TISLELIZUMAB (TIS) + CHEMOTHERAPY (CT) VS PLACEBO (PBO) + CT
IN HER2-NEGATIVE ADVANCED OR METASTATIC GASTRICOR GASTRO-OESOPHAGEAL JUNCTION ADENOCARCINOMA (GC/GEJC)
PD-L1 Biomarker Analysis from RATIONALE-305
Markus Moehler,1 Do-Youn Oh,2 Ken Kato,3 Josep Tabernero,4 Marcia Cruz Correa,5 Lucjan Wyrwicz,6Roberto Pazo-Cid,7 Antonio Cubillo Gracián,8 Ludovic Evesque,9 Lorenzo Fornaro,10 Efrat Dotan,11 Carys Morgan,12
Liyun Li,13 Yaling Xu,14 Tao Sheng,15 Silu Yang,13 Han Hu,13 Ruihua Xu,16 on behalf of the RATIONALE-305 Investigators
1Johannes Gutenberg-University Clinic, Mainz, Germany; 2Seoul National University Hospital, Cancer ResearchInstitute, Seoul National University College of Medicine, Seoul, South Korea; 3National Cancer Center Hospital,
Tokyo, Japan; 4Vall d’Hebron University Hospital, Barcelona, Spain; 5University of Puerto Rico, San Juan, Puerto Rico;
6Narodowy Instytut Onkologii, Warsaw, Poland; 7Hospital Universitario Miguel Servet, Zaragoza, Spain; 8Hospital
Universitario HM Sanchinarro, Madrid, Spain; 9Centre Antoine Lacassagne, Nice, France; 10Azienda OspedalieroUniversitaria Pisana, Pisa, Italy; 11Fox Chase Cancer Center, Temple University Health System, Philadelphia, PA, USA;
12Velindre Cancer Centre, Cardiff, UK; 13BeiGene (Beijing) Co., Ltd, Beijing, China; 14BeiGene (Shanghai) Co., Ltd,
Shanghai, China; 15BeiGene USA, Inc., San Mateo, CA, USA; 16Sun Yat-sen University Cancer Center State Key
Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Guangzhou, China

DECLARATION OF INTERESTS
Prof. Markus Moehler reports• Consultancy/advisory role for Bayer, Merck Sharp & Dohme (MSD), Merck Serono, Amgen, Taiho
Pharmaceutical, Pfizer, Roche, Lilly, Servier Laboratories, BeiGene, Bristol Myers Squibb (BMS),
AstraZeneca, Astellas, Dragonfly, and Novartis• Honoraria from Amgen, Roche/Genentech, Merck Serono, MSD Oncology, BMS, AstraZeneca/MedImmune,
Servier Laboratories, Pierre Fabre, Sanofi, Falk Foundation, Transcenta Holding, Daiichi Sankyo, Astellas
Pharma, and Nordic Pharma• Grant/research funding from Amgen, Leap Therapeutics, Merck Serono, and MSD• Other remuneration from Amgen, Merck Serono, Roche, Bayer, American Society for Clinical Oncology(ASCO), German Cancer Society, MSD, European Society for Medical Oncology (ESMO), BeiGene, andEuropean Organisation for Research and Treatment (EORTC)

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TISLELIZUMAB (TIS) + CHEMOTHERAPY (CT)VS PLACEBO (PBO) + CT IN HER2-NEGATIVEADVANCED OR METASTATIC GASTRIC OR
GASTRO-OESOPHAGEAL JUNCTIONADENOCARCINOMA (GC/GEJC)
PD-L1 Biomarker Analysis from RATIONALE-305

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BACKGROUND•

The PD-L1 Tumor Area Positivity (TAP) score is a newly developed scoring system evaluating both immune
and tumour cells. The TAP score has been analytically developed and validated for advanced GC/GEJC in the
RATIONALE-305 study• In RATIONALE-305, tislelizumab (TIS) + chemotherapy (CT) demonstrated significant overall survival (OS) benefit
vs CT as first-line therapy, in all randomised patients (HR=0.80; 95% CI: 0.70, 0.92; P=0.001) and patients withTAP score ≥5% (HR=0.71; 95% CI: 0.58, 0.86)1,2•

