Don’t Forget About HER2: Clinical Insights and Novel Therapies for HER2-Mutant NSCLC From ESMO 2025

Sanjay Popat, FRCP, PhD, and Xiuning Le, MD, PhD, discuss HER2-mutant NSCLC in this CE activity titled "Don’t Forget About HER2: Clinical Insights and Novel Therapies for HER2-Mutant NSCLC From ESMO 2025." For the full presentation, please visit us at www.peervoice.com/USJ870.

1. PeerVoice

Don't Forget About HER2: Clinical Insights and Novel
Therapies for HER2-Mutant NSCLC From ESMO 2025

Learning Objectives
Describe recent clinical trial data on novel targeted therapies for HER2-mutant NSCLC

Evaluate recent clinical trial data on novel HER2-targeted therapies within the wider
treatment landscape of NSCLC

This activity is supported by an independent grant from Boehringer Ingelheim.
PeerVoice is an EBAC® accredited provider since 2022

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2. PeerVoice

Part 1 of 2: Managing HER2-Mutant NSCLC:
Exploring the Evidence From ESMO 2025

Sanjay Popat, FRCP, PhD
Professor of Thoracic Oncology
Institute of Cancer Research
Consultant Medical Oncologist
Royal Marsden Hospital
London, United Kingdom

Xiuning Le, MD, PhD

Associate Professor

Department of Thoracic Head and Neck
Medical Oncology

UT MD Anderson Cancer Center
Houston, Texas, USA

Copyright © 2010-2025, Poervoi

3. PeerVoice

‘Sanjay Popat, FRCP, PhD, has a financial interest/relationship or affiliation in the form of:
Consultant for Amgen Inc; AnHeart Therapeutics; Arcus Biosciences; AstraZeneca; Bayer AG; Boehringer Ingelheim
International GmbH; Bristol Myers Squibb Company; Daiichi Sankyo Company, Limited; Eli Lilly and Company; Ellipses:
Pharma; Erasca, Inc. F. Hoffmann-La Roche Ltd; Gilead Sciences, Inc. GSK plo; Guardant Health, Inc. IO Biotech ApS;
Janssen Inc; Merck KGaA; Merck Sharp & Dohme Corp; Mirati Therapeutics, Inc; Novartis AG; Novocure GmbH; Pfizer
In Inc; PharmaMar S.A; Pierre Fabre Group; Sanofi; and Takeda Pharmaceutical Company Limited.

Advisory Board for Amgen Inc; AnHeart Therapeutics; Arcus Biosciences; AstraZeneca; Bayer AG; Boehringer Ingelheim
International GmbH; Bristol Myers Squibb Company; Daiichi Sankyo Company, Limited: Eli Lilly and Company; Ellipses
Pharma; Erasca, Inc, F. Hoffmann-La Roche Ltd; Gilead Sciences, Inc, GSK ple; Guardant Health, Inc; IO Biotech ApS;
Janssen Inc; Merck KGaA; Merck Sharp & Dohme Corp. Mirati Therapeutics, Inc; Novartis AG; Novocure GmbH; Pfizer
Inc; PharmaMar S.A; Pierre Fabre Group; Sanofi; and Takeda Pharmaceutical Company Limited.

Speaker or participant in accredited CME/CPD for Amgen Inc; AstraZeneca; Guardant Health, Inc.;

Johnson & Johnson; Merck KGaA; and PharmaMar S.A.

Xiuning Le, MD, PhD, has a financial interest/relationship or affiliation in the form of:
Grant/Research Support from ArriVent Biopharma and Teligene (institutional relationship)

Advisory Board for AbbVie Inc.; Abion Bio; Allist; ArriVent Biopharma; AstraZeneca; Aviston; Bayer AG; Blueprint
Medicines Corporation; Boehringer Ingelheim International GmbH; Daiichi Sankyo Company, Limited; Eli Lilly and
Company: Hengrui Therapeutics, Inc; Janssen Inc.; Merck KGaA; Novartis AG; PineTree Therapeutics Inc. Regeneron
Pharmaceuticals, Inc; and Spectrum Pharmaceuticals, Inc,

Coordinating PI via her institution tor Eli Lilly and Company; EMD Serono; Janssen Inc; and Regeneron
Pharmaceuticals, Inc.

