novel-cancer-modalities

新規がん治療モダリティ MOC

ADC (antibody-drug conjugate)、CAR-T / TCR-T、TIL therapy、BiTE / bispecific、NK cell therapy、mRNA vaccine、neoantigen vaccine、oncolytic virus 等の新規治療モダリティを統合する。

ドメイン定義

含む: ADC (antibody-drug conjugate) (trastuzumab deruxtecan, datopotamab, sacituzumab 等)、CAR-T (chimeric antigen receptor T 細胞) / TCR-T (T-cell receptor 改変 T 細胞)、TIL (tumor-infiltrating lymphocyte)、bispecific (BiTE = bispecific T-cell engager 含む: tarlatamab, ivonescimab 等)、NK (natural killer) cell therapy、mRNA (messenger RNA) / neoantigen vaccine、oncolytic virus、cytokine engineering、nanoparticle drug delivery、PROTAC (proteolysis-targeting chimera、がん応用)。

含まない: 古典的化学療法・標的薬・チェックポイント阻害薬の適応拡大 (→ 各疾患 MOC)、myeloid・好中球を中心とした免疫研究 (→ cancer-neutrophils)。Basic-Immunotherapy のうち T 細胞・NK 細胞・新規モダリティ寄りは本 MOC、myeloid 中心は cancer-neutrophils へ。

現状の合意 (State of the Field)

ADC のパラダイム転換と sequencing 時代の到来：HER2 / TROP2 / HER3 / CEACAM5 / c-MET / Integrin-β6 を標的とする ADC が肺癌領域で新規モダリティの中核に台頭し、driver subset 別の sequencing strategy が確立しつつある。Trastuzumab deruxtecan (T-DXd) は DESTINY-Lung01 で前治療歴のある HER2 変異 NSCLC (non-small cell lung cancer) 91 例に ORR (objective response rate、客観的奏効率) 55% / DoR (duration of response) 9.3 mo / OS (overall survival) 17.8 mo を示し (Li et al. NEnglJMed 2022)、DESTINY-Lung02 では 5.4 mg/kg が 6.4 mg/kg と同等の ORR (49.0% vs 56.0%) を保ちつつ ILD (interstitial lung disease、間質性肺疾患) を半減 (12.9% vs 28.0%) させ dose-optimization paradigm を確立した (Goto et al. JClinOncol 2023)。Datopotamab deruxtecan (Dato-DXd) は 2025-06 に EGFR mutant NSCLC 2L+ で FDA accelerated approval を取得 (TROPION-Lung01 EGFR subgroup ベース)、ICARUS-LUNG01 phase 2 (n=100) では全体 ORR 26.0% / mPFS (median progression-free survival、無増悪生存期間中央値) 3.6 mo / mOS 11.9 mo で非扁平上皮 (ORR 30.5%) に高い奏効を示し、特に KRAS 変異 (ORR 63.6%) や EGFR/BRAF 変異 (ORR 50.0%) の driver サブグループで顕著な活性を認め、TROP2 (trophoblast cell-surface antigen 2) 細胞質分布の均一性 (ADC 内在化促進) ・SLFN11 高発現 (CRISPR KO で感受性 10-50 倍低下) ・治療誘導性免疫活性化を奏効バイオマーカーとして同定する一方、DNA 修復経路 (RAD51) の早期活性化が抵抗性に関与しうると報告した (Planchard et al. CancerCell 2026)。Patritumab deruxtecan (HER3-DXd) は HERTHENA-Lung01 で EGFR-TKI 後 ORR 29.8% / mPFS 5.5 mo、Telisotuzumab vedotin は LUMINOSITY で c-MET high NSCLC ORR 35% を達成し FDA accelerated approval を得た。標的多様化の最前線として Integrin β6 標的 MMAE (monomethyl auristatin E、モノメチルアウリスタチン E) payload ADC の sigvotatug vedotin が first-in-human phase 1 拡大で全体 ORR 19% / DoR 11.3 mo、非扁平上皮・タキサン未治療例では ORR 29% / DoR 12.8 mo / PFS (progression-free survival) 6.4 mo と高い活性を示し RP2D (recommended phase 2 dose、推奨第 2 相用量) を 1.8 mg/kg (調整理想体重) 隔週投与に定めた (Peters et al. JClinOncol 2026)。Osimertinib 後の ADC 4 系列 (Dato-DXd / HER3-DXd / T-DXd / Teliso-V) は driver subtype に応じた使い分けが現状の rule of thumb で、deruxtecan platform 系列の cross-resistance が懸念だが target が異なれば response 独立しうる。共通課題は ILD class toxicity (deruxtecan 系列 grade ≥3 約3-7%, fatal 約1%) で、5.4 mg/kg dose optimization paradigm が他 ADC にも適用される設計原理になった。3rd-gen ADC (dual-payload / conditionally activatable / STING agonist payload / immune-stimulating) が phase 1 で次のジャンプを準備する。

