Inetetamab

▎药明康德内容团队编辑 HER2阳性乳腺癌约占所有乳腺癌病例的15%-20%。靶向药物已经大幅改善了患者预后，但如能在维持疗效的同时实现治疗“降阶”（降低治疗的强度或时间），则有助于进一步改善患者的治疗耐受性和治疗负担。 肿瘤浸润淋巴细胞（TILs）已在多种癌症中显示出预测疗效的潜力。在HER2阳性乳腺癌中，TILs水平较高的患者通常对治疗反应更佳，但此前研究大多关注短期指标如病理完全缓解率、复发风险，缺乏长期生存数据支持。 ShortHER试验探索了不同疗程长短对于HER2阳性早期乳腺癌患者的长期生存影响，且纳入了TILs等预后标志物进行分析。近期，ShortHER试验近10年的随访数据发表于《美国医学会杂志-肿瘤学》（JAMA Oncology），研究结果揭示了TILs对长期生存的独立影响，对于TILs≥20%的患者，曲妥珠单抗辅助治疗的疗程从1年缩短至9周并未增加死亡风险，这为个体化治疗提供了新依据。 截图来源：JAMA Oncology 这是一项在意大利开展的3期多中心试验，共纳入1253例HER2阳性早期乳腺癌患者，1:1随机分组接受两种不同疗程的辅助治疗方案： 长疗程组：1年曲妥珠单抗+标准化疗（4周期蒽环类[多柔比星或表柔比星]联合环磷酰胺，随后4周期紫杉类） 短疗程组：9周曲妥珠单抗+减量化疗（3周期紫杉类，随后3周期FEC方案[氟尿嘧啶+表柔比星+环磷酰胺]） 最终总生存（OS）分析的中位随访时间长达9年。此前已在JCO发表的数据显示，长疗程组和短疗程组的10年无病生存（DFS）率分别为77%和78%（HR 1.06 [90%CI，0.86-1.31]），10年OS率分别为89%和88%（HR 1.15 [90%CI，0.85-1.56]）。尽管在所有患者中的数据不支持短疗程方案非劣效于长疗程方案（研究设定的HR 90%CI上限为1.29），但在中低风险（淋巴结转移状态N0和N1-3）患者中的差异很小，而淋巴结转移状态N4+患者使用1年曲妥珠单抗方案有明显获益。 此次分析则重点针对TILs的影响。所有受试者中，866名（69%）患者具有可评估的TILs数据，临床病例特征与缺乏TILs数据的患者相似，在广泛患者中具有代表性。 分析发现，TILs具有独立预后价值：TILs水平与远端无病生存期（DDFS）和OS独立相关，且具有统计学意义。 在调整了相关因素（年龄、绝经状态、解剖分期、组织学分级和激素受体状态）之后，TILs越高，DDFS和OS就越长： TILs每增加5%，患者远端转移或死亡风险降低13%（HR 0.87），总死亡风险降低11%（HR 0.89）。 TILs≥20%、TILs≥30%、TILs≥50%的患者，10年OS率分别达91.3%、93.3%和98.1%。以TILs 30%为截断值，TILs≥30%的患者死亡风险显著降低62%（HR 0.38 [95%CI，0.16-0.95]，P=0.04）。 TILs水平也影响治疗方案之间的疗效差异，TILs≥20%的患者可考虑短疗程方案。 低TILs（<20%）患者：长疗程的疗效显著更优。10年DDFS率在短疗程组为81.0%，在长疗程组为88.7%（HR 1.78 [95%CI，1.17-2.70]）；10年OS率在短疗程组为86.9%，在长疗程组为91.3%（HR 1.36 [95%CI，0.82-2.23]）。 高TILs（≥20%）患者：短疗程与长疗程的疗效相当，甚至略优。10年DDFS率在短疗程组为92.2%，在长疗程组为87.1%（HR 0.38 [95%CI，0.12-1.22]）；10年OS率在短疗程为93.1%，在长疗程为89.3%（HR 0.36 [95%CI，0.10-1.36]）。 ▲不同TILs水平患者接受不同治疗方案的DDFS和OS结局差异（图片来源：参考资料[1]） 由于在多因素分析中，疾病分期是另一个与预后独立且显著关联的因素，研究团队进一步分析发现，仅在II期患者中，TILs与DDFS和OS之间均具有统计学显著关联：TILs每增加5%，远端转移或死亡风险降低27%（HR 0.73 [95%CI，0.59-0.91]），死亡风险降低31%（HR 0.69 [95%CI，0.51-0.95]）。在I期和III期患者中，虽然呈现出随着TILs增加、生存改善的趋势，但不具有统计学显著差异。 总体而言，此次分析证明了TILs对HER2阳性早期乳腺癌患者的OS具有独立预测作用，在曲妥珠单抗和蒽环类药物辅助治疗中，TILs≥20%的患者（尤其是II期）采用降阶治疗不会面临远处复发或死亡的过高风险。 研究团队指出，未来还需要针对更多治疗方案来验证、确认是否高TILs患者普遍可以安全地接受降阶治疗。但这些发现支持将免疫相关特征整合到HER2阳性早期乳腺癌的预后工具中，在临床病理特征的基础上，更好指导个体化治疗策略。 点击文末“阅读原文/Read more”，即可访问JAMA Oncology官网阅读完整论文。 推荐阅读 欢迎投稿：学术成果、前沿进展、临床干货等主题均可，点此了解投稿详情。 题图来源：123RF 参考资料 [1] Maria Vittoria Dieci, et al., (2025). Tumor-Infiltrating Lymphocytes and Survival Outcomes in Early ERBB2-Positive Breast Cancer. JAMA Oncol, doi:10.1001/jamaoncol.2024.6872 [2] Conte P, et al., (2023). Nine-week versus one-year trastuzumab for early human epidermal growth factor receptor 2-positive breast cancer: 10-year update of the ShortHER phase III randomized trial. J Clin Oncol, doi:10.1200/JCO.23.00790 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。 版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「医学新视点」微信公众号留言联系。 如有其他合作需求，请联系wuxi_media@wuxiapptec.com 分享，点赞，在看，传递医学新知

USA News Group News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, March 8, 2025 /PRNewswire/ -- As the global cancer crisis intensifies, the demand for breakthrough treatments is reaching new heights. Statista data projects a 20% rise in annual cases by 2030 and a staggering 75% increase by 2050. According to the World Health Organization (WHO), breast cancer cases are projected to rise by nearly 40% by 2050. Despite the concerning trends in cancer incidence, 2025 has seen key advancements from biotech companies at the forefront of oncology research, with Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Exelixis, Inc. (NASDAQ: EXEL), Cardiff Oncology, Inc. (NASDAQ: CRDF), ALX Oncology Holdings Inc. (NASDAQ: ALXO), and Verastem, Inc. (NASDAQ: VSTM) continuing to push the boundaries of cancer treatment. Continue Reading Pelareorep Facts (PRNewsfoto/USA News Group) The article continued: Within a new research report on the Global Oncology Market from Vision Research Reports, cancer therapies are projected to surpass US$903.81 billion by 2034, growing at a 10.9% CAGR along the way. The World Economic Forum is optimistic, recently touting 12 new breakthroughs in the fight against cancer. