針對婦科腫瘤，創新ADC展現治療潛力；不依賴于特定突變，三聯癌癥療法獲積極臨床進展…… | 一周盤點

本期看點：

1. Zymeworks公司公布了其抗體偶聯藥物（ADC）ZW191的1期臨床試驗新數據， 該藥在 鉑類耐藥 卵巢癌（PROC）及子宮內膜癌患者中展現出顯著的抗腫瘤活性。

2. Aptose Biosciences公司公布了tuspetinib聯用標準劑量的venetoclax和azacitidine（TUS+VEN+AZA）三聯療法治療新確診的急性髓系白血病（AML）患者的1/2期試驗的新數據。

ZW191：公布1期臨床試驗的新數據

Zymeworks公司公布了其ADC療法ZW191的1期臨床試驗新數據。ZW191靶向葉酸受體α（FRα），該靶點在約75%的高級別漿液性卵巢癌和約70%的肺腺癌中表達。ZW191具有獨特的設計，可高效進入FRα陽性細胞，并釋放Zymeworks開發的具旁觀者效應的載荷——拓撲異構酶I抑制劑ZD06519。

此次公布的結果顯示，ZW191在鉑類耐藥卵巢癌及子宮內膜癌患者中展現出顯著的抗腫瘤活性。截至2026年3月9日的數據，在療效可評估的PROC患者中，FRα陽性與陰性腫瘤患者的確認客觀緩解率（cORR）分別達到78.6%和47.4%，疾病控制率（DCR）分別為100.0%和89.5%；整體PROC人群的cORR為58.8%。FRα陰性子宮內膜癌患者的cORR為40.0%，DCR為80.0%。兩癌種隊列的緩解出現較早且隨時間加深，中位緩解持續時間尚未達到，中位無進展生存期（PFS）為7.6個月。此外，該藥物具備良好的耐受性特征和較寬的治療窗口，支持繼續開展臨床開發。

Tuspetinib：公布1/2期聯合治療試驗數據

Aptose Biosciences公司公布了其針對新確診的急性髓系白血病患者開展的1/2期TUSCANY試驗的新數據。這些患者接受了不同劑量的tuspetinib聯用標準劑量的venetoclax和azacitidine。該三聯療法正在被開發作為一種安全且不依賴于特定突變的一線治療方案，用于治療那些無法接受誘導化療的新確診AML患者，這些患者具有多樣的突變。

此次公布的結果顯示，32名AML患者接受了TUS+VEN+AZA三聯療法，其中29名療效可評估患者的復合完全緩解率（CRc）達到86.2%；在獲得完全緩解（CR）或部分血液學恢復的完全緩解（CRh）的患者中，微小殘留病灶（MRD）陰性率達86.4%，所有給藥患者的MRD陰性率為62.5%。具有不同遺傳特征（包括TP53突變、復雜核型和未突變FLT3）的AML患者，在安全實現治療緩解的同時，也達到了MRD陰性。安全性方面，tuspetinib與標準劑量的VEN/AZA聯用耐受性良好，未發生與治療相關的死亡、QTc間期延長、CPK升高或分化綜合征，且其藥代動力學特性未受聯合用藥、抗真菌藥或食物的顯著影響。

KT-621：公布1期臨床試驗數據

Kymera Therapeutics公司公布了其在研口服、潛在“first-in-class”的STAT6降解劑KT-621在健康日本成年人中進行的1期臨床研究結果。該公司此前已報告KT-621在非日本健康志愿者及中重度特應性皮炎患者中的1期臨床數據。在這些研究中，KT-621使受試者血液和皮膚中的STAT6快速、深度且持續地降解，并顯著降低疾病相關2型炎癥生物標志物，特應性皮炎以及共病哮喘和過敏性鼻炎的臨床終點和患者報告結局顯著改善，安全性良好。

此次公布的結果顯示，KT-621展現出良好的藥代動力學（PK）特征，包括吸收迅速、血漿暴露量呈劑量比例增加，以及在血液中快速且持續地降解STAT6。在第7天時，兩種劑量水平下，STAT6的中位降解率均≥98%。此外，在兩種劑量下，該藥物的耐受性和安全性均良好。總體而言，這些在日本健康成人中獲得的結果與在非日本成人及特應性皮炎患者中觀察到的結果相當，進一步支持了KT-621作為慢性2型炎癥性疾病新型口服療法的潛力。

參考資料：

[1] Kymera Therapeutics Presents Phase 1 Data in Healthy Japanese Adults for KT-621, a First-in-Class Oral STAT6 Degrader, at the Japanese Dermatological Association Annual Meeting. Retrieved June 18, 2026, from https://www.globenewswire.com/news-release/2026/06/12/3310977/0/en/kymera-therapeutics-presents-phase-1-data-in-healthy-japanese-adults-for-kt-621-a-first-in-class-oral-stat6-degrader-at-the-japanese-dermatological-association-annual-meeting.html

[2] Celldex Presents Positive First-in-Human Results from Phase 1 Study of Novel Bispecific CDX-622 at the European Academy of Allergy and Clinical Immunology Annual Meeting. Retrieved June 18, 2026, from https://www.globenewswire.com/news-release/2026/06/14/3311438/24180/en/celldex-presents-positive-first-in-human-results-from-phase-1-study-of-novel-bispecific-cdx-622-at-the-european-academy-of-allergy-and-clinical-immunology-annual-meeting.html

