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

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

RATIONALE-306 evaluated outcomes with etapidi + 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*

  • Key efficacy analysis in patients with a PD-L1 score 21% : n=481
  • Safety analysis population: n-645

RATIONALE-306 was stratified by:

  • Investigator-chosen chemotherapy (platinum + fluoropyrimidine vs platinum + paclitaxel)
  • Region (Asia [excluding Japan] vs Japan vs rest of world)
  • Previous definitive therapy (yes vs no)
etapidi was studied in multiple chemotherapy combinations—including oxaliplatin + 5-FU and CAPOX—allowing flexible dosing options for patients’ unique needs

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

Baseline characteristics for patients with a PD-L1 score ≥1% etapidi chemotherapy (n=231) chemotherapy only (n=250)
Age group, ≥65 years, % 43.3 50.8
Sex, % Female/Male 15.2/84.8 12.4/87.6
ECOG PS, % 0/1 32.5/67.5 35.2/64.8
Tobacco consumption, % Never
Former
Current
Missing 		19.5
60.2
16.5
3.9 		24.0
56.4
16.0
3.6
Race, % Asian
White
Other/not reported/unknown 		74.9
24.2
0.8 		76.8
21.6
1.2
Disease status at study entry, metastatic, % Yes
No 		86.6
13.4 		87.2
12.8
Number of metastatic sites at study entry, % 0-2
>2 		83.1
16.9 		81.2
18.8
Patients with at least 1 prior definitive therapy, % 43.7 42.0
Treatment
ICC option per IRT, % Platinum + fluoropyrimidine
Platinum + paclitaxel 		43.0
57.0 		46.4
53.6
Baseline characteristics for patients with a PD-L1 score ≥1% etapidi chemotherapy (n=231) chemotherapy only (n=250)
Age group, ≥65 years, % 43.3 50.8
Sex, % Female/Male 15.2/84.8 12.4/87.6
ECOG PS, % 0/1 32.5/67.5 35.2/64.8
Tobacco consumption, % Never Former Current Missing 19.5 60.2 16.5 3.9 24.0 56.4 16.0 3.6
Race, % Asian White Other/not reported/unknown 74.9 24.2 0.8 76.8 21.6 1.2
Disease status at study entry, metastatic, % Yes No 86.6 13.4 87.2 12.8
Number of metastatic sites at study entry, % 0-2 >2 83.1 16.9 81.2 18.8
Patients with at least 1 prior definitive therapy, % 43.7 42.0
Treatment
ICC option per IRT, % Platinum + fluoropyrimidine Platinum + paclitaxel 43.0 57.0 46.4 53.6

Baseline characteristics for patients with a PD-L1 score ≥1% etapidi chemotherapy
(n=231)		 chemotherapy only
(n=250)
Age group, ≥65 years, %
43.3
50.8
Sex, %
Female
Male
15.2
84.8
12.4
87.6
ECOG PS, %
0
1
32.5
67.5
35.2
64.8
Tobacco consumption, %
Never
Former
Current
Missing
19.5
60.2
16.5
3.9
24.0
56.4
16.0
3.6
Race, %
Asian
White
Other/not reported/unknown
74.9
24.2
0.8
76.8
21.6
1.2
Disease status at study entry, metastatic, %
Yes
No
86.6
13.4
87.2
12.8
Number of metastatic sites at study entry, %
0–2
≥3
83.1
16.9
81.2
18.8
Patients with at least 1 prior definitive therapy, %
43.7
42.0
Treatment
ICC option per IRT, %
Platinum + fluoropyrimidine
Platinum + paclitaxel
43.0
57.0
46.4
53.6
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

Explore ORR, mDoR, and mPFS in patients with 1L ESCC

*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 etapidi + 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. etapidi. Prescribing Information. BeOne Medicines USA, Inc.; 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.