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4. PeerVoice

Beamion LUNG-1 Phase 1a/1b: Dose Escalation and Cohorts

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Phase la (dose escalation)
Patients with HER2-altered advanced solid tumours

Patients received escalating doses of zongertinib either BID or QD in
3-wk cycles to determine RDE for phase 1b
MTD was not reached with either schedule; 2 doses were taken to
dose expansion for optimisation

Phase tb (dose expansion)
Patients with advanced/metastatic
HER2-mutant NSCLC
Selected dose after interim futility analysis:
Zongertinib 120 mg QD

Cohort 1: Previously treated with TKD mutations

Cohort 2: Treatment-naive with TKD mutations

Cohort 3: Previously treated with non-TKD mutations

Cohort 4: TKD mutations and active brain mets

Cohort 5: TKD mutations and prior HER2-directed ADC treatment

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Beamion LUNG-1 Phase 1a/1b: Patient Overview

Beamion LUNG-1

N = 3451
So en
= a
a =.
Frac Phase 1b Cohort land Cohort 2
E (both doses)
HE n= 221

Phase la

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I

Phase 1b Cohort 1 and Cohort 2
with evaluated ctDNA samples
n=148

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Beamion LUNG-1 Phase 1
Across Tumour Types

MaxVAF and HER2 VAF

MaxVAF, %

MaxVAF

HER2 VAF, %

HER2 VAF

60

n=73 n=63 n=37 n=31

Cycle1 Cycle 2 Cycle 3 Cycle 4
Dayı

Dayı

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Day!

Day!

r T T y
Cycle 1 Cycle 2 Cycle 3 Cycle 4

Day! Day! Day! Day!

— Biliary tree — Lung
— Breast — Mediastinum
— Gltract Cervix
— Colorectal colon rectum GU system
— Endometrial — NSCLC
— Oesophagus — Other

— Pancreas

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Beamion LUNG-1 Phase 1b: MaxVAF and HER2 VAF in

Cohorts 1 and 2
Changes in MaxVAF in Changes in HER2 VAF in
Phase 1b Cycle 1 of Phase 1b
Cohort 1 Cohort 2 so Cohort 1 Cohort 2
eo NN æ 40
w u
£ 40 S go
& N 2 2
2 2 20 u
o
o = o 100] ie reos
n= 95 n=93 n=50 n=50
+
cycle! Cycle 2 Cycle Cycle 2 Cycle Cycle 2 Cycle Cycle 2
Day! Day! Day! Day! Day Day? Day! Day?
Dose
— 20mg — 240mg

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Beamion LUNG-1 Phase 1b: HER2 VAF in Cohorts 1 and 2

HER2 VAF Patterns by
Best Overall Response in Phase 1b

Cohort 1 Cohort 2

Patients, %
5

HER2 VAF Pattern

Clearance m No detection mReduction MINE Incresse

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Probability of PFS

PFS According to ctDNA Detection
at BL in Phase lb

HR - Not detected, 262

F (140-492)
= a 003
os
os
0.25 | — Not detected (n = 29)
— Detected (n = 116)

o
012345 67 & 8 1011 1213 14 15 16 17 18 192021
Time, mo

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Beamion LUNG-1 Cohort 2: Study Design

Phase Ib (dose expansion):
In phase la, MTD was not reached at * Patients with advanced/metastatic nonsquamous
360 mg QD HER2-mutant NSCLC (TKD mutation)
In phase Ib, the selected dose after => + 21 measurable non-CNS lesion (RECIST v11)
interim futility analysis was + ECOG PS O/1
zongertinib 120 mg QD - Patients with stable/asymptomatic brain mets were
eligible