In advanced GC/GEJC, PD-L1 score based on combined positive score (CPS) using a mixture of immune and tumour
cell expression has shown predictive value to checkpoint inhibitors• In CheckMate 649, nivolumab demonstrated OS benefit in CPS ≥10, ≥5, and ≥1, and all randomised patients3• In KEYNOTE-859, pembrolizumab showed OS benefit in CPS ≥10 and ≥1, and all randomised patients4•

In this exploratory post hoc analysis, we report OS and progression-free survival (PFS) results in PD-L1 subgroups
defined by TAP score and CPS, as well as concordance of TAP score and CPS at multiple thresholds (1% vs 1, 5% vs 5,
and 10% vs 10) in RATIONALE-305

1. Moehler M, et al. Presented at ASCO GI 2023; Abstract #286. 2. Qiu MZ, et al. BMJ. 2024;385:e078876. 3. Shitara K, et al. Nature. 2022;603:942-948. 4. Rha SY, et al. Lancet Oncol. 2023;24:1181-1195.
Abbreviations: GC/GEJC, gastric or gastro-oesophageal junction adenocarcinoma; HR, hazard ratio; PD-1, programmed cell death protein 1; PD-L1, programmed death-ligand 1.

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.

STUDY DESIGN
Randomised, Double-blind, Global Phase 3 StudyKey Eligibility Criteria• Histologically confirmed GC/GEJC• Excluded patients with HER2-positive
tumours• No previous therapy for unresectable,
locally advanced or metastatic GC/GEJC
Stratification Factors• Regions of enrolment: China (including Taiwan) vsJapan and South Korea vs US and Europe andother regions• PD-L1 expression (PD-L1 score ≥5% vs PD-L1
score <5%)
• Presence of peritoneal metastasis (yes vs no)• Investigator-chosen chemotherapy (oxaliplatin +capecitabine or cisplatin + 5-fluorouracil)

TIS 200 mg IV Q3W+ CT (oxaliplatin + capecitabine or
cisplatin + 5-fluorouracil)aR
1:1

Primary Endpoints
OS in PD-L1–positive (PD-L1 TAP score ≥5%)and ITT analysis set

Maintenance treatment until unacceptable toxicity
or disease progression

PBO IV Q3W+ CT (oxaliplatin + capecitabine or
cisplatin + 5-fluorouracil)a

Post Hoc Analysis• Subgroup analysis of OS and PFS using
exploratory PD-L1 TAP score and CPS
cutoffs• TAP score vs CPS concordance• PD-L1 expression was assessed prospectively by central laboratory using the TAP score, stained by the
VENTANA PD-L1 (SP263) assay• For exploratory purposes, pathologists in the central laboratory scored the same stained samples according
to CPSbTAP Score (%)
CPS
Score Formula

Area occupied by PD-L1 staining
tumour cells and immune cells
Tumour area

× 100%

Cell Types Included in PD-L1 Score: Tumour cells, immune cellsc
Scoring Method: Visual-based estimation on tumour area

Score Formula# PD-L1 staining
tumour cells and immune cells
Total # viable tumour cells

× 100

Cell Types Included in PD-L1 Score: Tumour cells, immune cellsd
Scoring Method: Cell count (time consuming)a CT: oxaliplatin 130 mg/m2 day 1 + capecitabine 1000 mg/m2 BID, days 1-14, Q3W; cisplatin 80 mg/m2 day 1 + 5-

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fluorouracil 800 mg/m2/day, days 1-5, Q3W. b Off-label for the VENTANA PD-L1 (SP263) assay c Including lymphocytes,
macrophages, histiocytes, reticular dendritic cells, plasma cells, and neutrophils. d Including lymphocytes andmacrophages. Abbreviations: BID, twice daily; CPS, combined positive score; CT, chemotherapy; GC/GEJC, gastric or
gastro-oesophageal junction adenocarcinoma; HER2, human epidermal growth factor receptor 2; IV, intravenous;
ITT, intent-to-treat; OS, overall survival; PBO, placebo; PD-L1, programmed death-ligand 1; PFS, progression-free survival;
Q3W, once every 3 weeks; R, randomised; TAP, Tumor Area Positivity; TIS, tislelizumab.

