![]() ![]() The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. The data will be presented at a forthcoming medical meeting and shared with health authorities.įor More Such Health News, visit These first Phase III trial results from the datopotamab deruxtecan clinical programme provide compelling evidence for the potential role this TROP2-directed antibody drug conjugate can play in treating patients with lung cancer." ![]() Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said, "With TROPION-Lung01, we met the dual primary endpoint of progression-free survival, challenging the entrenched standard of care in a previously treated and unselected patient population that has long deserved an alternative to chemotherapy. In the trial, datopotamab deruxtecan's safety profile was consistent with previous clinical trials with no new safety signals identified. For this, the data were not mature and an early trend was observed in favour of datopotamab deruxtecan versus docetaxel that did not meet the prespecified threshold for statistical significance at this interim analysis. Dato-DXd is an ADC, composed of a recombinant humanized anti-TROP2 IgG1 mAb conjugated with a Topo I inhibitor (DXd) via a tetrapeptide-based linker to reduced cysteine residues at the interchain disulfide bonds of datopotamab (Fig. The company said the trial will continue to assess the dual primary endpoint of overall survival. This was compared to docetaxel, the current standard of care chemotherapy. In the trial, Datopotamab deruxtecan met dual primary endpoint of statistically significant improvement in progression-free survival in previously treated locally advanced or metastatic disease. It is designed using Daiichi Sankyo's proprietary DXd ADC technology. MedwireNews is an independent medical news service provided by Springer Healthcare Ltd.(RTTNews) - British drug major AstraZeneca plc (AZN, AZN.L) announced Monday positive high-level results from the TROPION-Lung01 Phase III trial of datopotamab deruxtecan (Dato-DXd) in patients with advanced non-small cell lung cancer.ĭatopotamab deruxtecan is a specifically engineered TROP2-directed DXd antibody drug conjugate or ADC being jointly developed by AstraZeneca and Daiichi Sankyo. The investigator concluded that “further study in breast cancer is needed,” adding that “the hormone receptor-positive cohort is now enrolling.” Thus, the majority of patients had a decrease in tumor volume and the majority of these responses occurred within the first 2 months of treatment, Bardia commented. Just one patient experienced disease progression, giving a disease control rate of 95%. These included a confirmed complete or partial response in 24% of patients and responses pending confirmation in 19%. Turning to efficacy results, the presenter said Dato-DXd had “impressive antitumor activity,” citing an objective response rate of 43% for the 21 patients assessed by blinded independent central review. The majority of treatment-emergent AEs were nonhematologic grade 1 or 2 side effects the most common any-grade events were stomatitis (63%), nausea (63%), fatigue (42%), vomiting (42%), alopecia (25%), cough (21%), and pruritus (21%), while anemia, headache, and constipation were each experienced by 17% of patients.īardia highlighted that there were no reports of drug-related interstitial lung disease, or grade 3 or more severe episodes of diarrhea or neutropenia. ![]() There were no serious or fatal TRAEs and none of the patients discontinued treatment because of AEs, but 25% of patients required a dose reduction, most commonly for stomatitis (13%) and mucosal inflammation (8%). These included taxanes (83%), platinum-based chemotherapy (50%), and immunotherapy (33%), as well as sacituzumab govitecan (8%) or a PARP inhibitor (4%).ĭato-DXd was given intravenously every 3 weeks at a dose of 6 mg/kg (n=22) or 8 mg/kg (n=2), and at data cutoff 75% of patients were continuing treatment, while 25% of patients had discontinued following disease progression.Īll participants experienced at least one treatment-related adverse event (TRAE), and grade 3 and more severe TRAEs occurred in 17% of the cohort. The current TNBC cohort had 24 patients unselected for TROP2 expression who had previously been given a median of four systemic treatments, with 88% receiving at least two. Dato-DXd – an anti-TROP2 immunoglobulin G antibody combined with a topoisomerase I inhibitor and a cleavable linker – has previously shown activity in the study’s cohort of relapsed and refractory non-small-cell lung cancer patients. ![]()
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