nivolumab, Vaccine, Pharmaceutical industry

ENHERTU is a specifically engineered HER2-directed antibody drug conjugate developed by Daiichi Sankyo.

Key Points: 
  • ENHERTU is a specifically engineered HER2-directed antibody drug conjugate developed by Daiichi Sankyo.
  • The approval for use of the test as a companion diagnostic with ENHERTU in Japan is an expansion of the approval received from the U.S. Food and Drug Administration (FDA) for the same indication in August 2022.
  • “The ministry’s approval of Guardant360 CDx as a companion diagnostic for ENHERTU is great news for patients with metastatic non-small cell lung cancer with HER2 mutations,” said Helmy Eltoukhy, Guardant Health chairman and co-CEO.
  • “Oncologists in Japan now have the first blood-based companion diagnostic to determine if their patients are eligible to receive the first HER2 directed therapy approved to treat this specific condition.

RAIN Investors: Contact Robbins LLP for Information Regarding the Pending Lead Plaintiff Deadline in the Rain Oncology Inc. Securities Fraud Class Action

Retrieved on: 
Thursday, August 31, 2023
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Rain Oncology is a late-stage precision oncology company that develops therapies that target oncogenic drivers to genetically select patients in the United States.

Key Points: 
  • Rain Oncology is a late-stage precision oncology company that develops therapies that target oncogenic drivers to genetically select patients in the United States.
  • For more information, submit a form , email Aaron Dumas, Jr., or give us a call at (800) 350-6003.
  • What is this Case About: Rain Oncology Inc. (RAIN) Misled Investors Regarding the Viability of its Lead Drug Candidate Milademetan
    According to the complaint, Rain’s lead drug candidate was milademetan, a drug designed to treat dedifferentiated liposarcoma (“DD LPS”).
  • A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.