Polatuzumab Vedotin-Piiq

BOULDER, Colo.--( BUSINESS WIRE )-- Foresight Diagnostics , a leader in ultrasensitive minimal residual disease (MRD) testing, today announced the presentation of multiple studies showcasing Foresight CLARITY™ MRD at the upcoming 66 th American Society of Hematology Annual Meeting and Exposition taking place December 7-10 in San Diego, California. The presentations span various lymphoma types and treatment settings, demonstrating the broad applicability of the Foresight CLARITY MRD detection technology for monitoring treatment response and predicting patient outcomes. The studies include collaborations with multiple pharmaceutical companies and research institutions, including AstraZeneca, Bristol Myers Squibb (BMS), Daiichi Sankyo (DSI), Stanford University, Washington University, and others. "These studies add to the growing body of evidence supporting ultra-sensitive MRD testing as a critical tool in lymphoma care and drug development," said David Kurtz, MD, PhD, Chief Medical Officer and Head of Research at Foresight Diagnostics. "We see in these studies that MRD measurement with Foresight CLARITY consistently enables earlier and more accurate treatment response assessment than conventional imaging-based methods. The ability to monitor disease status in real-time with ultra-sensitive MRD assays like Foresight CLARITY may help accelerate clinical trials and lead to more personalized decision-making for patient care." Results utilizing Foresight CLARITY MRD technology are featured in six abstracts, including three that are co-authored by Foresight. Presentation highlights include: LBCL/DLBCL: ctDNA-MRD as a surrogate endpoint for 2L CAR T – Analysis of the Phase 3 TRANSFORM trial in second-line treatment for large B-cell lymphoma (LBCL) reinforced the potential of circulating tumor DNA (ctDNA) as an earlier endpoint for response assessment and assessment of clinical trial results. In the TRANSFORM study, patients receiving lisocabtagene maraleucel (liso-cel) had significantly improved event-free survival compared to standard of care. Consistent with this result, patients receiving liso-cel also demonstrated higher rates of MRD clearance, demonstrating CLARITY's ability to measure differential treatment responses. MRD Response with novel first-line therapy in high-risk DLBCL – Analysis of a Phase 1b trial CC-220-DLBCL-001 combining golcadomide with R-CHOP in previously untreated aggressive B-cell lymphoma showed promising MRD clearance rates. The data demonstrated that 90% of patients achieved MRD negativity at end of treatment with golcadomide 0.4mg + R-CHOP, with strong responses observed even in high-risk patients. These data further support the ongoing Phase 3 GOLSEEK-1 study investigating this novel combination therapy in high-risk 1L LBCL. Enhanced risk stratification by MRD vs. traditional methods – New research investigates