TROPION-Lung01 Study Design and Baseline demographics
Most Common (>15% of Study Total) TEAEs, Regardless of Causality
Daiichi-Sankyo
System
organ class
preferred All Grade
term, n (%)³ grades 23
SCLC
(n=22)
ESCC
(n=29)
mCRPC
(n=75)
sqNSCLC
(n=18)
Study total
(N=174)
All Grade
All Grade
grades ≥3 grades 23
All Grade
grades 23
All Grade
grades 23
Nausea
13 (59.1) 1 (4.5) 13 (44.8) 1 (3.4) 51 (68.0) 2 (2.7) 11 (61.1) 2 (11.1) 105 (60.3) 6 (3.4)
Anemia
6 (27.3) 1(4.5) 12(41.4) 8 (27.6) 27 (36.0) 15 (20.0) 4 (22.2) 3 (16.7) 57 (32.8) 33 (19.0)
IRRad
3 (13.6) 0
11 (37.9) 0
25 (33.3)
0
5 (27.8)
0
57 (32.8) 0
Decreased
appetite
5(22.7) 1 (4.5) 11 (37.9) 2 (6.9) 24 (32.0)
0
4 (22.2)
0
56 (32.2) 3 (1.7)
Fatigue
11 (50.0)
0
6 (20.7)
0
32 (42.7) 1 (1.3) 1 (5.6)
0
55 (31.6) 1 (0.6)
Vomiting
6 (27.3)
0
2 (6.9)
0
Diarrhea 3 (13.6)
0
2 (6.9)
0
33 (44.0) 2 (2.7) 5 (27.8) 1 (5.6) 54 (31.0) 3 (1.7)
21 (28.0) 2 (2.7) 3 (16.7) 1 (5.6) 30 (17.2) 3 (1.7)
.
No new safety signals were observed; the
safety profile was consistent with previous
reports
• The most common TEAEs associated with
drug discontinuation were pneumonitis (n=3)
and ILD (n=2)
• The most common (≥3%) Grade ≥3 TEAEs
were anemia (19.0%), neutropenia (4.0%),
and nausea and lymphocyte count
decreased (3.4% each)
• Overall, 10/174 patients (5.7%) had confirmed
ILD that was adjudicated as drug- related; 5
of these cases led to drug discontinuation.
Most cases of ILD were Grade 1 or 2 (n=8);
one Grade 4 ILD occurred in the 12 mg/kg
cohort, and one Grade 5 ILD occurred in the
16 mg/kg cohort
Pyrexia
4 (18.2)
0
6 (20.7)
0
11 (14.7)
0
3 (16.7)
0
30 (17.2) 0
Constipation 4 (18.2) 1(4.5) 6 (20.7) 1 (3.4) 13 (17.3)
0
3 (16.7)
0
29(16.7) 2 (1.1)
aAdverse events were coded using MedDRA, version 25.1. Includes patients with SCLC, ESCC, mCRPC, sqNSCLC and other tumor types.
Prophylactic premedication for nausea, vomiting, and IRR was not permitted for primary prophylaxis during Cycle 1 of dose escalation.
dFor Grade 2 IRRs, prophylactic medication (with or without corticosteroids) was administered for ≤24 hours at the discretion of the investigator before subsequent administration of I-DXd.
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