2026年欧洲血液学会（EHA）年会暨第31届欧洲血液学协会大会（以下简称EHA 2026年会）将于当地时间2026年6月11日-14日在瑞典斯德哥尔摩隆重召开。注射用埃普奈明（aponermin商品名:沙艾特）相关的多项研究成果中选壁报展示环节，内容涵盖多发性骨髓瘤患者在接受CAR-T治疗前的桥接治疗探索，以及联合双特异性抗体、细胞毒类药物、XPO-1抑制剂、CD38单抗、免疫调节剂等多种不同作用机制的药物用于复发难治多发性骨髓瘤的治疗尝试，以及与BCL-2抑制剂协同效应的体外试验探索等。注射用埃普奈明为人肿瘤坏死因子相关凋亡诱导配体（TRAIL）的环化变构体，是全球首个上市的DR4/DR5激动剂，通过结合肿瘤细胞膜上的死亡受体4（DR4）和/或死亡受体5（DR5）激活外源性细胞凋亡通路，触发细胞内含半胱氨酸的天冬氨酸蛋白水解酶（Caspase）的级联反应，诱导不依赖P53的细胞凋亡。此外，多项研究表明，DR4／DR5激动剂还具有免疫调节作用，对肿瘤微环境中的调节性T细胞、肿瘤相关巨噬细胞、骨髓源性抑制细胞等具有抑制作用，有助于改善肿瘤免疫微环境。

本次会议由全球血液学领域最具影响力的学术组织之一——欧洲血液学协会（EHA）主办，并将采用线上线下结合的形式连接全球血液同仁。作为全球血液学领域极具权威性与影响力的顶尖学术盛会，EHA年会一直被誉为行业发展的“风向标”。本届大会将吸引来自全球100多个国家超17,000名专业人士齐聚一堂，汇聚全球血液学领域权威专家、临床医师、科研学者及患者权益倡导者等。本届大会不仅是展示前沿研究成果的宏大舞台，也是推动血液病诊疗水平提升、促进国际多中心合作的关键桥梁。

注射用埃普奈明在EHA 2026年会多篇摘要被选为壁报展示，体现了国际血液学界对死亡受体激动剂用于血液肿瘤治疗前景的进一步认可，武汉黄金城集团生物制药股份有限公司也将再接再厉，加速推进现有研究进展，早日为患者带来更多安全、有效、创新的治疗选择。

The 2026 Annual Congress of the European Hematology Association (EHA), namely the 31st EHA Congress, will be grandly held in Stockholm, Sweden, from June 11 to 14 (local time), 2026. Multiple research achievements related to Aponermin for Injection (brand name: SunHiTrail) have been selected for the poster session. The research scope includes the exploration of bridging therapy prior to CAR-T therapy in patients with multiple myeloma, the therapeutic exploration of combining with bispecific antibodies, cytotoxic drugs and other agents with distinct mechanisms of action for relapsed and refractory multiple myeloma, as well as in vitro research on the synergistic effect with BCL-2 inhibitors. As a circularly permuted endogenous human tumor necrosis factor-related apoptosis-inducing ligand (TRAIL), Aponermin for Injection is the world’s first marketed DR4/DR5 agonist. It activates the exogenous apoptosis pathway by binding to death receptor 4 (DR4) and/or death receptor 5 (DR5) on tumor cell membranes, triggering a cascade reaction of intracellular cysteine-aspartic proteases (Caspases) and inducing p53-independent apoptosis. Furthermore, numerous studies have shown that DR4/DR5 agonists exert immunomodulatory effects, which can suppress regulatory T cells, tumor-associated macrophages, myeloid-derived suppressor cells and other immunosuppressive cells in the tumor microenvironment, thereby helping remodel and optimize the tumor immune microenvironment.

Hosted by the European Hematology Association (EHA), one of the most influential academic organizations in the global hematology community, the 2026 EHA Congress will adopt a hybrid online-offline format to connect hematology professionals worldwide. As a top academic event with high authority and influence in global hematology, the EHA Annual Congress is hailed as the "vane" of industrial development. This year’s congress will gather over 17,000 professionals from more than 100 countries worldwide, including leading global hematology experts, clinicians, researchers and patient advocacy representatives. It serves not only as a prestigious platform for presenting cutting-edge research findings, but also as a critical bridge for advancing the diagnosis and treatment of hematological diseases and promoting international multicenter cooperation.

The selection of multiple Aponermin abstracts for poster presentation at the upcoming EHA Annual Congress highlights the promising clinical prospects of death receptor agonists in treating hematological malignancies, as recognized by the international hematology community. Wuhan Hiteck Biopharmaceutical Co., Ltd.will continue to accelerate the progress of ongoing clinical and preclinical research, and strive to bring more safe, effective and innovative treatment options to patients at an early date.

