DESTINY-Breast03 Phase 3 Study Results
BEGONIA (NCT03742102) Study Design
Females aged ≥18 years
Unresectable a/mTNBC
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 or
TOPO I-based ADCa
First 20 patients
Part 1 (this presentation includes results from part 1)
Paclitaxel Durvalumab (P + D) (N=20)
Dato-DXd+Dc (N=30)
Q3W until PD
Capivasertib +P+D (N=30)
All others
randomized to
an open cohort
Oleclumab +P+D (N=30)
T-DXd+D (N=30)
Randomized
Each novel combination cohort
Primary endpoint:
Safety and tolerability
Secondary endpoints:
ORR, PFS, DOR, OS
Part 2 expansion (currently active/ongoing)
Dato-DXd + Db
Q3W until PD
if multiple
cohorts open
T-DXd + D
Daiichi-Sankyo
Simon
2-stage futility
analysis for
Part 2 expansion
Enroll
additional 27
patients in
each arm
Primary endpoint:
ORR
Secondary endpoints:
PFS, DOR, PFS6, OS
Data cutoff: November 15, 2021
ESMO BC 2022 #166 Mini Oral
*ADC-cohort-specific criteria. Dato-DXd 6 mg/kg + D 1120 mg. "Novel treatment combinations may enter Part 2 expansion if confirmed ORR is at least 57%.
ADC, antibody-drug conjugate; a/mTNBC, locally advanced/metastatic triple negative breast cancer; DLT, dose-limiting toxicity; DoR, duration of response; ECOG PS, Eastern Cooperative
Oncology Group performance scale; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; PD, progressive disease; Q3W, every 3 weeks; RECIST, Response
Evaluation Criteria In Solid Tumors; T-DXd, trastusumab deruxtecan; TOPO I, topoisomerase I.
74View entire presentation