First-Line Nivolumab and Relatlimab Plus Chemotherapy for Gastric or Gastroesophageal Junction Adenocarcinoma: The Phase II RELATIVITY-060 Study
Jazyk angličtina Země Spojené státy americké Médium print-electronic
Typ dokumentu časopisecké články, klinické zkoušky, fáze II, randomizované kontrolované studie, multicentrická studie
PubMed
38723227
PubMed Central
PMC11191068
DOI
10.1200/jco.23.01636
Knihovny.cz E-zdroje
- MeSH
- adenokarcinom * farmakoterapie patologie mortalita MeSH
- doba přežití bez progrese choroby MeSH
- dospělí MeSH
- gastroezofageální junkce * patologie MeSH
- lidé středního věku MeSH
- lidé MeSH
- nádory jícnu * farmakoterapie patologie mortalita MeSH
- nádory žaludku * farmakoterapie patologie mortalita MeSH
- nivolumab * terapeutické užití aplikace a dávkování škodlivé účinky MeSH
- protein genu 3 aktivace lymfocytů * MeSH
- protokoly protinádorové kombinované chemoterapie * terapeutické užití škodlivé účinky MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze II MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
- Názvy látek
- Lag3 protein, human MeSH Prohlížeč
- nivolumab * MeSH
- protein genu 3 aktivace lymfocytů * MeSH
PURPOSE: Open-label phase II study (RELATIVITY-060) to investigate the efficacy and safety of first-line nivolumab, a PD-1-blocking antibody, plus relatlimab, a lymphocyte-activation gene 3 (LAG-3)-blocking antibody, plus chemotherapy in patients with previously untreated advanced gastric cancer (GC) or gastroesophageal junction cancer (GEJC). METHODS: Patients with unresectable, locally advanced or metastatic GC/GEJC were randomly assigned 1:1 to nivolumab + relatlimab (fixed-dose combination) + chemotherapy or nivolumab + chemotherapy. The primary end point was objective response rate (ORR; per RECIST v1.1 by blinded independent central review [BICR]) in patients whose tumors had LAG-3 expression ≥1%. RESULTS: Of 274 patients, 138 were randomly assigned to nivolumab + relatlimab + chemotherapy and 136 to nivolumab + chemotherapy. Median follow-up was 11.9 months. In patients with LAG-3 expression ≥1%, BICR-assessed ORR (95% CI) was 48% (38 to 59) in the nivolumab + relatlimab + chemotherapy arm and 61% (51 to 71) in the nivolumab + chemotherapy arm; median progression-free survival (95% CI) by BICR was 7.0 months (5.8 to 8.4) versus 8.3 months (6.9 to 12.1; hazard ratio [HR], 1.41 [95% CI, 0.97 to 2.05]), and median overall survival (95% CI) was 13.5 months (11.9 to 19.1) versus 16.0 months (10.9 to not estimable; HR, 1.04 [95% CI, 0.70 to 1.54]), respectively. Grade 3 or 4 treatment-related adverse events (TRAEs) occurred in 69% and 61% of all treated patients, and 42% and 36% of patients discontinued because of any-grade TRAEs in the nivolumab + relatlimab + chemotherapy and nivolumab + chemotherapy arms, respectively. CONCLUSION: RELATIVITY-060 did not meet its primary end point of improved ORR in patients with LAG-3 expression ≥1% when relatlimab was added to nivolumab + chemotherapy compared with nivolumab + chemotherapy. Further studies are needed to address whether adding anti-LAG-3 to anti-PD-1 plus chemotherapy can benefit specific GC/GEJC patient subgroups.
Austin Health Heidelberg VIC Australia
Baylor University Medical Center Dallas TX
Bristol Myers Squibb Boudry Switzerland
Bristol Myers Squibb Princeton NJ
City of Hope Comprehensive Cancer Center Duarte CA
Guy's and St Thomas's NHS Foundation Trust London United Kingdom
Hematology Oncology Practice Eppendorf Hamburg Germany
Hospital Miguel Servet Zaragoza Spain
Hospital Universitario Fundacion Favaloro Buenos Aires Argentina
Royal Brisbane and Womens Hospital Herston QLD Australia
St John of God Murdoch Hospital Murdoch WA Australia
The Christie NHS Foundation Trust Manchester United Kingdom
University Hospitals Gasthuisberg and University of Leuven Leuven Belgium
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ClinicalTrials.gov
NCT03662659