the predictive value of the International Prognostic Index (IPI), currently the primary pre-treatment risk assessment tool for DLBCL. The study revealed that pre-treatment IPI scores did not significantly correlate with end-of-treatment MRD status, with MRD testing being a superior predictor of progression-free survival. Follicular Lymphoma: MRD-based response assessment of novel FL therapies – Two studies demonstrated the value of MRD assessment in follicular lymphoma trials, with new treatment approaches showing early clearance. The CD19xCD3 bispecific antibody AZD0486 achieved 89% MRD negativity in relapsed or refractory FL patients by 12 weeks in complete responders. In the 1L setting, the chemotherapy-free combination of mosunetuzumab and polatuzumab vedotin showed similar early MRD clearance, with 7 of 8 complete responders achieving MRD negativity before cycle 3. These results highlight the potential for MRD as an early indicator of therapeutic response in FL clinical trials. PTCL: ctDNA as a prognostic biomarker for T-cell lymphoma – Analysis from the VALENTINE-PTCL01 Phase 2 trial in relapsed/refractory peripheral T-cell lymphoma (PTCL) revealed that patients achieving early, deep ctDNA reduction (>5-fold decrease by Cycle 2 Day 1) experienced significantly longer progression-free survival, establishing ctDNA monitoring as a powerful tool for early response assessment. Information on abstract presentation time and dates can be found below. To meet with Foresight Diagnostics, visit booth #3423 or contact us at BD@foresight-dx.com. Oral Presentations: Circulating Tumor DNA (ctDNA) as an Early Outcome Predictor in Patients with Second-Line Large B-Cell Lymphoma After Lisocabtagene Maraleucel Versus Standard of Care Treatment from the Phase 3, Randomized TRANSFORM Study Presenter: Ash Alizadeh, MD, PhD (Stanford University) Session 628 Date/Time: Saturday, December 7, 2024, 10:45 a.m. Sponsor: Bristol Myers Squibb Co-authored by Foresight Diagnostics Escalating Doses of AZD0486, a Novel CD19xCD3 T-Cell Engager, Result in High Complete Remissions with Rapid Clearance of Minimal Residual Disease in Patients with Relapsed/Refractory Follicular Lymphoma Presenter: Jing-Zhou Hou, MD, PhD (UPMC Hillman Cancer Center) Session 623 Date/Time: Saturday, December 7, 2024, 5 p.m. Sponsor: AstraZeneca Golcadomide (GOLCA) Plus R-CHOP Has High Minimal Residual Disease (MRD) Negativity across High-Risk, Untreated Aggressive B-Cell Lymphoma (a-BCL) Presenter: Jason R. Westin, MD (MD Anderson) Session 627 Date/Time: Sunday, December 8, 2024, 12:30 p.m. Sponsor: Bristol Myers Squibb International prognostic index poorly predicts EOT ctDNA MRD status in DLBCL and has limited impact on its predictive value for outcomes Presenter: Jordan S. Goldstein, MD, MS (Stanford University) Session 626 Date/Time: Sunday, December 8, 2024, 5 p.m. Co-authored by Foresight Diagnostics