2026 EHA年会含埃普奈明壁报/收录明细一览

展示形式	标题（Title）	摘要编号（Final Abstract Code）
壁报展示	Phase 2 Study Of Aponermin + Bispecific Antibodies In Patients(Pts) With Relapsed/Refractory Multiple : A Prospective Single-Arm Study	PS1893
壁报展示	Plasmacytoma Reduced Quickly In Patients(Pts) With Relapsed/Refractory Multiple Myeloma By Aponermin +KT-DECP Regimen	PF794
壁报展示	Safety And Efficacy Of Aponermin-Based Chemotherapy As Bridging Therapy Before Car-T Cell Treatment In Relapsed/Refractory Multiple Myeloma	PS1881
壁报展示	DR4/DR5 Agonists Synergize With Bh3 Mimetics Venetoclax To Promote Apoptosis In Multiple Myeloma	PS1844
大会收录	A Prospective Comparison Of Aponermin-Based Regimens Weekly Versus Monthly In Patients(Pts) With Relapsed/Refractory Multiple Myeloma	PB3234
大会收录	Real-World Safety And Efficacy Of Aponermin And Daratumumab-Based Regimens In Patients With Multiple Myeloma	PB3289
大会收录	Efficacy And Safety Of Aponermin-Selinexor-Dexamethasone (Apo-Sd) In Heavily Pre-Treated Relapsed/Refractory Multiple Myeloma	PB3326
大会收录	Aponermin Combined With Thalidomide-Dexamethasone (Td) Or Td Plus Other Agents (Td+) In Relapsed/Refractory Multiple Myeloma	PB3333
大会收录	Aponermin+Sd Regimen: An Effective And Safe Preferred Bridging Strategy Before Bcma Car-T Therapy In Relapsed/Refractory Multiple Myeloma Patients	PB3275
大会收录	Efficacy And Safety Of Aponermin Combined With Pomalidomide-Based Regimens In Relapsed/Refractory Multiple Myeloma	PB3325

2026 EHA年会含埃普奈明壁报/收录全文

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DR4/DR5 AGONISTS SYNERGIZE WITH BH3 MIMETICS VENETOCLAX TO PROMOTE APOPTOSIS IN MULTIPLE MYELOMA

Yiwen Jiang

Author(s): Yiwen Jiang,  Qingyu Xu,  Jingjing Deng,  Huixing Zhou,  Zhiyao Zhang,  Menghan Liu,  Wenjing Li,  Ying Tian,  Guangzhong Yang,  Yin Wu,  Yun Leng,  Ai-jun Liu,  Wen Gao,  Honghu Zhu,  Wenming Chen

(Abstract release date: 05/12/26) EHA Library. Jiang Y. 06/11/2026; 4208396; PS1844;

Abstract

This abstract is embargoed until Thursday, June 11, 2026, 08:00 CEST.

Presentation during EHA2026:All (e)Poster presentations will be made available as of until Thursday, June 11, 2026, 08:00 CEST and will be accessible for on-demand viewing from June 17 to October 15, 2026 on the Congress platform.

                                                                                                                                                                   

Abstract: EHA-4501 Short: PS1844

Title: DR4/DR5 AGONISTS SYNERGIZE WITH BH3 MIMETICS VENETOCLAX TO PROMOTE APOPTOSIS IN MULTIPLE MYELOMA

Type: Poster Presentation

Session title: Myeloma and other monoclonal gammopathies - Biology & translational research

Background:
Multiple myeloma (MM) remains incurable despite treatment advances, with most patients developing relapsed or refractory disease. Circularly Permuted TRAIL (CPT, Aponermin) activates the extrinsic apoptotic pathway via death receptors DR4 and DR5, whereas Venetoclax targets the intrinsic BCL-2–dependent pathway. We therefore hypothesized that dual targeting of these complementary apoptotic mechanisms could overcome resistance and produce synergistic antitumor efficacy.

Aims:
To evaluate the synergistic effects of CPT and Venetoclax in myeloma cells by dissecting DR4/DR5- and BCL-2–mediated apoptotic pathways, and to identify predictive biomarkers that could inform patient selection for combination therapy.

Methods:
Cell viability was measured using CellTiter-Glo, apoptosis by flow cytometry and caspase-8, -9, and -3/7 activity, and cell cycle by DAPI staining. Dose–response relationships were characterized for both single-agent and combination treatments, and caspase dependency was examined using selective inhibitors. RNA sequencing followed by gene set enrichment analysis was performed to evaluate pathway activation and mechanisms. Primary patient-derived plasma cells were isolated from bone marrow aspirates via CD138? MACS. Purified primary cells were used for ex vivo drug treatment across dose–response matrices to assess synergy using the Bliss model, and for flow cytometry analysis of DR4/DR5 and key BCL2 family proteins (BCL2, MCL1, BCL-xL).

Results:
CPT synergized with Venetoclax in killing both dexamethasone-resistant MM1R and bortezomib-resistant KMS11/BTZ cells (Bliss synergy scores = 10.88 and 20.29, respectively). Venetoclax activity was also enhanced in combination with DR4/DR5 agonists in KMS12 PE cells (Bliss synergy score = 6.75). RNA-seq analysis of KMS11/BTZ cells demonstrated that combination treatment further enriched the apoptosis and TNF signaling pathway compared with either agent alone (NES = 1.506 and 2.11, respectively; nominal p-value

Summary/Conclusion:
CPT synergizes with Venetoclax to induce caspase-dependent apoptosis in multiple myeloma, and DR4/DR5 expression levels predict the magnitude of synergy, highlighting their potential as biomarkers for guiding combination therapy.

Keyword(s): BCL2 | Apoptosis | TRAIL | Multiple myeloma

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SAFETY AND EFFICACY OF APONERMIN-BASED CHEMOTHERAPY AS BRIDGING THERAPY BEFORE CAR-T CELL TREATMENT IN RELAPSED/REFRACTORY MULTIPLE MYELOMA

Yi Wang

Author(s): Huanxin zhang,  Yi Wang,  Zhenyu Li,  Yanli Feng,  yang Liu

(Abstract release date: 05/12/26) EHA Library. Wang Y. 06/11/2026; 4208432; PS1881;

Abstract

This abstract is embargoed until Thursday, June 11, 2026, 08:00 CEST.

Presentation during EHA2026:All (e)Poster presentations will be made available as of until Thursday, June 11, 2026, 08:00 CEST and will be accessible for on-demand viewing from June 17 to October 15, 2026 on the Congress platform.

