Safety profile of nivolumab administered as 30-min infusion: analysis of data from CheckMate 153 Article

Industry Collaboration

cited authors

  • Waterhouse, David, Horn, Leora, Reynolds, Craig, Spigel, David, Chandler, Jason, Mekhail, Tarek, Mohamed, Mohamed, Creelan, Ben, Blankstein, Kenneth B., Nikolinakos, Petros, McCleod, Michael J., Li, Ang, Oukessou, Abderrahim, Agrawal, Shruti, Aanur, Nivedita

funding text

  • Medical writing and editorial assistance were provided by Mark Palangio and Anne Cooper of StemScientific, funded by Bristol-Myers Squibb. Preliminary results from this analysis were presented at the American Society of Clinical Oncology 2016 Annual Meeting; June 3-7, 2016; Chicago, IL, USA; Poster 3059. This study was funded by Bristol-Myers Squibb. The funder provided the study drug and worked with investigators to design and conduct the study and to collect, manage, analyze, and interpret the data. The funder, in collaboration with the authors, contributed to the preparation, review, and approval of the manuscript and the decision to submit the manuscript for publication.

abstract

  • Nivolumab has been administered using a 60-min infusion time. Reducing this time to 30 min would benefit both patients and infusion facilities. This analysis compared the safety of 30- and 60-min infusions of nivolumab in patients with previously treated advanced non-small cell lung cancer. CheckMate 153 is an open-label, phase 3b/4, predominantly community-based study ongoing in the United States and Canada. Patients with stage IIIB/IV disease with progression/recurrence after at least one prior systemic therapy received nivolumab 3 mg/kg every 2 weeks over 30 or 60 min for 1 year or until disease progression. The primary outcome overall was to estimate the incidence of grade 3-5 treatment-related select adverse events; a retrospective objective was to estimate the incidence of hypersensitivity/infusion-related reactions (IRRs) with the 30-min infusion. Exploratory pharmacokinetic analyses were performed using a population pharmacokinetics model. Of 1420 patients enrolled, 369 received only 30-min infusions and 368 received only 60-min infusions. Similar frequencies of hypersensitivity/IRRs were noted in patients receiving 30-min [2% (n = 8)] and 60-min [2% (n = 7)] infusions. Grade 3-4 treatment-related hypersensitivity/IRRs led to treatment discontinuation in < 1% of patients in each group; < 1% of patients in each group received systemic corticosteroids. Hypersensitivity/IRRs were managed by dosing interruptions, with minimal impact on total dose received. Nivolumab pharmacokinetics were predicted to be similar in the two groups. Nivolumab infused over 30 min had a comparable safety profile to the 60-min infusion, including a low incidence of IRRs.

authors

Publication Date

  • April 1, 2018

webpage

published in

category

start page

  • 679

end page

  • 686

volume

  • 81

issue

  • 4

WoS Citations

  • 1

WoS References

  • 18