New Indication: Trastuzumab Deruxtecan for her2 Mutant NSCLC
Study
Multicenter, blinded, phase 2 study |
Previously treated (platinum-containing therapy) patients with HER2m mNSCLC |
Trastuzumab deruxtecan: 5.4 mg/kg (n=102) vs. 6.4 mg/kg (n=52) |
Efficacy
ORR: 49.0% vs. 56.0 % |
mDOR: 16.8 mos [6.4-NR] vs. NR [8.3-NR] |
mPFS: 9.9 mos vs. 15.4 mos |
12 mos PFS: 45 % vs. 53% |
mOS: 19.5 mos vs. NR |
12 mos OS: 67% vs. 73% |
Safety
Grade≥3 AEs: Neutropenia (18.8% vs 36.0%), anemia (10.9% vs. 16.0%), fatigue (7.9% vs. 10.0%). |
Journal of Clin Oncol SEP, 2023
http://doi.org/10.1200/JCO.23.01361
Reviewed by Elvin Chalabiyev, MD on Sep 23, 2023
New Indication: Trastuzumab Deruxtecan for her2-Mutant NSCLC
Study
Multicenter, international, phase 2 study |
Metastatic HER2-mutant NSCLC (refractory to standard treatment) |
Trastuzumab deruxtecan >= 6.4 mg per kilogram of body weight |
Efficacy
ORR: 55% (95% CI, 44 to 65) |
Median DOR: 9.3 months (95% CI, 5.7 to 14.7) |
Median PFS: 8.2 months (95% CI, 6.0 to 11.9) |
Median OS:17.8 months (95% CI, 13.8 to 22.1). |
Safety
Grade >=3 AEs: 46%, neutropenia 19% |
Drug-related interstitial lung disease: 26% => 2 death |
N Engl J Med 2022; 386:241-251
Trastuzumab Deruxtecan in HER2-Mutant Non–Small-Cell Lung Cancer
http://doi.org/ 10.1056/NEJMoa2112431
Reviewed by Hasan Cagri Yildirim, MD on Mar 16, 2022