                                                                                                                                                                   

Abstract: EHA-1318 Short: PS1881

Title: SAFETY AND EFFICACY OF APONERMIN-BASED CHEMOTHERAPY AS BRIDGING THERAPY BEFORE CAR-T CELL TREATMENT IN RELAPSED/REFRACTORY MULTIPLE MYELOMA

Type: Poster Presentation

Session title: Myeloma and other monoclonal gammopathies - Clinical

Background:
Chimeric antigen receptor (CAR) T-cell therapy represents a breakthrough in the treatment of relapsed or refractory (R/R) multiple myeloma (MM), however, severe cytokine release syndrome and neurotoxicity may compromise outcomes. A well-tolerated bridging therapy that controls disease without additional toxicities could improve the safety and efficacy of subsequent CAR-T infusion. Aponermin, a novel circularly permuted TRAIL ligand, induces selective apoptosis in malignant plasma cells through death receptors DR4 and DR5. The safety and efficacy of Aponermin-based regimens as bridging therapy before CAR-T treatment remain to be explored.

Aims:
The primary endpoint is overall response rate (ORR). The secondary endpoints.include-ORR.after Aponermin-based-bridging-therapy and-adverse-events.

Methods:
We performed a retrospective, three-centre cohort study of consecutive RRMM patients who received Aponermin-based chemotherapy after leukapheresis and before lymphodepletion (fludarabine 30 mg/m²/day and cyclophosphamide 300 mg/m²/day × 3 days) followed by a single BCMA- based CAR-T infusion. Safety and efficacy were assessed from the start of bridging therapy until 30 days after CAR-T administration.

Results:
A total of 30 patients were included. Median age was 55 years (range 44–81); median prior lines of therapy were 4 (range 2–7). Thirteen patients (43.3%) had prior autologous HSCT. Nineteen (63.3%) had high-risk cytogenetics and 27 (90%) had extramedullary disease (EMD). All patients were refractory to proteasome inhibitors, immunomodulatory drugs, and CD38 monoclonal antibodies. Sixteen patients received anti-BCMA CAR-T, and fourteen received BCMA/GPRC5D dual-target CAR-T.
All patients received Aponermin-based bridging regimens, most commonly Apo-Td (n=12) and Apo-KTd (n=5), with other combinations administered according to prior exposure and disease characteristics.
Of the 30 patients, 25 received one cycle of bridging therapy, 3 received two cycles, and 2 patient received three cycles. After Aponermin-based bridging therapy, ORR was 26.7% (8/30), including a complete response (CR) in 6.7 % (2/30) patients and a partial response (PR) in 20.0 % (6/30) patients. Stable disease (SD) was observed in 18 (60.0%) patients, and 2 (6.7%) patients experienced disease progression after bridging therapy.
The safety profile of bridging therapy was favorable, with only one case of hypersensitivity reaction and two cases of elevated transaminases.Hematologic toxicity was manageable: grade 3–4 cytopenias occurred mainly in combination-intensive regimens (notably Apo-KTd and Apo-DECP). No grade ≥3 hepatotoxicity was observed. Importantly, 6 patients with SD after Apo-Td bridging experienced significant platelet recovery, potentially reducing bleeding risk during subsequent CAR-T therapy.
Among 27 evaluable patients after CAR-T infusion, ORR reached 85.7%, including sCR 7.4%, CR 18.5%, VGPR 7.4%, and PR 55.6%. CRS occurred in 23 patients (85.2%), with grade 3–4 CRS in 4 patients. Median PFS was 8.0 months.

Summary/Conclusion:
Aponermin-based bridging therapy is well tolerated, does not exacerbate organ dysfunction or marrow suppression, and provides significant disease control or platelet recovery. These findings support prospective evaluation of Aponermin-based regimens as an effective bridge to BCMA-based CAR-T therapy in R/R MM.

Keyword(s): Multiple myeloma | CAR-T

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PLASMACYTOMA REDUCED QUICKLY IN PATIENTS(PTS) WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA BY APONERMIN +KT-DECP REGIMEN

Aijun Liu

Author(s): Menghan Liu,  Jingrong Wang,  Yanru Zhang,  xiaoqi qin,  Weiwei Tian,  Yuechen Zhang,  Lefu Huang,  jing jia,  Wenjing Li,  Donghai Han,  Yanping Ma,  Da Gao,  Guangzhong Yang,  Wen Gao,  Yan Yan,  Aijun Liao,  Liping Su,  Honghu Zhu,  Wenming Chen,  Aijun Liu

(Abstract release date: 05/12/26) EHA Library. Liu A. 06/11/2026; 4207782; PF794;

Abstract

This abstract is embargoed until Thursday, June 11, 2026, 08:00 CEST.

Presentation during EHA2026:All (e)Poster presentations will be made available as of until Thursday, June 11, 2026, 08:00 CEST and will be accessible for on-demand viewing from June 17 to October 15, 2026 on the Congress platform.

                                                                                                                                                                   

Abstract: EHA-3651 Short: PF794

Title: PLASMACYTOMA REDUCED QUICKLY IN PATIENTS(PTS) WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA BY APONERMIN +KT-DECP REGIMEN

Type: Poster Presentation

Session title: Myeloma and other monoclonal gammopathies - Clinical

Background:
Extramedullary Disease (EMD) occurred often in Relapsed/refractory multiple myeloma (RRMM), the survival was still poor (3-year OS: 58%). Aponermin (Apo), the first approved DR4/DR5 agonist, triggers the extrinsic apoptotic pathway through caspase cascade activation.

Aims:
This study was to evaluate the efficacy and safety of Apo+KT-DECP* regimen in pts of RRMM and EMD.