Bispecific / BiTE の急速拡大と SCLC での phase III エビデンス確立：Tarlatamab (DLL3×CD3 BiTE) は phase 2 DeLLphi-301 で再発 SCLC (small cell lung cancer) に ORR 40% / mOS (median overall survival) 14.3 mo の歴史的応答を示し外来 step-up dosing で CRS (cytokine release syndrome、サイトカイン放出症候群) 管理プロトコルを確立した後、プラチナ既治療 SCLC 509 例の phase III DeLLphi-304 で標準化学療法に対し OS 中央値 13.6 vs 8.3 mo / HR (hazard ratio) 0.60 (95% CI (confidence interval) 0.47-0.77, P<0.001) の有意な延長を達成し、grade ≥3 有害事象もむしろ低率 (54% vs 80%) で 2 次標準を塗り替えた (Mountzios et al. NEnglJMed 2025)。これにより BiTE は「奏効率の高い新規モダリティ」から「OS を延長する標準治療」へと位置づけが移行した。Amivantamab (EGFR×MET bispecific) は MARIPOSA で lazertinib 併用 1L PFS が osimertinib 単剤に HR 0.70 で優越し最終 OS 解析でも OS HR 0.75 を確認、PAPILLON (1L EGFR exon 20 ins) でも標準療法を凌駕した。PD-1×VEGF bispecific の Ivonescimab (HARMONi-2) は PD-L1+ NSCLC 1L で pembrolizumab 単剤に PFS HR 0.51 を示し IO (immuno-oncology、免疫療法) 1L 概念を揺さぶる (国際 phase 3 進行中)。Tebentafusp (ImmTAC = immune-mobilizing monoclonal TCR against cancer、がん指向 TCR 二重特異性, gp100×CD3) は uveal melanoma で承認済みで、固形腫瘍向け次世代設計の prototype となる。

細胞療法の固形腫瘍応用と次世代エンジニアリング：CD19 CAR-T (Kymriah / Yescarta) の血液腫瘍成功 (NEJM 2013–2018) を起点に、固形腫瘍では mesothelin / HER2 / ROR1 / EGFRvIII / IL13Rα2 / Claudin18.2 / GD2 等多数 CAR が試行されたが、antigen escape / exhaustion / TME (tumor microenvironment、腫瘍微小環境) 抑制 / CRS-ICANS (immune effector cell-associated neurotoxicity syndrome) が課題として残る。Lifileucel TIL therapy は melanoma で承認され NSCLC anti-PD-1 refractory で活性兆候を示す。次世代設計では 2 つの方向が並走する。第一に CAR-NK が GvHD (graft-versus-host disease、移植片対宿主病) 回避 + allogeneic “off-the-shelf” 利点で再注目され、酵母ディスプレイと一次 NK 細胞 mRNA スクリーニングで膜近傍エピトープを標的とし可溶性 mesothelin の decoy を回避する新規 scFv (single-chain variable fragment、一本鎖可変領域抗体) (CLMS10) を同定し、circRNA (circular RNA、環状 RNA) と IL-21 共発現で持続性を付与することで CAF (cancer-associated fibroblast、がん関連線維芽細胞) 誘導性の抗原脱落 (trogocytosis) 下でもレンチウイルス CAR-NK と同等の活性を転移性膵がんモデルで達成した (Chung et al. SignalTransductTargetTher 2026)。CAR-NK のもう一つの固形腫瘍障壁として TME のグルココルチコイド (cortisol) ニッチ が定量化され、肺癌組織で cortisol が最豊富ステロイド (平均 42.5 ng/g) であり CAF / M2 様 TAM (tumor-associated macrophage、腫瘍関連マクロファージ) の HSD11B1 を介した cortisone→cortisol 再活性化が腫瘍浸潤 NK の機能不全と低酸素ストレスを駆動する一方、glucocorticoid 受容体 (NR3C1) を CRISPR 欠失した CEACAM5 CAR-NK は cortisol 富化環境でも PI3K-AKT-NFκB シグナルと細胞傷害を維持し、全身デキサメタゾン曝露下のヒト肺転移モデルで通常 CAR-NK に優越した (Chakraborty et al. SignalTransductTargetTher 2026)。第二に armored CAR が TME の myeloid 区画を能動的に再編する設計が登場し、DLL3 / GD3 dual-target で抗原脱落を封じた IL-36γ 分泌型 CAR-T はリンパ球枯渇前処置なしで免疫正常マウスの固形腫瘍を根絶し、腫瘍内好中球を腫瘍殺傷能と MHC class I/II 抗原提示能を持つ表現型に reprogram することで CAR 標的以外の抗原を認識する内因性 T 細胞 (antigen spreading) と抗原陰性腫瘍の再チャレンジ拒絶を誘導した — 好中球枯渇で効果が完全消失し「armored × 宿主免疫温存」がリンパ球枯渇パラダイムを書き換えうることを示した (Zuo et al. CancerCell 2026)。

