![]() Garon added earlier in the presentation that since the 8 mg/kg dose did not have a favorable efficacy-to-toxicity ratio, it is no longer being developed throughout this program.ĭata from the phase 1 TROPION-PanTumor01 trial previously demonstrated that Dato-DXd led to encouraging antitumor activity in 210 patients with advanced/metastatic NSCLC who were previously heavily pretreated. That was at the 8 mg/kg dosing level, which has since been discontinued.” “There was one case of fatal interstitial lung disease felt to be associated with the drug. “One adverse event of particular concern with this agent is interstitial lung disease,” Garon said. Researchers reported one incidence of interstitial lung disease related to treatment with Dato-DXd, which was considered a grade 5 event at a dose of 8 mg/kg. Hematologic toxicities related to Dato-DXd were infrequent. The most common any-grade adverse events observed throughout the study included stomatitis (56%) and nausea (62%). The overall response rate confirmed by blinded independent central review was 35% across all doses (95% CI, 19.7-53.5), with a median duration of response of 9.5 months (95% CI, 3.3-NE), “indicating a significant level of efficacy in heavily previously treated advanced non-small cell lung cancer patients with actionable genomic alterations,” Garon explained. This study was conducted for a median of 13 months. In addition, 69% of patients with EGFR mutations previously received osimertinib (Tagrisso). Most patients in this study received at least 3 prior regimens (82%) and were previously treated with tyrosine kinase inhibitors (85%). The actionable genomic alterations reported by investigators included ALK (n = 3), EGFR (n = 29) and ROS 1 and RET (both n = 1). “It’s composed of a humanized anti-TROP2 monoclonal antibody conjugated to a potent topoisomerase I inhibitor via a stable tetrapeptide-based cleavable linker.” “ … is an antibody drug conjugate,” Garon said. Patients were treated with Dato-DXd at doses of 4 mg/kg (n = 8), 6 mg/kg (n = 10) or 8 mg/kg (n = 16). ![]() Increased expression of TROP2 has been associated with poor outcomes.” ![]() “TROP2 is known to be highly expressed in non-small cell lung cancer including non-small cell lung cancer with actionable genomic mutations. ![]() Garon, MD, MS, professor of medicine and director of the Thoracic Oncology Program at the David Geffen School of Medicine at the University of California, Los Angeles, during the presentation. “For patients who have actionable genomic alterations such as EGFR mutations or ALKgene rearrangements, once patients have exhausted their tyrosine kinase inhibitor therapy as well as platinum-based chemotherapy, the options are not particularly good,” said Edward B. In this presentation at the 2021 European Society for Medical Oncology Congress, results focused on 34 patients (median age, 62 years 56% women) with advanced/metastatic NSCLC and actionable genomic alterations. For patients with advanced/metastatic non-small cell lung cancer (NSCLC) and actionable genomic alterations, datopotamab deruxtecan (Dato-DXd) showed safe antitumor activity, according to results from the TROPION-PanTumor01 trial (NCT03401385). ![]()
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