Initial data from 15 patients with relapsed/refractory (r/r) marginal zone lymphoma (MZL) show 13 patients achieved a complete response and one patient achieved a partial response with ZYNLONTA®

15例复发/难治性（r/r）边缘区淋巴瘤（MZL）患者的初步数据显示，13例患者完全缓解，1例患者使用ZYNLONTA®获得部分缓解

All patients achieving responses maintained them at the time of data cutoff

所有获得反应的患者在数据截止时都保持了反应

ZYNLONTA was generally well-tolerated and safety was consistent with known profile

ZYNLONTA通常耐受性良好，安全性与已知特征一致

Data were presented at Lymphoma Research Foundation’s 2024 Marginal Zone Lymphoma Scientific Workshop

数据发表在淋巴瘤研究基金会2024年边缘区淋巴瘤科学研讨会上

LAUSANNE, Switzerland, May 06, 2024 (GLOBE NEWSWIRE) -- ADC Therapeutics SA (NYSE: ADCT) today announced that initial data from an investigator-initiated Phase 2 clinical trial evaluating ZYNLONTA® (loncastuximab tesirine-lpyl) demonstrated a high response rate in patients with relapsed/refractory (r/r) marginal zone lymphoma (MZL)..

瑞士洛桑，2024年5月6日（环球通讯社）--ADC Therapeutics SA（纽约证券交易所：ADCT）今天宣布，来自研究者发起的评估ZYNLONTA®（loncastuximab tesirine lpyl）的2期临床试验的初步数据显示复发/难治性（r/r）边缘区淋巴瘤（MZL）患者的高反应率。。

The 50-patient single-arm, open-label Phase 2 multicenter study is currently being conducted at the Sylvester Comprehensive Cancer Center at University of Miami and City of Hope, and led by Izidore Lossos, MD, Professor, Director, Lymphoma Program at the Sylvester Comprehensive Cancer Center, University of Miami.

这项50名患者的单臂开放标签2期多中心研究目前正在迈阿密大学和希望之城的西尔维斯特综合癌症中心进行，由迈阿密大学西尔维斯特综合癌症中心淋巴瘤项目教授、主任Izidore Lossos博士领导。

This study is evaluating the safety and efficacy of six cycles of ZYNLONTA across 18 weeks in patients with r/r MZL previously treated with ≥1 line of systemic therapy (ClinicalTrials.gov identifier: NCT05296070). As of the data cutoff date of March 30, 2024, 15 patients were evaluable. Of these 15 patients evaluated, 13 achieved a complete response (CR) and one patient achieved a partial response (PR).

这项研究正在评估先前接受≥1线全身治疗（ClinicalTrials.gov标识符：NCT05296070）的r/r MZL患者在18周内六个周期的ZYNLONTA的安全性和有效性。截至2024年3月30日的数据截止日期，有15名患者可评估。在评估的15例患者中，13例获得完全缓解（CR），1例获得部分缓解（PR）。

All patients who achieved responses had maintained them at the time of the data cutoff..

所有获得反应的患者在数据截止时都保持了这些反应。。

In this study, ZYNLONTA was generally well-tolerated and safety was consistent with the known profile, with two patient discontinuations. One patient discontinued after cycle 2 and a second patient discontinued after cycle 4 due to a toxicity, which fully resolved upon discontinuation of treatment. Both of these patients remain in CR at 10 and 6 months, respectively..

在这项研究中，ZYNLONTA通常耐受性良好，安全性与已知特征一致，有两名患者停药。一名患者在第2周期后停药，第二名患者在第4周期后因毒性而停药，停药后完全缓解。这两名患者分别在10个月和6个月时仍处于CR状态。。

These initial data were presented at the Lymphoma Research Foundation’s 2024 Marginal Zone Lymphoma Scientific Workshop by the trial’s lead investigator, Izidore Lossos, MD, Professor, Director, Lymphoma Program at the Sylvester Comprehensive Cancer Center, University of Miami.

这些初步数据由该试验的首席研究员，迈阿密大学西尔维斯特综合癌症中心淋巴瘤项目教授、主任Izidore Lossos博士在淋巴瘤研究基金会2024年边缘区淋巴瘤科学研讨会上发表。

“Achievement of complete response to treatment represents the strongest predictor of positive outcomes in MZL so these initial results are encouraging,” said Dr. Lossos. “We are now expanding the number of sites to accelerate enrollment in this trial.”