NK 動員・腫瘍溶解性ウイルス・ワクチンによる TME 再プログラミング：細胞外からの innate 免疫動員も新軸となっている。NE (neuroendocrine、神経内分泌) 型 SCLC は本来 NK 感受性が高いにもかかわらず腫瘍から NK が排除されるが、その gatekeeper が腫瘍血管内皮の STING シグナル不活性化であり、STING アゴニストが VCAM1 / SELE 発現を誘導して NK 浸潤を回復させ、DLL3 CAR-CIML (cytokine-induced memory-like、サイトカイン誘導記憶様) NK との併用でヒト血管化異種移植モデルの増殖を有意に抑制した (Campisi et al. CancerCell 2026)。Neoantigen mRNA vaccine + PD-1 併用は mRNA-4157 (intismeran autogene) + pembrolizumab が KEYNOTE-942 で resected melanoma RFS (recurrence-free survival、無再発生存期間) HR 0.561 を達成し肺癌領域への展開試験が進行中。腫瘍溶解性ウイルス (OV) + サイトカイン遺伝子治療は H101 (中国) / G47Δ テセルパツレブ (日本承認、悪性神経膠腫 OS 中央値 20.2 mo) / T-VEC / nadofaragene firadenovec (BCG 不応 NMIBC (non-muscle-invasive bladder cancer、筋層非浸潤性膀胱癌) で 3 mo CR (complete response、完全奏効) 53.4%) を含む 5 製品が承認済みで、OV は「腫瘍選択的細胞傷害剤」から「免疫抑制 TME を hot 化する多モーダル免疫療法」へと再定義されつつある。ただし T-VEC は OPTiM phase III で DRR (durable response rate) 16.3% にとどまり、MASTERKEY-265 では pembrolizumab 併用が OS/PFS を改善できず (HR 0.96) 上乗せ価値は限定的で、奏効の本体はウイルスがクリアされた後も持続する CD8 浸潤・epitope spreading・免疫記憶 (IFNγ 慢性刺激による checkpoint 代償的 upregulation が抵抗性) にあると総括され、患者選択バイオマーカー・投与経路 (局所投与は中和抗体を回避)・低用量反復投与・ICI (immune checkpoint inhibitor、免疫チェックポイント阻害薬)/放射線/養子細胞療法併用の最適化が臨床的ブレークスルーの鍵とされる (Bernstock et al. NatCancer 2026)。

主要エンティティ

薬剤 (モダリティ別、10 classes — Phase B Top 20 拡張)

Checkpoint inhibitor (3):

• PD-1-inhibitor — Pembrolizumab / Nivolumab 等 8 members
• PD-L1-inhibitor — Atezolizumab / Durvalumab / Avelumab / Sugemalimab
• CTLA-4-inhibitor — Ipilimumab / Tremelimumab (dual IO partner)

Targeted molecular paradigm (1):

• KRAS-G12C-inhibitor — Sotorasib / Adagrasib (“undruggable” → druggable historic transition、本 MOC は novel modality 起点としても)

