Mitoxantrone Hydrochloride

Publication follows oral presentation at the American Society of Hematology (ASH) Annual Meeting Combination in r/r follicular lymphoma shows best ORR of 97% and CR rate of 77% with 12-month PFS of 95% Additional IIT data also presented at ASH on ZYNLONTA monotherapy in marginal zone lymphoma shows ORR of 91% and 70% CR LAUSANNE, Switzerland, Dec. 9, 2024 /PRNewswire/ -- ADC Therapeutics SA (NYSE: ADCT), a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), today announced updated data from the investigator-initiated Phase 2 clinical trial evaluating ZYNLONTA® (loncastuximab tesirine-lpyl) in combination with rituximab to treat relapsed or refractory (r/r) follicular lymphoma (FL) were published in the December issue of The Lancet Haematology, following an oral presentation of the data at the recent 66th American Society of Hematology (ASH) Annual Meeting and Exposition. "We are excited by the publication of these results in The Lancet Haematology demonstrating ZYNLONTA's robust clinical activity in follicular lymphoma, particularly in patients classified as high-risk POD24 and those with high tumor burden where there remains significant unmet need," said Mohamed Zaki, MD, PhD, Chief Medical Officer of ADC Therapeutics. "In addition, encouraging data from another investigator-initiated trial of ZYNLONTA as a single agent to treat marginal zone lymphoma were also presented at ASH. Collectively, we believe these data underscore ZYNLONTA's promise for patients with indolent B-cell lymphomas and add to a growing body of evidence showing the potential of ZYNLONTA beyond diffuse large B-cell lymphoma." ZYNLONTA in combination with rituximab to treat r/r follicular lymphoma (FL) The investigator-initiated trial conducted at the Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine evaluated the combination in patients with r/r FL treated with ≥1 line of systemic therapy presenting high-disease burden as defined by GELF criteria or POD24 at enrollment. The primary endpoint of the study is complete response rate (CR) by week 12 PET/CT based on Lugano 2014 criteria. The trial enrolled 39 patients, all of which were evaluated for safety and 35 of which were evaluated for efficacy. Patients were a median age of 68 years (range 47 to 89) and the majority received one previous line of therapy (n=26; 67%). R-CHOP was the most common first-line therapy (n=22; 56%) followed by bendamustine with rituximab (n=10; 26%), single-agent rituximab (n=6; 15%) and fludarabine, mitoxantrone and dexamethasone (n=1; 3%). Highlights from the results published in The Lancet Haematology included: Best overall response rate (ORR) of 97.4% (n=38) and CR rate of 76.9% (n=30) After a median follow-up of 15.6 months, the median progression-free survival (PFS) was not reached, and the 12-month PFS was 94.6% The most common treatment-emergent adverse events (TEAEs) were hyperglycemia (n=17; 43.6%) followed by increased alkaline phosphatase (n=16; 41%) and neutropenia, fatigue and increased aspartate aminotransferase and alanine aminotransferase (n=15; 38.5%) The most common grade ≥3 TEAE were lymphopenia (n=8; 20.5%) followed by neutropenia (n=5; 12.9%) No Grade 5 TEAEs occurred. The publication titled, "Loncastuximab tesirine with rituximab in patients with relapsed or refractory follicular lymphoma: a single centre, single arm Phase 2 trial," is now available online and will be published in the December issue of The Lancet Haematology. The results were also presented during a session on indolent B-cell lymphomas at ASH by Juan Pablo Alderuccio, MD, lead investigator and Associate Professor of Medicine and Hematologist at Sylvester. More details on the trial can be found at (identifier: NCT04998669). ZYNLONTA as a single agent to treat r/r marginal zone lymphoma (MZL) Data from an open-label, multi-institutional investigator-initiated trial evaluating the safety and efficacy of ZYNLONTA in 23 adult r/r MZL patients, previously treated with ≥1 line of systemic therapy, were also shared as a poster presentation at ASH by lead investigator, Izidore Lossos, MD, Professor of Medicine and Chief of the Lymphoma Section of the Division of Hematology at the Sylvester Comprehensive Cancer Center, University of Miami. The median age in this study was 65 years (range 45-82). The median number of previous treatments was 2 (range 1 to 4). As of October 15, 2024, 23 patients were evaluable for response. Highlights from the results presented include: ORR