BioSpace News Archive

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.

Positive results from the pivotal TROPION-Breast01 Phase III 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.

Novartis today presents data from the Phase III PSMAfore trial at the 2023 European Society for Medical Oncology (ESMO) Congress.

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.

Positive results from the pivotal TROPION-Lung01 Phase III 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.

TC BioPharm therapies today announced submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for the use of TCB-008 in the treatment of relapse/refractory Acute Myeloid Leukemia.

Immunomic Therapeutics, Inc. today announced safety and tolerability results from its phase 1 clinical trial evaluating ITI-3000, a plasmid DNA (pDNA) vaccine, targeting patients with Merkel cell carcinoma (MCC), a rare but aggressive form of skin cancer that is typically caused by the Merkel cell polyomavirus (MCPyV).

VUNO Inc., South Korean medical AI company has received 510(k) clearance from the Food and Drug Administration (FDA) for its AI-powered brain quantification device, VUNO Med®-DeepBrain®.

Iterative Health, a pioneer in precision-medicine technologies for gastroenterology, announced today the results of new research unveiled at the American College of Gastroenterology (ACG) Annual Scientific Meeting.

ImmuneOncia (CEO Heung Tae Kim) announced the results of its Phase 1a solid tumour clinical trial (IMC-002-K102 Study) of IMC-002, a CD47 monoclonal antibody, at the European Society for Medical Oncology (ESMO 2023) held in Madrid, Spain on October 23rd, 2023.