ADC / bispecific (2):

• ADC — T-DXd / Dato-DXd / HER3-DXd / Telisotuzumab vedotin / Sacituzumab govitecan (payload diversity, ILD class effect)
• BiTE-bispecific — Tarlatamab (DLL3) / Amivantamab (EGFR×MET) / Ivonescimab (PD-1×VEGF) / Tebentafusp (gp100, ImmTAC)

Cell therapy (2):

• CAR-T-therapy — CD19 CAR-T (Kymriah / Yescarta), BCMA CAR-T, 固形腫瘍 mesothelin/HER2/MAGE-A4 CAR 開発中
• TIL-therapy — Lifileucel (メラノーマ承認、NSCLC anti-PD-1 refractory で活性兆候)

Vaccine (1):

• mRNA-vaccine — BNT122 / mRNA-4157 (intismeran autogene), KEYNOTE-942 melanoma で adjuvant Pembro+vaccine RFS HR 0.561

Gene/RNA-editing therapeutic (1):

• KRAS-G12C-CRISPR-modality — Cas12a2 が G12C transcript を認識し無差別 dsDNA shredding→apoptosis を解放 (sotorasib 耐性株にも有効、Cas9/Cas13 と独立した第三の CRISPR therapeutic axis、pre-clinical)

(Phase B 拡張候補: LAG-3 inhibitor / TIGIT inhibitor / oncolytic virus / cytokine engineering / PROTAC / bispecific NK engager 等)

試験 (1 entity 化済 + 拡張候補多数)

• DeLLphi-301 — Tarlatamab (DLL3 BiTE) 既治療 SCLC, ORR 40% / mOS 14.3 mo, paradigm-shift

(Phase B 拡張候補: DESTINY-Lung01/02 (T-DXd HER2), TROPION-Lung01 (Dato-DXd TROP2), HERTHENA-Lung01 (HER3-DXd), MARIPOSA / PAPILLON (Amivantamab), HARMONi-2 (Ivonescimab), KEYNOTE-942 (mRNA-4157), ZUMA-1 / Tisagenlecleucel pivotal)

標的・分子 (biomarker entity 化済)

• PD-L1 — IO predictive biomarker (22C3 / 28-8 / SP263 / SP142 platform)
• HER2 — T-DXd ADC 標的 (exon 20 ins, amplification, overexpression)

(Phase B 拡張候補: TROP2 / DLL3 / B7-H3 / CEACAM5 / BCMA / CD19 / HER3 等の標的分子 entity 化)

主要概念

• KRAS-co-mutation-landscape — STK11/KEAP1 IO 抵抗性 (KL/KC 群) — IO+novel modality 戦略の出発点
• irAE-pathophysiology — ICI 治療下 irAE 機序 (ADC ILD / CAR-T CRS-ICANS との対比含む)
• Cancer-dormancy — IO long-term plateau の生物学、ADC 後 MRD、neoantigen vaccine と dormancy maintenance

(Phase D 拡張候補: ADC bystander effect / ADC ILD class toxicity / CAR-T antigen escape / neoantigen vaccine response / IO primary resistance / IO acquired resistance)

