Nivolumab Plus Chemotherapy in Epidermal Growth Factor Receptor-Mutated Metastatic Non-Small-Cell Lung Cancer After Disease Progression on Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors: Final Results of CheckMate 722.
Journal
Journal of clinical oncology : official journal of the American Society of Clinical Oncology
Journal Volume
42
Journal Issue
11
Start Page
1252
End Page
1264
ISSN
1527-7755
Date Issued
2024-04-10
Author(s)
Mok, Tony
Nakagawa, Kazuhiko
Park, Keunchil
Ohe, Yuichiro
Girard, Nicolas
Kim, Hye Ryun
Wu, Yi-Long
Gainor, Justin
Lee, Se-Hoon
Chiu, Chao-Hua
Kim, Sang-We
CHENG-TA YANG
Wu, Chien Liang
Wu, Lin
Lin, Meng-Chih
Samol, Jens
Ichikado, Kazuya
Wang, Mengzhao
Zhang, Xiaoqing
Sylvester, Judi
Li, Sunney
Forslund, Ann
Abstract
The phase III CheckMate 722 trial (ClinicalTrials.gov identifier: NCT02864251) evaluated nivolumab plus chemotherapy versus chemotherapy in patients with epidermal growth factor receptor ()-mutated metastatic non-small-cell lung cancer (NSCLC) after disease progression on EGFR tyrosine kinase inhibitors (TKIs).
Patients with disease progression after first- or second-generation EGFR TKI therapy (without T790M mutation) or osimertinib (with/without T790M mutation) were randomly assigned 1:1 to nivolumab (360 mg once every 3 weeks) plus platinum-doublet chemotherapy (once every 3 weeks) or platinum-doublet chemotherapy alone (once every 3 weeks) for four cycles. Primary end point was progression-free survival (PFS). Secondary end points included 9- and 12-month PFS rates, overall survival (OS), objective response rate (ORR), and duration of response (DOR).
Overall, 294 patients were randomly assigned. At final analysis (median follow-up, 38.1 months), PFS was not significantly improved with nivolumab plus chemotherapy versus chemotherapy (median, 5.6 5.4 months; hazard ratio [HR], 0.75 [95% CI, 0.56 to 1.00]; = .0528), with 9- and 12-month PFS rates of 25.9% versus 19.8%, and 21.2% versus 15.9%, respectively. Post hoc PFS subgroup analyses showed a trend favoring nivolumab plus chemotherapy in patients with tumors harboring sensitizing mutations (HR, 0.72 [95% CI, 0.54 to 0.97]), one line of previous EGFR TKI (0.72 [95% CI, 0.54 to 0.97]), or both (0.64 [95% CI, 0.47 to 0.88]). Median OS was 19.4 months with nivolumab plus chemotherapy versus 15.9 months with chemotherapy, while ORR was 31.3% versus 26.7%, and median DOR was 6.7 versus 5.6 months, respectively. Grade 3/4 treatment-related adverse events occurred in 44.7% and 29.4% of patients treated with nivolumab plus chemotherapy and chemotherapy alone, respectively.
Nivolumab plus chemotherapy did not significantly improve PFS versus chemotherapy in patients with mutated metastatic NSCLC previously treated with EGFR TKIs. No new safety signals were identified.
SDGs
Type
journal article