JP2019519499A5 - - Google Patents
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- JP2019519499A5 JP2019519499A5 JP2018559738A JP2018559738A JP2019519499A5 JP 2019519499 A5 JP2019519499 A5 JP 2019519499A5 JP 2018559738 A JP2018559738 A JP 2018559738A JP 2018559738 A JP2018559738 A JP 2018559738A JP 2019519499 A5 JP2019519499 A5 JP 2019519499A5
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Claims (35)
- 対象における腫瘍を処置または腫瘍の成長を阻害する方法で、放射線療法と組み合わせて使用するための、プログラム細胞死1(PD−1)に特異的に結合する単離された抗体またはその抗原結合断片を含む医薬組成物であって、前記方法は:
(a)がんを有する対象を選択する工程;および
(b)放射線療法の1つまたはそれ以上の線量を、プログラム細胞死1(PD−1)に特異的に結合する抗体またはその抗原結合断片の治療上有効量の1つまたはそれ以上の用量と組み合わせて、それを必要とする対象に投与する工程であって、抗PD−1抗体またはその抗原結合断片は、重鎖可変領域(HCVR)の3つの重鎖相補性決定領域(HCDR1、HCDR2、およびHCDR3)と、軽鎖可変領域(LCVR)の3つの軽鎖相補性決定領域(LCDR1、LCDR2、およびLCDR3)とを含み、HCDR1は、配列番号3のアミノ酸配列を含み;HCDR2は、配列番号4のアミノ酸配列を含み;HCDR3は、配列番号5のアミノ酸配列を含み;LCDR1は、配列番号6のアミノ酸配列を含み;LCDR2は、配列番号7のアミノ酸配列を含み;およびLCDR3は、配列番号8のアミノ酸配列を含む、該工程
を含む、
前記医薬組成物。 - 抗PD−1抗体またはその抗原結合断片の各用量は、対象の体重1kgあたり0.1〜20mgを含む、請求項1に記載の医薬組成物。
- 抗PD−1抗体またはその抗原結合断片の各用量は、対象の体重1kgあたり0.3、1、3、5または10mgを含む、請求項1または2に記載の医薬組成物。
- 各用量は抗PD−1抗体またはその抗原結合断片の20〜600mgを含む、請求項1に記載の医薬組成物。
- 放射線の各線量は2〜80グレイ(Gy)を含む、請求項1〜4のいずれか1項に記載
の医薬組成物。 - 抗PD−1抗体またはその抗原結合断片の各用量は対象の体重1kgあたり1、3、または10mgを含み、放射線療法の各線量は20〜50Gyを含む、請求項1に記載の医薬組成物。
- 放射線療法は分割放射線療法である、請求項5または6に記載の医薬組成物。
- 分割放射線療法は2〜10分割を含む、請求項7に記載の医薬組成物。
- 分割放射線療法は30Gyの5分割を含む、請求項8に記載の医薬組成物。
- 分割放射線療法は27Gyの3分割を含む、請求項8に記載の医薬組成物。
- 抗PD−1抗体またはその抗原結合断片の各用量は、直前の用量の0.5〜4週間後に投与される、請求項1〜10のいずれか1項に記載の医薬組成物。
- 抗PD−1抗体またはその抗原結合断片の各用量は、直前の用量の2週間後に投与される、請求項11に記載の医薬組成物。
- 抗PD−1抗体またはその抗原結合断片は、放射線療法の前、同時、または後に投与される、請求項1〜12のいずれか1項に記載の医薬組成物。
- 抗PD−1抗体またはその抗原結合断片は放射線療法の前に投与される、請求項13に記載の医薬組成物。
- 組合せの投与によって、抗体、その抗原結合断片、または放射線単独の投与と比較して治療効能の増強が得られる、請求項1〜14のいずれか1項に記載の医薬組成物。
- 治療効能の増強は、腫瘍の退縮、アブスコパル効果、腫瘍転移の阻害、経時的な転移病変の低減、化学療法剤または細胞傷害剤の使用の低減、腫瘍負荷の低減、無増悪生存の延長、全生存の延長、完全奏効、部分奏効、および安定からなる群より選択される効果を含む、請求項15に記載の医薬組成物。
- 治療効能の増強は、照射した腫瘍に対して遠位の腫瘍における腫瘍の退縮を含む、請求項15に記載の医薬組成物。
- 腫瘍の成長は、抗体または放射線単独のいずれかを投与した対象と比較して、少なくとも50%阻害される、請求項15に記載の医薬組成物。
- 腫瘍の成長は、抗PD−1抗体の投与前に放射線の線量を投与された対象と比較して、少なくとも50%阻害される、請求項15に記載の医薬組成物。
- 対象は、過去の治療に抵抗性である、もしくは不適切に反応する、または過去の治療後に再燃している、請求項1〜19のいずれか1項に記載の医薬組成物。
- がんは再発または転移性がんである、請求項1〜20のいずれか1項に記載の医薬組成物。
- 方法は、追加の治療剤または治療を、対象に投与することをさらに含む、請求項1〜2