Current
analysis:
Cohort 2

Zongertinib 120 mg given as first-line therapy to
treatment-naive patients with TKD mutations

Primary endpoint: Objective response by BICR (RECIST v1.1)
Secondary endpoints: DCR, DOR, PFS by BICR (RECIST v1.1)

inib has been approved in US (accelerated), China (conditional), and Japan for patients with previously treated advanced HER2-mutant NSCLC.
Additional cohorts not included in the current analysis: Cohort 1 (previously treated patients with TKD mutations); Cohort 3 (previously treated patients
with non-TKD mutations); Cohort 4 (treatment-naive or previously treated patients with TKD mutations and active brain mets at BL); and Cohort 5
(previously treated patients with HER2-directed ADC and TKD mutations).
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Beamion LUNG-1 Cohort 2: Baseline Patient and

Disease Characteristics

Median age, y (range) GARE) Tobacco use, %**

‘Age group, % Never 64
65to<75 y 40 Former 34
2755 18 Current 1

Female, % 50 Brain mets, % 30

+

pes a6 HER2 TKD mutation, type, %**

en 25 A775_G776insYVMA 66
Other 32

ECOG PS, %

5 46 Median time since diagnosis, mo 17041274)
a 54 (range)

Data cutoff 8 May 2025. Two patients had received prior treatment and had protocol deviations.
* Not reported, n = 7. **Not reported, n = 1

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10

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Beamion LUNG-1 Cohort 2: Tumour Response

irmed Response by

Patients

aa (RECIST vi 74)
ORR, % (95% Cl) 77 (66-85)
PE <.0001

CR% 8
PR, % 69
DCR, % (95% Cl) 96 (89-99)
SD, % 19
PD, %** il

Two patients not evaluable for response.

* Null hypothesis: ORR s40%. **PD due to non-target lesion progression. ! Due to central review process, lesion measurements are available for

Investigator assessment.

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Case Study 1

69-year-old female former smoker, with a 20 pack-year history
At the initial CT imaging, the patient was diagnosed as Stage IV (T4 N2 Mic), with bone and lung metastases

+ CtDNA and tissue DNA next-generation sequencing identified the presence of the HER2 A775_G776insYVMA
mutation

Endobronchial ultrasound-guided biopsy (station 7 & 4R) confirmed the presence of a TTFI-positive,
PD-LI-negative adenocarcinoma

Achieved a durable PR with first-line zongertinib from first post-treatment CT scan

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Case Study 2

+ 85-year-old female never smoker
+ Presented with cough, progressive shortness of breath, and weight loss
+ Diagnosed with Stage IV lung adenocarcinoma, with a HER2 V777L mutation and metastatic to the brain

+ Received first-line zongertinib and experienced a decrease in size in nearly all metastatic lesions from first
post-treatment CT scan

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Beamion LUNG-1 Cohort 2: Safety Profile

TRAES,n(%) All
Diarrhoea 40(54)
Rash 17 (23)

ALTincreased 13 (18)
AST increased 12 (16)
Dysgeusia 12 (6)

Nausea 12 (16)
Dry skin 10 (14)
Pruritus 19 (14)

Paronychia 9(12)
Stomatitis 8(n)

Median duration of treatment, 10.3 mo (range, 0-16.0).

10 DE
° _]

Outcome

TRAEs

Grade 3 TRAEs 18
AEs leading to dose reduction* 15
AEs leading to dose discontinuation** 9
Grade 2 ILD/pneumonitis 3

Grade m1

o

20

40 60 80 mo
Patients, %

* Per protocol, some patients later discontinued. * Includes patients already counted under reductions (mainly comorbidity or progression).
TRAES are assessed by investigator that occurred in 210% of patients. Diarrhoca and rash are grouped terms.

