The FLAMINGO-01 DSMB met twice in 2024, most recently in December 2024, and recommended to continue the study as is without modification. No serious adverse events related to GLSI-100 have been ...
and in some markets – including the US – its label already allows use as a second-line after trastuzumab, based on data from phase 2 studies comparing the drug to chemotherapy after at least ...
New study results presented at the European Lung Cancer Congress (ELCC) 2025, 26 to 29 March, demonstrate the role of AstraZeneca’s Tagrisso (osimertinib), as monotherapy and as the backbone for novel ...
It's a key moment for the two companies, as expansion into HER2-low breast cancer has been held up as a key requirement for Enhertu (trastuzumab ... on the product's label. DESTINY-Breast03 ...
Antibody-Drug Conjugates BNT323/DB-1303 (trastuzumab pamirtecan ... In December 2024, preliminary data from the first-in-human, open-label Phase 1/2 clinical trial (NCT05914116) were presented at the ...
Second-line treatment with fam-trastuzumab deruxtecan-nxki (T-DXd ... DESTINY-Gastric04 was a global, randomized, open-label trial that enrolled patients at least 18 years of age with pathologically ...
Trastuzumab deruxtecan demonstrated a significant survival ... The global, randomized, open-label DESTINY-Gastric04 trial is evaluating the efficacy and safety of T-DXd given at a dose of 6.4 mg/kg vs ...
Efficacy and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early HER2-positive breast cancer (NeoSphere): a randomised multicentre, open-label ...
The complete response letter, issued by the FDA, does not identify what deficiencies regulators found in ...
Trastuzumab, tested only as a single agent, has been shown to achieve 7% response in heavily pretreated patients with AOC with 3+ and 2+ HER2 immunostaining by immunohistochemistry (IHC).