Interim analyses show INBRX-106 + pembrolizumab achieved a 44.0% confirmed Objective Response Rate (cORR):

中期分析显示，INBRX-106 + 帕博利珠单抗（pembrolizumab）达到了 44.0% 的确认客观缓解率 (cORR)：

In the preliminary confirmed response-evaluable population, the INBRX-106 + pembrolizumab combination achieved a cORR of 44.0% versus 21.4% with pembrolizumab alone, representing a 22.6% absolute increase in cORR.

在初步确认的可评估反应人群中，INBRX-106 + 帕博利珠单抗组合的总体缓解率（cORR）达到了44.0%，而单独使用帕博利珠单抗的总体缓解率为21.4%，绝对提升了22.6%。

Superior depth of response:

更优的响应深度：

Responding patients in the combination arm demonstrated deeper tumor reductions overall, with the majority achieving target lesion shrinkage exceeding 50%; notably, three patients achieved a complete radiographic response.

联合治疗组的应答患者总体上表现出更显著的肿瘤缩小，大多数患者的靶病灶缩小超过50%；值得注意的是，三名患者达到了完全的影像学缓解。

Up to 15-fold mean increase in systemic T-Cell expansion:

系统性T细胞扩增平均增加高达15倍：

Peripheral blood analysis showed robust CD8+ and CD4+ T-cell proliferation in combination-treated patients, providing mechanistic support for the observed clinical activity.

外周血分析显示，联合治疗的患者中CD8+和CD4+ T细胞增殖强劲，为观察到的临床活性提供了机制支持。

Manageable safety profile:

可控的安全性概况：

The combination demonstrated a manageable preliminary safety profile consistent with that expected from an immunotherapy combination.

该组合展示了一个与免疫疗法组合预期相符的可控初步安全特性。

SAN DIEGO

圣地亚哥

,

，

May 11, 2026

2026年5月11日

/PRNewswire/ -- Inhibrx Biosciences, Inc. (Nasdaq:

/PRNewswire/ -- Inhibrx生物科学公司（纳斯达克：

INBX

收件箱

) ('Inhibrx' or the 'Company'), a clinical-stage biopharmaceutical company focused on developing novel biologic therapeutic candidates, today announced positive interim results from the randomized, first-line Phase 2 portion of the HexAgon study. The trial evaluated the safety and efficacy of INBRX-106, a hexavalent OX40 agonist, in combination with pembrolizumab (the combination arm) versus pembrolizumab monotherapy (the control arm) in first-line patients with treatment-naïve, PD-L1 positive (CPS ≥ 20) metastatic or unresectable recurrent Head and Neck Squamous Cell Carcinoma (HNSCC)..

）（“Inhibrx”或“公司”），一家处于临床阶段的生物制药公司，专注于开发新型生物治疗候选药物，今天宣布了HexAgon研究随机第一线二期部分的积极中期结果。该试验评估了INBRX-106（一种六价OX40激动剂）与pembrolizumab联合使用（联合组）对比pembrolizumab单药治疗（对照组）在一线治疗中PD-L1阳性（CPS ≥ 20）、未接受过治疗、转移性或不可切除的复发性头颈部鳞状细胞癌（HNSCC）患者中的安全性和有效性。

HNSCC was selected as a proof-of-concept indication, as PD-1 monotherapy is active in this tumor type but leaves significant room for improvement. The trial design was modeled after KEYNOTE-048, focusing on patients with high PD-L1 expression (CPS ≥ 20) in order to further sharpen the ability to detect a treatment effect above checkpoint inhibition alone.

HNSCC被选为概念验证适应症，因为PD-1单药治疗在此肿瘤类型中具有活性，但仍有显著的改进空间。试验设计参照了KEYNOTE-048，专注于高PD-L1表达（CPS ≥ 20）的患者，以进一步增强检测超越单独检查点抑制治疗效果的能力。

A clear signal of added benefit in this study design would support INBRX-106's potential to enhance checkpoint inhibitor efficacy across checkpoint inhibitor-sensitive indications..

