FY2022 Q3 Financial and R&D Update
Best Percent Change in SOD
From Baseline by BICR (n=40).%
Progression-free survival, %
100
80
60
Dato-DXd
40
20
--------
0
-20
-40
-80
-80
* Prior Topo I inhibitor-based ADC
-100
100-
80-
60-
40-
20-
TROPION-PanTumor01 Study
SABCS 2022, TNBC Cohort
Efficacy
Antitumor Responses by BICR (n=40)
aPostbaseline tumor assessments were not available for 1 patient at data cutoff.
Three patients were not confirmed to have a target lesion per BICR and therefore had
a best overall response of non-CR/non-PD.
PFS (All Patients)
29/44 (66)
Median (95% CI), mo
Events n/N (%)
0-
All patients
4.4 (3.0-7.3)
T
T
T
T
0
3
6
9
12
15
18
21
Time, months
Data cutoff: July 22, 2022
Progression-free survival, %
100-
80-
60-
40°
20-
PFS (Topo I Inhibitor-Naïve Patients)
Median (95% CI), mo
Events n/N (%)
0-
Topo I inhibitor-naive patients
7.3 (3.0-18.0)
16/30 (53)
T
T
T
T
0
3
6
9
12
15
18
21
Time, months
TROPION-Pan Tumor01
TNBC Cohort
Daiichi-Sankyo
Cohort of patients with unresectable or metastatic
TNBC (including HER2 low) in Ph1 trial to evaluate
safety and efficacy of Dato-DXd. Patients in this cohort.
received a median of three lines of treatment for
metastatic disease previously.
ORR was 32% in all patients (n=44) and 44% in
Topo I inhibitor-naïve patients (n=27) with
measurable disease; mDOR was 16.8 months in
both groups
■mPFS was 4.4 months in all patients and 7.3
months in Topo I inhibitor-naïve patients
mOS was 13.5 months in all patients and 14.3
months in Topo I inhibitor-naïve patients
■No cases of ILD, febrile neutropenia, or grade ≥3
diarrhea were reported
Results demonstrate encouraging efficacy and manageable safety profile
in TNBC and support ongoing TROPION-Breast02 study
BICR: blinded independent central review, CI: confidence interval, ILD: interstitial lung disease, mDOR: median duration of response, mOS: median overall survival, mPFS: median progression-free survival, ORR: objective response rate,
PFS: progression-free survival, SABCS: San Antonio Breast Cancer Symposium, TNBC: triple-negative breast cancer
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