1L ESCC trial design
RATIONALE-306 evaluated outcomes with TEVIMBRA + chemotherapy vs placebo + chemotherapy in patients with 1L unresectable 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 eligibility criteria
- Unresectable, locally advanced or metastatic ESCC
- No prior systemic treatment for advanced disease
- ECOG PS 0 or 1
- Measurable or evaluable disease per RECIST v1.1
R
1:1
(N=649)
TEVIMBRA
200 mg IV Q3W +
investigator-chosen
platinum-containing
chemotherapy (n=326)
Placebo IV Q3W +
investigator-chosen
platinum-containing
chemotherapy (n=323)
Treatment until disease progression, intolerable toxicity, or withdrawal for other reasons
Key outcomes
Key efficacy outcome:
- OS in patients with a PD-L1 score ≥1%†
Additional efficacy outcomes:
- ORR and PFS in patients with a PD-L1 score ≥1%†
Key secondary outcome:
- Safety in the all-comer population
Key efficacy analysis in patients with a PD-L1 score ≥1%†‡: n=481
Safety analysis population: n=645
The patients of RATIONALE-306 were 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)
TEVIMBRA was studied in multiple chemotherapy combinations—including oxaliplatin + 5-FU and CAPOX—allowing flexible dosing options for patients’ unique needs2
.
Leading Expert Discusses RATIONALE-306 Study Design
Dr. Marcia Cruz-Correa, MD, PhD, AGAF, FASGE, reviews RATIONALE-306, a phase 3 trial that evaluated efficacy and safety outcomes with TEVIMBRA + chemotherapy in patients with 1L, unresectable, advanced or metastatic ESCC.
TEVIMBRA + chemotherapy was tested across a broad range of patients with a PD-L1 score ≥1%4
PD-L1 scores were measured in RATIONALE-306 using TAP, or tumor area positivity, which demonstrated substantial concordance with CPS, with ~90% overall agreement4
You may use your preferred PD-L1 testing method to identify patients in clinical practice
Watch the video below to see how PD-L1 scores were tested for clinical trials with TEVIMBRA.
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Leader in Oncology Discusses PD-L1 Testing (TAP vs CPS)
Frequently Asked Questions
How was TEVIMBRA studied in 1L advanced ESCC?
*Oceania included Australia.1
†PD-L1 scores were measured in RATIONALE-306 using TAP, which demonstrated substantial concordance with CPS, with ~90% agreement. You may use your preferred PD-L1 testing method to identify patients in clinical practice.4
‡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). Therefore, the efficacy data shared in this presentation do not reflect the all-comer population.1