PREVALENCE OF PD-L1 SUBGROUPS BY TAP SCORE OR CPS•

Of 997 patients randomised, 997 had evaluable TAP scores and 974 had evaluable post-hoc CPS results•

Prevalence was comparable across arms by TAP score or CPS under different thresholds

PD-L1 Status TAP Score/CPS

TAP Score, n (%)
N=997

CPS, n (%)
N=974

TIS + CT
N=501

PBO + CT
N=496

TIS + CT
N=491

PBO + CT
N=483

≥1%/≥1432 (86.2)

453 (91.3)

420 (85.5)

434 (89.9)<1%/<169 (13.8)

43 (8.7)

71 (14.5)

49 (10.1)≥5%/≥5274 (54.7)

272 (54.8)

254 (51.7)

269 (55.7)<5%/<5227 (45.3)

224 (45.2)

237 (48.3)

214 (44.3)≥10%/≥10

136 (27.1)

145 (29.2)

151 (30.8)

138 (28.6)<10%/<10

365 (72.9)

351 (70.8)340 (69.2)

345 (71.4)

Abbreviations: CPS, combined positive score; CT, chemotherapy; PBO, placebo; PD-L1, programmed death-ligand 1; TAP, Tumor Area Positivity; TIS, tislelizumab.

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OS IMPROVEMENT FOR TIS + CT VS PBO + CT IN PD-L1
SUBGROUPS BY TAP SCORE AND CPS
PD-L1
Status
TAP score
≥1%
<1%
≥5%
<5%
≥10%
<10%
CPS
≥1
<1
≥5
<5
≥10
<10

Event/Total

HR for Death (95% CI)

OS, Unstratified
HR (95% CI)

TIS + CTPBO + CT

318/432
52/69
192/274
178/227
84/136286/365

370/453
36/43
219/272
187/224
118/145288/351

0.78 (0.67, 0.90)
0.98 (0.64, 1.50)
0.72 (0.59, 0.88)
0.91 (0.74, 1.12)
0.57 (0.43, 0.76)
0.91 (0.77, 1.07)

308/42053/71
175/254
186/237
100/151261/340

356/434
39/49
211/269
184/214111/138
284/3450.78 (0.67, 0.91)
1.01 (0.66, 1.52)
0.73 (0.60, 0.89)
0.89 (0.72, 1.09)
0.68 (0.52, 0.90)
0.87 (0.73, 1.03)
0 0.250.75 1

TIS + CT better• Similar to previously reported
results in patients with PD-L1 TAPscore ≥5%, addition of TIS to CT
as first-line treatment for
GC/GEJC improved OS inpatients with PD-L1 TAP scores of≥10% and ≥1%• OS results defined by TAP scores
and CPS were similar

2

PBO + CT better
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Abbreviations: CI, confidence interval; CPS, combined positive score; CT, chemotherapy;
GC/GEJC, gastric or gastro-oesophageal junction adenocarcinoma; HR, hazard ratio; OS,overall survival; PBO, placebo; PD-L1, programmed death-ligand 1; TAP, Tumor Area Positivity;
TIS, tislelizumab.

