REZILIENT2
13 evidence topics · 5 sources
Objective
Location and study date
Cohort C data cutoff
Study design
Eligibility criteria
Active CNS metastases: molecular population
Treatment
Cohort C dose and administration
Study outcomes
Rationale for using RECIST v1.1 objective response rate as the primary endpoint
Investigator-assessed systemic primary endpoint
Statistical analysis description
Number of participants (Planned and analyzed)
Cohort C enrollment
| Population | Participants |
|---|---|
| Total enrolled | “32” |
Description of analysis sets
Results
Participant disposition
No evidence found.
Baseline characteristics
Cohort C biomarker population
| Characteristic | Participants, n (%) |
|---|---|
| EGFR exon 20 insertion mutations among all 32 participants | “21 (66)” |
Efficacy results
Active CNS metastases: intracranial response
Additional cohort C response results
| Endpoint | Value |
|---|---|
| Confirmed systemic responses, n/N (%) | “8/29 (27.6%)” |
| Median intracranial DOR, months | “8.1” |
Health-related quality of life and patient-reported outcomes
No evidence found.
Safety results
Study limitations
Summary
The cohort enrolled 32 participants, of whom 21 (66%) had EGFR exon 20 insertions. Systemic response was reported in 8 of 29 evaluable participants and intracranial response in 5 of 16. These are different analysis populations, and the pooled results are not restricted to exon 20 insertions. The ongoing phase 2b cohort does not provide a randomized treatment comparison.