Open Questions

• ADC の payload 多様化 (topo-I 以外: TOP2、Bcl-xL、STING agonist 等) と ILD を含む class 毒性の最適化、deruxtecan platform 内 cross-resistance の有無。ICARUS-LUNG01 で示された TROP2 cytoplasmic uniformity / SLFN11 / DDR (DNA damage repair、DNA 損傷修復) 早期活性化を実臨床の patient selection・combination (PARP/ATR/WEE1) にどう翻訳するか
• DeLLphi-304 で 2 次標準を確立した Tarlatamab を、1L 維持 (DeLLphi-305) や限局期 consolidation (DeLLphi-306) へ前倒しした際の OS 上乗せと CRS/ICANS 管理。DLL3 を巡る BiTE と CAR-NK / CAR-T の棲み分け
• Bispecific の使い分け：T-cell engager (BiTE) vs. PD-1×VEGF dual-checkpoint (Ivonescimab) vs. EGFR×MET (Amivantamab) の patient selection と sequencing、従来 IO 1L を置換しうるか
• 固形腫瘍 cell therapy の効率化：antigen escape 対策 (shed-resistant 膜近傍エピトープ scFv、dual-target CAR、circRNA 持続化)、リンパ球枯渇非依存の armored CAR (IL-36γ 等) による myeloid 再編と antigen spreading が臨床用量で再現するか、CAR-NK / γδ-T 等 allogeneic platform の優劣
• CAR 細胞の TME レジリエンス工学：cortisol 富化ニッチ (CAF / TAM の HSD11B1 由来) に対する NR3C1 欠失や、irAE (immune-related adverse event、免疫関連有害事象) 管理用の全身ステロイド投与下でも機能を保つ CAR-NK/T の設計が、安全性 (off-tumor CEACAM5 等) を担保しつつ臨床で持続性・記憶を発揮するか
• 血管・innate 区画の動員：vascular STING 活性化による NK 排除解除 (VCAM1/SELE 誘導) や OV (oncolytic virus、腫瘍溶解性ウイルス) + cytokine 遺伝子治療の TME 再プログラミングを、投与経路・抗ウイルス免疫・内因性 NK 絶対数の制約下で全身的効果へ広げられるか
• Neoantigen vaccine + IO の真の臨床効果：HLA 多様性、clonal vs. subclonal neoantigen 選択、mRNA platform スケーラビリティと肺癌への外挿可能性
• 新規モダリティの sequencing：ADC → IO → cell therapy の最適順序、ADC 後耐性の分子基盤、bispecific と従来 IO/化学療法併用の優先順位

重要論文 Top 10

1. ★★★★★ Grupp et al. NEnglJMed 2013 — CD19 CAR-T 臨床有効性確立、全モダリティの起点
2. ★★★★★ Maude et al. NEnglJMed 2014 — 持続寛解を示し細胞療法の標準化を牽引
3. ★★★★ Campisi et al. CancerCell 2026 — SCLC で NK 主導の血管 STING 軸を提示
4. ★★★★ Bernstock et al. NatCancer 2026 — OV + cytokine 遺伝子治療の TME 再編原理
5. ★★★★ Chung et al. SignalTransductTargetTher 2026 — circRNA-CAR-NK で抗原 shedding 耐性と持続性を両立
6. ★★★★★ Li et al. NEnglJMed 2022 — DESTINY-Lung01 — T-DXd HER2 mutant NSCLC pivotal、ADC paradigm を NSCLC へ
7. ★★★★★ Drilon et al. NEnglJMed 2018 — Larotrectinib — pan-cancer NTRK fusion、tissue-agnostic targeted therapy paradigm
8. ★★★★★ Skoulidis et al. NEnglJMed 2021 — CodeBreaK 100 — Sotorasib、KRAS undruggable→druggable 転換の historic milestone
9. ★★★★★ Mountzios et al. NEnglJMed 2025 — Tarlatamab DLL3 BiTE — SCLC paradigm shift、外来 step-up dosing 確立
10. ★★★★ Planchard et al. CancerCell 2026 — ICARUS-LUNG01 — Datopotamab deruxtecan TROP2 NSCLC ADC efficacy/biomarker

最新追加論文 Top 10

• Routy et al. Science 2018 — Basic-Immunotherapy
• Wu et al. JImmunotherCancer 2026 — Basic-Immunotherapy
• George et al. CancerRes 2026 — Basic-Immunotherapy
• Morrissey et al. eLife 2018 — Basic-Immunotherapy
• Yue et al. Cell 2026 — Basic-Immunotherapy
• Huang et al. NatBiomedEng 2026 — Basic-Immunotherapy
• Pei et al. Immunity 2026 — Basic-Immunotherapy
• Khan et al. Nature 2019 — Basic-Immunotherapy
• Galon et al. Science 2006 — Basic-Immunotherapy
• Sender et al. ProcNatlAcadSciUSA 2023 — Basic-Immunotherapy

全論文リスト (カテゴリ別、自動生成)