SIMILAR OS BENEFIT IN PD-L1–POSITIVE SUBGROUPS WITH
CUTOFF AT 1%, 5%, AND 10% THRESHOLDS FOR EACH SCORE
Events0.8

318Median (95% CI)

0.7

370

15.0 (13.3, 16.7)

HR (95% CI)

0.6

12.8 (12.1, 14.1)

0.5
0.4
0.3
0.2
0.1

TIS + CT (n=274)

PBO + CT (n=272)

192

219

Events0.9

0.78 (0.67, 0.90)

TAP ≥10%

1.0

Survival Probability

Survival Probability

TAP ≥5%
TIS + CT (n=432) PBO + CT (n=453)

0.8Median (95% CI)

0.7

16.4 (13.6, 19.1)

HR (95% CI)

0.6

1.0
0.9

Survival Probability

TAP ≥1%1.0
0.9

12.8 (12.0, 14.5)

0.72 (0.59, 0.88)

0.5
0.4
0.3
0.2
0.1
0.0

0.0
0

2

4

6

Time (Months)

No. at Risk

0.8

Median (95% CI)

0.7

HR (95% CI)

PBO + CT (n=145)

84

118

22.5 (16.4, 26.4)

12.3 (11.3, 14.9)

0.57 (0.43, 0.76)

0.6
0.5
0.4
0.3
0.2
0.1
0.0

0

8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 50

TIS + CT (n=136)

Events2468

10 12 14 16 18 20 22 24

26 28 30 32 34 36 38 40 42 44 46

48 50

No. at Risk

0

2

4

6

8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 50

Time (Months)

No. at Risk

TIS + CT

432

412

387

355

309

277

242

219

196

175

159

146

134

113

93

68

53

48

39

28

21

12

9

4

1

0

TIS + CT

274

263

247

228

199

178

156

145

133

120

109

102

97

84

68

50

38

34

27

19

14

9

7

3

1

0

TIS + CT

136

129

122

112

101

94

83

78

77

73

66

64

59

53

41

31

25

22

17

12

9

6

4

2

1

0

PBO + CT

453

429

390

359

312

274

239

197

168

140

122

108

98

85

65

46

33

23

20

15

12

5

3

2

0

0

PBO + CT

272

261

236

215

190

168

148

120

99

83

69

59

53

51

39

29

23

16

14

9

7

3

2

1

0

0

PBO + CT

145

138

125

114

97

86

75

63

56

44

39

33

30

29

22

16

13

9

9

5

4

2

2

1

0

0

CPS ≥5
TIS + CT (n=420) PBO + CT (n=434)

Events0.8

Median (95% CI)

0.7

308

356

0.9

Events15.1 (13.6, 17.2)

12.9 (12.1, 14.1)

0.8Median (95% CI)

HR (95% CI)

0.6

0.78 (0.67, 0.91)

0.5
0.4
0.3
0.2
0.1
0.0

Survival Probability

Survival Probability

0.9

CPS ≥101.0

0.7

TIS + CT (n=254)

PBO + CT (n=269)

1.0

175

211

0.9

Events17.8 (14.8, 20.8)

13.2 (12.1, 14.6)

0.8

Median (95% CI)

HR (95% CI)

0.6

0.73 (0.60, 0.89)

0.5
0.4
0.3
0.2
0.1
0.0

0

2

4

6

8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 50

Time (Months)

No. at Risk

Survival Probability

CPS ≥1
1.0

TIS + CT (n=151)

0.7

111

18.0 (13.6, 23.2)

12.9 (11.5, 15.5)

HR (95% CI)

0.6

PBO + CT (n=138)

100
0.68 (0.52, 0.90)

0.5
0.4
0.3
0.2
0.1
0.0

0

2

4

6

8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 50

Time (Months)

No. at Risk

0

2

4

6

8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 50

Time (Months)

No. at Risk

TIS + CT

420

400

376

345

301

270

235

215

193

173

156

144

132

111

89

64

51

46

37

26

19

10

7

3

1

0

TIS + CT

254

242

230

213

189

172

152

142

128

118

106

99

92

75

59

40

33

29

20

13

10

6

4

1

1

0

TIS + CT

151

143

137

128

114

102

86

82

77

71

64

62

57

49

37

25

21

19

13

9

8

5

3

1

1

0

PBO + CT

434

417

379

351

307

270

233

192

162

134

116

104

94

83

63

44

32

22

20

15

12

5

3

2

0

0

PBO + CT

269

258

234

219

191

168

147

120

102

86

73

63

57

54

44

32

24

18

16

11

9

4

3

2

0

0

PBO + CT

138

134

119

112

96

86

76

62

54

44

39

34

32

30

22

14

14

9

8

4

4

2

2

1

0

0

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Abbreviations: CI, confidence interval; CPS, combined positive score; CT, chemotherapy; HR,hazard ratio; OS, overall survival; PBO, placebo; PD-L1, programmed death-ligand 1; TAP, Tumor
Area Positivity; TIS, tislelizumab.

