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Nivolumab versus docetaxel in a predominantly Chinese patient population with previously treated advanced non-small cell lung cancer: 2-year follow-up from a randomized, open-label, phase 3 study (CheckMate 078)
- Source :
- Lung Cancer. 152:7-14
- Publication Year :
- 2021
- Publisher :
- Elsevier BV, 2021.
-
Abstract
- Background In the phase 3 CheckMate 078 study, nivolumab showed significant overall survival (OS) benefit and superior tolerability versus docetaxel in a predominantly Chinese patient population with non-small cell lung cancer (NSCLC). However, data on long-term outcomes with immunotherapy in Asian patients are limited. We report 2-year efficacy and safety data. Methods Patients with advanced/metastatic NSCLC and disease progression after platinum-doublet chemotherapy were randomized 2:1 to nivolumab (3 mg/kg every 2 weeks; n = 338) or docetaxel (75 mg/m2 every 3 weeks; n = 166) until progression, unacceptable toxicity, or other protocol-defined reasons. The primary endpoint was OS; secondary endpoints included progression-free survival, objective response rate, and safety. Results After 25.9 months minimum follow-up, 21 patients (6 %) remained on nivolumab versus 0 on docetaxel. Median OS was 11.9 months with nivolumab versus 9.5 months with docetaxel (HR: 0.75; 95 % CI: 0.61–0.93); 2-year OS rates were 28 % versus 18 %, respectively. Survival benefits were observed across a variety of predefined subgroups. At 2 years, 39 % and 0 % of responders had ongoing responses with nivolumab and docetaxel, respectively. Grade 3–4 treatment-related adverse events occurred in 12 % of patients with nivolumab versus 47 % with docetaxel, leading to discontinuation in 4 % and 5 % of patients, respectively. No new treatment-related deaths occurred. Conclusion At 2 years, nivolumab maintained a favorable safety profile and continued to demonstrate superior OS versus docetaxel in this predominantly Chinese patient population with previously treated NSCLC. These data are consistent with long-term outcomes from the global CheckMate 017/057 studies.
- Subjects :
- 0301 basic medicine
Pulmonary and Respiratory Medicine
Oncology
China
Cancer Research
medicine.medical_specialty
Lung Neoplasms
medicine.medical_treatment
Phases of clinical research
Docetaxel
03 medical and health sciences
0302 clinical medicine
Carcinoma, Non-Small-Cell Lung
Internal medicine
medicine
Clinical endpoint
Humans
Lung cancer
Chemotherapy
business.industry
medicine.disease
Discontinuation
Nivolumab
030104 developmental biology
Tolerability
030220 oncology & carcinogenesis
business
Follow-Up Studies
medicine.drug
Subjects
Details
- ISSN :
- 01695002
- Volume :
- 152
- Database :
- OpenAIRE
- Journal :
- Lung Cancer
- Accession number :
- edsair.doi.dedup.....861b8472a098a3a662d4e5e35464fc28