ESMO 2021: Can Modified Dosing Schedule of Ipilimumab Improve Tolerability in Renal Cell Carcinoma?
Posted: Monday, September 27, 2021
Naveen S. Vasudev, PhD, MBChB, of St. James’s University Hospital Leeds, Great Britain, and colleagues conducted the phase II PRISM trial to evaluate tolerability among patients with renal cell carcinoma when ipilimumab, combined with nivolumab, is given at an alternative schedule. They found that when ipilimumab was given every 12 weeks instead of every 3 weeks, there was a significant reduction in grade 3 or 4 treatment-related adverse events, with similar clinical outcomes. Their results were presented during the European Society for Medical Oncology (ESMO) Congress 2021 (Abstract LBA29).
A total of 192 patients with untreated, clear cell advanced renal cell carcinoma were randomly assigned to receive four doses of ipilimumab every 3 (n = 64) or 12 (n = 128) weeks, in combination with nivolumab. Treatment was continued until disease progression or unacceptable toxicity.
Of the total participants, 69.8% were intermediate/poor-risk; 90 and 44 patients received ipilimumab at modified and conventional dosing schedules, respectively. Notably, participants who received ipilimumab at 12-week intervals experienced a significantly lower frequency of grade 3 or 4 treatment-related adverse events than those receiving it at 3-week intervals (32.8% vs. 53.1%; P = .0075).
In both the intent-to-treat and intermediate/poor-risk populations, a partial response was the best response among patients receiving the modified dosing schedule (39.1% and 40.0%); the best response among the intent-to-treat population receiving the conventional dosing was stable disease, accounting for 39.1% of patients. In the intermediate/poor-risk group, however, stable disease and partial response were both achieved by 38.6% of individuals.
The progressive disease affected 22.7% and 23.4% of patients on the modified and conventional dosing schedules in the intent-to-treat population and 26.7% and 20.5% of those at intermediate/poor risk, respectively. Additionally, progression-free survival across all groups was similar among the modified and conventional dosing groups in both the intent-to-treat (46% and 45%) and intermediate/poor-risk (43% and 46%) groups.
Disclosure: For full disclosures of the study authors, visit oncologypro.esmo.org.