PFS IMPROVEMENT FOR TIS + CT VS PBO + CT IN PD-L1
SUBGROUPS BY TAP SCORE AND CPS
PD-L1
Status
TAP score
≥1%
<1%
≥5%
<5%
≥10%
<10%
CPS
≥1
<1
≥5
<5
≥10
<10

Event/Total

HR for Death (95% CI)

PFS, Unstratified
HR (95% CI)

TIS + CTPBO + CT

316/432
45/69
189/274
172/227
88/136273/365

364/453
27/43
216/272
175/224
119/145272/351

0.78 (0.67, 0.91)
0.87 (0.54, 1.41)
0.69 (0.57, 0.84)
0.92 (0.75, 1.14)
0.56 (0.42, 0.74)
0.90 (0.76, 1.06)

303/42049/71
179/254
173/237
102/151
250/340

348/434
36/49
212/269
172/214107/138
277/3450.77 (0.66, 0.90)
0.80 (0.52, 1.23)
0.73 (0.60, 0.90)
0.82 (0.67, 1.02)
0.69 (0.53, 0.91)
0.82 (0.69, 0.97)
TIS + CT better

1

PBO + CT better

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• Similar to previously reported
results in patients with PD-L1 TAPscore ≥5%, addition of TIS to CT
as first-line treatment for
GC/GEJC improved PFS inpatients with PD-L1 TAP scoresof ≥10% and ≥1%• PFS results defined by TAP
scores and CPS were similar

Abbreviations: CI, confidence interval; CPS, combined positive score; CT, chemotherapy;
GC/GEJC, gastric or gastro-oesophageal junction adenocarcinoma; HR, hazard ratio; PBO,
placebo; PD-L1, programmed death-ligand 1; PFS, progression-free survival; TAP, Tumor Area
Positivity; TIS, tislelizumab.

SUBSTANTIAL CONCORDANCE FOR TAP SCORE AND CPS IN
GC/GEJC•Good correlation was observed between TAP score and CPS based on interclass correlation coefficient (ICC=0.81 [0.79, 0.83])•

TAP score and CPS showed substantial concordance in terms of overall percent agreement (OPA) and Cohen’s Kappa at matched thresholds foreach score (OPA [95% CI]: 95% [94, 97], 82% [80, 85], and 85% [83, 87] at 1%, 5%, and 10% thresholds of each score, respectively)

100

PD−L1
CPS
TAP score75

PD-L1 Expression (%)

TAP score 1% vs CPS 1

ICC=0.81 (95% CI: 0.79, 0.83)

TAPCPS+
1.6% (16)

TAP score 5% vs CPS 5

TAP+
TAP+
CPS+
CPS+
57.5%(443)
(309)
45.5%

TAP+
TAPCPSCPS+
3.0% (29) 8.2% (80)

TAP+
CPS+
86.0% (838)

50

TAP+
CPS9.4% (92)TAPCPS9.3% (91)

25

0
0

250

500

750

1000

n/N

Agreement

PPA, % (95% CI)

838/854

98 (97, 99)

NPA, % (95% CI)

91/12076 (68, 83)

OPA, % (95% CI)

929/974

95 (94, 97)

Cohen’s Kappa (95% CI)

Individual Tumour Samples

0.78 (0.71, 0.84)

Moderate(0.50-0.75)

Good(0.75-0.90)

TAPCPS+
8.3% (81)

