Mosunetuzumab

100 r/r DLBCL patients treated at the selected 150 µg/kg dose of ZYNLONTA® plus glofitamab Full data expected in fourth quarter of 2026 LAUSANNE, Switzerland , June 30, 2026 /PRNewswire/ -- ADC Therapeutics SA (NYSE: ADCT), a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), today announced the completion of enrollment in the LOTIS-7 Phase 1b open-label clinical trial evaluating the safety and efficacy of ZYNLONTA® (loncastuximab tesirine-lpyl) in combination with the bispecific antibody glofitamab (COLUMVI®) in patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (r/r DLBCL). LOTIS-7 trial enrollment is now complete with 100 r/r DLBCL patients dosed at the selected 150 µg/kg dose of ZYNLONTA plus glofitamab. Enrollment occurred in 30 total sites with 70% of patients in the US and 30% in the EU. The study enrolled patients with baseline characteristics similar to other bispecific combination studies in this space and included 46% relapsed and 54% primary refractory patients with a median age of 66 years. Primary endpoints of the study include safety and tolerability. Secondary endpoints include overall response rate, duration of response, complete response, relapse free survival, progression-free survival, and overall survival, as well as pharmacokinetics and immunogenicity. As part of the study protocol, anti-infective prophylaxis, intravenous immunoglobulin (in patients experiencing B-cell loss with an increased risk of infection) and vaccination are strongly recommended. "We are excited by the previously reported data from this study which demonstrated an 89.8% ORR and 77.6% CR and a manageable safety pro the 49 efficacy-evaluable patients with a minimum of 6 months of follow-up," said Mohamed Zaki, MD, PhD, Chief Medical Officer of ADC Therapeutics. "We continue to believe this ZYNLONTA combination has the potential to be the best-in-class bispecific antibody-based combination in 2L+ DLBCL. With enrollment now complete, we look forward to sharing more comprehensive results from LOTIS-7 later this year." Further to the previously reported results from LOTIS-7 demonstrating promising clinical activity for the combination of ZYNLONTA plus glofitamab in patients with r/r DLBCL, the Company plans to share full data from LOTIS-7 at a medical meeting and submit the results for publication by the end of 2026. In addition, the Company plans to assess potential regulatory and compendia pathways for the combination. About LOTIS-7 LOTIS-7 is a Phase 1b global multicenter, multi-arm study in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL) including Part 1 (dose escalation) and Part 2 (dose expansion). The three dosing arms include ZYNLONTA plus polatuzumab vedotin, ZYNLONTA plus glofitamab, and ZYNLONTA plus mosunetuzumab T-cell-engaging bispecific monoclonal antibodies (BsAbs). Enrollment in LOTIS-7 includes Part 1 of the study with a 3+3 dose escalation in 3L+ heavily pre-treated patients with ZYNLONTA doses starting at 90 µg/kg and then proceeding to 120 µg/kg and 150 µg/kg. Part 2 includes dose expansion in 2L+ large B-cell lymphoma in the ZYNLONTA plus glofitamab arm at dose levels determined from Part 1 (120 µg/kg and 150 µg/kg of ZYNLONTA plus the approved dosing of glofitamab). For more information about the LOTIS-7 trial, visit clinicaltrials.gov (NCT04970901). About ZYNLONTA ® 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. This ultimately results in cell cycle arrest and tumor cell death. 