J 2024

First-Line Nivolumab and Relatlimab Plus Chemotherapy for Gastric or Gastroesophageal Junction Adenocarcinoma: The Phase II RELATIVITY-060 Study

HEGEWISCH-BECKER, Susanna, Guillermo MENDEZ, Joseph CHAO, Radim NĚMEČEK, Kynan FEENEY et. al.

Basic information

Original name

First-Line Nivolumab and Relatlimab Plus Chemotherapy for Gastric or Gastroesophageal Junction Adenocarcinoma: The Phase II RELATIVITY-060 Study

Authors

HEGEWISCH-BECKER, Susanna, Guillermo MENDEZ, Joseph CHAO, Radim NĚMEČEK (203 Czech Republic, belonging to the institution), Kynan FEENEY, Van Cutsem ERIC, Salah-Eddin AL-BATRAN, Wasat MANSOOR, Nicholas MAISEY, Pazo Cid ROBERTO, Matthew BURGE, David PEREZ-CALLEJO, R William HIPKIN, Sourav MUKHERJEE, Ming LEI, Hao TANG, Satyendra SURYAWANSHI, Ronan J KELLY and Niall C TEBBUTT

Edition

Journal of clinical oncology, PHILADELPHIA, LIPPINCOTT WILLIAMS & WILKINS, 2024, 0732-183X

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30204 Oncology

Country of publisher

United States of America

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

Impact factor

Impact factor: 45.300 in 2022

Organization unit

Faculty of Medicine

DOI

UT WoS

001244487700006

Keywords in English

Nivolumab; Relatlimab; Adenocarcinoma

Tags

Tags

International impact, Reviewed
Změněno: 5/8/2024 13:29, Mgr. Tereza Miškechová

Abstract

V originále

PURPOSEOpen-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).METHODSPatients 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%.RESULTSOf 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.CONCLUSIONRELATIVITY-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.