Title :

First-line nivolumab (NIVO) plus ipilimumab (IPI) plus two cycles of chemotherapy (chemo) versus chemo alone (4 cycles) in patients with advanced non-small cell lung cancer (NSCLC): Two-year update from CheckMate 9LA.

Author(s) :

Reck, Martin [Auteur]
German Center for Lung Research
Ciuleanu, Tudor-Eliade [Auteur]
Cobo, Manuel [Auteur]
Instituto de Investigación Biomédica de Málaga y Plataforma en Nanomedicina = Biomedical Research Institute of Málaga and Nanomedicine Platform [IBIMA Plataforma BIONAND ]
Schenker, Michael [Auteur]
Zurawski, Bogdan [Auteur]
Janoski de Menezes, Juliana [Auteur]
Richardet, Eduardo [Auteur]
Bennouna, Jaafar [Auteur]
Immunogenic Cell Death and Mesothelioma Therapy [CRCINA-ÉQUIPE 4]
Felip, Enriqueta [Auteur]
Vall d'Hebron University Hospital [Barcelona]
Juan-Vidal, Oscar [Auteur]
Hospital Universitari i Politècnic La Fe = University and Polytechnic Hospital La Fe
Alexandru, Aurella [Auteur]
Sakai, Hiroshi [Auteur]
Scherpereel, Arnaud [Auteur]
Thérapies Assistées par Lasers et Immunothérapies pour l'Oncologie - U 1189 [OncoThAI]
Lu, Shun [Auteur]
Shangaï Jiao Tong University [Shangaï]
Paz-Ares, Luis [Auteur]
Universidad Complutense de Madrid = Complutense University of Madrid [Madrid] [UCM]
Carbone, David Paul [Auteur]
The Ohio State University [Columbus] [OSU]
Memaj, Arteid [Auteur]
Bristol-Myers Squibb [Princeton]
Marimuthu, Sathiya [Auteur]
Tran, Phuong [Auteur]
John, Tom [Auteur]
Austin Hospital [Melbourne]

Journal title :

Journal of Clinical Oncology

Pages :

9000-9000

Publisher :

American Society of Clinical Oncology

Publication date :

2021-05-20

ISSN :

0732-183X

HAL domain(s) :

Sciences du Vivant [q-bio]/Cancer

English abstract : [en]

In the randomized phase 3 CheckMate 9LA trial (NCT03215706), first-line NIVO + IPI combined with 2 cycles of chemo significantly improved overall survival (OS), progression-free survival (PFS), and objective response rate ...
Show more >In the randomized phase 3 CheckMate 9LA trial (NCT03215706), first-line NIVO + IPI combined with 2 cycles of chemo significantly improved overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) vs chemo alone (4 cycles). Clinical benefit was observed regardless of programmed death ligand 1 (PD-L1) expression level and histology. Here we report data with 2 years’ minimum follow-up from this study. Methods: Adult patients (pts) with stage IV / recurrent NSCLC, ECOG performance status ≤ 1, and no known sensitizing EGFR/ALK alterations were stratified by PD-L1 (< 1% vs ≥ 1%), sex, and histology (squamous vs non-squamous) and were randomized 1:1 to NIVO 360 mg Q3W + IPI 1 mg/kg Q6W + chemo (2 cycles; n = 361) or chemo alone (4 cycles; n = 358). Pts with non-squamous NSCLC in the chemo-alone arm could receive pemetrexed maintenance. The primary endpoint was OS. Secondary endpoints included PFS and ORR by blinded independent central review, and efficacy by different PD-L1 levels. Safety was exploratory. Results: At a minimum follow-up of 24.4 months for OS (database lock: Feb 18, 2021), pts treated with NIVO + IPI + chemo continued to derive OS benefit vs chemo, with a median OS of 15.8 months vs 11.0 months, respectively (HR, 0.72 [95% CI, 0.61–0.86]); 2-year OS rates were 38% vs 26%. Median PFS with NIVO + IPI + chemo vs chemo was 6.7 months vs 5.3 months (HR, 0.67 [95% CI, 0.56–0.79]); 8% and 37% of pts who had disease progression received subsequent immunotherapy, respectively. ORR was 38% with NIVO + IPI + chemo vs 25% with chemo. Similar clinical benefit with NIVO + IPI + chemo vs chemo was observed in all randomized pts and across the majority of subgroups, including by PD-L1 expression level (Table) or histology. Any grade and grade 3–4 treatment-related adverse events were reported in 92% and 48% of pts in the NIVO + IPI + chemo arm vs 88% and 38% in the chemo arm, respectively. Conclusion: With 2 years’ minimum follow-up, first-line NIVO + IPI + chemo demonstrated durable survival and benefit versus chemo in pts with advanced NSCLC; no new safety signals were identified.Show less >

Language :

Anglais

Peer reviewed article :

Oui

Audience :

Internationale

Popular science :

Non

Collections :

• Thérapies Lasers Assistées par l'Image pour l'Oncologie (ONCO-THAI) - U1189

Source :

Harvested from HAL