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. 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. 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 . ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy. About ADC Therapeutics ADC Therapeutics (NYSE: ADCT) is a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), transforming treatment for patients through our focused portfolio with ZYNLONTA (loncastuximab tesirine-lpyl). ADC Therapeutics' CD19-directed ADC ZYNLONTA 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. Headquartered in Lausanne (Biopôle), Switzerland, with operations in New Jersey, ADC Therapeutics is focused on driving innovation in ADC development with specialized capabilities from clinical to manufacturing and commercialization. Learn more at and follow us on LinkedIn . Forward-Looking Statements 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. 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: whether future LOTIS-7 results will be consistent with or different from the prior disclosure, the timing, results and publication of the full LOTIS-7 trial; the adequacy of the LOTIS-5 clinical trial data to support full regulatory approval and our ability to maintain accelerated approval in the United States and foreign jurisdictions for our product; the timing, content and outcome of meetings with and feedback or other communications provided by regulatory authorities including U.S. FDA; the timing, submission and acceptance of an sBLA submission related to LOTIS-5 and potential approval; the actual and perceived benefit-risk pro ZYNLONTA as studied in the LOTIS-5 trial; the assessment of the data from LOTIS-5 study, including additional analyses of outcomes observed for safety, efficacy and within key geographic regions and across certain patient sub-populations; the path for full regulatory approval for ZYNLONTA in the United States and foreign jurisdictions; our ability to identify and execute value-maximizing options and the cost and impact of such options; our expected cash runway into at least 2028; our ability to comply with the terms of our indebtedness; changes in our regulatory and commercial strategy; the Company's ability to sustain or grow ZYNLONTA® revenue in the United States and potential peak revenue; the ability of our partners to commercialize ZYNLONTA® in foreign markets, the timing and amount of future revenue and payments to us from such partnerships and their ability to obtain regulatory approval for ZYNLONTA® in foreign jurisdictions; the timing and results of the Company's clinical trials; the timing, publication and results of investigator-initiated trials including those studying FL and MZL and the potential regulatory and/or compendia strategy and the future opportunity; the timing and outcome of regulatory submissions