这项研究设计中明确的附加效益信号将支持INBRX-106增强检查点抑制剂在检查点抑制剂敏感适应症中的疗效潜力。

The Phase 2 portion of the HexAgon study enrolled 68 patients: 33 randomized to the combination arm and 35 to the control arm. Baseline prognostic factors are largely balanced between both arms and the study is being conducted at over 80 sites in the United States, Europe and Asia. Today, the Company presented preliminary data from 53 patients (25 in the INBRX-106 combination arm and 28 in the control arm) with a data cutoff of May 7, 2026, representing the evaluable population for confirmed response, defined as patients who had either experienced confirmed disease progression or death, or completed at least two on-study tumor assessments.

HexAgon研究的第二阶段部分招募了68名患者：33名随机分配到联合治疗组，35名分配到对照组。基线预后因素在两组之间基本平衡，该研究正在美国、欧洲和亚洲的80多个研究中心进行。今天，公司展示了截至2026年5月7日的53名患者（25名在INBRX-106联合治疗组，28名在对照组）的初步数据，这些患者代表了可用于确认反应的可评估人群，定义为经历过确认的疾病进展或死亡，或已完成至少两次在研究期间的肿瘤评估的患者。

The remaining 15 patients in the overall population across both arms had not yet reached the maturity threshold for response confirmation or were not evaluable at the time of this data cut and were therefore not included in this analysis. Active unconfirmed responses and ongoing tumor increases/reductions are present in both arms, and these patients are expected to contribute to the final efficacy dataset in a subsequent update..

总体人群中两个组的其余15名患者尚未达到反应确认的成熟阈值，或在本次数据截止时无法评估，因此未纳入本次分析。两个组中均存在活跃但未确认的反应以及持续的肿瘤增大/缩小，预计这些患者将在后续更新中为最终的疗效数据集做出贡献。

In the evaluable population, 11 out of 25 patients (44.0%) in the INBRX-106 combination arm achieved a confirmed objective response, compared with 6 out of 28 patients (21.4%) in the control arm. This represents a 22.6% absolute increase in confirmed responses. Three complete responses were observed in the INBRX-106 combination arm, reflecting tumor clearance, while no complete responses were observed with pembrolizumab alone.

在可评估人群中，INBRX-106联合治疗组的25名患者中有11名（44.0%）获得了确认的客观缓解，而对照组的28名患者中有6名（21.4%）获得确认缓解。这代表确认缓解率绝对提高了22.6%。INBRX-106联合治疗组观察到三例完全缓解，反映了肿瘤清除，而单独使用pembrolizumab时未观察到完全缓解。

Complete responses in first-line HNSCC remain uncommon and are generally associated with more durable outcomes..

一线治疗头颈部鳞状细胞癌（HNSCC）的完全缓解仍然很少见，且通常与更持久的疗效相关。

These clinical findings were supported by pharmacodynamic data, which showed up to a 15-fold increase in peripheral CD8+ and CD4+ T-cell proliferation and up to a four-fold increase in activation in INBRX-106 combination-treated patients compared with up to 2.5-fold and 1.5-fold increases, respectively, in those receiving pembrolizumab alone.

这些临床发现得到了药效学数据的支持，数据显示，与单独接受派姆单抗治疗的患者相比，INBRX-106联合治疗的患者外周CD8+和CD4+ T细胞增殖增加了高达15倍，活化增加了高达4倍，而单独使用派姆单抗的患者分别仅增加2.5倍和1.5倍。

The observation of robust systemic T-cell expansion and activation in combination-treated patients, alongside the clinical activity observed in this arm, is consistent with the expected mechanism of action of INBRX-106 as a potent T-cell costimulator..

在联合治疗的患者中观察到强劲的系统性T细胞扩增和激活，同时这一组别中也观察到了临床活性，这与INBRX-106作为一种强效T细胞共刺激剂的预期作用机制是一致的。

The combination of INBRX-106 and pembrolizumab was generally manageable, with a safety profile consistent with the addition of an active immunostimulatory agent to checkpoint blockade. The most common treatment-related adverse events were rash, diarrhea, fatigue, and infusion-related reactions, which were predominantly low-grade.

INBRX-106与pembrolizumab的组合通常可控，其安全性特征与在检查点阻断中加入一种活性免疫刺激剂相符。最常见的治疗相关不良事件为皮疹、腹泻、疲劳和输注相关反应，大多为低级别。

No treatment-related deaths were reported in either arm..