of 91% (n=21); 70% CR (n=16). ZYNLONTA led to CR in 7 of 11 patients (64%) with POD24 assessed for response and one patient who progressed after CAR-T. All but 1 CR are currently maintained with the longest follow-up of 27 months from the start of treatment (median duration of CR is 11.5 months). All of the 23 enrolled patients experienced expected adverse events (AE), most commonly grade 1 or 2. Grade 3 and 4 AEs were observed in 15 and 1 (neutropenia) patients, respectively. Local edema was observed in 10 (43.4%) patients. Three patients needed dose reduction and one patient discontinued treatment after cycle 4 because of cholestatic hepatitis. The patient clinically fully recovered with normalization in liver function test abnormalities. More details on this ongoing Phase 2 clinical trial can be found at (identifier: NCT05296070). About ZYNLONTA® (loncastuximab tesirine-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. 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). The Company is advancing its proprietary ADC technology to transform the treatment paradigm for patients with hematologic malignancies and solid tumors. 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. In addition to ZYNLONTA, ADC Therapeutics has multiple ADCs in ongoing clinical and preclinical development. ADC Therapeutics is based in Lausanne (Biopôle), Switzerland, and has operations in London and New Jersey. For more information, please visit the Company website at adctherapeutics.com and follow us on LinkedIn. ZYNLONTA® is a registered trademark of ADC Therapeutics SA. 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 the interim results for the investigator-initiated trials led by the University of Miami studying FL and MZL are predictive of future results and the timing and success of the same IIT trials, the potential regulatory and/or compendia strategy and the future opportunity for FL and MZL; the expected cash runway into mid-2026 the Company's ability to grow ZYNLONTA® revenue in the United States; 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 or its partners' research and development projects or clinical trials including LOTIS 5 and 7, ADCT 602 as well as early research in certain solid tumors with different targets, linkers and payloads; 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. 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. CONTACTS: Investors Marcy Graham ADC Therapeutics [email protected] +1 650-667-6450 Media Nicole Riley ADC Therapeutics [email protected] +1 862-926-9040 SOURCE ADC Therapeutics SA WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

近日，华润三九与NNIT就CSV（计算机化系统验证）验证咨询与验证服务项目达成重要合作，启动会于2024年11月27日在深圳华润三九集团总部顺利举行，出席此次会议的有华润三九生产运营中心副总经理徐影、华润三九观澜基地副总经理兼质量受权人张挺、华润三九深蓝（智能制造）实验室执行主任包彦宇、华润三九智能与数字化中心智造数字化经理丁飞、NNIT总裁兼首席执行官Pär Fors、NNIT亚太区总经理邢振胜、NNIT质量合规部总监李彭，以及来自双方的项目组成员。 本次CSV咨询项目旨在通过深度优化管理体系与流程、加强管理组织建设及人员能力建设，助力华润三九集团完善“标准化、可落地、全生命周期”的计算机化系统管理体系。项目内容涵盖IT全生命周期合规管理咨询、CSV流程咨询以及IT技术底座CSV验证服务等多个方面，确保集团计算机化系统管理符合监管要求。 华润三九观澜基地副总经理兼质量受权人张挺对NNIT的专业能力和丰富经验表示高度认可。她提到，NNIT在验证领域的知识与表现无疑将为华润三九集团整体验证的专业能力提升注入强劲动力。在项目推进过程中，观澜基地团队将全力配合，确保项目顺利进行。 华润三九深蓝（智能制造）实验室执行主任包彦宇同样对NNIT的验证能力表示肯定，并期待此次合作能够助力华润三九在符合国内外法规的前提下，完善集团计算机化系统管理体系，提升管理质量。他相信，在双方项目团队的共同努力下，项目必将取得圆满成功。 华润三九生产运营中心副总经理徐影针对项目提出了具体建议。她希望项目组能够结合华润三九的实际情况，选取典型案例，完善体系和管理制度；同时，在项目执行过程中，建立计算机化系统合规管理能力模型，通过针对性的培训和实操，提升华润三九集团计算机化系统合规团队的工作能力。 NNIT亚太区总经理邢振胜对华润三九的信任表示感谢，并承诺将投入优质资源，同时借助NNIT国外专家顾问的力量，确保项目与国际法规接轨，为华润三九提供优质、专业的服务。 NNIT首席执行官Pär Fors则表示，此次项目不仅是一次知识与经验的共享，更是一次助力华润三九团队能力提升、推动企业长期发展的宝贵机会。NNIT凭借对业务的深刻理解、丰富的项目管理经验及实施经验，以及众多成功的应用实施案例，有信心为华润三九提供高质量的服务交付。同时，他还透露NNIT正在计划设立华南区办公室，以便更好地为华润三九等华南地区的企业提供服务。 展望未来，项目预计将于2025年4月完成交付。在华润三九集团与NNIT的通力合作下，双方有信心实现项目目标，完善集团计算机化系统质量管理体系，为集团高质量数字化转型保驾护航。 关于 华润三九 华润三九医药股份有限公司（简称“华润三九”）是大型国有控股医药上市公司，主要从事医药产品的研发、生产、销售及相关健康服务。上市以来，公司多次获评中国主板上市公司“金牛百强”、 “价值百强”企业。截止目前，华润三九被纳入深证成份指数、中证500和富时罗素（FTSE Russell）指数股之列。 华润三九主营核心业务定位于CHC健康消费品和处方药领域，产品线丰富，并持续丰富品种。CHC健康消费品业务覆盖了感冒、皮肤、胃肠、止咳、骨科、儿科、膳食营养补充剂等近10个品类，其核心产品占据了较高的市场份额；处方药业务覆盖心脑血管、抗肿瘤、消化系统、骨科、儿科、抗感染等治疗领域，拥有血塞通三七系列产品、参附注射液、示踪用盐酸米托蒽醌注射液、华蟾素片剂及注射剂、益血生胶囊、瘀血痹、注射用头孢比罗酯钠等药品，在医疗端享有较高声誉。 「THANK YOU FOR YOUR READING」 NNIT是知名的跨国生命科学行业IT服务提供商， 总部位于丹麦哥本哈根，在中国、新加坡、美国、德国、瑞士、英国、爱尔兰、捷克，波兰和菲律宾设有公司。NNIT中国始终致力于为生命科学企业提供卓越的技术支持与数字化解决方案，业务覆盖质量数字化及IT合规，实验室数字化，生产数字化，商业营销数字化，IT/OT基础架构及云服务，安全服务，流程自动化及人工智能，GxP/non-GxP应用运维等领域，赋能医药全生命周期管理的关键环节，能为客户提供从咨询、规划、实施到运维的全流程服务，帮助客户实现业务目标，提升核心竞争力。目前，NNIT中国已与超过200家在华的跨国、本土知名药械企业展开业务，获得众多客户的信任。  文章来源：NNIT 声明：本文仅代表作者个人观点，不代表任何组织及本公众号立场，如有不当之处，敬请指正。如需转载，请注明作者及来源：蒲公英Biopharma。