Poster Presentations: Prediction of Clinical Response by Phased Variants in Circulating Tumor DNA (ctDNA) in the VALENTINE-PTCL01 trial of Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma Presenter: Neha Mehta-Shah, MD, MSCI (Washington University) Abstract #4342, Session 621 Date/Time: Monday, December 9, 2024, 6-8 p.m. Sponsor: Daiichi Sankyo Co-authored by Foresight Diagnostics Mosunetuzumab Plus Polatuzumab Vedotin Induces Early Complete Responses in Previously Untreated High Tumor Burden Follicular Lymphoma Presenter: David A Russler-Germain, MD, PhD (Washington University) Abstract #4414, Session 623 Date/Time: Monday, December 9, 2024, 6-8 p.m. About Foresight Diagnostics Foresight Diagnostics is a privately-held cancer diagnostics company and CLIA-registered laboratory. Its liquid biopsy platform, Foresight CLARITY™, is a novel assay that measures minimal residual disease (MRD) with reported detection limits in parts per million 1. The improved sensitivity of Foresight CLARITY has the potential to provide actionable information to physicians and biopharmaceutical companies to enable more personalized treatment approaches for patients with solid tumor and hematologic malignancies. For more information, please visit foresight-dx.com and follow us on Twitter and LinkedIn. Foresight CLARITY™ IUO is an investigational device. Limited by United States Law to investigational use. 1 Foresight CLARITY™ IUO is an investigational device. Limited by United States Law to investigational use.

“值此中国抗癌协会40周年之际，我衷心地希望CACA整合淋巴瘤专委会能够成为推动我国淋巴瘤领域发展强大的一支学术队伍，共同攻克淋巴瘤这一顽疾，为淋巴瘤患者带来更多的生存治愈和更好的生活质量，共同开创淋巴瘤诊疗的新篇章！” ——张清媛教授 编者按 CACA光辉四十载，薪火相传续新篇。2024年11月14日至17日，备受瞩目的2024中国整合肿瘤学大会（CCHIO）在古都西安盛大召开。值此盛会之际，《肿瘤瞭望-血液时讯》有幸邀请到中国抗癌协会整合淋巴瘤委员会执行主任、哈医大星联杰出教授、哈尔滨医科大学附属肿瘤医院张清媛教授，为我们深入剖析《CACA整合淋巴瘤指南》中侵袭性淋巴瘤领域的重点更新内容，为优化临床实践、提升患者治疗效果提供宝贵的指导与启示。 《CACA整合淋巴瘤指南》编撰心得 科学为基，前瞻为导，实用为要 Q1、您作为《CACA整合淋巴瘤指南》的主编，在2024中国整合肿瘤学大会（CCHIO）上的《主编讲更新》环节中对该指南进行了深入解读。在此，我们想请您分享一下，在确保指南内容的科学性、前瞻性等方面，您有哪些心得体会或感悟？您认为其在临床实践中的实用价值体现在哪些方面？ 张清媛教授：在编撰《CACA整合淋巴瘤指南》的过程中，我们始终将科学性、实用性与前瞻性置于核心地位。首先，在科学性方面，我们严格遵循循证医学的基本原则，广泛搜集全球范围内的最新研究成果和临床数据，通过严谨的分析和专家评审，确保指南中的每项建议均建立在坚实而充分的证据基础之上。此外，我们还邀请到众多国内淋巴瘤领域的权威专家参与编纂和审校工作，以保障内容的权威性和准确性。 在前瞻性方面，我们密切关注淋巴瘤领域的最新研究进展和未来发展趋势。本指南不仅系统总结了当前已证实的最佳实践，还对新兴的治疗方法和技术进行了展望和探讨。我们希望通过这种方式，引导临床医生关注淋巴瘤领域的最新动态，并积极探索和实践创新的治疗策略与技术。因此，本指南为临床医生提供了最新、全面、系统的淋巴瘤诊疗指导，无论是初涉此领域的年轻医生还是经验丰富的资深医生，均可从中汲取宝贵的参考与启示。 在实用性方面，我们充分考虑了我国淋巴瘤患者的实际情况和临床需求，全面覆盖了淋巴瘤的诊断、治疗、评估和随访等各个环节。针对不同类型的淋巴瘤患者，我们提供了个性化、精准化的治疗建议，旨在提升治疗效果、改善预后，并尽可能减少不必要的药物使用及经济负担。此外，本指南还着重强调了跨学科合作与整合医学的重要性，通过促进不同学科间的深入交流与紧密合作，共同推动淋巴瘤领域的持续进步与发展，携手为患者提供更加全面、优质的医疗服务。 从单药应用到创新联合 格菲妥单抗引领R/R DLBCL治疗新趋势 Q2、在淋巴瘤治疗领域，双特异性抗体作为一种新型T细胞免疫疗法，正逐步展现出其独特的优势和广阔的应用前景。其中，格菲妥单抗（Glofit）作为国内首个IgG1样全人源化的CD20×CD3双特异性抗体，在临床研究及临床应用中积累了丰硕成果。请问在《CACA整合淋巴瘤指南》中，对于格菲妥单抗的应用具体有哪些推荐？ 张清媛教授：我们知道，复发/难治性弥漫大B细胞淋巴瘤（R/R DLBCL）患者通常预后不佳。传统上，免疫化疗一直是此类患者的主要治疗方案，但遗憾的是，该方案普遍存在着患者生存期有限的严峻挑战。在此领域背景下，格菲妥单抗在治疗R/R DLBCL方面的表现令人瞩目。