JP2019533711A - 非成人のヒトに対する抗cd30抗体−薬物コンジュゲートの投与 - Google Patents
非成人のヒトに対する抗cd30抗体−薬物コンジュゲートの投与 Download PDFInfo
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Abstract
Description
本願は、2016年11月14日に出願した米国特許仮出願第62/421,527号に基づく優先権を主張するものである。上記出願の教示全体は、参照により、本明細書に援用される。
標準治療、治癒的治療、延命治療または緩和的治療が存在しないか、または有効ではなくなっている再発または難治性の全身性未分化大細胞型リンパ腫(ALCL)またはホジキンリンパ腫(HL)の小児患者におけるブレンツキシマブベドチン(BV)の第1/2相オープンラベル単剤多施設用量漸増試験として、小児試験を設計した。この試験には、その目的の1つとして、小児患者におけるBVの薬物動態の評価がある。
本明細書に記載されている薬物動態解析には、初期解析のために、30人の小児患者から得た薬物動態データを含めた。
標準治療、治癒的治療、延命治療または緩和的治療が存在しないか、または有効ではなくなっている再発または難治性(R/R)のホジキンリンパ腫(HL)または全身性未分化大細胞型リンパ腫(sALCL)の小児(非成人のヒト)患者を得て、ブレンツキシマブベドチン(BV)を投与する。ただし、用量は、体重ではなく、体表面積(BSA)に合わせて調整する。小児試験対象に、BVを71.5mg/m2の用量で投与する(静脈内注入による投与、3週間(21日)に1回)。21日間の各治療サイクルは、1日目の試験薬物治療と、その後の20日間のモニタリング期間で構成されている。患者には、BVを最大で16サイクルにわたって投与してよい。独立評価機関(IRF)が、International Working Group(IWG)Revised Response Criteria for Malignant Lymphomaに従って、PET、CT、MRI及び臨床評価を用いて、客観的奏効率(ORR、完全寛解(CR)+部分寛解(PR))を求める。無憎悪期間(試験治療の初回投与時から、進行性疾患が最初に文書化された日までの期間)、奏効までの期間(試験治療の初回投与時から、完全奏効または部分奏効が最初に文書化された日までの期間)、奏効期間(奏効が最初に文書化された日から、進行性疾患の日までの期間)、無イベント生存期間(初回投与時から、治療失敗までの期間)、無増悪生存率(PFS、試験治療の初回投与時から、疾患の増悪または死亡までの期間)及び全生存率(OS、試験治療の初回投与時から、死亡までの期間)も評価する。治療終了(EOT)時の診察から12カ月間、12週間おきに、患者の無増悪生存率(PFS)及び全生存率(OS)を追跡する。その後、OSの評価は、死亡時もしくは試験終了時のうち早い時点、または最後の患者を登録してから最長で2年間の時点まで、6カ月おきに継続する。BVを用いない治療と比べて、BVで治療した小児患者は、CR、PR、PFSまたはOSのうちの1つ以上が改善する。BSA換算用量のBVで治療した小児患者では、体重換算用量の1.8mg/kbのBVで治療した小児の対象と比べても、CR、PR、PFSまたはOSのうちの1つ以上が改善する。
進行性古典的ホジキンリンパ腫と診断された小児(非成人のヒト)患者を得る。1)ブレンツキシマブベドチン(BV)を48mg/m2の用量で、静脈内注入によって、28日間の各サイクルの1日目と15日目に投与するとともに、AVDを投与する(アドリアマイシン25mg/m2、ビンブラスチン6mg/m2及びダカルバジン(DTIC)375mg/m2をそれぞれ、静脈内注入によって、28日間の各サイクルの1日目と15日目に投与)治療、または2)ABVDによる治療(ドキソルビシン25mg/m2、ブレオマイシン10単位/m2、ビンブラスチン6mg/m2及びダカルバジン(DTIC)375mg/m2をそれぞれ、静脈内注入によって、28日間の各サイクルの1日目と15日目に投与)のうちの1つに、試験対象を無作為に割り付け、その治療を行う。
CD30陽性成熟T細胞リンパ腫(未分化大細胞型リンパ腫、非ホジキンリンパ腫、T細胞リンパ腫)の小児(非成人のヒト)患者を得る。1)BV(3週間(21日)に1回、IV投与)を71.5mg/m2の用量で6〜8サイクルと、CHP(シクロホスファミド750mg/m2を3週間おきに静脈内注入によって6〜8サイクル、ドキソルビシン50mg/m2を3週間おきに静脈内注入によって6〜8サイクル、プレドニゾン100mgを3週間の各サイクルの1〜5日目に、経口によって6〜8サイクル)による化学療法との併用、または2)CHOPによる化学療法(ドキソルビシン50mg/m2を3週間おきに静脈内注入によって6〜8サイクル、プレドニゾン100mgを3週間の各サイクルの1〜5日目に、経口で6〜8サイクル、ビンクリスチン1.4mg/m2(最大2mg)を3週間おきに静脈内注入によって6〜8サイクル、及びシクロホスファミド750mg/m2を3週間おきに静脈内注入によって6〜8サイクル))という治療の1つに、試験対象を無作為に割り付ける。
