本期看點(diǎn)：

1. 潛在“best-in-class”布魯頓酪氨酸激酶（BTK）降解劑bexobrutideg（NX-5948）1期臨床試驗(yàn)結(jié)果發(fā)布，中位隨訪時(shí)間為22.4個(gè)月時(shí)，慢性淋巴細(xì)胞白血病（CLL）患者的中位無(wú)進(jìn)展生存期（PFS）為22.1個(gè)月，客觀緩解率（ORR）為83.0%。

2. IKZF1/3分子膠降解劑cemsidomide聯(lián)合地塞米松治療復(fù)發(fā)/難治性多發(fā)性骨髓瘤（RRMM）的最新分析結(jié)果發(fā)布，推薦2期劑量/最大耐受劑量下的ORR為53%。

Bexobrutideg：公布1a/b期臨床試驗(yàn)的新數(shù)據(jù)

Nurix Therapeutics公布了其進(jìn)行的NX-5948-301 1a/b期臨床試驗(yàn)的更新臨床數(shù)據(jù)。該試驗(yàn)正在評(píng)估其在研BTK降解劑bexobrutideg用于治療慢性淋巴細(xì)胞白血病患者的療效。Bexobrutideg是一款具有口服生物利用度、具有腦滲透性的在研小分子BTK降解劑，由Nurix和羅氏（Roche）開(kāi)發(fā)。新聞稿指出，它有望成為用于腫瘤、免疫和神經(jīng)系統(tǒng)疾病領(lǐng)域的潛在“best-in-class”療法。

截至2026年1月1日數(shù)據(jù)截止時(shí)，中位隨訪時(shí)間為22.4個(gè)月；患者的中位PFS為22.1個(gè)月（95% CI：14.0–NR），ORR為83.0%（95% CI：69.2–92.4）；緩解包括2例完全緩解（CR）、1例淋巴結(jié)部分緩解（nPR）和36例PR。在攜帶BTK抑制劑耐藥突變、具有高危分子特征以及存在中樞神經(jīng)系統(tǒng)（CNS）受累的患者中均觀察到緩解。

Nurix還公布了來(lái)自兩個(gè)1b期隊(duì)列的新數(shù)據(jù)，這兩個(gè)隊(duì)列評(píng)估了bexobrutideg在較早線治療中的表現(xiàn)，包括既往接受過(guò)BTK抑制劑治療但未接受過(guò)BCL2抑制劑治療的患者（隊(duì)列5），以及未接受過(guò)BTK抑制劑治療的患者，包括初治患者（隊(duì)列15）。在隊(duì)列5（n=19）中，可評(píng)估患者（n=14）的ORR為92.9%（95% CI：66.1–99.8）。在隊(duì)列15（n=20）中，可評(píng)估患者（n=19）的ORR為84.2%（95% CI：60.4–96.6）。

Cemsidomide：公布1期臨床試驗(yàn)數(shù)據(jù)

C4 Therapeutics公司公布了其已完成入組的cemsidomide 1期臨床試驗(yàn)的進(jìn)一步分析結(jié)果。Cemsidomide是一款下一代口服IKZF1/3降解劑，IKZF1/3是多發(fā)性骨髓瘤生物學(xué)中的關(guān)鍵轉(zhuǎn)錄因子。該試驗(yàn)評(píng)估其聯(lián)合地塞米松治療復(fù)發(fā)/難治性多發(fā)性骨髓瘤（RRMM）的療效。

數(shù)據(jù)截止日期為2026年2月27日，參與試驗(yàn)的患者此前接受過(guò)大量治療，既往治療線數(shù)中位數(shù)為7線。在推薦2期劑量/最大耐受劑量（100 μg）下，cemsidomide達(dá)到53%的ORR。在75 μg劑量水平下，cemsidomide達(dá)到40%的ORR。在所有評(píng)估劑量中，cemsidomide達(dá)到36%的ORR。

關(guān)鍵新數(shù)據(jù)顯示，在cemsidomide 75 μg和100 μg劑量水平下，患者緩解程度隨時(shí)間進(jìn)一步加深。

• 在75 μg劑量水平下，1例此前最佳緩解為PR的患者加深至非常好的部分緩解（VGPR）。

• 在100 μg劑量水平下，多例患者實(shí)現(xiàn)更深緩解：1例此前最佳緩解為PR的患者加深至嚴(yán)格完全緩解（sCR）；1例此前最佳緩解為PR的患者加深至VGPR。

• 在100 μg劑量水平下，2例達(dá)到sCR和CR的患者實(shí)現(xiàn)微小殘留病（MRD）陰性。

ELVN-001：公布1期臨床試驗(yàn)的新數(shù)據(jù)

