In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 35, No. 15_suppl ( 2017-05-20), p. e14595-e14595
Abstract:
e14595 Background: The PD-1 inhibitor Nivo and antiCTLA-4 Ipi in combination was registered by FDA and EMA for the treatment of metastatic melanoma.The accelerated approval of this indication was based on PFS data.OS data in previously untreated melanoma pts was reported only in the Phase II CheckMate 069 study.In the Nivo+Ipi group the 1YOS% was 73,4% and 63,8% at 2Y, in the Ipi group 1YOS% was 64,8%, 2YOS% was 53,6% at median follow up of 24,5 months.The median OS had not been reached, the outcome measures could not assess the long-term benefit of antitumor immun response. Methods: In order to measure the relative clinical values, we analyzed the 1Y, 2Y survival data and calculated the ARR (absolut risk reduction) and NNT values (the number of patients who need to be treated to prevent one death) of the Phase II CheckMate 069 trial Nivo+Ipi vs Ipi group, and the overall survival data in subgroup of pts who discontinued the immun-therapy due to treatment related AEs. We used GraphPad Software QuickCalcs/NNT for calculating the results of 95% CI. Results: In the CheckMate 069, the Nivo+Ipi group vs Ipi group ARR was 10,93, the NNT was 10(95%CI 3,6-17,8) at 1Y.The ARR was 13,19, the NNT value was 8(95%CI 3,3-24,1) at 2Y. 1 in every 8-10 pts will benefit from the Nivo+Ipi combined immuno-therapy in order to prevent one death. In the subgroup of patients (37%) who discontinued treatment, the ARR was 21,16 at 1Y and 21,76 at 2Y. Despite of discontinuation, 1 in every 5 pts will benefit from immuno-therapy at 1Y and 2Y, the NNT was 5 (95%CI 2,5-40,4) and 2Y (95%CI 2,3-127,2). Conclusions: These results of NNT 5-10 represent the exceptional survival benefit of combined immuno-therapy. The limitations of NNT bias the pts demographic parameters and the value depends on comparator drug. The risk reduction was not constant over the follow up time and the long term benefit of immuno-therapy is not linear.The NNT data provide measurement of relative clinical value and clinical impact.
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/JCO.2017.35.15_suppl.e14595
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2017
detail.hit.zdb_id:
2005181-5
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