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
PURPOSE: The phase III CheckMate 722 trial (ClinicalTrials.gov identifier: NCT02864251) evaluated nivolumab plus chemotherapy versus chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated metastatic non-small-cell lung cancer (NSCLC) after disease progression on EGFR tyrosine kinase inhibitors (TKIs).
METHODS: Patients with disease progression after first- or second-generation EGFR TKI therapy (without EGFR 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).
RESULTS: 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 v 5.4 months; hazard ratio [HR], 0.75 [95% CI, 0.56 to 1.00]; P = .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 EGFR 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.
CONCLUSION: Nivolumab plus chemotherapy did not significantly improve PFS versus chemotherapy in patients with EGFR-mutated metastatic NSCLC previously treated with EGFR TKIs. No new safety signals were identified.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:42 |
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| Enthalten in: |
Journal of clinical oncology : official journal of the American Society of Clinical Oncology - 42(2024), 11 vom: 10. Apr., Seite 1252-1264 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Mok, Tony [VerfasserIn] |
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| Links: |
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| Themen: |
31YO63LBSN |
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| Anmerkungen: |
Date Completed 08.04.2024 Date Revised 10.04.2024 published: Print-Electronic ClinicalTrials.gov: NCT02864251 Citation Status MEDLINE |
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| doi: |
10.1200/JCO.23.01017 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM36743394X |
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| 100 | 1 | |a Mok, Tony |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a 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 |b Final Results of CheckMate 722 |
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| 500 | |a Date Completed 08.04.2024 | ||
| 500 | |a Date Revised 10.04.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT02864251 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a PURPOSE: The phase III CheckMate 722 trial (ClinicalTrials.gov identifier: NCT02864251) evaluated nivolumab plus chemotherapy versus chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated metastatic non-small-cell lung cancer (NSCLC) after disease progression on EGFR tyrosine kinase inhibitors (TKIs) | ||
| 520 | |a METHODS: Patients with disease progression after first- or second-generation EGFR TKI therapy (without EGFR 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) | ||
| 520 | |a RESULTS: 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 v 5.4 months; hazard ratio [HR], 0.75 [95% CI, 0.56 to 1.00]; P = .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 EGFR 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 | ||
| 520 | |a CONCLUSION: Nivolumab plus chemotherapy did not significantly improve PFS versus chemotherapy in patients with EGFR-mutated metastatic NSCLC previously treated with EGFR TKIs. No new safety signals were identified | ||
| 650 | 4 | |a Clinical Trial, Phase III | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Randomized Controlled Trial | |
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| 700 | 1 | |a Nakagawa, Kazuhiko |e verfasserin |4 aut | |
| 700 | 1 | |a Park, Keunchil |e verfasserin |4 aut | |
| 700 | 1 | |a Ohe, Yuichiro |e verfasserin |4 aut | |
| 700 | 1 | |a Girard, Nicolas |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Hye Ryun |e verfasserin |4 aut | |
| 700 | 1 | |a Wu, Yi-Long |e verfasserin |4 aut | |
| 700 | 1 | |a Gainor, Justin |e verfasserin |4 aut | |
| 700 | 1 | |a Lee, Se-Hoon |e verfasserin |4 aut | |
| 700 | 1 | |a Chiu, Chao-Hua |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Sang-We |e verfasserin |4 aut | |
| 700 | 1 | |a Yang, Cheng-Ta |e verfasserin |4 aut | |
| 700 | 1 | |a Wu, Chien Liang |e verfasserin |4 aut | |
| 700 | 1 | |a Wu, Lin |e verfasserin |4 aut | |
| 700 | 1 | |a Lin, Meng-Chih |e verfasserin |4 aut | |
| 700 | 1 | |a Samol, Jens |e verfasserin |4 aut | |
| 700 | 1 | |a Ichikado, Kazuya |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Mengzhao |e verfasserin |4 aut | |
| 700 | 1 | |a Zhang, Xiaoqing |e verfasserin |4 aut | |
| 700 | 1 | |a Sylvester, Judi |e verfasserin |4 aut | |
| 700 | 1 | |a Li, Sunney |e verfasserin |4 aut | |
| 700 | 1 | |a Forslund, Ann |e verfasserin |4 aut | |
| 700 | 1 | |a Yang, James Chih-Hsin |e verfasserin |4 aut | |
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