A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2 Expressing Tumors (DESTINY-PanTumor02)

Advanced HER2+ solid tumors w/ HER2 IHC 2+

267 patients w/ HER2 IHC 2+ or IHC 3+, median 2 prior therapies (0-13); 40 OC, median 3 prior (1-12)

Recurrence

Open-Label, Non-randomized

ORR, DCR, DoR, OS, evaluated per RECIST

HER2+ IHC 2+

ORR: 45% (4CR, 14PR, n=40)
DCR (3 months): 70% (4CR, 14PR, 10SD, n=40)
DoR: 11.3 months
PFS: 5.9 months
OS: 13.2 months

Exploratory analysis, HER2 IHC:
HER2 IHC 3+ (n=11): ORR: 63.6%; PFS: 12.5 months; OS: 20.0 months
HER2 IHC 2+ (n=19): ORR: 36.8%; PFS: 4.1 months

Serious AE: overall (13.5%)
Grade 3-4 AE: overall (40.8%), neutropenia (19.1%), anemia (10.9%)
ILD/pneumonitis: all grades (10.5%), grade 3-5: (1.5%), grade 5 events seen at 8.0 mg/kg dose which has been discontinued

Trastuzumab Deruxtecan (T-DXd) has a manageable safety profile and shows encouraging shows encouraging activity in OC patients with HER2 IHC 2+

Meric-Bernstam F et al. Trastuzumab deruxtecan (T-DXd) for pretreated patients (pts) with HER2-expressing solid tumors: Primary analysis from the DESTINY-PanTumor02 (DP-02) study. Ann Oncol (2023) 34(2) abstract LBA34
https://www.clearityfoundation.org/wp-content/uploads/2023/11/DESTINY-PanTumor02-ESMO-2023.pdf

Meric-Bernstam F et al. Efficacy and Safety of Trastuzumab Deruxtecan in Patients With HER2-Expressing Solid Tumors: Primary Results From the DESTINY-PanTumor02 Phase II Trial. J Clin Oncol (2024) 42(1):47-58
https://pubmed.ncbi.nlm.nih.gov/37870536/