for the Company's products or product candidates; actions by the FDA or foreign regulatory authorities; projected revenue and expenses; the Company's indebtedness, including HealthCare Royalty Management and Blue Owl and Oaktree facilities, and the restrictions imposed on the Company's activities by such indebtedness, the ability to comply with the terms of the various agreements and repay such indebtedness and the significant cash required to service such indebtedness; and the Company's ability to obtain financial and other resources for its research, development, clinical, and commercial activities; and the uncertainties of international trade policies, including tariffs, sanctions, trade barriers and most favored nation drug pricing and the potential impact they may have on our business, financial condition, and results of operations. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K and in the Company's other periodic and current reports and filings with the U.S. Securities and Exchange Commission. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this document. CONTACT: Investors & Media Nicole Riley ADC Therapeutics Nicole.Riley@adctherapeutics.com +1 862-926-9040 View original content to download multimedia: SOURCE ADC Therapeutics SA

本周 5 个最重要信号： FDA继续释放友好监管信号。 罕见病终点推进试点（RDEA）开放申请，对衰老相关罕见病研发有间接利好。 中国创新药国际化还在推进。 复宏汉霖 HLX43 联合疗法获澳大利亚临床批准，说明本土平台型创新仍具外溢能力。 “口服化”成为老年适应症的重要价值点。GSK/Spero 的 Utebzi 获批，验证了老年感染治疗从住院向居家转移的趋势。 疫苗与免疫仍是健康寿命延长的重要底层赛道。 Moderna 的 mRNA 流感疫苗进入 FDA 咨询审议阶段，老年感染防控逻辑进一步强化。 行业进入数据积累期。 大事件减少，不代表机会减少，反而更适合公司围绕监管路径、给药方式和合作对象做中期布局。    无尽方舟     ——     EonArk 延寿生物医药行业周报   01 学术与临床进展 <   02 产业与商业化动态 <   03政策与行业基础设施 <   04战略展望与行业启示 <   一、学术与临床进展▼   1）FDA开放 2026 年度罕见病终点推进试点计划申请 2026年6月15日，FDA药物信息官方账号（@FDA_Drug_Info）在X平台发布推文，宣布罕见病终点推进（Rare Disease Endpoint Advancement, RDEA）试点计划正在接受申请，申请截止日期为2026年6月30日。 该计划由FDA药物评价与研究中心（CDER）发起，旨在支持治疗罕见病药物的新型疗效终点开发，通过早期与FDA沟通，帮助申办方设计和验证适用于罕见病临床试验的创新终点。 对长寿科学领域而言，该计划对涉及罕见衰老相关疾病的药物开发具有间接支持意义，因为这些疾病的患者数量极少，传统临床试验终点难以适用。 2）复宏汉霖 HLX43 联合疗法 NSCLC 新辅助治疗 II 期临床获澳大利亚批准 2026年6月16日，复宏汉霖（2696.HK）宣布其创新型程序性死亡-配体1（PD-L1）抗体偶联药物（ADC）注射用HLX43联合H药汉斯状®（斯鲁利单抗注射液，抗PD-1单抗）用于非小细胞肺癌（NSCLC）新辅助治疗的II期临床试验（HLX43-NSCLC203），已获得相关人类研究伦理委员会批准，并通过澳大利亚药品管理局的临床试验备案。 该研究旨在评估HLX43联合斯鲁利单抗在可切除II-III期NSCLC患者新辅助治疗中的有效性和安全性。据GLOBOCAN数据，2022年全球约有超过248万新发肺癌病例，其中NSCLC约占85%。对于早中期NSCLC患者，即使获得根治性切除机会，超过半数的II-III期患者术后仍面临局部复发或远处转移风险。 虽然该事件主要属于肿瘤免疫治疗领域，但ADC联合免疫检查点抑制剂的策略对衰老相关肿瘤（癌症是衰老的主要标志之一，即Hallmark of Aging中的"基因组不稳定"和"细胞衰老"的直接后果）的治疗具有参考价值。 肺癌作为老年人群高发疾病（确诊年龄中位数约70岁），其围手术期免疫治疗的进展与延长健康寿命的目标高度相关。该试验的获批也标志着中国本土创新药企的ADC技术平台获得国际监管机构认可。 3）绿叶制药 LY03015 治疗迟发性运动障碍中国 II 期临床完成 2026年6月16日，绿叶制药集团（2186.HK）宣布其自主研发的1类创新药LY03015（VMAT2抑制剂）用于治疗迟发性运动障碍（Tardive Dyskinesia, TD）的中国II期临床试验已完成，取得积极结果，达到主要终点。 迟发性运动障碍是一种与长期使用抗精神病药物或某些止吐药物相关的严重神经系统不良反应，表现为面部、躯干或四肢的不自主运动。该疾病在老年精神病患者中发病率较高，且目前治疗选择有限，美国FDA仅批准了Ingrezza（valbenazine）和Austedo（deutetrabenazine）两款药物。 该进展体现了中国本土药企在神经系统疾病领域的创新能力。从长寿科学角度看，运动障碍严重影响老年患者的生活质量和独立生活能力，LY03015的积极结果意味着未来可能为衰老相关运动障碍提供新的治疗选择，有助于维持老年人群的躯体功能完整性，这是健康老龄化的核心维度之一。绿叶制药计划基于II期数据推进至III期临床。   二、产业与商业化动态▼   1）CPHI China 2026 在上海举行，产业侧继续向创新聚集 2026年6月16日至18日，亚洲最大的制药行业展会CPHI & PMEC China 2026在上海新国际博览中心（SNIEC）举行。