Many patients have to stop the ipi/nivo combo due to side effects. This report is pretty much a new take on a prior one, which is summed up in the title: ASCO 2016 - Nivo plus ipi, CheckMate 069 trial....18 month OS similar even if you stop meds due to side effects!! Here's the new version:
Efficacy and Safety Outcomes in Patients With Advanced Melanoma Who Discontinued Treatment With Nivolumab and Ipilimumab Because of Adverse Events: A Pooled Analysis of Randomized Phase II and III Trials. Schadendorf, Wolchok, Hodi, … Chesney, Robert, Grossmann, McDermott, … Postow. J Clin Oncol. 2017 Aug 25: [Epub ahead of print]
Data were pooled from phase II and III trials of patients who received nivolumab 1 mg/kg plus ipilimumab 3 mg/kg, every 3 weeks for four doses, followed by nivolumab monotherapy 3 mg/kg every 2 weeks (N = 409). Efficacy was assessed in all randomly assigned patients who discontinued because of AEs during the induction phase (n = 96) and in those who did not discontinue because of AEs (n = 233). Safety was assessed in treated patients who discontinued because of AEs (n = 176) at any time and in those who did not discontinue because of AEs (n = 231).
At a minimum follow-up of 18 months, median progression-free survival was 8.4 months for patients who discontinued treatment because of AEs during the induction phase and 10.8 months for patients who did not discontinue because of AEs . Median overall survival had not been reached in either group. The objective response rate was 58.3% for patients who discontinued because of AEs during the induction phase and 50.2% for patients who did not discontinue. The vast majority of grade 3 or 4 AEs occurred during the induction phase, with most resolving after appropriate management.
Efficacy outcomes seemed similar between patients who discontinued nivolumab plus ipilimumab treatment because of AEs during the induction phase and those who did not discontinue because of AEs. Therefore, even after discontinuation, many patients may continue to derive benefit from combination therapy.
In this report, efficacy is emphasized. Here's the deal -
40% of melanoma patients who take ipi/nivo have to stop due to side effects during the "induction phase" (the first 12 weeks when ipi and nivo are given together).
This study looked at 409 patients.
Efficacy (effectiveness) was assessed in all randomly assigned patients: 96 who had to discontinue treatment because of adverse events and 233 who did not.
Minimum average f/u was 18 months.
Median progression-free survival was 8.4 months for patients who had to stop treatment.
Median PFS was 10.8 months for those who did not stop.
Median OS was not reached in either group.
Response rate in those who stopped treatment due to side effects was 58.3%.
Response rate was 50.2% in those who did not discontinue.
Most AE's resolved with appropriate management.
As I concluded in the initial report....it's just me....but it seems clear that we are giving the ipi combo portion of this therapy too long!!! For what it's worth. - c