HARMONi-5
11 evidence topics · 3 sources
Objective
Treatment-line objective
Location and study date
Analysis data cutoff
Study design
Eligibility criteria
Prior immunotherapy status
Treatment
One investigated dose cohort
Study outcomes
Rationale for using objective response rate as a primary endpoint
Statistical analysis description
Number of participants (Planned and analyzed)
Enrolled and treated participants
Description of analysis sets
Results
Participant disposition
Baseline characteristics
Participants with PD-L1 tumor proportion score of at least 1%
Efficacy results
Overall objective response rate
Health-related quality of life and patient-reported outcomes
No evidence found.
Safety results
Study limitations
Summary
This phase 1b evidence concerns monotherapy, not the chemotherapy combination evaluated in the pivotal trials. Grade 3 or higher TRAEs occurred in 22.2%, and TRAEs leading to death were reported in 2.8%. The monotherapy response estimate should not be substituted for post-TKI combination-treatment efficacy.