Methods:
This multicenter, single-arm, phase 2 study (NCT05013190) aimed to enroll 31 pts with EMD-confirmed RRMM according to IMWG criteria. Patients received Apo-KT-DECP regimen*at least 4-6 cycles; and adding radiotherapy when efficacy less than complete remission (CR). The primary endpoint was overall response rate (ORR) after two cycles of treatment. Key secondary endpoints include CR, very good partial remission (VGPR), Time to response (TOR), Progression-Free Survival (PFS) and safety.

Results:
31 pts have been enrolled in this study, median age was 60 years, male was 41.9%, median prior lines of therapy was 2(range:1–9), 29.0% of pts with EMD≥3(1-7), 32.3% of pts with bone-independent and paraskeletal mass together, 25.8% of pts with big EMD(diameter≥5cm), high-risk cytogenetics was 29.0%, EMD of 3 pts with blast-type plasma cell, 2 pts with malignant pleural effusion, 3 triple-class refractory (TCR) was 38.7%, and no BCMA exposure pts.
By the data cutoff, all enrolled pts had received a median of 6 cycle of regimen as induction therapy (range: 2–6), 48.4%(15/31) of pts entered to maintenance. Median follow-up of 7 months, median PFS were not reached, 6-month and 12-month PFS rate was 79.3% and 58.1%, respectively. ORR of 2-cycle was 78.6% (22/28), much better than the efficacy of DECP in 20 pts with EMD(ORR 55%) that was published in 2014(National Medical Journal of China). The best response included 32.3% of pts achieving ≥VGPR (25.8% achieving ≥CR, 2 pts with radiotherapy)
In this study, 67.7% (21/31) of patients experienced adverse events (AEs) of any grade. The most common AEs were anemia (74.2%), thrombocytopenia (67.7%), infection (64.5%), and leukopenia (58.1%). The most frequent Grade 3/4 adverse events were leukopenia (35.5%), infection (32.3%), and thrombocytopenia (29.0%).

Summary/Conclusion:
Our study demonstrates that EMD decreased quickly, PFS was prolonged obviously with less toxicity in RRMM by the Apo-KT-DECP regimen. An ORR of 78.6% was achieved in pts with EMD in 2months and 58.1% of pts were not progressed in 12 months, a high-risk population with unmet need, supporting further evaluation of this combination.
Clinical trial information: NCT05013190

Keyword(s): Targeted therapy | Multiple myeloma

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PHASE 2 STUDY OF APONERMIN + BISPECIFIC ANTIBODIES IN PATIENTS(PTS) WITH RELAPSED/REFRACTORY MULTIPLE : A PROSPECTIVE SINGLE-ARM STUDY

Aijun Liu

Author(s): Lefu Huang,  Ying Tian,  Rui Zhang,  Tiejun Gong,  Huijuan Wang,  Jingrong Wang,  Zunmin Zhu,  Liping Su,  Xiaojing Yan,  Ma Jun,  Honghu Zhu,  Wenming Chen,  Aijun Liu

(Abstract release date: 05/12/26) EHA Library. Liu A. 06/11/2026; 4208444; PS1893;

Abstract

This abstract is embargoed until Thursday, June 11, 2026, 08:00 CEST.

Presentation during EHA2026:All (e)Poster presentations will be made available as of until Thursday, June 11, 2026, 08:00 CEST and will be accessible for on-demand viewing from June 17 to October 15, 2026 on the Congress platform.

                                                                                                                                                                   

Abstract: EHA-3646 Short: PS1893

Title: PHASE 2 STUDY OF APONERMIN + BISPECIFIC ANTIBODIES IN PATIENTS(PTS) WITH RELAPSED/REFRACTORY MULTIPLE : A PROSPECTIVE SINGLE-ARM STUDY

Type: Poster Presentation

Session title: Myeloma and other monoclonal gammopathies - Clinical

Background:
Although bispecific antibodies have shown promising efficacy with high infection in pts, relapsed/ refractory multiple myeloma (RRMM) remains incurable, particularly in pts exposed to multiple-lines of therapy and those with high-risk(HR) disease features. Aponermin (Apo), the first approved DR4/DR5 agonist, triggering the extrinsic apoptotic pathway through caspase cascade activation, presenting high anti-myeloma activity with low toxicity.

Aims:
This study was to evaluate the efficacy and safety of Apo+ Bispecific antibodies(BsAbs)+Thalidomide and Dexamethasone(Td) regimen* in pts of RRMM.

Methods:
This multicenter, single-arm, phase 2 study (ChiCTR2500106279) aimed to enroll 31 pts with RRMM according to IMWG criteria, RR to the last line of therapy (LOT). Pts received Apo+ BsAbs+Td regimen* for at least 4-6 cycles. The primary endpoint was overall response rate (ORR) after two cycles of treatment. AEs were graded per CTCAE v5.0. Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) were graded per ASTCT criteria.

Results:
As of February 28, 2026, 22 patients were enrolled. The median age was 66 years (range, 50–79), and the median number of prior lines of therapy was 4 (range, 2–11). High-risk cytogenetics were present in 59.1%, 68.2%(15/22) of pts with extramedullary disease (EMD), including 66.7%(10/15) of pts with big EMD(diameter≥5cm), 60.0% (9/15) with both HR cytogenetics and big EMD. 90.9% (20/22) were triple- class exposed, two patients had undergone BCMA-CART cell infusion, and 31.8% (7/22) had previously received Apo. Most of pts received BCMA-targeted bites, except 3 of GPRC5D -targeted bites.
The ORR of one and two months was 82.4% (14/17) and 86.6% (13/15), A ≥VGPR of two months was achieved in 66.7% (10/15), including a complete remission (CR) in 46.7% (7/15). Notably, the responses were rapid: 47.1% (8/17) achieving ≥VGPR, including 3 of pts with severe renal impairment(RI) at one month.
With a median follow-up of 5 months (range, 0.8–9.0), the median PFS and overall survival were not reached. Six months PFS rate was 100%(8/8).
The most common treatment-emergent adverse events (TEAEs) were CRS (85.0%; grade [gr] 3, 1, 5%, no gr 4), neutropenia (60%, gr≥3, 4, 23.5%); infections ( 41.2%, gr≥3, 4, 23.5%) , 3 pts received immunoglobulin Infusion; deep vein thrombosis(DVT) (4, 23.5%); 3 pts changed to pomalidomide cause of DVT or thalidomide intolerance. Severe TEAEs occurred in 3 of pts with severe AI. Overall, toxicities were manageable with supportive care and dose adjustments.