Basic-Immunotherapy

• Wiest et al. BrJCancer 2026 — Differential effects of prior versus concomitant steroid and antibiotic treatment on immunotherapy efficacy-A pooled
• Foidart et al. CancerCell 2026 — Whole-genome doubling drives immune evasion by silencing antigen presentation
• Karakousi et al. CancerCell 2026 — IFNgamma-dependent metabolic reprogramming restrains an immature, pro-metastatic lymphatic state in melanoma
• Kureshi et al. CancerCell 2026 — Dendritic cell redundancy enables priming of anti-tumor cd4+ t cells in pancreatic cancer
• Liu et al. CancerCell 2026 — Clonal lineage tracing of innate immune cells in human cancer
• Molina-Arcas et al. CancerDiscov 2026 — Sensitizing lung cancer to immunotherapy with a RAS(ON) inhibitor doublet
• Pinto et al. CancerGeneTher 2026 — Preclinical development of a mutant KRAS targeting therapeutic cancer vaccine
• Kamigaichi et al. CancerImmunolImmunother 2026 — Immunological impact of tumor-draining lymph node dissection on systemic th1-like CD4+ T cells in patients with
• George et al. CancerRes 2026 — Immune checkpoint blockade augments lymphodepleting chemotherapy-induced antitumor immunity by expanding effector CD8…
• Brown et al. Cell 2026 — Gut microbiota promotes immune tolerance at the maternal-fetal interface
• Chemla et al. Cell 2026 — HLA export by melanoma cells decoys cytotoxic T cells to promote immune evasion
• Davar et al. Cell 2026 — Improving immunotherapy in solid tumors using FMT
• Heieis et al. Cell 2026 — O-glcnacylation drives macrophage IL-4 responsiveness and tissue residency through metabolic and cell cycle calibration
• Marine et al. Cell 2026 — Mapping intratumor heterogeneity across layers for advancing immunotherapy
• Scharping et al. Cell 2026 — Proteostasis sustains t cell differentiation potential and tumor-infiltrating lymphocyte function
• Wang et al. Cell 2026 — A blood-brain barrier-like vascular gate limits immunotherapy efficacy in neuroendocrine cancers
• Wang et al. Cell 2026 — CLIM-TIME identifies metastatic microenvironment modulators for T cell therapy response
• Yue et al. Cell 2026 — Expansion and CAR engineering of granulocyte-monocyte progenitors for cellular immunotherapy
• Zhang et al. Cell 2026 — A convergent uPAR-positive tumor ecosystem creates broad vulnerability to CAR t cell therapy
• Chen et al. CellMetab 2026 — 16-h fasting optimizes cancer immunotherapy in mice and humans
• Nutt et al. CellMolImmunol 2026 — Defining the rules of engagement b cells, antibodies and cancer control
• Cremasco et al. CellRep 2026 — Natural killer cells swarm and cross-recruit cytotoxic T cells via CCR5
• Ma et al. CellRep 2026 — Multivalent nanoparticles activate t-dependent antibody response via antigen presentation by both b cells and dendritic
• Brennan et al. CellRepMed 2026 — Circulating natural killer cells are phenotypically and functionally altered in age-related macular degeneration
• Jung et al. FrontImmunol 2026 — ATG5-mediated inducible autophagy sustains CAR-T cell durability under solid tumor stress
• Mao et al. FrontImmunol 2026 — MicroRNA-targeted reprogramming of CD8+ T cells against cancer
• Smesseim et al. FrontMed(Lausanne) 2026 — Defining the abscopal effect in non-small cell lung cancer in the era of immunotherapy and lung ablation treatment a
• Pei et al. Immunity 2026 — Neutrophil regulation of immunotherapy for cancer is controlled by type II interferon
• Aires-Lopes et al. ImmunolCellBiol 2026 — Highlights of 2025 advancements in natural killer cell biology
• Bansal et al. JCOPrecisOncol 2026 — Immunotherapy response and survival outcome by immunophenotypic signature in non-small cell lung cancer
• Lopez-Janeiro et al. JClinInvest 2026 — Conventional type-1 DC density is associated with checkpoint inhibitor response across multiple types of cancer
• Akbar et al. JImmunol 2026 — Myelin antigen-specific effector CD8+ T cells induce chronic CNS autoimmunity in a CD4+ T cell-dependent manner
• Carreira et al. JImmunotherCancer 2026 — CXCR3 signaling promotes delta one T cell recruitment and antitumor efficacy in colorectal cancer
• Gonzalez et al. JImmunotherCancer 2026 — Morning versus afternoon administration of immune checkpoint inhibitors in metastatic non-small-cell lung cancer
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