Poster Presentation Joint 2016 COSA and ANZBCTG Annual Scientific Meeting

Safety Profile of Nivolumab Administered as 30-minute Infusion: Analysis of Data from CheckMate 153 (#260)

David Waterhouse 1 , Leora Horn 2 , Craig Reynolds 3 4 , David Spigel 5 , Jason Chandler 6 , Tarek Mekhail 7 , Mohamed Mohamed 8 , Ben Creelan 9 , Kenneth B Blankstein 10 , Petros Nikolinakos 11 , Michael J MaCleod 12 , Ang Li 13 , Ian M Waxman 13 , Nivedita Aanar 13 , Shruti Agrawal 13
  1. Oncology Haematology Care, Cincinnati, OH, USA
  2. Vanderbilt University Medical Center, Nashville, TN, USA
  3. Ocala Oncology Center, Ocala, FL, USA
  4. US Oncology Research, Houston, TX, USA
  5. Sarah Cannon Research Institute/Tennessee Oncology, PLLC, Nashville, TN, USA
  6. The West Clinic, P.C., Memphis, TN, USA
  7. Cancer Institute of Florida, Orlando, FL, USA
  8. Cone Health Cancer Center at Wesley Long, Greensboro, NC, USA
  9. H. Lee Moffitt Cancer Centre & Research Institute, Tampa, FL, USA
  10. Hunterdon Hematology Oncology, Flemington, NC, USA
  11. University Cancer and Blood Center, LLC, Athens, GA, USA
  12. Florida Cancer Specialists, Cape Coral, FL, USA
  13. Bristol-Myers Squibb, Princeton, NJ, USA

Aims: Nivolumab, anti-programmed death-1 (PD-1) antibody, is approved in the US for previously treated metastatic NSCLC and renal cell carcinoma, and for advanced melanoma, and in the EU for previously treated squamous NSCLC and advanced melanoma. The impact of infusion time on nivolumab safety was assessed in an ongoing, predominantly community-based trial (CheckMate 153; NCT02066636).

Methods: Patients with advanced/metastatic NSCLC who progressed during or after ≥1 prior therapy were enrolled. The primary study outcome was incidence of grade 3–4 and 5 and select treatment-related adverse events (TRAEs). Patients received nivolumab 3 mg/kg IV Q2W; infusion time was shortened from 60 to 30 minutes following a study protocol amendment.

Results: A total of 322 and 355 patients, respectively, received nivolumab by 30-minute or 60-minute infusion; demographics for these patients are comparable to the overall population (median follow-up, 6 mo). Any grade (grade 3–4) TRAEs occurred in 53% (11%) and 51% (12%) of patients with 30-minute or 60-minute infusions, respectively. Grade 3-4 select AEs of any cause in ≥2% of patients given 30-minute or 60-minute infusions occurred in pulmonary (3% and 2%), hepatic (2% and 3%), and gastrointestinal (2% and 2%) categories. Any grade (grade 3–4) hypersensitivity/infusion reaction of any cause occurred in 2% and 1% (<1% and <1%) of patients given 30-minute or 60-minute infusions, respectively; these led to nivolumab discontinuation in <1% and 1% (<1% and 1%) of patients, respectively. Systemic corticosteroids for hypersensitivity/infusion reactions were administered to 3 patients and 1 patient given the 30-minute and 60-minute infusions, respectively. The predicted nivolumab maximum plasma concentration after the first dose and at steady state was similar with 30-minute and 60-minute infusions.

Conclusions: Nivolumab 3 mg/kg can be safely infused over 30 minutes, with a safety profile comparable to 60-minute infusion and a low incidence of infusion-related reactions.

Reused with permission from the American Society of Clinical Oncology (ASCO). This abstract was accepted and previously presented at the 2016 ASCO annual meeting. All rights reserved.