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RATIONALE-305: A global, randomized, double-blind, placebo-controlled, phase 3 trial in nearly 1,000 patients with 1L, unresectable or metastatic, HER2-negative GC or GEJC1-3

This global trial was a randomized, double-blind, placebo-controlled, phase 3 trial conducted in 16 countries at 162 sites across multiple continents: Asia, Europe, North America, and Oceania*

  • Key efficacy analysis in patients with a PD-L1 score ≥1%*: n=885
  • Safety analysis population: n=992

RATIONALE-305 was designed to show consistent benefit across a broad range of patient types. The study was stratified by:

  • Region of enrollment
  • Peritoneal metastases (yes/no)
  • Investigator-chosen chemotherapy
  • PD-L1 score (PD-L1 ≥5% vs <5%)

RATIONALE-305 featured a broad range of patients, including those with difficult-to-treat characteristics3

Baseline Characteristics Table
Baseline characteristics for patients with a PD-L1 score ≥1% etapidi
chemotherapy
(n=432) 		Placebo +
chemotherapy
(n=453)
Median age, years 61 61
Male, % 70.6 69.8
Race, % Asian
White
Other* 		75.2
22.7
2.1 		74.6
22.1
3.3
ECOG PS, % 0/1 34.5/65.5 32/68
Primary location
of disease, % 		Gastroesophageal junction
Stomach 		19.7
80.3 		20.3
79.7
Metastatic disease status
at study entry, % 		Yes
No 		98.6
1.4 		99.1
0.9
Presence of peritoneal metastases, % 44 43.3
≥1 prior adjuvant/neoadjuvant
treatment, % 		Yes
No 		20.6
79.4 		18.8
81.2
PD-L1 scores were measured in RATIONALE-305 using TAP, which demonstrated substantial concordance with CPS, with ~90% agreement1,4

You may use your preferred PD-L1 testing method to identify patients in clinical practice

Explore the OS results in patients with 1L GC/GEJC

*The key efficacy analysis was a retrospective subgroup analysis of RATIONALE-305 in patients with a PD-L1 score ≥1%. PD-L1–negative patients were excluded from this analysis population due to TEVIMBRA + chemotherapy being indicated in patients whose tumors expressed PD-L1 (≥1).

†The race subcategory “Other” included not reported, unknown, and other.


1L, first line; CPS, combined positive score; DCR, disease control rate; ECOG, Eastern Cooperative Oncology Group; GC, gastric cancer; GEJC, gastroesophageal junction cancer; HER2, human epidermal growth growth factor 2; IV, intravenous; ORR, overall response rate; OS, overall survival; PD-L1, programmed death ligand 1; PFS, progression-free survival; PS, performance status; Q3W, every 3 weeks; R, randomization; TAP, tumor area positivity.


References: 1. etapidi. Prescribing Information. BeOne Medicines USA, Inc.; 2025. 2. Qiu MZ, Oh DY, Kato K, et al; RATIONALE-305 Investigators. BMJ. 2024;385:e078876. doi:10.1136/bmj-2023-078876 3. Moehler M, Oh DY, Kato K, et al. Adv Ther. 2025;42(5):2248-2268. doi:10.1007/s12325-025-03133-7 4. Raymond E, Xu J, Kato K, et al. Abstract presented at: ESMO Gastrointestinal Cancers Congress, June 26-29, 2024; Munich, Germany. Abstract 395MO.