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[Slide 1]
Study design (NCT05382559)
Patients with NSCLC:
Dose escalation
Dose expansion
Documented KRAS G12D
mutations
800 mg
Primary objective
Locally advanced unresectable
RP2D*
or metastatic disease
600 mg
Safety
600 mg
ECOG PS of 0-2
Secondary endpoints
elcc
European Lung
Cancer Congress 2026
(dose escalation) or
450 mg
Setidegrasib 600 mg
ORRᵇ, DCRᵇ, DOR
IV QW
0-1 (dose expansion)
Pharmacokinetics
Progressed on prior
Exploratory endpoints
300 mg
SOC therapy
PFS
NSCLC
No prior pan-RAS or
OS
200 mg
600 mg setidegrasib
KRAS G12D
Dose escalation (n = 5) +
Pharmacodynamics
inhibitors/degraders
Dose expansion (n = 40)
May have had asymptomatic,
140 mg
treated CNS metastases
. Proposed RP20; Per RECIST v1.1
Patient
Organisers
ESMO
LASLC
ESTRO
ETOP BCSQ
Dr Philippe A. Cassier
Content of this presentation is copyright and responsibility of the author Permission is required for re-use
elcc
European Lung
Cancer Congress 2026
[Slide 1]
Setidegrasib demonstrated a favorable safety profile
TRAEs in ≥ 20% of patients
Setidegrasib 600 mg
(N = 45)
IRRsᵃ
Median duration of exposure, weeks
30.6
Nauseab
TRAEs, n (%)
44 (97.8)
ALT increasedᵇ
Grade ≥ 3 TRAEs, n (%)
6 (13.3)
Serious TRAEs, n (%)
3 (6.7)
AST increasedᵇ
Grade 1-2
TRAEs leading to discontinuation, n (%)
0
Peripheral edemab
Grade 3
TRAEs leading to death, n (%)
0
0
10
20
30
40
50
60
70
80
Incidence, %
Patients experienced low rates of grade ≥ 3 TRAEs
No TRAEs leading to death or discontinuation were observed
IRRs were low-grade, manageable, and mainly occurred at 1st infusion
Data cutoff date: October 9. 2025
a
IRRs in > 20% of patients were pruntus (33.3%), rash (33.3%), and urticana (26 7%), $ Non IRR TRAE
Organisers
Partners
Dr Philippe A. Cassier
ESMO
IASLC
INTERNATIONAL
ESTRO
L
ETOP-IBCSG
CANCER
TARTNERS/POUNDATION
Content of this presentation is copyright and responsibility of the author Permission is required for re-use
---
[Slide 2]
Setidegrasib is a novel KRAS G12D-targeted protein degrader
E3
KRAS
Ubiquitin
G12D
..
setidegrasib
OF
KRAS
KRAS
G12D
G12D
Proteasome
E3
setidegrasib
Degradation
In a Phase 1 trial (NCT05382559) in patients with NSCLC harboring KRAS G12D mutations,
600 mg setidegrasib monotherapy IV QW previously demonstrated favorable safety and
early clinical activity¹
Here we show updated results in patients with NSCLC from the Phase 1 study
1. Spira Al et al Presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics 2025 Abstract LB-B010
Organisers
Partners
Dr Philippe A. Cassier
ESMO
IASLC
ESTRO
L
ETOP-IBCSG
CANCER
PARTNERS FOUNDATION
Content of this presentation is copyright and responsibility of the author Permission is required for re-use
---
[Slide 3]
Setidegrasib led to tumor reduction in most patients
60
2L
3L
4L+
40
SD
20
PD
Best Percent Change From Baseline
NE
NE PD SD SD SD SD SD SD
0
SD
SD SD
-20
SD SD SD SD
SD SD
SD SD
SD SD SD SD PR
-40
PR
PR
PR PR
PR
-60
ORR°, n/n (%)
PR
PR PR PR
PR
All patients
16b/45 (35.6)
-80
PR
PR
PR
2L/3L
12b/32 (37.5)
PR
-100
Light/nonsmokers
8/17 (47.1)
PR
ORR was 37.5% in the 2L/3L setting
Data are from patients with NSCLC who received 600 mg setidegrasib IV QW Data cutoff date: November 10. 2025. Three patients did not have postbaseline tumor assessments and are not included here. Dashed line represents 30% reduction
Patients without a postbaseline tumor assessment meeting SD critena > 35 days after study entry were classified as NE, One patient had an ongoing unconfirmed PR per RECIST v1.1; Defined as patients with BOR of CR/PR with confirmation,
or without confirmation but with possibility of confirmation at subsequent assessment
Organisers
Partners
Dr Philippe A. Cassier
ESMO
IASLC
ESTRO
L
ETOP-IBCSG
PARTNERS FOUNDATION