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Abbreviations and References

Beamion LUNG-1 Phase 1a/1b: Dose Escalation and Cohorts

Abbreviation(s): ADC: antibody-drug conjugate; BID: twice daily; HER2: human epidermal growth factor receptor 2;
MTD: maximum tolerated dose; NSCLC: non-small cell lung cancer; QD: once daily; RDE: recommended dose for
expansion; TKD: tyrosine kinase domain.

Reference(s): Heymach J et al. European Society for Medical Oncology Congress 2025 (ESMO Congress 2025).
Abstract 2020P.

Beamion LUNG-1 Phase la/1b: Patient Overview

Abbreviation(s): ctDNA: circulating tumour DNA.
Reference(s): Heymach J et al. ESMO Congress 2025. Abstract 2020P.

Beamion LUNG-1 Phase 1a: MaxVAF and HER2 VAF Across Tumour Types

Abbreviation(s): GU: gastrourinary; VAF: variant allele frequency.
Reference(s): Heymach J et al. ESMO Congress 2025. Abstract 2020P.

Beamion LUNG-1 Phase 1b: MaxVAF and HER2 VAF in Cohorts 1 and 2
Reference(s): Heymach J et al. ESMO Congress 2025. Abstract 2020P.

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Abbreviations and References (Cont'd)

Beamion LUNG-1 Phase 1b: HER2 VAF in Cohorts 1 and 2
Abbreviation(s): BL: baseline; NE: not evaluable.

Reference(s): Heymach J et al. ESMO Congress 2025. Abstract 2020P.
Beamion LUNG-1 Cohort 2: Study Design

Abbreviation(s): BICR: Blinded Independent Central Review; CNS: central nervous system; DCR: disease control rate;
DOR: duration of response; ECOG PS: Eastern Cooperative Oncology Group Performance Status; PFS: progression-free
survival; RECIST: Response Evaluation Criteria In Solid Tumors.

Reference(s): Popat S et al. ESMO Congress 2025. Abstract LBA74.

Beamion LUNG-1 Cohort 2: Baseline Patient and Disease Characteristics
Reference(s): Popat $ et al. ESMO Congress 2025. Abstract LBA74.

Beamion LUNG-1 Cohort 2: Tumour Response

Abbreviation(s): CR: complete response; ORR: objective response rate; PD: progressive disease; PR: partial response;
SD: stable disease.
Reference(s): Popat S et al. ESMO Congress 2025. Abstract LBA74.

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Abbreviations and References (Cont'd)

Case Study 1

Abbreviation(s): TTF-1: thyroid transcription factor-1; PD-Li: programmed death-ligand 1.
Reference(s): Courtesy of Sanjay Popat, FRCP, PhD; October 2025.

Case Study 2
Reference(s): Courtesy of Sanjay Popat, FRCP, PhD; October 2025.

Beamion LUNG-1 Cohort 2: Safety Profile

Abbreviation(s): ALT: alanine aminotransferase; AST: aspartate aminotransferase; ILD: interstitial lung disease;
TRAE: treatment-related adverse event.
Reference(s): Popat S et al. ESMO Congress 2025. Abstract LBA7A.

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18. PeerVoice

Part 2 of 2: HER2-Mutant NSCLC:
Expert Perspective on Data From ESMO 2025

Sanjay Popat, FRCP, PhD Xiuning Le, MD, PhD

Professor of Thoracic Oncology Associate Professor

Institute of Cancer Research Department of Thoracic Head and Neck
Consultant Medical Oncologist Medical Oncology

Royal Marsden Hospital UT MD Anderson Cancer Center
London, United Kingdom Houston, Texas, USA

Copyright © 2010-2025, Peer

19. PeerVoice

‘Sanjay Popat, FRCP, PhD, has a financial interest/relationship or affiliation in the form of:
Consultant for Amgen Inc; AnHeart Therapeutics; Arcus Biosciences; AstraZeneca; Bayer AG; Boehringer Ingelheim
International GmbH; Bristol Myers Squibb Company; Daiichi Sankyo Company, Limited; Eli Lilly and Company; Ellipses:
Pharma; Erasca, Inc. F. Hoffmann-La Roche Ltd; Gilead Sciences, Inc. GSK plo; Guardant Health, Inc. IO Biotech ApS;
Janssen Inc; Merck KGaA; Merck Sharp & Dohme Corp; Mirati Therapeutics, Inc; Novartis AG; Novocure GmbH; Pfizer
In Inc; PharmaMar S.A; Pierre Fabre Group; Sanofi; and Takeda Pharmaceutical Company Limited.