CD30陽性皮膚T細胞性リンパ腫(原発性皮膚未分化大細胞型リンパ腫、菌状息肉腫、皮膚T細胞性リンパ腫)の小児(非成人のヒト)患者を得る。1)BV(3週間(21日)に1回、IV投与)を71.5mg/m2の用量で、単独療法として、最大で合計16サイクル、または2)医師の選択によりメトトレキセートまたはベキサロテン(メトトレキセートを週に1回、経口投与し(5〜50mg)、用量の調整を患者の奏効と毒性に応じて行うか、または、ベキサロテンを飲食時に1日1回、経口投与する(300mg/m2))という治療の1つに、試験対象を無作為に割り付ける。
ブレンツキシマブベドチン(BV)と、新たに診断されたHLに対する最新の標準ケア(SOC)の一次治療レジメンに基づいている多剤併用化学療法レジメンとを組み合わせた場合の安全性と利用可能性を評価するとともに、この組み合わせの抗腫瘍活性を評価する試験において、進行期(ステージIII及びステージIVの疾患)ホジキンリンパ腫(HL、組織学的に確認したCD30+古典的HL、未治療)と新たに診断された小児の対象を得る。
Claims (16)
- 非成人のヒト対象の血液癌またはリンパ系癌の治療方法であって、1用量以上の抗CD30抗体−薬物コンジュゲート(ADC)を体表面積換算用量で投与することを含む前記方法。
- 前記抗CD30抗体−薬物コンジュゲート(ADC)を約32〜78mg/m2、
例えば約3週間おきに、例えば約64〜78mg/m2、例えば、約66〜76、68〜74、70〜72もしくは約71.5mg/m2、
例えば約2週間おきに、例えば約43〜53mg/m2、例えば、約45〜51、47〜49もしくは約48mg/m2、または
例えば約2週間おきに、例えば約32〜40mg/m2、例えば約34〜38、35〜37もしくは約36mg/m2の用量で投与する、請求項1に記載の方法。 - 前記抗CD30抗体−薬物コンジュゲート(ADC)を約71.5mg/m2、約48mg/m2または約36mg/m2の用量で投与する、先行請求項のいずれか1項に記載の方法。
- 前記対象が、AVD(アドリアマイシン、ビンブラスチン、ダカルバジン)もしくはCHP(ドキソルビシン、シクロホスファミド、プレドニゾン)のような併用化学療法、免疫療法(ニボルマブなど)、HSC(造血幹細胞)移植療法、放射線療法またはこれらを組み合わせた療法を受けている、先行請求項のいずれか1項に記載の方法。
- 前記対象の正規化薬物暴露量が、前記ADC濃度時間曲線下面積(AUC)によって測定した場合、示されている成人用量における成人AUCと実質的に同程度である、先行請求項のいずれか1項に記載の方法。
- 前記ADCが、cAC10の相補性決定領域(CDR)を含む抗CD30抗体を含む、先行請求項のいずれか1項に記載の方法。
- 前記ADCが、前記抗CD30抗体cAC10を含む、先行請求項のいずれか1項に記載の方法。
- 前記ADCが、オーリスタチンを含む、先行請求項のいずれか1項に記載の方法。
- 前記オーリスタチンが、モノメチルオーリスタチンE(MMAE)である、請求項8に記載の方法。
- 前記ADCが、カテプシン切断リンカーを含み、任意にスペーサーを含む、先行請求項のいずれか1項に記載の方法。
- 前記カテプシン切断リンカーが、バリン−シトルリンリンカーである、請求項10に記載の方法。
- 前記ADCが、ブレンツキシマブベドチンである、先行請求項のいずれか1項に記載の方法。
- 前記ADCを2サイクル以上、例えば、2サイクル、3サイクル、4サイクル、5サイクル、6サイクル、7サイクル、8サイクル、9サイクル、10サイクル、11サイクル、12サイクル、13サイクル、14サイクル、15サイクル、16サイクル、17サイクル、18サイクル、19サイクル、20サイクル、またはこれを超えるサイクル、例えば、1週間に1回、2週間に1回、3週間に1回、4週間に1回、5週間に1回または6週間に1回、例えば2週間または3週間に1回投与する、先行請求項のいずれか1項に記載の方法。
- 非成人のヒト対象の治療、例えば、血液癌またはリンパ系癌の治療に適する体表面積換算用量で、抗CD30抗体−薬物コンジュゲート(ADC)を含む製品。
- 非成人のヒト対象の血液癌またはリンパ系癌の治療方法であって、1用量以上のブレンツキシマブベドチンを前記対象に、約32〜78mg/m2、
例えば3週間おきに、例えば約64〜78mg/m2、例えば、約66〜76mg/m2、68〜74mg/m2、70〜72mg/m2もしくは約71.5mg/m2、
例えば2週間おきに、例えば約43〜53mg/m2、例えば、約45〜51mg/m2、47〜49mg/m2もしくは約48mg/m2、または
例えば約2週間おきに、例えば約32〜40mg/m2、例えば約34〜38、35〜37もしくは約36mg/m2の用量で投与することを含む前記方法。 - 非成人のヒト対象の血液癌またはリンパ系癌を治療するためのブレンツキシマブベドチンであって、約32〜78mg/m2、
例えば3週間おきに、例えば約64〜78mg/m2、例えば、約66〜76mg/m2、68〜74mg/m2、70〜72mg/m2もしくは約71.5mg/m2、
例えば2週間おきに、例えば約43〜53mg/m2、例えば、約45〜51mg/m2、47〜49mg/m2もしくは約48mg/m2、または
例えば約2週間おきに、例えば約32〜40mg/m2、例えば約34〜38、35〜37もしくは約36mg/m2の用量で提供する前記ブレンツキシマブベドチン。
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