1L ESCC icon

RATIONALE-306 evaluated outcomes with TEVIMBRA + chemotherapy vs placebo + chemotherapy in patients with 1L, unresectable, advanced or metastatic ESCC1-4

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*

1L ESCC RATIONALE-306 trial design diagram
1L ESCC RATIONALE-306 trial design diagram

Key efficacy analysis in patients with a PD-L1 score ≥1%: n=481

Safety analysis population: n=645

RATIONALE-306 was stratified by:

TEVIMBRA was studied in multiple chemotherapy combinations—including oxaliplatin + 5-FU and CAPOX—allowing flexible dosing options for patients’ unique needs

TEVIMBRA + chemotherapy was tested across a broad range of patients with a PD-L1 score ≥1%4

1L ESCC trial patient characteristics table
1L ESCC trial patient characteristics table

PD-L1 scores were measured in RATIONALE-306 using TAP, or tumor area positivity, which demonstrated substantial concordance with CPS, with ~90% overall agreement1,5

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

*Oceania including Australia.
†The key efficacy analysis was a retrospective subgroup analysis of RATIONALE-306 in patients with a PD-L1 score ≥1%. PD-L1–negative patients were excluded from this analysis population due to TEVIMBRA + chemotherapy being indicated only in patients whose tumors expressed PD-L1 (≥1).

1L, first line; 5-FU, 5-fluorouracil; CAPOX, capecitabine, oxaliplatin; CPS, combined positive score; ECOG, Eastern Cooperative Oncology Group; ESCC, esophageal squamous cell carcinoma; FDA, US Food and Drug Administration; ICC, investigator-chosen chemotherapy; IRT; interactive response technology; 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; RECIST, Response Evaluation Criteria in Solid Tumors.
References: 1. TEVIMBRA. Prescribing Information. San Mateo, CA: Beigene, Ltd.; 2025. 2. Xu J, Kato K, Raymond E, et al. Lancet Oncol. 2023;24(5):483-495. doi:10.1016/s1470-2045(23)00108-0 3. Xu J, Kato K, Raymond E, et al. Lancet Oncol. Supplementary appendix. 2023;24(5):483-495. doi:10.1016/s1470-2045(23) 00108-0 4. Xu J, Kato K, Hubner R, et al. Adv Ther. Published online March 13, 2025. doi:10.1007/s122325-025-03115-9 5. Raymond E, Xu J, Kato K, et al. Abstract presented at: ESMO Gastrointestinal Cancers Congress, June 26-29, 2024; Munich, Germany. Abstract 395MO.
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