From By David M. Waterhouse, MD, MPH, medical oncologist and co-director of research, OHC
January 29, 2018
David M. Waterhouse, MD, MPH
Co-Director of Research at OHC
OHC, the region’s premier source of treatment for nearly every form of adult cancer and complex blood disorder, announced that the results of a study led by David M. Waterhouse, MD, MPH, co-director of research at OHC, indicates that nivolumab may be administered in half the current time and still be effective.
Opdivo® (nivolumab) was the first immuno-oncology treatment to receive FDA approval based on overall survival for patients with relapsing non small cell lung cancer. Cincinnati-based OHC enrolled a significant number of patients to this landmark study.
Patients currently receive Opdivo® every other week for a one hour infusion. The study demonstrated that reducing the infusion time to 30 minutes would not be expected to affect the pharmacokinetics (absorption, distribution, metabolism, and elimination) of the treatment. Reductions in infusion times have been demonstrated to be feasible and safe for other therapeutic antibodies in clinical trials [11–14], supporting investigation of shorter infusions of Opdivo®.
“There were no notable differences in baseline characteristics between patients receiving the 30-minute and 60-minute infusions,” said David M. Waterhouse, MD, MPH, co-director of research at OHC and lead investigator. “This can be a considerable difference when you have a serious, complex illness. You can get in and out and back home in half the time.”
Overall, no new safety concerns were noted with 30-minute infusions of Opdivo®. The incidences of any cause or treatment-related side effects were low and similar in both the 30-minute and 60-minute infusion groups.
“Hopefully, as this information is submitted to the FDA, we will be allowed in the future to give this treatment over a 30 minute period of time, improving the quality of life of the patient.”
Safety profile of nivolumab administered as 30-minute infusion: Analysis of data from CheckMate 153. David Waterhouse, Leora Horn, Craig Reynolds, David Spigel, Jason Chandler, Tarek Mekhail, Mohamed Mohamed, Ben Creelan, Kenneth B. Blankstein, Petros Nikolinakos, Michael J. McCleod, Ang Li, Abderrahim Oukessou, Shruti Agrawal, Nivedita Aanur.
Oncology Hematology Care, Cincinnati, OH, and US Oncology Research, Houston, TX, USA; Vanderbilt University Medical Center, Nashville, TN, USA; Ocala Oncology Center, Ocala, FL and US Oncology Research, Houston, TX, USA; Sarah Cannon Research Institute/Tennessee Oncology, PLLC, Nashville, TN, USA; West Cancer Center, PC, Memphis, TN, USA; Florida Hospital Cancer Institute, Orlando, FL, USA; Cone Health Cancer Center at Wesley Long, Greensboro, NC, USA; H. Lee Moffitt Cancer Center, Tampa, FL, USA; Hunterdon Hematology Oncology, Flemington, NJ, USA; University Cancer & Blood Center, LLC, Athens, GA, USA; Florida Cancer Specialists, Cape Coral, FL, USA; Bristol-Myers Squibb, Princeton, NJ, USA.
Corresponding author: David Waterhouse, MD, MPH, david.waterhouse@usoncology.com, Phone: 513-751-2273.