Summary/Conclusion:
The aponermin–bispecific antibody–IMiDs regimen demonstrated rapid and meaningful clinical activity with manageable toxicities in heavily pretreated and high-risk RRMM, including patients with extramedullary disease, triple-class exposure, high-risk cytogenetics and severe renal impairment.
Clinical trial information: ChiCTR2500106279.

Keyword(s): Multiple myeloma | Immune therapy | Targeted therapy

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A PROSPECTIVE COMPARISON OF APONERMIN-BASED REGIMENS WEEKLY VERSUS MONTHLY IN PATIENTS(PTS) WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA

Aijun Liu

Author(s): Lefu Huang,  Ying Tian,  Yanru Zhang,  Menghan Liu,  Aijun Liu

(Abstract release date: 05/12/26) EHA Library. Liu A. 05/12/2026; 4209784; PB3234;

Abstract

Abstract: EHA-6487 Short: PB3234

Title: A PROSPECTIVE COMPARISON OF APONERMIN-BASED REGIMENS WEEKLY VERSUS MONTHLY IN PATIENTS(PTS) WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA

Type: Publication Only

Session title: Myeloma and other monoclonal gammopathies - Clinical

Background:
Multiple myeloma (MM) remains incurable, and therapeutic options for patients(pts) with relapsed/refractory MM (RRMM) are still limited. Aponermin (Apo), the first approved DR4/DR5 agonist, triggers the extrinsic apoptotic pathway through caspase cascade activation, presenting high anti-myeloma activity with low toxicity. The 2-month-ORR of the Apo-per two-week regimen in RRMM with EMD is much better than the phase III clinical trial of Apo-monthly (86.6% vs 30.4%). Due to its short half-life, weekly scheduled administration may be more effective than monthly administration. Here, we report the efficacy and safety of Apo-weekly regimens in patients with RRMM.

Aims:
This study was to evaluate the efficacy and safety of Apo-weekly regimens in patients with RRMM.

Methods:
We analyzed the Apo-weekly* data of three prospective, single-arm study(ChiCTR2500100365, ChiCTR2500106279, NCT05013190) in our center, with matched Apo-monthly data (matched for age and sex, Apo-based# regimens in the real world) as control. Patients with RRMM who had received ≥2 prior lines of therapy were enrolled in the weekly regimen cohort between July 2024 and December 2025. The primary endpoint was overall response rate (ORR). Secondary endpoints included very good partial response (VGPR) rate, progression-free survival (PFS), and safety.

Results:
As of December 31, 2025, 52 of RRMM were enrolled, 26 of Apo-weekly* pts(in those trials) and matched Apo-monthly pts (Apo-based# regemin). The median age was 61 years vs 62years (range 38-79 vs 43-79), and the median number of prior lines of therapy both was 4 (range 2-12 vs 2-11), with the exception of high-risk cytogenetics(73.1%, 19/26 vs 57.7%,15/26), TP53 deletion was 34.6% (9/26) vs 7.7% (2/26), extramedullary disease (EMD) was 69.2%(18/26) vs 53.8%(14/26), including big EMD(diameter ≥5cm) 33.3%(6/18) vs 21.4%(3/14). Triple- class-resistance and BCMA-CART exposure were higher in the weekly group, 80.8% (21/26) vs 73.1%(19/26),3 vs 1, respectively.
Efficacy (Weekly vs. Monthly):The weekly group demonstrated superior 2-month-ORR and ≥VGPR rate of 2 months compared to the monthly group 91.7%, (22/24) vs16%(4/25), 54.2%(13/24 ) vs 0%; including a complete response (CR) rate of the weekly group was 37.5%. Among pts with EMD in the weekly group, 2-month-ORR was higher,94.4%(17/18) vs 21.4%(3/14). Pts with TP53 deletion achieved a higher VGPR rate comparable to pts without TP53 deletion,57.2%(4/7, except one without tolerance to BsAbs, one died during treatment)vs 52.9%(9/17). 4 of pts with plasmablastic myeloma achieved optimal efficacy of CR, and 2 of pts with severe thrombocytopenia achieved optimal efficacy of CR in one month. After a median follow-up of 6 months (range 2-16), median PFS was not reached in the weekly group, 6-month-PFS rate was 94.1%, and 12-month PFS rate was 59.9%, respectively.
Safety (Weekly vs Monthly):The most common treatment-related adverse events (TRAEs) in the weekly cohort vs monthly were leukopenia,77.0% vs 69.2%; anemia, 77.0% vs 80.8%; thrombocytopenia, 61.5% vs 65.4%; infections, 50.0%vs 46.2%. Grade ≥3 TRAEs included cytopenias 61.5% vs 53.8% and infections 26.9% vs19.2%.

Summary/Conclusion:
The weekly Aponermin-based regimen demonstrates promising efficacy in heavily pretreated RRMM patients, including those with EMD, TP53 deletion, plasmablastic myeloma and severe cytopenias. The safety profile was manageable. These findings support further investigation of weekly Aponermin schedules in RRMM.

