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HOPA 2019: Flat-Dose Nivolumab Dosing in First-Line Treatment of NSCLC

By: Sarah Campen, PharmD
Posted: Wednesday, April 17, 2019

Flat-dose nivolumab plus weight-based, low-dose ipilimumab appears to be an effective alternative to weight-based dosing for first-line therapy in patients with non–small cell lung cancer (NSCLC). The results of the CheckMate 817 study were recently presented at the 2019 Hematology/Oncology Pharmacy Association (HOPA) Annual Conference in Dallas (poster CR004).

“The clinical profile of flat-dose nivolumab plus weight-based low-dose ipilimumab in CheckMate 817 Cohort A was consistent with previous reports of weight-based nivolumab plus low-dose ipilimumab from CheckMate 227 and CheckMate 568,” stated Luis Paz-Ares, MD, PhD, of Hospital Universitario Doce de Octubre, Madrid, and colleagues. “[It] may provide a more convenient option for patients and providers.”

This phase IIIb/IV, open-label study enrolled 391 chemotherapy-naive patients with NSCLC between 2016 and 2017 at 45 academic and 22 community-based centers in Europe and North America. All participants were given flat-dose nivolumab at 240 mg every 2 weeks and weight-based, low-dose ipilimumab at 1 mg/kg every 5 weeks.

The median duration of follow-up was 11.3 months, and the median durations of nivolumab and ipilimumab treatments were 4.0 and 3.0 months, respectively. The 6-month progression-free survival rate was 50%, with an objective response rate of 35%. Similar efficacy was observed in patients with nonsquamous and squamous histologies.

As for safety, treatment-related adverse events of any grade were reported in 75% of patients, leading to treatment discontinuation in 18% and 2 deaths (due to grade 5 cardiac failureand grade 3 Guillain-Barré syndrome that lasted 15 days). The most common treatment-related adverse events were skin events (29%). “No new safety signals were identified, and toxicities were manageable,” concluded the researchers.



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