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

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:

URL

Impact factor

Impact factor: 45.300 in 2022

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1200/JCO.23.01636

UT WoS

001244487700006

Keywords in English

Nivolumab; Relatlimab; Adenocarcinoma

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.

Citovat

HEGEWISCH-BECKER, Susanna, Guillermo MENDEZ, Joseph CHAO, Radim NĚMEČEK, 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. First-Line Nivolumab and Relatlimab Plus Chemotherapy for Gastric or Gastroesophageal Junction Adenocarcinoma: The Phase II RELATIVITY-060 Study. Journal of clinical oncology. PHILADELPHIA: LIPPINCOTT WILLIAMS & WILKINS, 2024, vol. 42, No 17, p. 1-16. ISSN 0732-183X. Available from: https://dx.doi.org/10.1200/JCO.23.01636.

@article{2421705,
   author = {HegewischandBecker, Susanna and Mendez, Guillermo and Chao, Joseph and Němeček, Radim and Feeney, Kynan and Eric, Van Cutsem and AlandBatran, SalahandEddin and Mansoor, Wasat and Maisey, Nicholas and Roberto, Pazo Cid and Burge, Matthew and PerezandCallejo, David and Hipkin, R William and Mukherjee, Sourav and Lei, Ming and Tang, Hao and Suryawanshi, Satyendra and Kelly, Ronan J and Tebbutt, Niall C},
   article_location = {PHILADELPHIA},
   article_number = {17},
   doi = {http://dx.doi.org/10.1200/JCO.23.01636},
   keywords = {Nivolumab; Relatlimab; Adenocarcinoma},
   language = {eng},
   issn = {0732-183X},
   journal = {Journal of clinical oncology},
   title = {First-Line Nivolumab and Relatlimab Plus Chemotherapy for Gastric or Gastroesophageal Junction Adenocarcinoma: The Phase II RELATIVITY-060 Study},
   url = {https://ascopubs.org/doi/10.1200/JCO.23.01636},
   volume = {42},
   year = {2024}
}

TY  - JOUR
ID  - 2421705
AU  - Hegewisch-Becker, Susanna - Mendez, Guillermo - Chao, Joseph - Němeček, Radim - Feeney, Kynan - Eric, Van Cutsem - Al-Batran, Salah-Eddin - Mansoor, Wasat - Maisey, Nicholas - Roberto, Pazo Cid - Burge, Matthew - Perez-Callejo, David - Hipkin, R William - Mukherjee, Sourav - Lei, Ming - Tang, Hao - Suryawanshi, Satyendra - Kelly, Ronan J - Tebbutt, Niall C
PY  - 2024
TI  - First-Line Nivolumab and Relatlimab Plus Chemotherapy for Gastric or Gastroesophageal Junction Adenocarcinoma: The Phase II RELATIVITY-060 Study
JF  - Journal of clinical oncology
VL  - 42
IS  - 17
SP  - 1-16
EP  - 1-16
PB  - LIPPINCOTT WILLIAMS & WILKINS
SN  - 0732183X
KW  - Nivolumab
KW  - Relatlimab
KW  - Adenocarcinoma
UR  - https://ascopubs.org/doi/10.1200/JCO.23.01636
N2  - 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.
ER  -

HEGEWISCH-BECKER, Susanna, Guillermo MENDEZ, Joseph CHAO, Radim NĚMEČEK, 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. First-Line Nivolumab and Relatlimab Plus Chemotherapy for Gastric or Gastroesophageal Junction Adenocarcinoma: The Phase II RELATIVITY-060 Study. \textit{Journal of clinical oncology}. PHILADELPHIA: LIPPINCOTT WILLIAMS \&{} WILKINS, 2024, vol.~42, No~17, p.~1-16. ISSN~0732-183X. Available from: https://dx.doi.org/10.1200/JCO.23.01636.

Detailed Information on Publication Record