TROPION-Lung01 Study Design and Baseline demographics
The BEGONIA Study (NCT03742102)
Rationale
Immune checkpoint inhibitors +
chemotherapy is the standard of care for
patients with PD-L1 positive a/mTNBC;
still, most progress within a year (median
PFS-9-10 months) 1.2
BEGONIA is evaluating combinations of
durvalumab (D), an anti-PD-L1 antibody,
with other novel therapies in first-line
a/mTNBC
Dato-DXd is a TROP2-directed ADC with
a TOPO I inhibitor payload and a tumour-
selective cleavable linker³
At median 7.2 months follow-up, ORR
was 74% for patients treated with
Dato-DXd + D in BEGONIA+
Eligibility criteria
Females aged ≥18 years
• Unresectable a/m TNBC
+ No prior treatment for
Stage IV TNBC
⚫ ≥12 months since prior
taxane therapy
• ECOG PS 0-1
♦ Adequate organ
function
◆ Measurable disease per
RECIST v1.1
◆ No prior treatment with
checkpoint inhibitor
◆ No prior treatment with
TOPO I-based ADC*
Study Design
Treatment arms
Arm 1: Paclitaxel (P) + D (N=20)
Arm 2: Capivasertib + P + D
(N=30)
Part 1
Part 2 expansion
Arm 5: Oleclumab +P + D (N=30)
Arm 6: T-DXd + D (N=30)
Safety run-in
(up to
Simon
6 patients)
Arm 7: Dato-DXd 6 mg/kg +
D 1120 mg (N=30)
Q3W until PD
2-stage futility
analysis for
Part 2 expansion*
Arm 8: Dato-DXd + D. PD-L1
positive (N=30)
1° endpoint: Safety and tolerability
2° endpoints: ORR, PFS, DOR, OS
Arms that meet
expansion criteria
enrol additional 27
patients
1° endpoint: ORR
2° endpoints: PFS,
DoR, PFS6, OS
We report updated results with longer follow-up for patients from Parts 1 and 2 treated with Dato-DXd + D in BEGONIA Arm 7
*ADC-cohort-specific criteria. "Currently enrolling; a safety run-in will not accur for this arm as Dato-DXd+ D was already evaluated and found to be tolerable with no dose-limiting toxicities reported. "Novel treatment combinations may enter Part 2 expansion if confirmed ORR is at least 57%.
1. Cortes J. et al. Lancet. 2020:396/10265):1817-1828. 2. Emens LA, et al. J Natl Cancer Inst. 2021;113(8):1005-1016. 3. Bardia A. et al. Presented at SABOS 2022. P6-10-03. 4. Schmid P, et al. Presented at SABCS 2022. PD11-08.
ADC, antibody-drug conjugate; almTNBC, advanced metastatic triple-negative breast cancer; Dato-DXd, datopolamab deruxtecan; DoR, duration of response; D, durvalumab; ECOG PS, Eastem Cooperative Oncology Group performance status; ORR, objective response rate; OS, overall survival; PD.
progressive disease; PD-L1. programmed death ligand-1; PFS progression-free survival; PFS6. progression-free survival at 6 months; 03W, every 3 weeks: RECIST, Response Evaluation Criteria In Solid Tumors; T-DXd, trastuzumab deruxtecan; TOPO I, topoisomerase I; TROP2, trophoblast cell-
surface antigen 2.
Daiichi-Sankyo
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