(Lung Cancer) Dose-Limiting Toxicity of Anti-TROP2 Antibody Drug DS-1062
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- June 1, 2020
- Read time: 2 minutes
From May 29–31, 2020, Aaron Elliott Lisberg presented at the ASCO 2020 Virtual Meeting "Efficacy and safety results of anti-TROP2 antibody drug DS-1062 in previously treated advanced non-small cell lung cancer patients in the Phase 1 clinical trial."
The Phase 1 clinical trial administered DS-1062 0.27–10.0 mg/kg monotherapy to advanced non-small cell lung cancer (NSCLC) patients. The primary endpoint was dose-limiting toxicity; the secondary endpoint was objective response rate. Patient dose groups were: 0.27 mg/kg (N=4), 0.5 mg/kg (N=5), 1.0 mg/kg (N=7), 2.0 mg/kg (N=6), 4.0 mg/kg (N=6), 6.0 mg/kg (N=19), 8.0 mg/kg (N=8), and 10.0 mg/kg (N=8). A total of 32 patients reached the maximum tolerated dose of DS-1062 at 8.0 mg/kg.
For the secondary endpoint objective response rate, among 88 evaluable patients, 22 achieved partial response. Partial response rates by dose group were: 2.0 mg/kg (1/6), 4.0 mg/kg (2/6), 6.0 mg/kg (5/18), 8.0 mg/kg (13/34), 10.0 mg/kg (1/8).
Regarding safety, the overall adverse event rate was 80% (N=76/95). Grade 3 or higher adverse event rate was 18% (N=17/95). The serious adverse event rate was 8% (N=8). Interstitial lung disease was confirmed in 8% of patients (2 patients in the 6.0 mg/kg group, 6 patients in the 8.0 mg/kg group; N=8 total).
Based on the Phase 1 trial results, Aaron Elliott Lisberg concluded: This was the first-in-human study of the anti-TROP2 antibody drug DS-1062. The trial confirmed that DS-1062 monotherapy at doses of 2.0–10.0 mg/kg demonstrated antitumor activity in previously treated advanced NSCLC patients.
[Important Note] Medical Supporter's translations of overseas clinical trial data and pharmaceutical information are not intended to encourage participation in clinical trials or use of new drugs. The translated information is for reference only and not intended as medication guidelines. Please discuss with healthcare professionals and refer to the original text below the article for accurate information.
Source: Dose escalation and expansion from the phase I study of DS-1062, a trophoblast cell-surface antigen 2 (TROP2) antibody drug conjugate (ADC), in patients (pts) with advanced non-small cell lung cancer (NSCLC). (2020 ASCO Virtual Scientific Program, Abstract No: 9619)
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