[3] Zymeworks Presents New Phase 1 Data for Folate Receptor Alpha-Targeting ADC ZW191 at ESMO Gynaecological Cancers Congress 2026. Retrieved June 18, 2026, from https://www.globenewswire.com/news-release/2026/06/14/3311472/0/en/zymeworks-presents-new-phase-1-data-for-folate-receptor-alpha-targeting-adc-zw191-at-esmo-gynaecological-cancers-congress-2026.html

[4] Aptose Presents Safety, Response, and MRD Clinical Data from TUSCANY Phase 1/2 Clinical Trial of Tuspetinib Triplet Therapy in Newly Diagnosed AML at the 2026 EHA Congress in Oral Presentation. Retrieved June 18, 2026, from https://www.globenewswire.com/news-release/2026/06/15/3311704/35575/en/aptose-presents-safety-response-and-mrd-clinical-data-from-tuscany-phase-1-2-clinical-trial-of-tuspetinib-triplet-therapy-in-newly-diagnosed-aml-at-the-2026-eha-congress-in-oral-pr.html

[5] Bambusa Therapeutics Presents Positive Preliminary Multiple Ascending Dose Phase 1 Data for BBT002 at the European Academy of Allergy & Clinical Immunology (EAACI) Annual Congress 2026. Retrieved June 18, 2026, from https://www.prnewswire.com/news-releases/bambusa-therapeutics-presents-positive-preliminary-multiple-ascending-dose-phase-1-data-for-bbt002-at-the-european-academy-of-allergy--clinical-immunology-eaaci-annual-congress-2026-302799221.html

[6] Context Therapeutics Announces Positive Interim Efficacy and Safety Results from Ongoing Phase 1 Clinical Trial for CTIM-76. Retrieved June 18, 2026, from https://www.globenewswire.com/news-release/2026/06/15/3311621/0/en/context-therapeutics-announces-positive-interim-efficacy-and-safety-results-from-ongoing-phase-1-clinical-trial-for-ctim-76.html

[7] Enterome presents Phase 1/2 iNHL interim data at EHA demonstrating durable OncoMimics?-induced CD8 T cell responses and clinical activity. Retrieved June 18, 2026, from https://www.enterome.com/news-events/enterome-presents-phase-1-2-inhl-interim-data-at-eha-demonstrating-durable-oncomimics-induced-cd8-t-cell-responses-and-clinical-activity/

[8] Marea Therapeutics Presents Phase 1 Data Supporting Potential Best-in-disease Profile of MAR002 for the Treatment of Acromegaly at ENDO 2026. Retrieved June 18, 2026, from https://www.mareatx.com/press-releases/marea-therapeutics-presents-phase-1-data-supporting-potential-best-in-disease-profile-of-mar002-for-the-treatment-of-acromegaly-at-endo-2026/

[9] 英矽智能與衡泰生物的合作達成首個臨床里程碑，AI 驅動的 NLRP3 抑制劑 ISM8969 完成 I 期臨床試驗首例受試者給藥. Retrieved June 18, 2026, from https://www.prnasia.com/story/537494-1.shtml

[10] Positive results from the Phase Ib clinical study of NeuroRestore ACD856, under development for Alzheimer’s. Retrieved June 18, 2026, from https://www.alzecurepharma.se/en/positive-results-from-the-phase-ib-clinical-study-of-neurorestore-acd856-under-development-for-alzheimers/

[11] HCW Biologics Announces Positive Results for Preliminary Human Data Readout for Phase 1 Clinical Trial Evaluating IL-2 Based Fusion Immunotherapeutic, HCW9302 Monotherapy, in Alopecia Areata. Retrieved June 18, 2026, from https://www.globenewswire.com/news-release/2026/06/16/3312406/0/en/hcw-biologics-announces-positive-results-for-preliminary-human-data-readout-for-phase-1-clinical-trial-evaluating-il-2-based-fusion-immunotherapeutic-hcw9302-monotherapy-in-alopeci.html

[12] Nectin Therapeutics Reports Encouraging Phase 1 Results for NTX1088 in Combination with Keytruda? (pembrolizumab) at ASCO 2026. Retrieved June 18, 2026, from https://www.prnewswire.com/news-releases/nectin-therapeutics-reports-encouraging-phase-1-results-for-ntx1088-in-combination-with-keytruda-pembrolizumab-at-asco-2026-302803053.html

[13] Lexeo Therapeutics Announces Publication in JAMA Cardiology of Phase I/II Data for LX2006 in Friedreich Ataxia. Retrieved June 18, 2026, from https://www.globenewswire.com/news-release/2026/06/17/3313795/0/en/lexeo-therapeutics-announces-publication-in-jama-cardiology-of-phase-i-ii-data-for-lx2006-in-friedreich-ataxia.html

[14] uniQure Announces Preliminary Data on the First Cohort in the Phase I/IIa Clinical Trial of AMT-260 in Refractory Mesial Temporal Lobe Epilepsy. Retrieved June 18, 2026, from https://www.globenewswire.com/news-release/2026/06/19/3314701/0/en/uniqure-announces-preliminary-data-on-the-first-cohort-in-the-phase-i-iia-clinical-trial-of-amt-260-in-refractory-mesial-temporal-lobe-epilepsy.html

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