1のいずれか1項に記載の医薬組成物であって、該追加の治療剤または治療は、手術、化学療法剤、がんワクチン、プログラム細胞死リガンド1(PD−L1)阻害剤、リンパ球活性化遺伝子3(LAG3)阻害剤、細胞傷害性Tリンパ球関連タンパク質4(CTLA−4)阻害剤、グルココルチコイド誘導腫瘍壊死因子受容体(GITR)阻害剤、T細胞免疫グロブリンおよびムチンドメイン含有タンパク質3(TIM3)阻害剤、BおよびTリンパ球アテニュエータ(BTLA)阻害剤、IgおよびITIMドメインを有するT細胞免疫受容体(TIGIT)阻害剤、CD47阻害剤、インドールアミン−2,3−ジオキシゲナーゼ(IDO)阻害剤、二重特異性CD3/CD20抗体、血管内皮増殖因子(VEGF)アンタゴニスト、アンジオポエチン−2(Ang2)阻害剤、トランスフォーミング増殖因子ベータ(TGFβ)阻害剤、CD38阻害剤、上皮成長因子受容体(EGFR)阻害剤、顆粒球−マクロファージコロニー刺激因子(GM−CSF)、シクロホスファミド、腫瘍特異抗原に対する抗体、カルメットゲラン桿菌ワクチン、細胞毒素、インターロイキン6受容体(IL−6R)阻害剤、インターロイキン4受容体(IL−4R)阻害剤、IL−10阻害剤、IL−2、IL−7、IL−21、IL−15、抗体−薬物コンジュゲート、抗炎症薬、ならびに栄養補助食品からなる群より選択される、前記医薬組成物。 - 追加の治療剤は抗GITR抗体である、請求項22に記載の医薬組成物。
- 追加の治療剤はシクロホスファミドである、請求項22に記載の医薬組成物。
- 追加の治療剤はGM−CSFである、請求項22に記載の医薬組成物。
- 追加の治療剤は、ドセタキセル、カルボプラチン、パクリタキセル、シスプラチン、ゲムシタビン、およびペメトレキセドからなる群より選択される、請求項22に記載の医薬組成物。
- 抗PD−1抗体またはその抗原結合断片は、静脈内、皮下、または腹腔内に投与される、請求項1〜26のいずれか1項に記載の医薬組成物。
- がんは固形腫瘍を含む、請求項1〜27のいずれか1項に記載の医薬組成物。
- 固形腫瘍は、結腸直腸がん、卵巣がん、前立腺がん、乳がん、脳がん、子宮頸がん、膀胱がん、肛門がん、子宮がん、結腸がん、肝臓がん、膵臓がん、肺がん、子宮内膜がん、骨がん、精巣がん、皮膚がん、腎臓がん、胃がん、食道がん、頭頸部がん、唾液腺がん、および骨髄腫からなる群より選択される、請求項28に記載の医薬組成物。
- 固形腫瘍は、肝細胞癌、非小細胞肺がん、頭頸部扁平上皮がん、基底細胞癌、乳癌、皮膚扁平上皮癌、軟骨肉腫、血管肉腫、胆管癌、軟部組織肉腫、結腸直腸がん、黒色腫、メルケル細胞癌、および多形膠芽腫からなる群より選択される、請求項28に記載の医薬組成物。
- HCVRは配列番号1のアミノ酸配列を含み、LCVRは配列番号2のアミノ酸配列を含む、請求項1〜30のいずれか1項に記載の医薬組成物。
- 抗PD−1抗体またはその抗原結合断片は、配列番号1と90%の配列同一性を有するHCVRを含む、請求項1〜31のいずれか1項に記載の医薬組成物。
- 抗PD−1抗体またはその抗原結合断片は、配列番号2と90%の配列同一性を有するLCVRを含む、請求項1〜32のいずれか1項に記載の医薬組成物。
- 抗PD−1抗体またはその抗原結合断片は、配列番号1と90%の配列同一性を有するHCVRと、配列番号2と90%の配列同一性を有するLCVRとを含む、請求項1〜33のいずれか1項に記載の医薬組成物。
- 抗PD−1抗体またはその抗原結合断片は、配列番号9のアミノ酸配列を含む重鎖と、配列番号10のアミノ酸配列を含む軽鎖とを含む、請求項1〜31のいずれか1項に記載の医薬組成物。
Applications Claiming Priority (15)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201662335743P | 2016-05-13 | 2016-05-13 | |
US62/335,743 | 2016-05-13 | ||
US201662340142P | 2016-05-23 | 2016-05-23 | |
US62/340,142 | 2016-05-23 | ||
US201662348546P | 2016-06-10 | 2016-06-10 | |
US62/348,546 | 2016-06-10 | ||
US201662350305P | 2016-06-15 | 2016-06-15 | |
US62/350,305 | 2016-06-15 | ||
US201662364920P | 2016-07-21 | 2016-07-21 | |
US62/364,920 | 2016-07-21 | ||
US201662374020P | 2016-08-12 | 2016-08-12 | |
US62/374,020 | 2016-08-12 | ||
US201762451274P | 2017-01-27 | 2017-01-27 | |
US62/451,274 | 2017-01-27 | ||
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