REZILIENT1
24 evidence topics · 15 sources
Objective
Original phase 1/2a efficacy objective
Location and study date
Phase 1/2a data cutoff
Study design
REZILIENT1: phase 1/2 development program, NCT04036682
Original phase 1/2a cohort-transition design
Eligibility criteria
Performance status eligibility
Treatment
Investigational monotherapy regimen
Study outcomes
Rationale for using RECIST v1.1 objective response rate as the primary endpoint
Primary endpoints and blinded central review
Regulatory rationale for objective response
Statistical analysis description
Number of participants (Planned and analyzed)
Original phase 1/2a planned enrollment
Pivotal analysis populations
| Population | Quoted description |
|---|---|
| Primary efficacy population | “Primary efficacy population (N=176)” |
| Safety population | “Safety population (N=244)” |
Updated prior-amivantamab cohort: data cutoff and enrollment
Description of analysis sets
Primary efficacy population: minimum follow-up requirement
Results
Participant disposition
Pivotal safety population: treatment-related discontinuations, n (%)
Baseline characteristics
Pivotal safety population: baseline characteristics
| Characteristic | Value |
|---|---|
| Median age, years (range) | “65 (31–86)” |
| Female participants, n (%) | “157 (64)” |
Efficacy results
Phase 1/2a results at the selected dose
Pivotal results: prior platinum-based chemotherapy only
Updated prior-amivantamab cohort: prior amivantamab only
Pivotal progression-free and overall survival
Health-related quality of life and patient-reported outcomes
No evidence found.
Safety results
Pivotal safety population: grade ≥3 treatment-related adverse events, n (%)
Pivotal treatment-related deaths
| Population | Endpoint | Result |
|---|---|---|
| “Safety population (N=244)” | “TRAE leading to death” | “2 (0.8)” |
Study limitations
Summary
The trial is open-label. Its pivotal efficacy population included 176 participants with approximately 8 months of minimum follow-up, whereas 244 participants formed the safety population. Prior-treatment cohorts and the later 84-participant amivantamab cohort have different eligibility histories and follow-up cutoffs. Their response estimates should not be treated as randomized comparisons or as interchangeable analyses. The phase 1/2a results are an earlier analysis of the same development program.