TROPION-Lung01 Study Design and Baseline demographics
DESTINY-Pan Tumor02: a Phase 2 study of T-DXd for
HER2-expressing solid tumors
An open-label, multicenter study (NCT04482309)
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Key eligibility criteria
Advanced solid tumors not eligible for curative therapy
• 2L+ patient population
⚫ HER2 expression (IHC 3+ or 2+)
Endometrial cancer
Cervical cancer
Daiichi-Sankyo
-
Local test or central test by Hercep Test if local test
T-DXd
Ovarian cancer
not feasible (ASCO/CAP gastric cancer scoring 1)a
5.4 mg/kg Q3W
Bladder cancer
• Prior HER2-targeting therapy allowed
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ECOG/WHO PS 0-1
Baseline characteristics
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⚫ 267 patients received treatment; 202 (75.7%) based on local HER2 testing
40 per cohortb
Other tumorsc
Biliary tract cancer
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111 (41.6%) patients were IHC 3+ based on HER2
test (local or central) at enrollment, primary efficacy analysis (all patients)
75 (28.1%) patients were IHC 3+ on central testing,
sensitivity analysis on efficacy endpoints (subgroup analyses)
Pancreatic cancer
Primary endpoint
•
Confirmed ORR
(investigator)
Secondary endpoints
DOR, DCR, PFS, OS
Exploratory analysis
•
Subgroup analyses by
HER2 status
Primary analysis
data cutoff: Jun 8, 2023
Median follow up: 12.75 mo
•
•
Safety
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Median age was 62 years (23-85) and 109 (40.8%) patients had received ≥3 lines of therapy
*Patients were eligible for either test. All patients were centrally confirmed; 'planned recruitment, cohorts with no objective responses in the first 15 patients were to be closed; "patients with tumors that express HER2, excluding tumors in the tumor-
specific cohorts, and breast cancer, non-small cell lung cancer, gastric cancer, and colorectal cancer
2L, second-line; ASCO, American Society of Clinical Oncology; CAP, College of American Pathologists; DCR, disease control rate; DOR, duration of response; ECOG, Eastern Cooperative Oncology Group; HER2, human epidermal growth factor
receptor 2; IHC, immunohistochemistry; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; PS, performance status; Q3W, every 3 weeks; T-DXd, trastuzumab deruxtecan; WHO, World Health Organization
1. Hofmann M, et al. Histopathology. 2008;52:797–805
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