本届展会由Informa Markets主办，汇聚超过110,000名专业参会者和3,600多家国内外参展商，覆盖原料药（API）、生物制药、合同研发与生产服务（CRDMO）、实验室仪器设备、包装与给药系统等全产业链。展会期间举办了超过100场专业会议，涵盖从分子发现到商业化生产的完整药物生命周期。 本届展会特别设置了中医药展馆（TCM Pavilions）和新一代API展示区，反映了中国市场在传统医药现代化和前沿化学合成方面的双重优势。对于长寿科学领域而言，中医药在衰老干预中的潜力正受到越来越多的关注。例如，黄芪中的黄芪甲苷、人参中的人参皂苷等传统药材活性成分，已被多项基础研究证实具有抗衰老、免疫调节和线粒体保护等作用。展会期间，多家中国药企展示了基于传统药材现代化开发的创新管线，为长寿科学提供了新的化合物来源。 2）GSK/Spero 口服碳青霉烯 Utebzi 获 FDA 批准 2026年6月17日，GSK plc（LSE/NYSE: GSK）与Spero Therapeutics（SPRO）联合宣布，美国FDA已批准Utebzi（tebipenem pivoxil，口服碳青霉烯抗生素）用于治疗成人复杂性尿路感染，包括肾盂肾炎，适用于由特定敏感病原体引起且口服治疗选择有限或无可替代方案的患者。这是美国首个且唯一获批的口服碳青霉烯类抗生素，填补了从静脉注射（IV）到口服（PO）转换治疗的空白。美国每年有超过300万例cUTI病例，其中高达34%的患者面临治疗失败，且常由多重耐药病原体引起，年医疗成本超过60亿美元。 该批准基于PIVOT-PO III期随机对照试验数据。试验中，口服tebipenem pivoxil（600mg）达到58.5%的总体成功率（261/446例，临床治愈+微生物根除的复合终点），与静脉注射亚胺培南-西司他丁（500mg）的60.2%（291/483例）相比达到非劣效性（调整后治疗差异：-1.3%；95% CI：-7.5%, 4.8%）。安全性方面，最常见的不良事件为腹泻和头痛（≥3%），均为轻中度且非严重。该药物预计将于2026年底前在美国上市。 对长寿科学的启示：老年人群（≥65岁）是复杂性尿路感染的高发群体，由于免疫功能下降、合并慢性病和留置导尿管等因素，老年患者感染耐药菌的风险显著增加。传统碳青霉烯类抗生素仅能通过静脉注射给药，需要住院治疗或频繁门诊输液，严重影响老年患者的生活质量并增加医疗系统负担。Utebzi作为口服替代方案，使老年患者可以在门诊或居家完成治疗，减少住院相关并发症（如院内感染、跌倒、谵妄等），间接支持健康寿命延长和老年患者独立生活能力的维持。   三、政策与行业基础设施▼   1）FDA接受Roche Polivy联合Lunsumio治疗LBCL申请 2026年6月18日，FDA接受了Roche的Polivy（polatuzumab vedotin，抗CD79b抗体药物偶联物）联合皮下注射Lunsumio（mosunetuzumab，CD20xCD3双特异性抗体）用于治疗复发或难治性大B细胞淋巴瘤（relapsed or refractory large B-cell lymphoma, r/r LBCL）的申请，包括弥漫大B细胞淋巴瘤，适用于至少接受过一线系统治疗后的成人患者。FDA设定的目标决定日期为2027年2月9日。该申请基于III期随机对照研究数据，在中位随访23个月后，Polivy+Lunsumio联合治疗相比Rituxan联合化疗方案将疾病进展或死亡风险降低59%。 同日，FDA还扩大了Merck肺炎球菌疫苗Capvaxive（V116，21价肺炎球菌结合疫苗）的适用人群标签，允许2-17岁已完成基础儿科肺炎球菌疫苗接种且患有以下任一疾病（糖尿病、慢性心脏病、慢性肾病、慢性肝病或慢性肺病）的儿童使用，这些疾病均增加肺炎球菌感染风险。该扩展基于III期非劣效免疫原性试验数据，显示高风险儿童中的免疫应答与60岁以上人群相当。虽然该疫苗扩展主要针对儿童，但反映了FDA对慢性病易感人群预防性疫苗接种的重视，这对老年人群的疫苗策略制定具有参考价值。 2）FDA疫苗咨询委员会审议Moderna mRNA流感疫苗 2026年6月18日，FDA疫苗及相关生物制品咨询委员会召开公开会议，审议Moderna TX Inc.提交的mRNA流感疫苗MFLUSIVA（STN 125869/0）的生物制品许可申请（BLA）。该疫苗申请用于预防疫苗中包含的甲型和乙型流感病毒亚型引起的流感疾病，目标人群为50岁及以上成人。会议通过YouTube在线直播，公众可实时观看委员会讨论和投票过程。FDA通常在咨询委员会会议后1-2个月内做出最终审批决定。 mRNA疫苗技术在COVID-19大流行后迅速扩展至其他传染病领域。与传统基于鸡胚或细胞培养的流感疫苗相比，mRNA疫苗具有生产周期短（仅需数周而非数月）、可快速应对病毒变异、无需使用活病毒等显著优势。对于老年人群（≥50岁），流感是导致住院和死亡的主要原因之一，且老年人对流感疫苗的免疫应答通常较弱（免疫衰老现象）。mRNA技术的高免疫原性可能为老年人群提供更优的保护效果。此外，mRNA平台的模块化特性使其可快速开发针对新出现病原体的疫苗，对应对未来大流行和老年人群感染性疾病防控具有战略意义。     四、战略展望与行业启示▼   本周延寿生物医药行业呈现出"监管密集、突破稀缺"的特征，对外部观察者而言，以下5个方向值得关注。 无尽方舟 第一，监管路径的清晰化是行业成熟的重要标志。FDA在6月密集处理多项申请（ensitrelvir PDUFA 6月16日、tebipenem批准6月17日、Roche LBCL申请接受6月18日），显示监管机构在创新疗法审评方面的效率提升。对于聚焦衰老相关适应症的研发团队而言，RDEA试点计划和快速通道资格（Fast Track）等工具值得重点跟踪，尤其适用于患者群体极小、传统终点难以适用的罕见病场景。 第二，口服制剂在老年适应症中的价值被重新评估。Utebzi作为首个口服碳青霉烯获批，凸显了"口服化"在降低老年患者医疗负担中的关键作用。对于需要长期干预或长期管理的老年适应症而言，口服或皮下给药通常更有利于提升依从性和生活质量，也更容易形成可持续的商业化路径。 第三，中医药与现代生物技术的融合趋势值得关注。CPHI China 2026专门设置中医药展馆，反映了中国市场对传统药材现代化开发的重视。对相关企业而言，传统药材活性成分、经典方剂的现代机制验证和临床转化，可能成为构建差异化管线的一条可选路径。中药复方的多靶点特性与衰老的多因素本质具有一定契合度，值得以更严谨的现代研发框架持续评估。 第四，本周新闻稀疏提示行业进入"数据积累期"。重大临床数据通常集中在学术会议（如ASCO、AGE年会、ARDD）前后发布，而6月中下旬处于会议间歇期。对行业参与者而言，更关键的是将关键临床节点、学术会议窗口与对外沟通节奏进行协调，以提升信息披露的有效性和市场理解度。 第五，mRNA技术的跨疾病应用正在加速。Moderna mRNA流感疫苗进入FDA审评阶段，加上此前mRNA在癌症疫苗（如Moderna的mRNA-4157黑色素瘤疫苗）和自身免疫疾病中的探索，该技术平台的可扩展性得到验证。对衰老生物学赛道而言，值得关注的并不只是单一产品进展，而是该平台在神经退行性疾病、心血管代谢疾病和肌少症等场景中的可扩展性，以及未来潜在的合作与技术外溢机会。 关注无尽方舟，持续追踪延寿生物医药、长寿科技与全球产业前沿。 点赞 分享 收藏