特别是对于那些不适合接受移植治疗的患者，在二线以后的治疗阶段，格菲妥单抗能够显著提高客观缓解率（ORR），为患者开辟了新的治疗路径。目前，我国已批准格菲妥单抗的单药适应证，用于治疗既往接受过至少二线系统性治疗的R/R DLBCL成年患者。同时，在《CACA整合淋巴瘤指南》中，格菲妥单抗单药也被纳入R/R DLBCL患者二线及后线治疗方案中，作为不适合移植人群的II级推荐1，并在附录内详细介绍了其单药治疗方案的具体应用方法和注意事项，为临床医生提供了规范的治疗指导。 《CACA整合淋巴瘤指南》中R/R DLBCL患者二线及后线治疗方案推荐1 值得注意的是，格菲妥单抗联合治疗的潜力同样不可忽视。然而，鉴于《CACA整合淋巴瘤指南》完成于今年上半年，故而未能及时纳入格菲妥单抗联合治疗的相关方案。我们期待在未来的指南更新中，能够依据格菲妥单抗与化疗药物、维泊妥珠单抗等不同药物联合治疗的最新研究成果，将这些创新的联合治疗方案纳入推荐范畴，从而为患者提供更加多样、全面的治疗选择，以期进一步提升治疗效果，满足患者的个体化治疗需求。 在探讨格菲妥单抗的联合治疗方案时，尤为值得关注的是Glofitamab与吉西他滨和奥沙利铂组成的Glofit-GemOx方案。在全球随机III期STARGLO研究中2，评估了Glofit-GemOx方案与R-GemOx方案治疗既往接受过至少1线治疗的R/R DLBCL患者的疗效与安全性：相较于R-GemOx组12.9个月的中位总生存期（OS），Glofit-GemOx组几乎增加了一倍，OS达到了25.5个月，实现了患者生存期的显著延长。同时，在无进展生存期（PFS）方面，Glofit-GemOx方案也取得了13.8个月的好成绩，并且实现了58.5%的完全缓解率（CRR）。STARGLO研究使得格菲妥单抗成为首个在随机III期试验中证明对DLBCL患者有OS获益的双特异性抗体，同时Glofit-GemOx方案有望革新现有的临床实践和指南，为患者带来更为持久的生存获益。 此外，Glofit-R-ICE、Glofit-DICE等方案也展现出了一定的潜力，值得我们在未来的研究中进一步探索。而无化疗（chemo-free）或轻化疗（chemo-light）方案，如格菲妥单抗与维泊妥珠单抗或CD19×4-1BB共刺激双特异性抗体融合蛋白Englumafusp alfa等创新药物的联合应用预示着治疗领域的崭新方向，同样值得我们期待。 目前，格菲妥单抗已在二线以后的治疗中获得了适应证批准。相信随着更多格菲妥单抗相关研究的不断深入，其应用范围将进一步扩大至前线。同时，对于老年、不适合接受化疗等特殊患者群体，格菲妥单抗也有望成为新的治疗选择，为他们带来积极的临床获益。 DLBCL一线获益更进一步 I级推荐方案Pola-R-CHP革新长期生存 Q3、维泊妥珠单抗（Pola）作为目前国内已上市的ADC之一，其在淋巴瘤治疗领域的应用一直备受瞩目。在《CACA整合淋巴瘤指南》中，维泊妥珠单抗也占据了举足轻重的地位。请问您能为我们解读一下指南中关于维泊妥珠单抗的相关内容？这些推荐是基于哪些关键研究和数据？ 张清媛教授：多年来，由利妥昔单抗、环磷酰胺、多柔比星、长春新碱和泼尼松构成的R-CHOP方案一直稳居DLBCL领域的“金标准”地位，众多研究均未能超越其疗效。然而，这一传统格局随着维泊妥珠单抗在一线治疗中的引入而发生了变化。 在POLARIX研究3-4中，与R-CHOP方案相比，Pola-R-CHP方案（维泊妥珠单抗、利妥昔单抗、环磷酰胺、多柔比星、泼尼松）在PFS率方面实现了显著提升。具体而言，Pola-R-CHP组2年PFS率高达76.7%，相较于R-CHOP方案提升了6.5%，3年PFS率差距则进一步扩大至7.7%，充分彰显了Pola-R-CHP方案在改善患者长期生存方面的显著优势。 基于该坚实的循证医学证据，在最新的《CACA整合淋巴瘤指南》中1，Pola-R-CHP方案获得了两项I级推荐：对于Ⅰ-Ⅱ期伴大包块的患者，推荐在完成6周期的Pola-R-CHP方案后，序贯2周期的利妥昔单抗治疗作为一线方案。而对于Ⅲ-Ⅳ期的患者，同样推荐Pola-R-CHP方案作为一线治疗之选，并在6周期后序贯2周期利妥昔单抗治疗。此外，针对高级别B细胞淋巴瘤（HGBL），Pola-R-CHP方案被推荐为伴有MYC/BCL2易位或非特指型患者初治治疗的II级推荐方案（2A类）。 这一系列推荐不仅是对Pola-R-CHP方案在临床研究与实践应用中卓越表现的认可，也是对传统DLBCL一线治疗格局的重要补充与革新，为临床医生提供了更为精准有效的治疗选项。展望未来，随着维泊妥珠单抗在临床实践中的广泛应用与深入探索，我们有充分的理由相信，其将为更多患者带来实质性的治疗获益。 《CACA整合淋巴瘤指南》中初治 DLBCL患者一线治疗方案推荐1 《CACA整合淋巴瘤指南》中HGBL-MYC/BCL2患者治疗方案推荐1 《CACA整合淋巴瘤指南》中HGBL-NOS患者治疗方案推荐1 坚守初心，共筑未来 砥砺奋进四十载，奋进新程再扬舟 Q4、在中国抗癌协会迎来40周年纪念之际，您作为首届中国抗癌协会整合淋巴瘤委员会的执行主任，无疑肩负着推动我国淋巴瘤领域发展的重要使命。在此，我们希望邀请您分享一些感悟和寄语。 张清媛教授：值此中国抗癌协会创立四十周年这一里程碑时刻，我诚挚地期望中国抗癌协会整合淋巴瘤委员会能够成为一支强大的学术队伍，引领并推动我国淋巴瘤诊疗与研究领域不断向前发展。我们满怀憧憬，愿与全国及世界各地的同仁们紧密合作，共同面对并致力于解决淋巴瘤这一复杂而严峻的健康挑战，为淋巴瘤患者带去更多的生存希望。在此征程中，我们会始终坚守初心，铭记使命，以更加昂扬的热情和更加坚定的决心，勇敢地迎接淋巴瘤领域中的每一个挑战。 展望未来，中国抗癌协会整合淋巴瘤委员会将持续聚焦于促进多学科协作、激发科研创新、强化患者教育与支持、拓展国际合作以及推进精准医疗等关键领域。通过这些核心方向的努力，进一步推动淋巴瘤诊疗与研究领域的繁荣发展，为患者带来更高效、更个性化的治疗方案，共同开启淋巴瘤领域的新篇章。 参考文献： 1.《CACA整合淋巴瘤指南》 2.Jeremy S. Abramson, et al. 2024 EHA Oral LB3438. 3.Tilly H, et al. Polatuzumab Vedotin in Previously Untreated Diffuse Large B-Cell Lymphoma. N Engl J Med. 2022;386(4):351-363. 4.Alex F. Herrera,et al. 2022 ASH, Oral 542# （来源：《肿瘤瞭望–血液时讯》编辑部） 声 明 凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。