Discover information about the DESTINY-Lung02 Trial for ENHERTU. See Prescribing Information, including Boxed WARNINGS.

Sep 11, 2023 · DESTINY-Lung02 is a phase II trial evaluating the efficacy and safety of T-DXd 5.4 mg/kg and 6.4 mg/kg once every 3 weeks in patients with HER2m (single-nucleotide variants [SNVs] and exon 20 insertions) mNSCLC, thereby charac-terizing the benefit/risk profile of T-DXd in this patient population.InterimanalysisofDESTINY-Lung02(datacutoff

Oct 14, 2024 · DESTINY-Lung02 is a global, randomised Phase II trial evaluating the safety and efficacy of Enhertu in patients with HER2-mutant unresectable and/or metastatic NSCLC with disease recurrence or progression during or after at least one regimen of prior anticancer therapy that must have contained a platinum-based chemotherapy.

Jan 27, 2025 · AstraZeneca and Daiichi Sankyo’s ENHERTU ® (fam-trastuzumab deruxtecan-nxki) has been approved in the US 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 Food and Drug …

Sep 27, 2023 · DESTINY-Lung02 is a phase II study evaluating the efficacy and safety of trastuzumab deruxtecan 5.4 mg/kg and 6.4 mg/kg once every 3 weeks in patients with HER2-mutated (single-nucleotide variants and exon 20 insertions) metastatic NSCLC.

Background: In the DESTINY-Lung02 primary analysis (data cutoff, Dec 23, 2022), T-DXd 5.4 mg/kg and 6.4 mg/kg demonstrated strong and durable responses and an acceptable and generally manageable safety profile in patients with previously treated HER2 (ERBB2)-mutant (HER2m) mNSCLC (Goto et al. 2023).

Aug 11, 2022 · DESTINY-Lung02 is a global phase 2 trial evaluating the safety and efficacy of two doses (5.4 mg/kg or 6.4 mg/kg) of ENHERTU in patients with HER2 mutant metastatic NSCLC with disease recurrence or

Sep 13, 2022 · On August 11, the Food and Drug Administration (FDA) gave accelerated approval to trastuzumab deruxtecan (Enhertu) for adults with NSCLC that has a certain kind of mutation in the HER2 gene (called an “activating” mutation). Around 3% of people with NSCLC have this kind of HER2 mutation.

Efficacy for accelerated approval was based on DESTINY-Lung02, a multicenter, multi-cohort, randomized, blinded, dose-optimization trial. Eligible patients were required to have...

Jun 6, 2024 · DESTINY-Lung02: Final Analysis of Trastuzumab Deruxtecan in Previously Treated HER2-Mutated Metastatic NSCLC