洛索斯博士说：“对治疗的完全反应是MZL积极结果的最强预测指标，因此这些初步结果令人鼓舞。”。“我们现在正在扩大网站数量，以加速此试验的注册。”

MZL is a rare, indolent non-Hodgkin lymphoma (NHL) and the third most common NHL subtype. There are few FDA-approved therapies for MZL.

MZL是一种罕见的惰性非霍奇金淋巴瘤（NHL），是第三常见的NHL亚型。很少有FDA批准的MZL疗法。

“Relapsed/refractory MZL can be difficult to manage, making this an indication of high unmet medical need,” said Mohamed Zaki, MD, PhD, Chief Medical Officer of ADC Therapeutics. “As this investigator-initiated trial progresses, assuming the results continue to be positive, we plan to potentially pursue a regulatory pathway and compendia in parallel as soon as sufficient data are available.”.

ADC Therapeutics首席医疗官Mohamed Zaki博士说：“复发/难治性MZL可能难以管理，这表明医疗需求尚未得到满足。”。“随着这项由研究者发起的试验的进展，假设结果仍然是积极的，我们计划一旦有足够的数据可用，就可能同时寻求监管途径和纲要。”。

“Approximately 3,000 to 4,000 relapsed/refractory MZL patients are treated in the U.S. annually,” said Ameet Mallik, Chief Executive Officer of ADC Therapeutics. “Based on the initial data from University of Miami’s Phase 2 trial evaluating ZYNLONTA in relapsed/refractory MZL, we are encouraged by the potential opportunity in the 2L+ setting for patients with this rare disease.”.

ADC Therapeutics首席执行官Ameet Mallik说：“美国每年约有3000至4000名复发/难治性MZL患者接受治疗。”。“根据迈阿密大学评估ZYNLONTA治疗复发/难治性MZL的2期临床试验的初步数据，我们对这种罕见疾病患者在2L+环境中的潜在机会感到鼓舞。”。

About ZYNLONTA® (loncastuximab tesirine-lpyl)

关于ZYNLONTA® （朗西妥昔单抗替西林lpyl）

ZYNLONTA® is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The potent payload binds to DNA minor groove with little distortion, remaining less visible to DNA repair mechanisms.

ZYNLONTA®是一种CD19定向抗体-药物偶联物（ADC）。一旦与表达CD19的细胞结合，ZYNLONTA就会被细胞内化，其中酶会释放吡咯并苯并二氮杂卓（PBD）有效载荷。有效的有效载荷与DNA小沟结合，几乎没有变形，DNA修复机制仍然不太可见。

This ultimately results in cell cycle arrest and tumor cell death..

这最终导致细胞周期停滞和肿瘤细胞死亡。。

The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma.

美国食品和药物管理局（FDA）和欧洲药品管理局（EMA）已批准ZYNLONTA（loncastuximab tesirine lpyl）用于治疗两种或两种以上全身治疗后复发或难治性（r/r）大B细胞淋巴瘤的成年患者，包括弥漫性大B细胞淋巴瘤（DLBCL），未另行说明（NOS），由低度淋巴瘤引起的DLBCL以及高度B细胞淋巴瘤。

The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with difficult-to-treat disease, including patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/triple hit genetics and patients who had stem cell transplant and CAR-T therapy prior to their treatment with ZYNLONTA.

该试验包括广泛的经过严重预处理的难治性疾病患者（中位数为前三种治疗方案），包括对一线治疗无反应的患者，对所有先前治疗方案无效的患者，双重/三重打击遗传学患者以及在用ZYNLONTA治疗前接受过干细胞移植和CAR-T治疗的患者。

This indication is approved by the FDA under accelerated approval and in the European Union under conditional approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Please see full prescribing information including important safety information about ZYNLONTA at www.ZYNLONTA.com..

该适应症由FDA在加速批准下批准，并在欧盟根据总体缓解率获得有条件的批准，并且该适应症的持续批准可能取决于验证性试验中临床益处的验证和描述。请在www.ZYNLONTA.com上查看完整的处方信息，包括有关ZYNLONTA的重要安全信息。。

ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy.

在其他B细胞恶性肿瘤和早期治疗方案的联合研究中，ZYNLONTA也被评估为一种治疗选择。

About ADC Therapeutics

关于ADC治疗

ADC Therapeutics (NYSE: ADCT) is a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs). The Company is advancing its proprietary ADC technology to transform the treatment paradigm for patients with hematologic malignancies and solid tumors.

