[Slide 1]
LATIFY study design
Phase 3, randomised, open-label, multicentre study (NCT05450692)
Primary endpoint
Key eligibility
os
Secondary endpoints included:
Locally advanced/metastatic
Ceralasertib 240 mg PO BID Days 1-7
PFS$
NSCLC without actionable
Durvalumab 1500 mg IV on Day 8 Q28D
ORR
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genomic alterations*
N=594
(N=299)
DoR$
OS at 12 months
Eligible for 2L or 3L treatment
R
PROs
following progression on or after
1:1
Safety
platinum-based CT and
anti-PD-(L)1 therapy
Stratified by
(concurrent or sequential)
Histology (squamous vs non- squamous)
Docetaxel 75 mg/m² IV on Day 1 Q21D
os and PFS in key subgroups
Resistance to prior andi-PD-(L)1 therapy
(N=295)
ATM protein (<25%/225%)
Documented PD-L1 status!
(primary in acquired?
ATM afteration presence absence)**
PD-L1 status (YTN is 21%)
Histology (squamous non-equamous)
ECOG/WHO PS 0 or 1
Descraphical region
North America and Western Europe is
PD-L1 expression (<1% 1-49% >50%)
other peographical regions)
Resistance to prior and PD-(L)1 therapy
(primary acquired)
TGR and ALK widhge no the ROST RET MET BRAF V000 NTRKY and NTRQ stations Per VENTANA POL (SP283) many
Presery resistence NON defined is Income progression 575 form start of peor - PD-(L)1 treatment and acquired resistance - docase progression vss - from the start of por and instruct Unvestgabe assessed per RECIST in
the protest expressen - evaluated - he Ventana Y170 many if pro- delined of - (425% total in 925% normal) a unknown) "ATM derations - defend by combining AIM Issue mutstion BONAATM mutation
- and ATM protest repression ATM mutations were classified - Intected (dditional or suspected felebrious) not detected NO pathoginic mutations - heAlth one) - unknown
a ascend the 1. ALK yephone - ADM Alamis mutal no be day CT, chemotherapy MONA circulating know ONA DeR duration of response
E000 Dooperative Group EGFR epidemal growth factor mapler N intravenously ORR response rate OS, overst survive PES progression free survival
PO only PROM policed reported outsomes PS performance Q210 every 21 tays COSO every a Says, R condomized RECIST of 1. Response valuation Criteria a Sold Tunors verson 11 WHO Mind Health Organization
elcc
European Lung
Cancer Congress 2026
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[Slide 2]
Conclusions
LATIFY did not meet its primary endpoint, ceralasertib + durvalumab did not demonstrate a statistically
significant improvement in OS compared with docetaxel
- OS HR = 0.90 (95% Cl: 0.75-1.09; p = 0.287); median OS was 11.1 months (95% Cl: 10.0-12.7) in the ceralasertib +
durvalumab arm VS 10.0 months (95% Cl: 8.5-11.7) in the docetaxel arm
PFS and ORR were also not improved with ceralasertib + durvalumab VS docetaxel
- Median PFS was 4.1 months (95% Cl: 3.8-4.4) in the ceralasertib + durvalumab arm VS 4.1 months (95% Cl: 3.5-4.3) in
the docetaxel arm
- ORR was 7.7% (95% Cl: 4.9-11.3) in the ceralasertib + durvalumab arm VS 17.3% (95% Cl: 13.2-22.1) in the
docetaxel arm
OS and PFS were generally consistent across prespecified subgroups
- In LATIFY, ORR, PFS, and OS among patients with ATM alterations did not replicate the clinical activity
observed in HUDSON
Ceralasertib + durvalumab was tolerable and AEs were consistent with the known safety profiles of each agent
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[Slide 3]
Secondary endpoint: Progression-free survival
1.0
Ceralasertib +
Docetaxel
durvalumab
(n=299)
(n=295)
0.8
Events, (%)
262 (87.6)
236 (80.0)
mPFS, months (95% CI)
4.1 (3.8-4.4)
4.1(3.5-4.3)
HR (95% CI)
0.87 (0.73-1.04)
0.6
Nominal p-value
0.133
Extramenting
Probability of PFS
Median duration of follow-up in
16.6 (0-31)
0.8 (0-29)
elcc
censored patients, months (range)
0.4
0.2
0
0
3
6
9
12
15
18
21
24
27
30
33
No. at risk
Time from randomisation (months)
Certificate
200
176
98
56
43
34
24
0
2
1
1
0
ourvalured
Docetased
295
151
01
a
10
13
11
5
3
1
0
0
Data a October 00. 2025
Tick marks indicate consored data
The 95% Cla for mPFS were calculated using the Brookneyer Crowdey method
