ESMO 2021: Novel Antibody-Drug Conjugate Under Study in Advanced Lung Cancer
Posted: Monday, October 11, 2021
For patients with non–small cell lung cancer (NSCLC) and actionable genomic alterations, the novel antibody-drug conjugate datopotamab deruxtecan showed antitumor activity with a tolerable safety profile. Datopotamab deruxtecan comprises a TROP2-directed monoclonal antibody conjugated to a topoisomerase I inhibitor. Edward B. Garon, MD, of the University of California Los Angeles, presented these findings on behalf of his colleagues during the 2021 European Society for Medical Oncology (ESMO) Congress (Abstract LBA49).
The TROPION-PanTumor01 trial is an ongoing multicenter, dose-expansion study evaluating the efficacy of datopotamab deruxtecan in patients with solid tumors who had experienced disease progression after standard therapies. There were 210 patients enrolled with NSCLC, 34 of whom had actionable genomic alterations. Most patients (82%) had received three or more prior treatment regimens, and 85% had been treated with tyrosine kinase inhibitors. Among patients with EGFR mutations, 69% had received osimertinib. There were 8 patients treated with 4 mg/kg of datopotamab deruxtecan, 10 treated with 6 mg/kg, and 16 treated with 8 mg/kg. The actionable genomic alterations in this group included EGFR (n = 29), ALK (n = 3), and ROS1 and RET (n = 1 each).
The median time spent on the study was 13 months, and the confirmed objective response rate across all doses was 35%. The median duration of response was 9.5 months. The most common any-grade adverse events included nausea (62%) and stomatitis (56%); hematologic toxicities were observed to be infrequent. There was one grade 5 treatment-related adverse event (interstitial lung disease) in a patient who received 8 mg/kg.
“The ongoing phase II TROPION-Lung05 trial (ClinicalTrials.gov identifier NCT04484142) is assessing [datopotamab deruxtecan] at 6 mg/kg in [advanced/metastatic] NSCLC with [actionable genetic alterations] after targeted therapies and platinum chemotherapy,” said the authors.
Disclosure: For a full list of authors’ disclosures, visit oncologypro.esmo.org.