Content of this : presentation is . copyright and responsibility of the author Permission is required for re-use
---
[Slide 4]
Setidegrasib demonstrated encouraging PFS
1.0
Median PFS, months (95% CI)
All patients
8.3 (4.1-NE)
0.8
2L/3L
11.2 (5.6-NE)
67%
Light/nonsmokers
11.2 (6.9-NE)
Probability
0.6
58%
44%
0.4
2L/3L
41%
0.2
All patients
0.0
0
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
Number at Risk
Months
All patients
45
41
37
32
28
26
23
21
19
13
8
7
5
4
2
2
1
0
2L/3L
32
29
26
25
23
22
20
18
16
11
6
5
4
4
2
2
1
0
Median PFS was 11.2 months in the 2L/3L setting
Data are from patients with NSCLC who received 600 mg setidegrasib IV QW Data cutoff date November 10, 2025 Median follow up time, months (95% CI) All patients, 9.7 (9 1-12.4); 2L/3L, 9.7 (8.7-13.3)
For all patients, PFS rate (95% CI) was 58% (41-71) at 6 months and 41% (22-59) at 12 months For 2L/3L patients, PFS rate (95% CI) was 67% (47-81) at 6 months and 44% (20-66) at 12 months
Organisers
Partners
Dr Philippe A. Cassier
ESMO
IASLC
study
ESTRO
CANCER
L
ETOP-IBCSG
PARTNERS/FOUNDATION
Content of this presentation is copyright and responsibility of the author Permission is required for re-use
3082-CL-0101 (NCT05382559) is a Phase 1 dose-escalation and dose-expansion study evaluating setidegrasib, a novel KRAS G12D-targeted protein degrader, in patients with advanced solid tumors harboring KRAS G12D mutations. Unlike conventional KRAS inhibitors, setidegrasib degrades the KRAS G12D protein through a proteasome-mediated mechanism. The study enrolled 45 patients with heavily pretreated KRAS G12D-mutant NSCLC receiving setidegrasib 600 mg IV weekly.
Phase 1 dose-escalation and dose-expansion study (NCT05382559) of setidegrasib, a KRAS G12D protein degrader, administered as 600 mg IV weekly in patients with ECOG PS 0-2.
Population
Patients with locally advanced unresectable or metastatic NSCLC harboring KRAS G12D mutations who had progressed on prior standard-of-care therapy (N=45). No prior pan-RAS or KRAS G12D inhibitors/degraders.
Interventions
Setidegrasib 600 mg administered intravenously once weekly (IV QW). Dose escalation ranged from 140 mg to 800 mg, with 600 mg selected as the recommended Phase 2 dose (RP2D).
Primary Endpoints
Primary endpoint: safety. Secondary endpoints: objective response rate (ORR), disease control rate (DCR), and duration of response (DOR) per RECIST v1.1. Exploratory endpoints: PFS, OS, pharmacodynamics.
Efficacy & PFS
Setidegrasib demonstrated a median PFS of 8.3 months in the overall NSCLC population (N=45). In the 2L/3L subgroup, median PFS was approximately 11.2 months. Early ctDNA molecular response (greater than or equal to 50% decrease in KRAS G12D VAF at Day 21) was strongly associated with PFS benefit (HR 0.12; 95% CI 0.03-0.46; p=0.0004), with median PFS of 9.6 months vs 2.6 months.
Setidegrasib demonstrated a favorable safety profile with median duration of exposure of 30.6 weeks. Treatment-related adverse events (TRAEs) occurred in 97.8% of patients, but grade 3 or higher TRAEs were observed in only 13.3% (6/45). Serious TRAEs occurred in 6.7%. Importantly, no TRAEs led to treatment discontinuation or death. The most common TRAEs (greater than 20%) were infusion-related reactions (IRRs), nausea, ALT increase, AST increase, and peripheral edema. IRRs were low-grade, manageable, and mainly occurred at the first infusion.
Setidegrasib represents a promising first-in-class KRAS G12D degrader with clinically meaningful activity in heavily pretreated NSCLC. The ORR of 35.6% and DCR of 84.4% in this difficult-to-treat population compare favorably with other emerging KRAS G12D-targeting agents. The strong ctDNA-PFS correlation (HR 0.12) may enable early response monitoring. This agent is investigational and not FDA-approved; further development in randomized trials is warranted.