Keyword(s): Targeted therapy | Multiple myeloma

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REAL-WORLD SAFETY AND EFFICACY OF APONERMIN AND DARATUMUMAB-BASED REGIMENS IN PATIENTS WITH MULTIPLE MYELOMA

Da Gao

Author(s): Da Gao,  Liping Su,  han donghai,  Peiling Zhang,  Shengjin Fan,  dong lu,  Yan Chen,  Baijun Fang,  xiaoqi qin,  Yan Yi,  zhao yu,  Aijun Liu,  Wenming Chen

(Abstract release date: 05/12/26) EHA Library. Gao D. 05/12/2026; 4209839; PB3289;

Abstract

Abstract: EHA-5604 Short: PB3289

Title: REAL-WORLD SAFETY AND EFFICACY OF APONERMIN AND DARATUMUMAB-BASED REGIMENS IN PATIENTS WITH MULTIPLE MYELOMA

Type: Publication Only

Session title: Myeloma and other monoclonal gammopathies - Clinical

Background:
Multiple myeloma, characterized by clonal proliferation of malignant plasma cells, is prone to progress to relapsed and refractory multiple myeloma (RRMM). Aponermin is a recombinant circularly permuted tumor necrosis factor-related apoptosis-inducing ligand (TRAIL). Its fundamental significance lies in its unique mechanism of action. It is the world's first and only approved death receptor 4/death receptor 5 (DR4/DR5) agonist. Non-clinical evidence had shown a synergistic effect between TRAIL agonists and CD38 monoclonal antibodies,suggesting that the combination of these two agents warrants further clinical exploration.

Methods:
We retrospectively analyzed the clinical data of 19 patients with RRMM who were treated with aponermin combined with daratumumab-based regimens for at least 2 cycles. The primary endpoint was overall response rate (ORR). The secondary endpoints included duration of response (DOR), and adverse events.

Results:
The median age was 65 years (range 51-86), with 57.89% male patients. Among all patients, 26.32% were R-ISS stage II and 31.58% stage III. Notably, 42.10% of patients presented with extramedullary disease, all with paraosseous involvement. High-risk cytogenetic abnormalities were present in 50% of the patients, with 1q21 gain/amplification in 36.84%, t(4;14) in 21.1%, and t (14;16) in 5.26%. Double-hit myeloma was present in 36.84% of cases. The number of prior lines of therapy was 2 (range 1-6), with 63.15% previously triple-class exposed to proteasome inhibitors, immunomodulatory drugs, and CD38 monoclonal antibodies. Treatment regimens consisted of aponermin combined with daratumumab and various backbone therapies: dexamethasone (31.58%), Proteasome Inhibitor (PI,including carfizomib and bortezomib)-dexamethasone (31.58%), Immunomodulatory Drugs(pomalidomide)-dexamethasone (36.84%). Patients received a median of 4 treatment cycles (range 2-10). Efficacy analysis demonstrated an overall response rate of 78.94%, with complete response in 21.05%, very good partial response in 10.52%, and partial response in 47.36% of patients. For Apo-Dd regimen, the ORR was 66.6%, for Apo-Dd-PI regimen, the ORR was 83.3%, and for Apo-Dd-imids, the ORR was 87.5%. The DOR was 3.7 months (range 2.13-9.3). The safety profile was favorable, with manageable adverse events including anemia (5.26%) and thrombocytopenia (5.26%).

Summary/Conclusion:
Real-world data demonstrate that aponermin and daratumumab-based regimens exhibit promising efficacy and favorable safety profiles, offering a potential new treatment option for this challenging population.

Keyword(s): Multiple myeloma | Real world data

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EFFICACY AND SAFETY OF APONERMIN-SELINEXOR-DEXAMETHASONE (APO-SD) IN HEAVILY PRE-TREATED RELAPSED/REFRACTORY MULTIPLE MYELOMA

Chunrui Li

Author(s): Chunrui Li,  Wenming Chen,  Ning An,  Di Wang,  Xin Li,  Peiling Zhang,  Weijian Zhu,  Meiling Li,  ;Rujiao Dong,  Yaping Liao,  Wen Gao

(Abstract release date: 05/12/26) EHA Library. Li C. 05/12/2026; 4209876; PB3326;

Abstract

Abstract: EHA-6054 Short: PB3326

Title: EFFICACY AND SAFETY OF APONERMIN-SELINEXOR-DEXAMETHASONE (APO-SD) IN HEAVILY PRE-TREATED RELAPSED/REFRACTORY MULTIPLE MYELOMA

Type: Publication Only

Session title: Myeloma and other monoclonal gammopathies - Clinical

Background:
Multiple myeloma (MM) is an incurable disease with frequent relapses, requiring continuous treatment. Recently, Aponermin(Apo) has been approved in China for the treatment of MM, with several clinical trials evaluating Aponermin-based therapies in relapsed/refractory MM (RRMM) patients. The results have shown significant improvements in survival rates.Aponermin is a recombinant cyclically modified human tumor necrosis factor-related apoptosis-inducing ligand (TRAIL) that activates death receptor 4 (DR4) and death receptor 5 (DR5) on the surface of tumor cells, triggering intracellular cascades to exert anti-tumor effects. Currently, this drug has been shown to synergize with proteasome inhibitors to enhance anti-myeloma activity. However, the efficacy and safety of combining Aponermin with Selinexor are still unclear.

Aims:
This study reports the efficacy and safety of the Aponermin-Selinexor-Dexamethasone (Apo-Sd) regimen in RRMM patients. The primary endpoints included overall response rate (ORR), duration of response (DOR), and adverse events.

