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MSI大腸癌に対するイピニボのCheckMate142試験

MSI-H/dMMR大腸癌に対するイピリムマブ+ニボルマブ併用療法のCheckMate 142試験って論文の論文が出たようです。すでに学会発表などはなされていましたが、やはりMSI-H/dMMRに対するイピリムマブ+ニボルマブの治療成績は圧倒的です。

First-Line Nivolumab Plus Low-Dose Ipilimumab for Microsatellite Instability-High/Mismatch Repair-Deficient Metastatic Colorectal Cancer: The Phase II CheckMate 142 Study | Journal of Clinical Oncology
PURPOSE Nivolumab received US Food and Drug Administration approval as a single agent or in combination with ipilimumab in patients with microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) metastatic colorectal cancer (mCRC) that progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan based on CheckMate 142. Presented are results of nivolumab plus low-dose ipilimumab in the first-line therapy cohort from the phase II CheckMate 142 study. PATIENTS AND METHODS Patients with no prior treatment in the metastatic setting for MSI-H/dMMR CRC were treated with nivolumab every 2 weeks plus low-dose ipilimumab every 6 weeks until disease progression. The primary end point was objective response rate (investigator assessment; RECIST v1.1). RESULTS Median age of treated patients was 66 years (N = 45). Median follow-up was 29.0 months. Objective response rate and disease control rate were 69% (95% CI, 53 to 82) and 84% (95% CI, 70.5 to 93.5), respectively, with 13% complete response rate. Median duration of response was not reached; 74% of responders had ongoing responses at data cutoff. Median progression-free survival and median overall survival were not reached with minimum follow-up of 24.2 months (24-month rates, 74% and 79%, respectively). Clinical benefit was observed regardless of baseline demographic and tumor characteristics, including BRAF or KRAS mutation status. In a post hoc analysis, of 14 patients who discontinued treatment and did not receive subsequent therapy, 10 remained progression-free. Patient-reported outcomes were stable over the treatment period. Grade 3-4 treatment-related adverse events occurred in 22% of patients; 13% discontinued because of any-grade treatment-related adverse events. CONCLUSION Nivolumab plus low-dose ipilimumab demonstrated robust and durable clinical benefit and was well tolerated as a first-line treatment for MSI-H/dMMR mCRC. Based on these promising data, randomized studies are warranted.
https://ascopubs.org/doi/10.1200/JCO.21.01015

このスパイダープロットの、いったんPR inしたら30ヶ月フォローしても誰一人としてその後PDになってないっていうのがメチャクチャ強い。今までの大腸癌ではこんな治療薬はありませんでした。

12ヶ月PFS 76.4%、18ヶ月PFS 76.4%、24ヶ月PFS 73.6%って、何か計算間違えたんじゃないかと思う図よ。12ヶ月以降では、ずっとSDだった人が20ヶ月目にPDになってしまった1人を除けば、誰も増悪していない。ホントにstageIVの大腸癌か?と思います。まるで、stageIIの術後化学療法のFigureみたいに見えます。24ヶ月先どころか4年でも5年でもプラトーが続きそうなこのCheckMate142のOS曲線を見たら勇気出ますね。

ところでCheckMate 142試験って、イピニボ群とニボ単独群の間でランダム割り付けされているのかどうかがハッキリ書かれていないように思うのですが、ここの割り付けってどういう風にされているのでしょうね?


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更新日:2021-11-12 閲覧数:613 views.