Monday, May 23, 2016

ASCO 2016 - Nivo plus ipi, CheckMate 069 trial....18 month OS similar even if you stop meds due to side effects!!!



Now this is just little 'ol me talking...but if patients who had to stop the combo early due to side effects...show an OS at 18 months that is the same as those who who continued treatment....it says to me that we are giving the meds too long!!!!  Of course we will have to see if that holds over time, but way to go, ratties!!! - c

Overall survival in patients with advanced melanoma (MEL) who discontinued treatment with nivolumab (NIVO) plus ipilimumab (IPI) due to toxicity in a phase II trial (CheckMate 069).  ASCO 2016. #9518.  J Clin Oncol 2016.  Hodi, Postow, Chesney, Pavlick, Robert, Agarwala, Wolchok, et al.

Background: Results from CheckMate 069 demonstrated a significant improvement in objective response rate (ORR) and progression-free survival (PFS) with NIVO+IPI vs IPI alone in treatment-na├»ve patients  with BRAF wild-type MEL. We evaluated overall survival (OS) in pts who discontinued treatment due to toxicity in this study. Methods: Pts (N = 142) were randomized 2:1 to receive NIVO 1 mg/kg plus IPI 3 mg/kg or IPI 3 mg/kg plus placebo every 3 weeks x 4 doses, followed by NIVO 3 mg/kg or placebo, respectively, every 2 weeks until disease progression or unacceptable toxicity. The primary endpoint was ORR in pts with BRAF wild-type tumors. Secondary and exploratory endpoints included PFS and OS. A post-hoc analysis was performed to evaluate OS in pts who discontinued treatment due to toxicity. Results: At a follow-up of greater than or = to,18 months, median OS in pts who discontinued treatment was not reached with NIVO+IPI and was 11.2 months for IPI alone. Similar 18-month OS rates were observed in pts who discontinued NIVO+IPI due to toxicity and in the overall treatment group. Among pts who discontinued NIVO+IPI, ORR was 68% (27% achieved a complete response). Median duration of response was not reached and 21 of 30 pts (70%) remain in response. Grade 3/4 treatment-related adverse events (AEs) occurred in 55% of pts in the NIVO+IPI group vs 22% with IPI, and led to discontinuation in 30% and 9% of pts, respectively. In pts who discontinued NIVO+IPI due to toxicity, resolution rates of treatment-related select AEs ranged from 89% to 100% (40% for endocrine AEs). Efficacy updates, including 2-year OS rates, will be presented for these pts. Conclusions: These data suggest that pts who discontinue NIVO+IPI treatment due to drug toxicity derive an OS benefit similar to that observed in the overall population. Clinical trial information: NCT01927419

All randomized pts who discontinued due to toxicity


All randomized
BRAF wild-type pts


NIVO+IPI
(n = 44)
IPI
(n = 10)
NIVO+IPI
(N = 72)
IPI
(N = 37)
Median OS, months   
             NR      
11.2
NR
NR



18-month OS rate, %   
79.5
40.0
73.2
56.0

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