Methods:
This was a multi-center retrospective study that included patients with relapsed/refractory MM who received Aponermin-Selinexor-Dexamethasone-based therapy. The main aim was to compare the efficacy and safety of the Aponermin-Selinexor+low-dose Dexamethasone regimen in RRMM.

Results:
As of February 10, 2026, 33 patients with relapsed/refractory multiple myeloma received the Aponermin-Selinexor-Dexamethasone-based regimen. The treatment regimens included ApoSd (n=24), ApoSK (Carfilzomib)d (n=3), and ApoSP (Pomalidomide)d (n=6). The median age of patients was 60 years, with 51.5% being male. 30.3% patients had extramedullary disease, and 54.5% had high-risk cytogenetic features(including 12.1% with p53 loss/mutation ). The median number of prior lines of treatment was 3, with 2 patients having received autologous stem cell transplants. 23 patients had been exposed to triple therapy. The overall response rate (ORR) was 51.2%, the complete response rate (CRR) was 15.2%. For patients with traceable disease progression (n=16), median time to first response is 1.5 months, and median progression-free survival (PFS) was 7.9 months (95% CI: 2.7 months to 13.0 months). The most common treatment-emergent adverse events were thrombocytopenia (12.1%), Anemia (9.1%), liver dysfunction(9.1%), manageable with supportive care.

Summary/Conclusion:
The Apo-Sd-based regimen shows promising efficacy in heavily pretreated RRMM patients, including those with high-risk prognostic factors and those who failed CAR-T therapy. Encouraging response rates were observed even in patients with multiple treatment failures and drug resistance. This highlights the unique mechanism of action of Aponermin and its synergistic effect with the Sd regimen. The safety of this combination is manageable. These findings support further evaluation of this novel combination regimen in larger clinical trials.

Keyword(s): Multiple myeloma

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APONERMIN COMBINED WITH THALIDOMIDE-DEXAMETHASONE (TD) OR TD PLUS OTHER AGENTS (TD+) IN RELAPSED/REFRACTORY MULTIPLE MYELOMA

Chuanying Geng

Author(s): Chuanying Geng,  Huihan Wang,  Guangzhong Yang,  Weiwei Tian,  Yanping Ma,  Yafei Guo,  lan lingqiong,  Jingrong Wang,  Baijun Fang,  Xiaoling Chen,  Wenming Chen

(Abstract release date: 05/12/26) EHA Library. Geng C. 05/12/2026; 4209883; PB3333;

Abstract

Abstract: EHA-5990 Short: PB3333

Title: APONERMIN COMBINED WITH THALIDOMIDE-DEXAMETHASONE (TD) OR TD PLUS OTHER AGENTS (TD+) IN RELAPSED/REFRACTORY MULTIPLE MYELOMA

Type: Publication Only

Session title: Myeloma and other monoclonal gammopathies - Clinical

Background:
Aponermin, a recombinant circularly permuted TRAIL, activates death receptors on tumor cells and has shown synergy with proteasome inhibitors and corticosteroids in multiple myeloma (MM). Thalidomide-dexamethasone (Td) remains a backbone regimen for relapsed/refractory MM (RRMM), but the benefit of adding aponermin to Td or Td-based combinations is unclear.

Aims:
To evaluate the efficacy and safety of aponermin combined with Td (Apo-Td) versus aponermin combined with Td plus other agents (Apo-Td+) in patients with RRMM. The primary endpoint was overall response rate (ORR) per IMWG criteria. Secondary endpoints included progression-free survival (PFS).

Methods:
This retrospective, multi-center study enrolled patients with RRMM who had received at least two prior lines of therapy. Patients were assigned to Apo-Td (thalidomide + dexamethasone) or Apo-Td+ (thalidomide + dexamethasone + additional drugs) based on physician's choice. Aponermin was administered at 10 mg/kg on days 1–5 of each 28-day cycle.

Results:
Between May 2024 and January 2026, 18 patients were enrolled (9 per group). Baseline characteristics: median age ≤65 years in 61.1% (11/18), male 66.7% (12/18), IgA type 61.1% (11/18), ISS stage III 53.3% (8/15 evaluable), high-risk cytogenetics 33.3% (3/9 evaluable), and extramedullary disease 47.1% (8/17 evaluable). Median prior lines of therapy were 2 (range 1–6) in the Apo-Td group and 4 (2–14) in the Apo-Td+ group (p=0.226) (Table 1). At a median follow-up of 2.5 months, ORR was 57.1% (4/7) in the Apo-Td group and 87.5% (7/8) in the Apo-Td+ group (p=0.412). The ≥VGPR rate was 14.3% vs 25.0%, respectively (Table 2). Median PFS was 5.4 months (Apo-Td) vs 4.9 months (Apo-Td+) (p=0.741).

Summary/Conclusion:
Aponermin-based regimens showed promising activity in heavily pretreated RRMM, with numerically higher response rates in the Apo-Td+ group, though not statistically significant. The combination was well-tolerated. Larger studies are warranted to identify optimal partners for aponermin in RRMM.

Keyword(s): Multiple myeloma | Thalidomide

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APONERMIN+SD REGIMEN: AN EFFECTIVE AND SAFE PREFERRED BRIDGING STRATEGY BEFORE BCMA CAR-T THERAPY IN RELAPSED/REFRACTORY MULTIPLE MYELOMA PATIENTS

Juan Li

Author(s): Meilan Chen,  Juan Li

(Abstract release date: 05/12/26) EHA Library. Li J. 05/12/2026; 4209825; PB3275;

Abstract

Abstract: EHA-5424 Short: PB3275

Title: APONERMIN+SD REGIMEN: AN EFFECTIVE AND SAFE PREFERRED BRIDGING STRATEGY BEFORE BCMA CAR-T THERAPY IN RELAPSED/REFRACTORY MULTIPLE MYELOMA PATIENTS

Type: Publication Only

Session title: Myeloma and other monoclonal gammopathies - Clinical

Background:
Bridging therapy is crucial for patients with relapsed/refractory multiple myeloma (R/R MM) prior to BCMA CAR-T cell infusion, aiming to rapidly reduce tumor burden, control disease progression, and improve the efficacy and safety of subsequent CAR-T therapy. The Aponermin + SD (Selinexor+dexamethasone) regimen is a commonly used chemotherapy combination, and its value as a preferred bridging strategy before CAR-T therapy needs to be further validated.

