Nivolumab monotherapy and nivolumab plus ipilimumab in recurrent small cell lung cancer: Results from the CheckMate 032 randomized cohort Journal Article


Authors: Ready, N. E.; Ott, P. A.; Hellmann, M. D.; Zugazagoitia, J.; Hann, C. L.; de Braud, F.; Antonia, S. J.; Ascierto, P. A.; Moreno, V.; Atmaca, A.; Salvagni, S.; Taylor, M.; Amin, A.; Camidge, D. R.; Horn, L.; Calvo, E.; Li, A.; Lin, W. H.; Callahan, M. K.; Spigel, D. R.
Article Title: Nivolumab monotherapy and nivolumab plus ipilimumab in recurrent small cell lung cancer: Results from the CheckMate 032 randomized cohort
Abstract: Introduction: Nivolumab monotherapy is approved in the United States for third-line or later metastatic small cell lung cancer based on pooled data from nonrandomized and randomized cohorts of the multicenter, open-label, phase 1/2 trial of nivolumab ± ipilimumab (CheckMate 032; NCT01928394). We report updated results, including long-term overall survival (OS), from the randomized cohort. Methods: Patients with small cell lung cancer and disease progression after one to two prior chemotherapy regimens were randomized 3:2 to nivolumab 3 mg/kg every 2 weeks or nivolumab 1 mg/kg plus ipilimumab 3 mg/kg every 3 weeks for four cycles followed by nivolumab 3 mg/kg every 2 weeks. Patients were stratified by number of prior chemotherapy regimens and treated until disease progression or unacceptable toxicity. The primary endpoint was objective response rate (ORR) by blinded independent central review. Results: Overall, 147 patients received nivolumab and 96 nivolumab plus ipilimumab. Minimum follow-up for ORR/progression-free survival/safety was 11.9 months (nivolumab) and 11.2 months (nivolumab plus ipilimumab). ORR increased with nivolumab plus ipilimumab (21.9% versus 11.6% with nivolumab; odds ratio: 2.12; 95% confidence interval: 1.06–4.26; p = 0.03). For long-term OS, minimum follow-up was 29.0 months (nivolumab) versus 28.4 months (nivolumab plus ipilimumab); median (95% confidence interval) OS was 5.7 (3.8–7.6) versus 4.7 months (3.1–8.3). Twenty-four–month OS rates were 17.9% (nivolumab) and 16.9% (nivolumab plus ipilimumab). Grade 3 to 4 treatment-related adverse event rates were 12.9% (nivolumab) versus 37.5% (nivolumab plus ipilimumab), and treatment-related deaths were n =1 versus n = 3, respectively. Conclusions: Whereas ORR (primary endpoint) was higher with nivolumab plus ipilimumab versus nivolumab, OS was similar between groups. In each group, OS remained encouraging with long-term follow-up. Toxicities were more common with combination therapy versus nivolumab monotherapy. © 2019 International Association for the Study of Lung Cancer
Keywords: adult; cancer chemotherapy; treatment response; aged; major clinical study; overall survival; fatigue; cancer recurrence; cancer growth; diarrhea; drug efficacy; drug safety; monotherapy; side effect; follow up; cancer grading; ipilimumab; progression free survival; multiple cycle treatment; nausea; vomiting; cohort analysis; cancer mortality; alanine aminotransferase blood level; arthralgia; aspartate aminotransferase blood level; asthenia; fever; pneumonia; pruritus; rash; alanine aminotransferase; aspartate aminotransferase; maculopapular rash; immunotherapy; colitis; drug cytotoxicity; hyperthyroidism; hypothyroidism; amylase blood level; triacylglycerol lipase blood level; amylase; triacylglycerol lipase; small cell lung cancer; randomized controlled trial (topic); decreased appetite; nivolumab; infusion related reaction; human; male; female; priority journal; article; programmed death-1 inhibitor; small cell lung cancer: nivolumab
Journal Title: Journal of Thoracic Oncology
Volume: 15
Issue: 3
ISSN: 1556-0864
Publisher: Elsevier Inc.  
Date Published: 2020-03-01
Start Page: 426
End Page: 435
Language: English
DOI: 10.1016/j.jtho.2019.10.004
PUBMED: 31629915
PROVIDER: scopus
DOI/URL:
Notes: Article -- Export Date: 1 April 2020 -- Source: Scopus
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MSK Authors
  1. Margaret Kathleen Callahan
    145 Callahan
  2. Matthew David Hellmann
    282 Hellmann