Advisory Board for Amgen Inc; AnHeart Therapeutics; Arcus Biosciences; AstraZeneca; Bayer AG; Boehringer Ingelheim
International GmbH; Bristol Myers Squibb Company; Daiichi Sankyo Company, Limited: Eli Lilly and Company; Ellipses
Pharma; Erasca, Inc, F. Hoffmann-La Roche Ltd; Gilead Sciences, Inc, GSK ple; Guardant Health, Inc; IO Biotech ApS;
Janssen Inc; Merck KGaA; Merck Sharp & Dohme Corp. Mirati Therapeutics, Inc; Novartis AG; Novocure GmbH; Pfizer
Inc; PharmaMar S.A; Pierre Fabre Group; Sanofi; and Takeda Pharmaceutical Company Limited.

Speaker or participant in accredited CME/CPD for Amgen Inc; AstraZeneca; Guardant Health, Inc.;

Johnson & Johnson; Merck KGaA; and PharmaMar S.A.

Xiuning Le, MD, PhD, has a financial interest/relationship or affiliation in the form of:
Grant/Research Support from ArriVent Biopharma and Teligene (institutional relationship)

Advisory Board for AbbVie Inc.; Abion Bio; Allist; ArriVent Biopharma; AstraZeneca; Aviston; Bayer AG; Blueprint
Medicines Corporation; Boehringer Ingelheim International GmbH; Daiichi Sankyo Company, Limited; Eli Lilly and
Company: Hengrui Therapeutics, Inc; Janssen Inc.; Merck KGaA; Novartis AG; PineTree Therapeutics Inc. Regeneron
Pharmaceuticals, Inc; and Spectrum Pharmaceuticals, Inc,

Coordinating PI via her institution tor Eli Lilly and Company; EMD Serono; Janssen Inc; and Regeneron
Pharmaceuticals, Inc.

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SOHO-01: Study Design

Dose escalation/backfill . o
Patients with advanced NSCLC with Expansion and extension*
HER2 or EGFR mutations Cohorts of patients with HER2 mutations**
Patients treated with increasing oral doses r=
of sevabertinib to identify RDE Evaluate the safety, tolerability, and efficacy and
(5 QD dose levels and 3 BID dose levels from to characterise PK of sevabertinib at the RDE
10 mg QD to 40 mg BID)

Efficacy and safety from expansion/extension with sevabertinib 20 mg BID

Cohort D: Previously treated, naive to HER2-targeted therapies
Cohort E: Previously treated with HER2-targeted ADCs
Cohort F: Naive to systemic therapy for advanced disease

Current
Analysis:
Cohorts D, E, F

Primary endpoint: Objective response by BICR (RECIST v11)
Secondary endpoints: DCR, DOR, PFS by BICR/investigator (RECIST v1.1); safety

“Patients from dose escalation/backfill treated with 20 mg BID and who met same eligibility criteria were combined for statistical analysis,
Cohorts of patients with EGFR mutations are not shown.

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SOHO-01: Baseline Patient and Disease Characteristics

CohortD* GohortE® CohortF
Ei (= 81) (n=55) (=73)
Female, % 62 65 63
70 ss 70
2 2 26
Black or Arican American 1 7 o
Not reported 6 7 4
Median age, y (range) 60 (29-82) | 65(35-01) | 65(182)
Bassline ECOG PS, %
0 38 2 25
1 82 73 Tas
‘Smoking habits at informed
nen 8 es »
Former or current = = 2
“Adenocarcinoma histology % ES 100 97
Brain mets at BL, % 2 E 2

Data cutoff 27 June 2025.