两组均未报告与治疗相关的死亡。

'We are greatly encouraged by these early clinical results,' said Mark Lappe, Chief Executive Officer of Inhibrx. 'These data, coupled with the clear evidence of T-cell expansion and superior depth of response, give us confidence that INBRX-106 could be the first costimulatory agent to fundamentally shift the efficacy ceiling of immunotherapy, and open the door to combinations with new modalities that could be enhanced by OX40 agonism.'.

“我们对这些早期临床结果感到非常鼓舞，”Inhibrx首席执行官马克·拉普表示。“这些数据，加上T细胞扩增的明确证据和更深层次的反应效果，使我们相信INBRX-106可能成为首个从根本上提升免疫治疗效力上限的共刺激剂，并为与可通过OX40激动作用增强的新模式的联合应用打开大门。”

Next Steps

下一步

The progression-free survival data from the Phase 2 portion of the HexAgon study are expected to become available in the fourth quarter of 2026. The Company plans to begin the Phase 3 portion of the HexAgon study during the third quarter of 2026.

HexAgon研究第二阶段的无进展生存数据预计将在2026年第四季度公布。公司计划在2026年第三季度开始HexAgon研究的第三阶段。

Based on these promising early results, the Company also aims to evaluate INBRX-106 across broader indications to potentially improve the efficacy of checkpoint inhibitors. This strategy includes initiating a study in the perioperative setting in non-small cell lung cancer (NSCLC) later this quarter.

基于这些令人鼓舞的早期结果，该公司还旨在评估 INBRX-106 在更广泛的适应症中的应用，以潜在提高检查点抑制剂的疗效。该策略包括本季度晚些时候在非小细胞肺癌（NSCLC）围手术期启动一项研究。

The Company believes OX40 agonism has the greatest potential to drive cure in earlier-stage disease settings, where patients typically retain a more active and responsive immune system. In addition, the Company is beginning to plan for expansion into the front-line metastatic NSCLC setting, with studies expected to begin in 2027.

公司相信，在早期疾病环境中，OX40激动剂最有潜力推动治愈，因为患者通常仍保留更活跃和响应更强的免疫系统。此外，公司正开始计划扩展到一线转移性非小细胞肺癌（NSCLC）领域，预计相关研究将于2027年开始。

Outside of combination with checkpoint inhibitors, the Company plans to explore combinations with agents that could benefit from T-cell costimulation, such as vaccines, T-cell engagers, and CAR-Ts..

除了与检查点抑制剂联合使用外，公司还计划探索与可能受益于T细胞共刺激的药物联合使用，例如疫苗、T细胞接合器和CAR-T疗法。

About INBRX-106

关于INBRX-106

INBRX-106 is a hexavalent agonist targeting OX40 (CD134), a costimulatory receptor on T-cells. Utilizing Inhibrx's proprietary single-domain antibody (sdAb) platform, INBRX-106 is designed to achieve the high-order receptor clustering necessary for robust T-cell activation and survival, a feat that has eluded traditional bivalent antibody approaches.

INBRX-106 是一种六价激动剂，靶向 T 细胞上的共刺激受体 OX40 (CD134)。利用 Inhibrx 专有的单域抗体 (sdAb) 平台，INBRX-106 能够实现高效激活和维持 T 细胞所需的高阶受体簇集，而这是传统二价抗体方法难以实现的。

To date, over 175 patients have been treated with INBRX-106..

迄今为止，已有超过175名患者接受了INBRX-106的治疗。

About Inhibrx Biosciences, Inc.

关于Inhibrx生物科学公司

Inhibrx Biosciences is a clinical-stage biopharmaceutical company focused on developing a broad pipeline of novel biologic therapeutic candidates. Inhibrx Biosciences utilizes diverse methods of protein engineering to address the specific requirements of complex target and disease biology, including its proprietary protein engineering platforms.

Inhibrx生物科学公司是一家临床阶段的生物制药公司，专注于开发广泛的新型生物治疗候选药物管道。Inhibrx生物科学公司利用多种蛋白质工程方法来满足复杂靶标和疾病生物学的具体需求，包括其专有的蛋白质工程平台。

Inhibrx Biosciences was incorporated in January 2024 as a direct, wholly-owned subsidiary of Inhibrx, Inc. Prior to the sale of Inhibrx, Inc. and the INBRX-101 program to Sanofi S.A., Inhibrx Biosciences acquired certain corporate infrastructure and other assets and liabilities through a series of internal restructuring transactions effected by Inhibrx, Inc.