Aims:
The study aimed to explore the effective and safe of Aponermin+SD regimen as bridging strategy before BCMA CAR-T therapy in R/RMM.

Methods:
This research included 6 R/RMM patients who received the Apo+SD regimen as bridging therapy before BCMA CAR-T cell infusion. We analyzed the effective and safe of Aponermin+SD regimen as bridging strategy before BCMA CAR-T therapy.

Results:
A total of 6 patients with R/R MM were enrolled, with a median age of 61.0 years (range, 48-72). The cohort included 4 males and 2 females. High-risk cytogenetic abnormalities were common, including t(4;14) (33.3%), t(14;16) (16.7%), t(14;20) (16.7%), and gain/amplification of 1q21 (66.7%). Additionally, 66.7% of patients had penta-drug resistance, and 50.0% had double-hit myeloma.Efficacy Outcomes: After Apo+SD regimen, 4 of 6 patients (66.7%) achieved a very good partial response (VGPR), 2 of 6 patients (33.3%) achieved partial response (PR),and resulting in an overall response rate (ORR) of 100%.It has no obvious toxic and is well-tolerated by patients.All 6 patients (100%) achieved MRD-negative status at 1 month post-CAR-T infusion, and this negative status was sustained in subsequent follow-up evaluations.

Summary/Conclusion:
The Apo +SD regimen, as a bridging therapy before BCMA CAR-T infusion, is an effective, safe strategy .

Keyword(s): B-cell maturation antigen | CAR-T | Regimen | Multiple myeloma

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EFFICACY AND SAFETY OF APONERMIN COMBINED WITH POMALIDOMIDE-BASED REGIMENS IN RELAPSED/REFRACTORY MULTIPLE MYELOMA

Xin Li

Author(s): Xin Li,  Yan Yi,  Qian Cheng,  Liping Su,  Peiling Zhang,  Fan Zhou,  wenyin hou,  Wen Gao,  Jing Bao,  xiaoqi qin,  wang yaomei,  zhong jinfa,  lan lingqiong,  Wenming Chen

(Abstract release date: 05/12/26) EHA Library. Li X. 05/12/2026; 4209875; PB3325;

Abstract

Abstract: EHA-5957 Short: PB3325

Title: EFFICACY AND SAFETY OF APONERMIN COMBINED WITH POMALIDOMIDE-BASED REGIMENS IN RELAPSED/REFRACTORY MULTIPLE MYELOMA

Type: Publication Only

Session title: Myeloma and other monoclonal gammopathies - Clinical

Background:
Multiple myeloma (MM) is a common hematologic malignancy. Patients with relapsed/refractory multiple myeloma (RRMM) are often faced with limited treatment options due to disease progression and drug tolerance after multiple lines of therapy. Aponermin (Apo) has been approved for the treatment of RRMM, but additional studies are needed.

Aims:
To evaluate the efficacy and safety of Apo combined with pomalidomide-based regimens in RRMM patients.

Methods:
This is a multicenter retrospective study including patients who received at least two cycles of Apo plus pomalidomide-based therapy between June 2024 and January 2026. The primary endpoint is overall response rate (ORR). The secondary endpoints included rate of very good partial response or better(≥VGPRR), and adverse events.

Results:
A total of 40 RRMM patients were included in this study The median patient age was 66 years (range: 43-86), with a slight male predominance (78.8%). Disease stages were predominantly advanced (Durie-Salmon stage II/III: 84.4%; ISS stage II/III: 68.8%; R-ISS stage II/III: 53.6%). Patients had received a median of 2 prior lines of therapy (range: 1-7), with 56.3% (18/32) being triple-class exposed (PI, IMiD, and anti-CD38). Extramedullary disease (EMD) was present in 33.3% (11/33) of patients, and 56.3% (18/32) harbored high-risk cytogenetic abnormalities (HRCA). Regimens administered included APO+PD (n=19), APO+DPD (n=8), and APO+KPD (n=5). The median number of treatment cycles was 4 (range: 2-11). The overall ORR was 56.3% (18/32), with a ≥VGPR rate of 21.9% (7/32). The ORR showed an increasing trend with prolonged treatment, reaching 70.0% (14/20) in patients who completed ≥4 cycles. Subgroup analyses revealed no significant differences in ORR between patients with and without HRCA (61.1% vs. 50.0%), with and without EMD (45.5% vs. 61.9%), or between those with and without triple-class exposure (55.6% vs. 53.8%). Among the different regimens, the APO+DPD combination yielded the highest ORR (75%), compared to 47.4% for APO+PD and 60% for APO+KPD. The most common treatment-emergent adverse events were nausea (5%), thrombocytopenia (5%), leukopenia (5%), lymphocytopenia (5%), manageable with supportive care.

Summary/Conclusion:
Aponermin combined with pomalidomide-based regimens demonstrate a favorable overall response rate in treating RRMM patients. This combination appears to provide clinical benefit even for patients with high-risk cytogenetic abnormalities, extramedullary disease, or those who have failed multiple prior lines of therapy.

Keyword(s): Real world data | Multiple myeloma

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