= 5 Cohort D* | GohortE® cohort
Characteristic (Cont'd) ene | ES
‘Activating HERZ mutations, %
¥772_AT75dupYVMA © 73 »
Other HER2 ex20ins 2 6 s
HERZ point mutation s 9 1
Not applicable 1 2 8
HERZ TKD mutation %
Yes ES ss ”
No 9 5 3
Not applicable 1 9 °
Number of previous systemic
anticancer therapies, %
o o o 2
1 57 2 5
22 3 7 3
Previous anticancer therapies %
chr 96 80 8
Plat and no 10 25 2 4
Plat and 10 69 ES 4
Trastuzumab deruxtecan 2 75 6

® Patients were naive to HER2-targeted therapies. Patients were pretreated with HER2-targeted ADCs. * Patients were nalve to systemic therapy for
advanced disease. ‘1 patient had ECG PS score of at screening, but at treatment start (BL), the score changed to 2.

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Confirmed Response by

BICR (RECIST v1.1)
ORR, % (95% Cl)

64 (53-75)
2

CR, %

PR, % 62

SD, % 25

PD, % 7

NE, % 4
DCR, % (95% Cl) 81 (71-89)
Median DOR, mo 9.2
Median PFS, mo 83

Median follow-up, 13.8 mo (range, 1-32).

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Best % Change in SLD

MicrMpriliso POM NE

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SOHO-01 Cohort D (Nonsquamous; HER2 TKD Mutation):

Efficacy Outcomes

IECRINPR ISO PDI NE

Nonsquamous TKD mutation
(n = 68/70)

% Change in Tumour Size

Confirmed ORR by BICR
(RECIST v1.1;n = 70),
7%

Patients without target lesion measurement of % change from BL are not displayed.

1

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i PFS

2
Zoe
8
Boe Median, 9.6 mo
à
5“
=
2

02
3

0 3 6 9 12 15 18 21 24 27 30 33
Time, mo

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SOHO-01 Cohort E (Previous HER2 ADCs): ORR by BICR

Confirmed Response by

BICR (RECIST v1 (n=55)
ORR, % (95% Cl) 38 (25-52)

CR, % 5

PR, % 33

SD, % 42

PD, % 13

NE, % 7
DCR, % (95% Cl) 71 (57-82)
Median DOR, mo 85
Median PFS, mo 55

Median follow-up, 116 mo (range, 2-22).

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Best % Change in SLD

cr PR Gls OPD E NE

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SOHO-01 Cohort F (Treatment-Naive): ORR by BICR

Confirmed Response by Patients
BICR (RECIST v (n =73)
ORR, % (95% Cl) 71(59-81)

CR, % 4

PR, % 67

SD, % 22

PD, % 3

NE, % il

NA, % 3
DCR, % (95% CI) 89 (80-95)
Median DOR, mo 1.0
Median PFS, mo NE

Median follow-up, 9.9 mo (range, <1-1),

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Best % Change in SLD

CR PR D SD OPD E NE

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SOHO-01: Safety Profile

Most Frequent TRAEs (210% of Total)

Cohort D (n = 81) Cohort D, E, F (n = 209)
= a Diarrhoea cy vum
‘1 » Rash a Ib
2 Paronychia o

Cohort Cohort | Cohort

11m Stomatitis
lo Nausea CASTO D 3 lz
41 Hypokalaemia
m TRAEs 96 100 97
"Is Anaemia Grade 3 TRAEs 36 El 21
7 Y Weight =
= pore Grade 3 diarrhoea | 23 il 5
» Dry skin ILD/pneumonitis o o o
» PAST
Grace v2 » Pruritus Cohort D: Previously treated, naive to HER2-targeted therapies
rade Y an y Appetite Cohort E: Previously treated with HER2-targeted ADCs
Grades D amylase Cohort F: Naive to systemic therapy for advanced disease
2. Lipase
100 80 60 40 20 0 40 60 80 100
Patients, % Patients, %

Data cutoff 27 June 2025. Grade categories do not necessarily equal total due to rounding.