ADC Therapeutics（纽约证券交易所：ADCT）是抗体-药物偶联物（ADC）领域的商业舞台全球领导者和先驱。该公司正在推进其专有的ADC技术，以改变血液恶性肿瘤和实体瘤患者的治疗模式。

ADC Therapeutics’ CD19-directed ADC ZYNLONTA (loncastuximab tesirine-lpyl) received accelerated approval by the FDA and conditional approval from the European Commission for the treatment of relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy. ZYNLONTA is also in development in combination with other agents and in earlier lines of therapy.

ADC Therapeutics的CD19定向ADC ZYNLONTA（loncastuximab tesirine lpyl）获得了FDA的加速批准，并获得了欧盟委员会的条件性批准，用于治疗两种或多种全身治疗后复发或难治性弥漫性大B细胞淋巴瘤。ZYNLONTA也正在与其他药物和早期治疗方案联合开发。

In addition to ZYNLONTA, ADC Therapeutics has multiple ADCs in ongoing clinical and preclinical development..

除ZYNLONTA外，ADC Therapeutics在正在进行的临床和临床前开发中还拥有多个ADC。。

ADC Therapeutics is based in Lausanne (Biopôle), Switzerland and has operations in London and New Jersey. For more information, please visit https://adctherapeutics.com/ and follow the Company on LinkedIn.

ADC Therapeutics总部位于瑞士洛桑（Biopôle），并在伦敦和新泽西州开展业务。有关更多信息，请访问https://adctherapeutics.com/并在LinkedIn上关注该公司。

ZYNLONTA® is a registered trademark of ADC Therapeutics SA.

ZYNLONTA®是ADC Therapeutics SA的注册商标。

Forward-Looking Statements

前瞻性声明

This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. In some cases you can identify forward-looking statements by terminology such as “may”, “will”, “should”, “would”, “expect”, “intend”, “plan”, “anticipate”, “believe”, “estimate”, “predict”, “potential”, “seem”, “seek”, “future”, “continue”, or “appear” or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words.

本新闻稿包含1995年《私人证券诉讼改革法案》安全港条款所指的前瞻性声明。在某些情况下，您可以通过术语来识别前瞻性陈述，例如“可能”，“将”，“应该”，“将”，“期望”，“打算”，“计划”，“预期”，“相信”，“估计”，“预测”，“潜在”，“似乎”，“寻求”，“未来”，“继续”或“出现”或这些术语或类似表达的否定词，尽管并非所有前瞻性陈述都包含这些识别词。

Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to: the timing and future results from the University of Miami’s investigator-initiated trial in MZL, future FDA approval and/or NCCN compendia inclusion and the market size and potential opportunity; the effectiveness of the new commercial go-to-market strategy, competition from new technologies, and the Company’s ability to grow ZYNLONTA® revenue in the United States; Swedish Orphan Biovitrum AB’s (Sobi®) ability to successfully commercialize ZYNLONTA® in the European Economic Area and market acceptance, adequate reimbursement coverage, and future revenue from the same; approval by the NMPA of the BLA for ZYNLONTA® in China submitted by Overland ADCT BioPharma and future revenue from the same, our strategic partners’, including Mitsubishi Tanabe Pharma Corporation, ability to obtain regulatory approval for ZYNLONTA® in foreign jurisdictions, and the timing and amount of future revenue and payments to us from such partnerships; the timing and results of the Company’s or its partners’ clinical trials including LOTIS 5 and.

前瞻性陈述受到某些风险和不确定性的影响，这些风险和不确定性可能导致实际结果与所描述的结果存在重大差异。可能导致这种差异的因素包括但不限于：迈阿密大学研究者在MZL发起的试验的时间和未来结果，未来FDA的批准和/或NCCN纲要的纳入以及市场规模和潜在机会；新商业上市战略的有效性、新技术的竞争以及公司在美国增加ZYNLONTA®收入的能力；瑞典Orphan Biovitrum AB（Sobi®）在欧洲经济区成功商业化ZYNLONTA®的能力和市场接受度，足够的报销范围以及未来的收入；NMPA批准Overland ADCT BioPharma提交的ZYNLONTA®在中国的BLA，以及我们的战略合作伙伴（包括三菱田边制药公司）的未来收入，在外国司法管辖区获得ZYNLONTA®监管批准的能力，以及此类合作伙伴未来收入和付款的时间和金额；该公司或其合作伙伴的临床试验的时间和结果，包括LOTIS 5和。

CONTACT:

联系人：

Investors and Media

投资者和媒体

Nicole Riley

赖莉

ADC Therapeutics

ADC治疗学

Nicole.Riley@adctherapeutics.com

Nicole.Riley@adctherapeutics.com

+1 862-926-9040

+1 862-926-9040