#CHECKMATE 9LA TRIAL TRIAL#
#CHECKMATE 9LA TRIAL PLUS#

Neutropenia, anemia, diarrhea, increased lipase, and asthenia were the most common grade 3 or 4 treatment-related adverse events (TRAEs).

#CHECKMATE 9LA TRIAL PLUS#

At an additional 3.5 months of follow-up (median 13.2 months), the nivolumab and ipilimumab plus chemotherapy cohort had a median OS of 15.6 months (95% CI, 13.9-20), while the chemotherapy alone group had a median OS of 10.9 months (95% CI, 9.5-12.6). The primary end point was overall survival (OS).Īt an interim analysis after a median follow-up of 9.7 months, OS in the combination therapy cohort was significantly longer than in the chemotherapy control group (median OS 14.1 months vs 10.7 months, respectively).

Of the 1150 enrolled patients, 719 were randomized to receive either 4 cycles of chemotherapy alone (n = 358) or nivolumab (360 mg intravenously every 3 weeks) plus ipilimumab (1 mg/kg intravenously every 6 weeks) with 2 cycles of histology-based, platinum doublet chemotherapy (n = 361). Patients aged 18 years or older with treatment-naïve stage IV or recurrent NSCLC and an Eastern Cooperative Oncology Group performance status of 0-1 were eligible.

#CHECKMATE 9LA TRIAL TRIAL#

The randomized, open-label, phase 3 CheckMate 9LA trial enrolled 1150 patients at 103 hospitals in 19 countries between Augand January 30, 2019. The application was approved based on CheckMate 9LA data 2 months ahead of schedule after being granted priority review and fast track designation by the FDA. The combination of nivolumab plus ipilimumab and chemotherapy was approved by the FDA on May 26, 2020, as a first-line treatment for metastatic or recurrent NSCLC cancer with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations. Combination nivolumab and ipilimumab has demonstrated efficacy in the first-line setting for non–small cell lung cancer (NSCLC), and recently published results from the ongoing CheckMate 9LA trial ( NCT03215706) show that adding a limited course of chemotherapy to the combination treatment is effective and tolerable.

Checkmate 9la trial