The 2023 European Society for Medical Oncology (ESMO) Congress will be held from October 20 to 24 in Madrid, Spain. AsOne of the most influential oncology conferences globallyThe ESMO official website recently announced the clinical research of the key abstracts of this meeting.
Among them, Daiichi Sankyo's DXd antibody-drug conjugate (ADC) product Dato-DXd (generic name: Datopotamab deruxtecan, code: DS-1062a) treatmentDriver Gene AbnormalityClinical outcomes for patients with advanced non-small cell lung cancer (NSCLC) positive for AGA will be presented at the conference (1314MO).
Once targeted therapy and platinum-based chemotherapy are ineffective for patients with advanced/metastatic non-small cell lung cancer combined with AGAs, there are few available treatment options.
Dato-DXd is aTargeting TROP2(Trophoblast cell surface antigen 2) ADC drug, composed of a humanized anti-TROP2 IgG1 monoclonal antibody conjugated with a potent topoisomerase I inhibitor payload through a stable tetrapeptide cleavable linker.
TROP2 is a transmembrane glycoprotein that is widely expressed in various solid tumors, including non-small cell lung cancer. Although TROP2 is expressed in all subtypes of lung cancer, it is highly expressed inAdenocarcinoma(64%) andSquamous Cell Carcinoma(75%). Currently, no TROP2-targeted therapies have been approved for the treatment of non-small cell lung cancer patients.
Generic Name:Datopotamab deruxtecan
Code:DS-1062a
Target:TROP2
Manufacturer:Daiichi Sankyo, AstraZeneca
First Approval Date in the United States:Not yet approved
First Approval Time in China:Not yet approved
Clinical Data
In this global, open-label, Phase II TROPION-Lung05 trial (NCT04484142), the efficacy and safety of Dato-DXd in treating advanced/metastatic non-small cell lung cancer were evaluated in patients who had previously received≥1 line of targeted therapy and platinum-based chemotherapy。
Patients enrolled had an ECOG status of 0 or 1 and harbored driver gene abnormalities, such as EGFR, ALK, ROS1, NTRK, BRAF, MET exon 14 skipping mutations, or RET mutations.
TrialPrimary EndpointIt is the Objective Response Rate (ORR) assessed by Blinded Independent Central Review (BICR);Secondary EndpointIncluding BICR-assessed duration of response (DOR), disease control rate (DCR), and safety.
A total of 137 patients received ≥1 dose of Dato-DXd treatment, with a median age of 61.0 years; 71.5% of the patients had previously received ≥3 lines of therapy, and 56.9% had EGFR mutations.
The trial results showed that the objective response rate (ORR) was35.8%, Complete Response (CR) Rate2.9%, Partial Response (PR) Rate32.8%; Disease Control Rate (DCR) is78.8%, The median duration of response (DOR) was7.0 months. A similar response was observed in patients with EGFR mutations: ORR was43.6%。
In terms of safety, the most common ≥3 grade treatment-related adverse events (TEAEs) included:Stomatitis（9.5%）、Anemia(5.8%) andElevated Amylase（5.8%）。
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