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage company focused on immunotherapy for cancer, has just released its Q4 and full-year 2024 financial results, providing investors with a clearer picture of its progress as it moves toward potential future FDA approvals for its lead drug, pelareorep, a promising immunotherapy designed to help the immune system recognize and destroy cancer cells more effectively. "With multiple clinical trials surpassing expectations in 2024, 2025 is shaping up to be a defining year for Oncolytics," said Wayne Pisano, Chair of Oncolytics' Board of Directors and Interim CEO. "Our top priority is HR+/HER2- metastatic breast cancer, in which two randomized trials involving over 100 patients have shown substantial clinical benefit for patients receiving pelareorep and paclitaxel compared to paclitaxel monotherapy. We believe that if we can approximate the benefit we saw in BRACELET-1 in our planned registrational study, the progression-free survival benefit alone would support an accelerated approval submission." The data mentioned by Pisano from BRACELET-1 showed that patients receiving pelareorep and paclitaxel lived longer and responded better to treatment compared to those receiving paclitaxel alone. Given the consistency of these results, Oncolytics believes that its upcoming registration-enabling trial could pave the way for an accelerated approval submission with the FDA. This is an important development, as HR+/HER2- breast cancer is one of the most commonly diagnosed and treated breast cancers worldwide, representing a massive market opportunity for the company. Beyond breast cancer, Oncolytics is making significant progress in two other hard-to-treat cancers: pancreatic cancer and anal carcinoma. "When adding pancreatic and anal carcinoma to the list of addressable indications where we have generated compelling efficacy signals, pelareorep could have a meaningful impact for a multitude of patients," added Pisano. Oncolytics recently presented new data at the 2025 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium, showcasing pelareorep's potential to improve patient outcomes in these aggressive diseases. In anal cancer, results from the ongoing GOBLET study showed that 33% of patients responded to treatment when pelareorep was combined with atezolizumab, a checkpoint inhibitor. Notably, one patient experienced a complete response, with their cancer disappearing and staying undetectable for over 15 months. This level of response in such a difficult-to-treat cancer is highly encouraging, leading Oncolytics to expand the trial to enroll additional patients. Meanwhile, in pancreatic cancer, the company successfully cleared a critical safety review for its combination study using pelareorep with modified FOLFIRINOX with and without atezolizumab, allowing the trial to progress to the next phase. Pancreatic cancer has one of the lowest survival rates of any major cancer, and with few effective treatments available, pelareorep's continued success in this area could position Oncolytics as a key player in gastrointestinal oncology. From a financial standpoint, Oncolytics reported a cash position of $15.9 million at the end of 2024, giving it enough runway to continue executing on its clinical development strategy through the third quarter of 2025. While the company operates at a loss—as is typical for clinical-stage biotechs—it has been strategically managing its spending to ensure that key trials remain funded. Research and development expenses remained stable compared to the previous year, reflecting a disciplined financial approach that prioritizes high-impact studies. With several potentially transformative catalysts on the horizon, including the initiation of a registration-enabling study in breast cancer and new pancreatic cancer data expected later in the year, investors will be watching closely to see how Oncolytics navigates its next steps. The coming months will be crucial for Oncolytics as it pushes forward in its mission to bring pelareorep to market. With strong clinical results, growing regulatory support, and a well-managed cash position, the company is well-positioned to capitalize on its momentum. If its upcoming breast cancer study confirms the benefits seen in BRACELET-1, Oncolytics could find itself on a fast track to regulatory approval, potentially opening the door to a major commercial opportunity. Infographic - CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: Exelixis, Inc. (NASDAQ: EXEL), reported promising results earlier this year from a subgroup analysis of its Phase 3 CABINET trial, which evaluated cabozantinib in patients with advanced gastrointestinal (GI) neuroendocrine tumors (NETs). The data presented at ASCO GI 2025 showed that cabozantinib significantly improved progression-free survival (PFS) compared to placebo, with a