Enliven Therapeutics公司公布其小分子激酶抑制劑ELVN-001的1期ENABLE臨床試驗(yàn)的新數(shù)據(jù)，該研究旨在評(píng)估ELVN-001對(duì)現(xiàn)有酪氨酸激酶抑制劑（TKI）不耐受、復(fù)發(fā)或難治的慢性髓系白血病（CML）患者的療效。ELVN-001是一種強(qiáng)效、高選擇性、潛在“best-in-class”的小分子激酶抑制劑，專門針對(duì)CML患者的致癌驅(qū)動(dòng)因子BCR-ABL1融合蛋白。ELVN-001還具有針對(duì)耐藥性最強(qiáng)的BCR-ABL1耐藥突變體T315I和其他已知耐藥突變體的活性。

截至2026年3月10日的數(shù)據(jù)，在每日一次80 mg劑量組中，總主要分子學(xué)緩解率（MMR）達(dá)61%，在24周時(shí)的MMR率為48%，深度分子緩解（DMR）達(dá)成率為30%。對(duì)于既往僅接受過(guò)1-2種TKI治療的患者，總MMR為67%，24周時(shí)的MMR率為55%。安全性方面，ELVN-001整體耐受性良好，因不良事件停藥的比例為6%，多數(shù)治療伴發(fā)不良事件為1-2級(jí)。

▲ENABLE試驗(yàn)的研究結(jié)果（圖片來(lái)源：參考資料[13]）

Briumvi（ublituximab）：公布1期臨床試驗(yàn)數(shù)據(jù)

TG Therapeutics公司公布了其皮下注射的Briumvi治療重癥肌無(wú)力（MG）的積極1期臨床試驗(yàn)數(shù)據(jù)，并啟動(dòng)了一項(xiàng)2期臨床試驗(yàn)。Briumvi是一種靶向CD20表達(dá)B細(xì)胞上獨(dú)特表位的新型單克隆抗體，通過(guò)糖基工程改造去除了抗體上通常表達(dá)的某些糖分子，從而能夠在低劑量下實(shí)現(xiàn)高效的B細(xì)胞耗竭。

此次公布的結(jié)果顯示，82%的患者在第24周達(dá)到了重癥肌無(wú)力日常生活活動(dòng)（MG-ADL）評(píng)分的最小臨床重要差異（MCID，定義為下降≥2分）。總體而言，第24周觀察到MG-ADL評(píng)分平均改善4.6分。該療法耐受性良好，安全性特征與靜脈注射的Briumvi在多發(fā)性硬化中的已知安全性一致。

參考資料：

[1] Climb Bio Presents CLYM116 Initial Phase 1 Safety Data and Translational Modeling Results at European Renal Association (ERA) Congress 2026 Supporting Continued Development. Retrieved June 12, 2026, from https://www.globenewswire.com/news-release/2026/06/05/3307292/0/en/climb-bio-presents-clym116-initial-phase-1-safety-data-and-translational-modeling-results-at-european-renal-association-era-congress-2026-supporting-continued-development.html

[2] Antag Therapeutics presents positive Phase 1 results at the 2026 Scientific Sessions of the American Diabetes Association for AT7687, a first-in-class GIPR antagonist. Retrieved June 12, 2026, from https://www.globenewswire.com/news-release/2026/06/07/3307739/0/en/antag-therapeutics-presents-positive-phase-1-results-at-the-2026-scientific-sessions-of-the-american-diabetes-association-for-at7687-a-first-in-class-gipr-antagonist.html

[3] Amphista Therapeutics announces FDA clearance of IND application for AMX-883, its lead Targeted Glue? degrader for acute myeloid leukaemia. Retrieved June 12, 2026, from https://www.globenewswire.com/news-release/2026/06/08/3307957/0/en/amphista-therapeutics-announces-fda-clearance-of-ind-application-for-amx-883-its-lead-targeted-glue-degrader-for-acute-myeloid-leukaemia.html

[4] Shattuck Labs Announces Phase 1 Results for SL-325. Retrieved June 12, 2026, from https://www.globenewswire.com/news-release/2026/06/08/3307885/0/en/shattuck-labs-announces-phase-1-results-for-sl-325.html

[5] Lifordi Immunotherapeutics Presents Phase 1 Clinical Data for LFD-200, a Subcutaneous Glucocorticoid Antibody Drug Conjugate, at EULAR 2026. Retrieved June 12, 2026, from https://www.newsfilecorp.com/release/300497

[6] Atavistik Bio Announces U.S. FDA Clearance of Investigational New Drug Application and Fast Track Designation for ATV-1601 for the Treatment of Hereditary Hemorrhagic Telangiectasia (HHT). Retrieved June 12, 2026, from https://www.globenewswire.com/news-release/2026/06/09/3308700/0/en/atavistik-bio-announces-u-s-fda-clearance-of-investigational-new-drug-application-and-fast-track-designation-for-atv-1601-for-the-treatment-of-hereditary-hemorrhagic-telangiectasia.html

[7] Kymera Therapeutics Announces First Participant Dosed in Phase 1 Trial of Oral IRAK4 Degrader, KT-485, and Milestone Achievement Under Sanofi Collaboration. Retrieved June 12, 2026, from https://www.globenewswire.com/news-release/2026/06/09/3308699/0/en/kymera-therapeutics-announces-first-participant-dosed-in-phase-1-trial-of-oral-irak4-degrader-kt-485-and-milestone-achievement-under-sanofi-collaboration.html