TAP+
CPS+
21.4% (208)TAPCPS36.9% (359)n/N

Agreement

PPA, % (95% CI)

443/52385 (81, 88)

NPA, % (95% CI)

359/451

80 (76, 83)

OPA, % (95% CI)

802/974

82 (80, 85)

Cohen’s Kappa (95% CI)

Strength of Reliability (ICC)
Poor
<0.50

TAP score 10% vs CPS 10

0.64 (0.60, 0.69)

TAP+
CPS6.5% (63)TAPCPS63.9% (622)n/N

Agreement

PPA, % (95% CI)

208/289

72 (66, 77)

NPA, % (95% CI)

622/685

91 (89, 93)

OPA, % (95% CI)

830/974

85 (83, 87)

Cohen’s Kappa (95% CI)

0.64 (0.59, 0.69)

Strength of Agreement (Kappa)
Excellent(≥0.90)Slight(0.01-0.20)

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Fair(0.21-0.40)

Moderate(0.41-0.60)

Substantial(0.61-0.80)

Almost perfect(0.81-1.0)

Abbreviations: CI, confidence interval; CPS, combined positive score; GC/GEJC, gastric or gastrooesophageal junction adenocarcinoma; NPA, negative percent agreement; PPA, positive percent
agreement; PD-L1, programmed death-ligand 1; TAP, Tumor Area Positivity.

CONCLUSIONS•Both TAP score and CPS are viable for PD-L1 expression measurement in patients with GC/GEJC••

TIS + CT improved OS and PFS in patients with PD-L1 TAP scores of ≥10% and ≥1%, as well as theprespecified population with TAP score ≥5%••

TAP score and CPS at matched thresholds (1% vs 1, 5% vs 5, 10% vs 10) exhibited substantial
concordance in GC/GEJC among patients enrolled

Comparable OS and PFS results were observed in PD-L1 subgroups by TAP score at a prespecified
cutoff of 5% and by CPS at cutoff of 5, TAP score 10% vs CPS 10, and TAP score 1% vs CPS 1

These PD-L1 subgroup results, along with previous results from the RATIONALE-305 primary analysis in all
randomised patients, support TIS + CT as a new first-line treatment option for advanced HER2-negative
GC/GEJC

Abbreviations: CPS, combined positive score; CT, chemotherapy; GC/GEJC, gastric or gastro-oesophageal junction adenocarcinoma; HER2, human epidermal growth factor receptor 2; OS, overall survival;
PBO, placebo; PD-L1, programmed death-ligand 1; PFS, progression-free survival; TAP, Tumor Area Positivity; TIS, tislelizumab.

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ACKNOWLEDGEMENTS•

We would like to thank the investigators, the site support staff, and especially the patients for participatingin this study•

This study was sponsored by BeiGene•

Medical writing support was provided by Nitya Venkataraman, PhD, of Parexel, with funding provided
by BeiGene

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THANK YOU

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APPENDIX

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SCORING METHODS COMPARISON BETWEEN TAP SCORE AND CPS•

PD-L1 expression was assessed prospectively by central laboratory using the TAP score, stained by the VENTANA PD-L1(SP263) assay•

For exploratory purposes, pathologists in the central laboratory scored the same stained samples according to CPSa
TAP Score (%)

Score Formula

Area occupied by PD-L1 staining
tumour cells and immune cells
Tumour area

CPS

× 100%# PD-L1 staining
tumour cells and immune cells
Total # viable tumour cells

× 100

Cell Types Included in PD-L1 Score• Tumour cells• Immune cells (including lymphocytes,
macrophages, histiocytes, reticular dendritic
cells, plasma cells, and neutrophils)• Tumour cells• Immune cells (including lymphocytes andmacrophages)

Scoring Method• Visual-based estimation on tumour area

• Cell count (time consuming)a Off-label for the VENTANA PD-L1 (SP263) assay.

Abbreviations: CPS, combined positive score; PD-L1, programmed death-ligand 1; TAP, Tumor Area Positivity.

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