Inhibrx生物科学公司于2024年1月成立，是Inhibrx公司的直接全资子公司。在Inhibrx公司及INBRX-101项目出售给赛诺菲之前，Inhibrx生物科学公司通过Inhibrx公司实施的一系列内部重组交易，获得了某些企业基础设施及其他资产和负债。

Inhibrx, Inc. also completed a distribution to holders of its shares of common stock of 92% of the issued and outstanding shares of Inhibrx Biosciences. Following such transactions, Inhibrx Biosciences' current clinical pipeline of therapeutic candidates includes ozekibart (INBRX-109) and INBRX-106, both of which utilize multivalent formats where the precise valency can be optimized in a target-centric way to mediate what we believe to be the most appropriate agonist function.

Inhibrx, Inc. 还向其普通股股东分配了 Inhibrx Biosciences 已发行和流通股份的 92%。在这些交易之后，Inhibrx Biosciences 当前的治疗候选药物临床管线包括 ozekibart（INBRX-109）和 INBRX-106，这两者均采用了多价格式，其中精确的价态可以以目标为中心进行优化，从而实现我们认为最合适的激动剂功能。

For more information, please visit .

如需更多信息，请访问 。

www.inhibrx.com

www.inhibrx.com

.

。

Forward-Looking Statements

前瞻性声明

Inhibrx cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on Inhibrx's current beliefs and expectations. These forward-looking statements include, but are not limited to, statements regarding: Inhibrx's judgments and beliefs regarding the strength of Inhibrx's pipeline; statements regarding the safety and efficacy of its therapeutic candidate, INBRX-106, based on topline and interim results; the potential for INBRX-106 to be used for the treatment of HNSCC; the clinical development of INBRX-106, including expected enrollment in the expansion cohort, data readouts, regulatory submissions and interactions, and the timing thereof; any presumption that topline, interim or preliminary data will be representative of final data or data in later clinical trials, including data from the remaining 15 patients in the overall population for the Phase 2 trial for INBRX-106 in first-line HNSCC; Inhibrx's plans to evaluate INBRX-106 across broader indications and to explore combinations with other therapies; Inhibrx's plans to expand into the front-line metastatic NSCLC setting, with studies expected to begin in 2027; and Inhibrx's plans to begin the Phase 3 portion of the HexAgon study during the third quarter of 2026.

Inhibrx提醒您，本新闻稿中包含的关于非历史事实的陈述为前瞻性声明。这些声明基于Inhibrx当前的信念和期望。这些前瞻性声明包括但不限于以下内容：Inhibrx对其研发管线实力的判断和信念；关于其治疗候选药物INBRX-106的安全性和有效性，基于初步和中期结果的声明；INBRX-106用于治疗头颈部鳞状细胞癌（HNSCC）的潜力；INBRX-106的临床开发进展，包括扩展队列的预期招募、数据读取、监管递交及互动，以及相关时间安排；任何假设认为初步、中期或预试验数据将代表最终数据或后期临床试验的数据，包括INBRX-106一线治疗HNSCC二期试验整体人群中剩余15名患者的数据；Inhibrx计划在更广泛的适应症中评估INBRX-106，并探索与其他疗法的联合应用；Inhibrx计划于2027年进入一线转移性非小细胞肺癌（NSCLC）领域并启动研究；以及Inhibrx计划在2026年第三季度开始HexAgon研究的三期部分。

Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Inhibrx's business, including, without limitation, risks and uncertainties regarding: topline data may not accurately reflect the complete results of a particular study or trial and remain subject to audit, and final data may differ materially from topline data; the initiation, timing, progress and results of its preclinical studies and cl.

由于Inhibrx业务中固有的风险和不确定性，实际结果可能与此新闻稿中所述的结果不同，这些风险和不确定性包括但不限于：顶线数据可能无法准确反映特定研究或试验的完整结果，并且仍需接受审计，最终数据可能与顶线数据存在重大差异；其临床前研究的启动、时间、进展和结果以及临床试验等。

Investor and Media Contact:

投资者和媒体联系人:

Kelly Deck, CFO

凯莉·德克，首席财务官

[email protected]

电子邮件地址

858-795-4260

858-795-4260

SOURCE Inhibrx Biosciences, Inc.

来源：Inhibrx生物科学公司

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