[8] TG Therapeutics Announces Positive Topline Phase 1 Data for Subcutaneous BRIUMVI in Patients with Myasthenia Gravis and Initiation of Potential Registration Directed Randomized Phase 2 Trial. Retrieved June 12, 2026, from https://www.globenewswire.com/news-release/2026/06/09/3308725/8790/en/tg-therapeutics-announces-positive-topline-phase-1-data-for-subcutaneous-briumvi-in-patients-with-myasthenia-gravis-and-initiation-of-potential-registration-directed-randomized-pha.html

[9] Imviva Biotech Receives FDA Investigational New Drug Approval for CTA313, a Dual-Targeted CD19/BCMA Allogeneic CAR-T Cell Therapy for Autoimmune Diseases. Retrieved June 12, 2026, from https://www.globenewswire.com/news-release/2026/06/09/3308823/0/en/imviva-biotech-receives-fda-investigational-new-drug-approval-for-cta313-a-dual-targeted-cd19-bcma-allogeneic-car-t-cell-therapy-for-autoimmune-diseases.html

[10] Lynk Pharmaceuticals' Partner Formation Bio Doses First Participant in Phase 1 Trial of BLKR201 (originally designated as LNK01006), a CNS-Penetrant TYK2 Inhibitor. Retrieved June 12, 2026, from https://www.prnewswire.com/news-releases/lynk-pharmaceuticals-partner-formation-bio-doses-first-participant-in-phase-1-trial-of-blkr201-originally-designated-as-lnk01006-a-cns-penetrant-tyk2-inhibitor-302795362.html

[11] Matter Bio Announces FDA Clearance of IND Application for LM-LLO-TT in Pancreatic Ductal Adenocarcinoma. Retrieved June 12, 2026, from https://www.prnewswire.com/news-releases/matter-bio-announces-fda-clearance-of-ind-application-for-lm-llo-tt-in-pancreatic-ductal-adenocarcinoma-302796786.html

[12] Cellectis Presents Final Phase 1 Results of Lasme-cel and Preliminary Results on Eti-cel at EHA 2026 Congress. Retrieved June 12, 2026, from https://www.globenewswire.com/news-release/2026/06/11/3310207/0/en/cellectis-presents-final-phase-1-results-of-lasme-cel-and-preliminary-results-on-eti-cel-at-eha-2026-congress.html

[13] Enliven Therapeutics Announces Updated Positive Phase 1 Clinical Data and Alignment with FDA on Key Phase 3 Trial Design Components. Retrieved June 12, 2026, from https://www.prnewswire.com/news-releases/enliven-therapeutics-announces-updated-positive-phase-1-clinical-data-and-alignment-with-fda-on-key-phase-3-trial-design-components-302797424.html

[14] Theriva? Biologics Announces Results from VCN-01 Phase 1 Clinical Trial in Head and Neck Cancer Published in Clinical Cancer Research. Retrieved June 12, 2026, from https://www.globenewswire.com/news-release/2026/06/11/3310376/0/en/theriva-biologics-announces-results-from-vcn-01-phase-1-clinical-trial-in-head-and-neck-cancer-published-in-clinical-cancer-research.html

[15] C4 Therapeutics Presents Phase 1 Data at European Hematology Association (EHA) 2026 Congress Highlighting Cemsidomide as a Potential Best-in-Class IKZF1/3 Degrader for Multiple Myeloma in Heavily Pretreated Relapsed/Refractory Population. Retrieved June 12, 2026, from https://www.globenewswire.com/news-release/2026/06/11/3310320/0/en/c4-therapeutics-presents-phase-1-data-at-european-hematology-association-eha-2026-congress-highlighting-cemsidomide-as-a-potential-best-in-class-ikzf1-3-degrader-for-multiple-myelo.html

[16] Climb Bio Announces Initial Phase 1b Data Demonstrating On-Target Clinical Activity for Budoprutug in Immune Thrombocytopenia at EHA Congress 2026. Retrieved June 12, 2026, from https://www.globenewswire.com/news-release/2026/06/11/3310326/0/en/climb-bio-announces-initial-phase-1b-data-demonstrating-on-target-clinical-activity-for-budoprutug-in-immune-thrombocytopenia-at-eha-congress-2026.html

[17] Nurix Therapeutics to Report Updated Phase 1a/b Results for BTK Degrader Bexobrutideg, Highlighting Durable Responses in Relapsed/Refractory CLL/SLL and Promising Activity in Earlier Lines of Therapy. Retrieved June 12, 2026, from https://www.globenewswire.com/news-release/2026/06/11/3310331/0/en/nurix-therapeutics-to-report-updated-phase-1a-b-results-for-btk-degrader-bexobrutideg-highlighting-durable-responses-in-relapsed-refractory-cll-sll-and-promising-activity-in-earlie.html

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