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SOHO-01 Exploratory Analysis: ORR by HER2 TKD Mutation

Best Overall Response by Cohort D Cohort E
BICR (RECIST v1.1)
According to HER2 TKD u Non-TKD TKD Non-TKD
Mutation Status (n=73) (n =7) (n = 52) (n=3)
CR, % 3 O 6 0
PR, % 67 14 33 33
SD, % 18 86 44 o
PD, % 8 ° 10 67
NE, % 4 O 8 0

70 14 38 33
RARO) (580-801) | (0.4-57.9) | (253-580) | (08-906)

patient in Cohort D was excluded as TKD variant and a non-TKD HER? variant were detected,

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SOHO-01 Exploratory Analysis: ORR by HER2 YVMA Mutation

Best Overall Response by Cohort D Cohort E
ee HU YVMA YVMA Other YVMA Other
Mutation Status (n= 49) (n = 23) (n = 40) (n = 12)
CR, % 4 fe) 8 O

PR, % 73 57 38 7
SD, % 14 22 43 50
PD, % 6 13 8 7

NE, % 2 9 5 7
ER ERS) + (exo ll cas | as

Other refers to other HER2 TKO mutations.

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Abbreviations and References

SOHO-01: Study Design

Abbreviation(s): ADC: antibody-drug conjugate; BICR: Blinded Independent Central Review; BID: twice daily;

DCR: disease control rate; DOR: duration of response; EGFR: epidermal growth factor receptor; HER2: human epidermal
growth factor receptor 2; NSCLC: non-small cell lung cancer; PFS: progression-free survival; RECIST: Response
Evaluation Criteria in Solid Tumors; PK: pharmacokinetics; QD: once daily; RDE: recommended dose for expansion.
Reference(s): Le X et al. European Society for Medical Oncology Congress 2025 (ESMO Congress 2025). Abstract
LBA75.

SOHO-01: Baseline Patient and Disease Characteristics

Abbreviation(s): BL: baseline; ChT: chemotherapy; ECOG PS: Eastern Cooperative Oncology Group Performance Status;
10: immunotherapy; Plat: platinum; TKD: tyrosine kinase domain.
Reference(s): Le X et al. ESMO Congress 2025. Abstract LBA75.

'SOHO-01 Cohort D (Previously Treated): ORR by BICR

Abbreviation(s): CR: complete response; NE: not evaluable; ORR: objective response rate; PD: progressive disease; PR
partial response; SD: stable disease.
Reference(s): Le X et al. ESMO Congress 2025. Abstract LBA75.

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Abbreviations and References (Cont'd)

SOHO-01 Cohort D (Nonsquamous; HER2 TKD Mutation): Efficacy Outcomes
Reference(s): Le X et al. ESMO Congress 2025. Abstract LBA75.

SOHO-01 Cohort E (Previous HER2 ADCs): ORR by BICR
Reference(s): Le X et al. ESMO Congress 2025. Abstract LBA7S.

SOHO-01 Cohort F (Treatment-Naive): ORR by BICR
Reference(s): Le X et al. ESMO Congress 2025. Abstract LBA75.

SOHO-01: Safety Profile

Abbreviation(s): ALT: alanine aminotransferase; AST: aspartate aminotransferase; ILD: interstitial lung disease; TRAE:
treatment-related adverse event.
Reference(s): Le X et al. ESMO Congress 2025. Abstract LBA75.

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Abbreviations and References (Cont'd)

SOHO-01 Exploratory Analysis: ORR by HER2 TKD Mutation
Reference(s): Girard N et al. ESMO Congress 2025. Abstract 2001P.

SOHO-01 Exploratory Analysis: ORR by HER2 YVMA Mutation
Reference(s): Girard N et al. ESMO Congress 2025. Abstract 2001P.

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