Results
SECONDARY
Two data cuts have been used for the analyses in this manuscript. PERLA primary analyses were conducted using data available as of August 4, 2022. Due to the immature overall survival (OS) and duration of response (DOR) data from the primary analyses, additional analyses were planned for more mature data and better understanding of these endpoints; pre-planned updated analyses were conducted using data available as of July 7, 2023. To provide data on the primary outcome (ORR) and safety using the longest available follow-up, ORR and safety analyses from the July 7, 2023 data cut are included in the main manuscript; results from the August 4, 2022 data cut are available in the Supplementary Information. PFS was a secondary endpoint, and results from the August 4 data cut are presented here in the main text; based on the maturity of data at the time of the primary analysis, PFS was not re-analyzed in the updated analysis. OS and DOR analyses using the July 7, 2023 data cut are reported in the main manuscript.