median PFS of 8.5 months versus 5.6 months. The findings highlight cabozantinib's potential to become a new standard of care for GI NETs, an area with limited treatment options. The FDA is currently reviewing Exelixis' supplemental New Drug Application (sNDA), with a decision expected by April 3, 2025. "These new data add to the robust results from the CABINET trial that demonstrate the benefits of cabozantinib across a wide range of patients with neuroendocrine tumors and further underscore the potential of cabozantinib to become a much-needed new option for those with GI NET, which accounts for the majority of real-world patients with this tumor type," said Amy Peterson, M.D., Executive Vice President, Product Development & Medical Affairs, and Chief Medical Officer, Exelixis. "We look forward to continuing to work with the U.S. FDA as they review our regulatory application for cabozantinib for the treatment of patients with previously treated advanced neuroendocrine tumors." Cardiff Oncology, Inc. (NASDAQ: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, recently shared its Q4 2024 and FY 2024 results and business update as it continues to advance its lead program, onvansertib, a promising PLK1 inhibitor targeting RAS-mutated metastatic colorectal cancer (mCRC). "2024 was a significant year for Cardiff Oncology as we shared positive data from the first 30 patients in our lead program in first-line RAS-mut mCRC," said Mark Erlander, Ph.D., CEO of Cardiff Oncology. In its latest Phase 2 trial (CRDF-004), patients receiving the 30mg dose of onvansertib showed a 64% objective response rate, nearly doubling the 33% response rate in the control group. Cardiff also secured a new U.S. patent covering the use of onvansertib in combination with bevacizumab (bev) for previously untreated KRAS-mutant mCRC patients, adding long-term value to its intellectual property. ALX Oncology Holdings Inc. (NASDAQ: ALXO) is pushing forward with key advancements in its clinical pipeline, including the continued development of evorpacept, a CD47-blocking immunotherapy designed to enhance the effects of existing cancer treatments. The company announced plans to expand clinical trials into breast and colorectal cancer, aiming to evaluate evorpacept in combination with trastuzumab for HER2-positive breast cancer and with cetuximab for colorectal cancer. "Our conviction in evorpacept's potential to deepen responses to important available anti-cancer antibody therapies, particularly in patients with HER2-positive cancers, has been strengthened by recent data," said Jason Lettmann, CEO at ALX Oncology. "We look forward to our near-term milestones with ASPEN-03 and ASPEN-04 topline results in head and neck cancer and discussion with the FDA regarding the registrational path in gastric cancer based on the ASPEN-06 data." In addition to its immunotherapy efforts, ALX Oncology is preparing to advance ALX2004, a novel EGFR-targeted antibody-drug conjugate (ADC), into the clinic, with an Investigational New Drug (IND) application planned for Q1 2025. Verastem, Inc. (NASDAQ: VSTM) is making strides in RAS/MAPK pathway-driven cancers, with new Phase 2 trial data on its lead combination therapy, avutometinib plus defactinib, set to be presented at the 2025 Society of Gynecologic Oncology (SGO) Annual Meeting. The investigational treatment has already earned Priority Review from the FDA, with a PDUFA decision expected by June 30, 2025, for patients with KRAS-mutant low-grade serous ovarian cancer (LGSOC). "The presentation of the RAMP 201 primary analysis, which served as the basis of the acceptance of our NDA that is under Priority Review with the FDA, includes additional subgroup analysis by KRAS mutational status," said Dan Paterson, President, and CEO of Verastem Oncology. "We also recognize the importance of these findings to the broader cancer community as part of our growing pool of data reinforcing the potential to change expectations in managing RAS/MAPK pathway-driven cancers." As Verastem moves forward with its RAMP clinical trials, the company continues to expand its pipeline, including a Phase 3 confirmatory trial (RAMP 301) in LGSOC and a collaboration with Amgen to evaluate its therapy in combination with LUMAKRAS™ for KRAS G12C mutant lung cancer. Source: CONTACT: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. 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