The HR and associated 95% Cla were calculated from a strattlied Cox proportional hazands model
mPFS median progression- the service
elcc
European Lung
Cancer Congress 2026
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[Slide 4]
Primary endpoint: Overall survival
1.0
Ceralasertib +
Docetaxel
durvalumab
(n=299)
(n=295)
0.8
Events, (%)
214(71.6)
219 (74.2)
mOS, months (95% CI)
11.1(10.0-12.7)
10.0 (8.5-11.7)
HR (95% CI)
0.90 (0.75-1.09)
elcc
Probability of os
0.6
p-value
0.287
Median duration of follow-up in
19.9 (0-32)
19.5(0-31)
40.2%
-
censored patients, months (range)
0.4
43.0%
0.2
0
0
3
6
9
12
15
18
21
24
27
30
33
No. risk
Time from randomisation (months)
Certificate
200
258
202
100
durvalurnab
127
101
11
43
22
9
5
0
Doortased
255
234
185
145
110
97
78
47
24
11
1
0
Date a October 06, 2025
Tick marks indicate ownered date
The 95% Chs for nos were calculated wing the Brookmeyer Crewtity method
The HR and associated 95% Ch were calculated tom straided Cox perportional hazanda model
The significance level by testing os at his final analysis - 4. 15% 2 sided) at the oversl 4. 90% level allowing for strong elpha control across interm and trat analysis Imports
nos median overal survival
elcc
European Lung
Cancer Congress 2026
LATIFY (NCT05450692) is a phase 3, randomised, open-label, multicentre study evaluating ceralasertib (an ATR inhibitor) plus durvalumab versus docetaxel in patients with locally advanced or metastatic NSCLC who progressed after prior platinum-based chemotherapy and anti-PD-(L)1 therapy. The study enrolled 594 patients without actionable genomic alterations. The trial was presented at ELCC 2026 by Dr. Benjamin Besse and was reported as negative across all primary and secondary endpoints.
Phase 3, randomised 1:1, open-label, multicentre study. Patients were stratified by histology (squamous vs non-squamous), resistance to prior anti-PD-(L)1 therapy (primary vs acquired), ATM protein expression, PD-L1 status, and geographical region.
Population
Adults with locally advanced or metastatic NSCLC without actionable genomic alterations (EGFR, ALK, ROS1, RET, MET, BRAF V600E, NTRK), eligible for 2nd or 3rd line treatment following progression on or after platinum-based chemotherapy and anti-PD-(L)1 therapy (concurrent or sequential). ECOG PS 0-1 with documented PD-L1 status.
Interventions
Experimental arm: ceralasertib 240 mg orally twice daily on Days 1-7 plus durvalumab 1500 mg IV on Day 8 every 28 days (N=299). Control arm: docetaxel 75 mg/m2 IV on Day 1 every 21 days (N=295).
Primary Endpoints
Primary endpoint: overall survival (OS). Key secondary endpoints included PFS, ORR, duration of response (DoR), OS at 12 months, patient-reported outcomes (PROs), and safety. Subgroup analyses by ATM status, PD-L1 expression, histology, and resistance type were pre-specified.
Progression-Free Survival (PFS)
The LATIFY trial did not demonstrate a statistically significant improvement in PFS for ceralasertib plus durvalumab compared to docetaxel. No numerical PFS data have been publicly reported beyond the negative outcome statement at ELCC 2026.
The primary endpoint of overall survival was not met. Ceralasertib plus durvalumab did not show a statistically significant OS benefit compared to docetaxel in the overall study population. The presenter noted a potential signal of benefit in approximately 7% of patients who may require molecular characterization for identification.
Detailed safety data from LATIFY have not yet been fully reported in the public domain beyond the ELCC 2026 presentation. The safety profile of ceralasertib plus durvalumab was assessed as a secondary endpoint.
The LATIFY trial represents a setback for ATR inhibitor-based combination strategies in post-immunotherapy NSCLC. While the overall trial was negative, a potential benefit signal in approximately 7% of patients suggests that molecular characterization (including ATM status) may identify a subgroup that could benefit. This underscores the need for biomarker-driven patient selection in future DDR-targeted therapy trials.