KEY TAKEAWAYS
- Phase 3 RELATIVITY-047 trial evaluated the efficacy of NIVO + RELA FDC in untreated metastatic or unresectable melanoma patients.
- The study aimed to assess the (PFS) in patients receiving NIVO + RELA FDC versus NIVO alone.
- NIVO + RELA FDC showed a significant improvement in PFS and a higher (ORR) than NIVO alone.
- (OS) also improved with NIVO + RELA FDC, but the difference was insignificant.
- The findings suggested that NIVO + RELA FDC had a favorable benefit-risk profile across key subgroups, including those with poor prognoses, and maintained a manageable safety profile.
Patients (pts) with untreated metastatic or unresectable melanoma saw a significant improvement in the primary endpoint of progression-free survival (PFS) when treated with NIVO + RELA as a fixed-dose combination (FDC) in the phase 2/3 RELATIVITY-047 study. Clinically substantial, but not statistically significant, improvements in overall survival (OS) and objective response rate(ORR) were observed as secondary goals. Previous reports indicated that NIVO + RELA was superior to NIVO across all predetermined stratification criteria for both PFS and OS (LAG-3 expression, PD-L1 expression, BRAF V600 mutation status, and metastasis stage). In this study, researchers presented the first public analysis of ORR by predetermined stratification criteria and OS and ORR in further subgroups. Patients were assigned to receive NIVO 480 mg intravenously Q4W or NIVO 480 mg FDC with RELA 160 mg. Progression-free survival was the main goal per RECIST v1.1 assessed by BICR. The secondary endpoints were a hierarchy test of OS and ORR by BICR.
Prespecified subgroups were used in exploratory analyses of progression-free survival, overall survival, and objective response rate. In all essential subgroups, NIVO + RELA maintained its PFS advantage over NIVO. Overall survival and objective response rates were better with NIVO + RELA than with NIVO across all subgroups, even those with poor prognoses. ORR favored NIVO + RELA over NIVO for pts with LAG-3 expression ≥ 1% (47% vs 35%) and < 1% (31% vs 24%), PD-L1 expression ≥ 1% (53% vs 45%) and < 1% (36% vs 24%), and BRAF wild-type (43% vs 34%) and mutant (43% vs 31%) melanoma, respectively. Researchers will also highlight some more important subgroups that have already been identified. There were no unanticipated adverse events or safety alerts in any patients who were given NIVO + RELA. Regarding progression-free survival, overall survival, and objective response rate, NIVO + RELA proved superior to NIVO across all relevant subgroups. The benefits outweighed the risks with NIVO + RELA.
Source: https://meetings.asco.org/abstracts-presentations/206811
Clinical Trial: https://clinicaltrials.gov/ct2/show/NCT03470922
Hussein A. Tawbi, F. Stephen Hodi, Evan J. Lipson, Dirk Schadendorf, Paolo Antonio Ascierto, Luis Matamala, Pamela Salman, Erika Castillo Gutiérrez, Piotr Rutkowski, Helen Gogas, Christopher D. Lao, Juliana Janoski De Menezes, Stéphane Dalle, Ana Maria Arance, Jean-Jacques Grob, Sarah Keidel, Karin Jonczak, Anne Marie Sobiesk, Sonia Dolfi, Georgina V. Long/Nivolumab (NIVO) + relatlimab (RELA) versus NIVO in previously untreated metastatic or unresectable melanoma: OS and ORR by key subgroups from RELATIVITY-047/J Clin Oncol 40, 2022 (suppl 16; abstr 9505) DOI10.1200/JCO.2022.40.16_suppl.9505
